Headache PDF

*** Drug Safety Alert ***
May 6, 2013, the U.S. Food and Drug Administration (FDA) advised health care professionals and
women that the anti-seizure medication valproate sodium and related products, valproic acid and
divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention
of migraine headaches. Based on information from a recent study, there is evidence that these
medications can cause decreased IQ scores in children whose mothers took them while pregnant.
Stronger warnings about use during pregnancy will be added to the drug labels, and valproates
pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in
pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant
women clearly outweighs any possible benefit of the drug).
Valproate products will remain in pregnancy category D for treating epilepsy and manic episodes
associated with bipolar disorder.
BACKGROUND: Valproate products are approved for the treatment of certain types of epilepsy, the
treatment of manic episodes associated with bipolar disorder, and the prevention of migraine
headaches. They are also used off-label (for uses not approved by FDA) for other conditions,
particularly other psychiatric conditions.
This alert is based on the final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD)
study showing that children exposed to valproate products while their mothers were pregnant had
decreased IQs at age 6 compared to children exposed to other anti-epileptic drugs. For additional
details, see the Drug Safety Communication Data Summary section.
RECOMMENDATION: Valproate products should not be used in pregnant women for prevention of
migraine headaches and should be used in pregnant women with epilepsy or bipolar disorder only if
other treatments have failed to provide adequate symptom control or are otherwise unacceptable.
Women who are pregnant and taking a valproate medication should not stop their medication but
should talk to their health care professionals immediately. Stopping valproate treatment suddenly can
cause serious and life-threatening medical problems to the woman or her baby.
Healthcare professionals and patients are encouraged to report adverse events or side effects related
to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting
Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the
address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the complete MedWatch safety alert, including a link to the Drug Safety Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350
868.htm.
Health Care Guideline
Diagnosis and Treatment of Headache
How to cite this document:
Beithon J, Gallenberg M, Johnson K, Kildahl P, Krenik J, Liebow M, Linbo L, Myers C, Peterson S,
Schmidt J, Swanson J. Institute for Clinical Systems Improvement. Diagnosis and Treatment of Headache.
http://bit.ly/Headache0113. Updated January 2013.
Copies of this ICSI Health Care Guideline may be distributed by any organization to the organizations
employees but, except as provided below, may not be distributed outside of the organization without the
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constituted medical group, the ICSI Health Care Guideline may be used by the medical group in any of
the following ways:
copies may be provided to anyone involved in the medical groups process for developing and
implementing clinical guidelines;
the ICSI Health Care Guideline may be adopted or adapted for use within the medical group only,
provided that ICSI receives appropriate attribution on all written or electronic documents and
copies may be provided to patients and the clinicians who manage their care, if the ICSI Health
Care Guideline is incorporated into the medical groups clinical guideline program.
All other copyright rights in this ICSI Health Care Guideline are reserved by the Institute for Clinical
Systems Improvement. The Institute for Clinical Systems Improvement assumes no liability for any adap-
tations or revisions or modifications made to this ICSI Health Care Guideline.
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Copyright 2013 by Institute for Clinical Systems Improvement
Health Care Guideline:
Eleventh Edition Main Algorithm
January 2013 1
1
Diagnosis algorithm Migraine is the most
Evaluate type of headache common headache
Take a detailed history disorder seen by primary
and assess functional care providers.
impairment
Rule out causes for
concern
Text in blue in this algorithm Consider secondary
indicates a linked corresponding headache disorder
annotation. Refer to specialist when
indicated
2 3 4
Migraine Treatment Tension-Type Headache Cluster Headache

algorithm algorithm algorithm
Categorize and select Establish diagnosis Establish diagnosis
treatment based on Acute treatment Acute treatment
severity and functional Prophylactic treatment Prophylactic treatment
impairment Patient education and Patient education and
Consider special lifestyle modifications lifestyle modifications
treatment (including
DHE) for status
headache (See
Dihydroergotamine
Mesylate [DHE] algorithm)
Patient education and
lifestyle modifications
Is patient a female
no
whose headache may be
hormonally related?
yes
6 7 8
Menstrual-Associated Perimenopausal or On Estrogen-Containing

Migraine algorithm Menopausal Contraceptives or
Migraine algorithm Considering Estrogen-
Containing Contraceptives
Migraine algorithm Diagnosis and treatment of
headache is a complex issue
necessitating the considerable
9 length and detail in this document.
Algorithms: Pages 1-10
Migraine Prophylactic
Treatment algorithm
Annotations: Pages 18-45

Return to Table of Contents Drug Tables: Pages 76-80
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Copyright 2013 by Institute for Clinical Systems Improvement 1
Eleventh Edition/January 2013
Diagnosis Algorithm
10
11 Text in blue in this algorithm
indicates a linked corresponding
Patient presents with
Detailed History
complaint of a
annotation.
Characteristics of the
headache
headache
Assess functional
impairment
11
Past medical history
Critical first steps: Family history of migraines
12 Detailed history Current medications and
Causes for concern: Focused physical previous medications for
Subacute and/or examination headache (Rx and
progressive headache over Focused over-the-counter)
months neurological Social history
New or different headache examination Review of systems - to rule
"Worst headache ever" out systemic illness
Any headache of maximum
severity at onset 12
Onset after the age of 50 13
years old Causes for yes Consider secondary

Symptoms of systemic concern? headache disorder
illness
Seizures
Any neurological signs no
21 24
Specialty yes
14 Refer to headache
consultation
specialist
indicated?
Meets
criteria for primary no
no
headache disorder?
25
22
Perform diagnostic Diagnosis of yes

yes testing if indicated primary headache
confirmed?
no
23
26
Findings
consistent with yes Determine secondary
no
secondary headache type
headache? Out of guideline
15
Evaluate type of
primary headache.
Initiate patient education
and lifestyle management
16 17 18 19 20
Migraine Tension-type Cluster
(See Migraine (See Tension-Type (see Cluster Chronic daily
Headache Other headache
Treatment Headache headache
algorithm) algorithm) algorithm)
Sinus Headache 15
Migraine-associated symptoms are often misdiagnosed as "sinus
headache" by patients and clinicians. Most headaches characterized as
"sinus headaches" are migraines.
The International Classifications of Headache Disorders (ICHD-II) defines
sinus headache by purulent nasal discharge, pathologic sinus finding by
imaging, simultaneous onset of headache and sinusitis, and headache
localized to specific facial and cranial areas of the sinuses.
Return to Table of Contents

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Institute for Clinical Systems Improvement 2

Migraine Treatment Algorithm

27
Patient meets criteria

for migraine
For information on adolescents The patient would enter this

(ages 12-17), refer to the "Special 28 algorithm from box 16 of the
Circumstances" section. Diagnosis algorithm.
29
Is patient
experiencing a no Return to Diagnosis
typical headache? algorithm
Text in blue in this algorithm

yes

30
Categorize according to peak severity based
annotation.
on functional impairment, duration of
symptoms, and time to peak impairment
31 35 38 43
Status
Mild Moderate Severe
(> 72 hour duration)
32 36 39
44
Mild treatment:** Moderate Severe
- APAP/ASA/ treatment:** - Prochlorperazine Adjunctive therapy
Caffeine - DHE - Chlorpromazine
- ASA - Ergotamine - DHE
- Lidocaine nasal tartrate - Ketorolac IM
- Midrin - Lidocaine nasal - Magnesium
- NSAIDs - Midrin and Sulfate IV 45
47
- 5 HT agonists others - 5 HT agonists

- NSAIDs (triptans) Chlorpromazine,
(triptans)
- 5 HT agonists See treatment Patient meets no IV valproate sodium,
Almotriptan
(triptans) in #32 criteria for IV magnesium sulfate
Eletriptan
See treatment - IV valproate DHE? or prochlorperazine
Frovatriptan
Naratriptan in #32 sodium
Rizatriptan yes
Sumatriptan Adjunctive drug Adjunctive drug
Sumatriptan/ therapy therapy 46
Naproxen Refer to DHE 48
Zolmitriptan algorithm yes
Successful?
Adjunctive drug
therapy
no
37
33 40 49
no
no Successful? yes Opiates
Successful? Successful?
yes
yes no
50
yes
Successful?
41
Specialty
no no
consultation
indicated? 51
Dexamethasone
yes
52
42
Consultation with no Successful?

headache specialist
34 yes
54
Headache resolved
Refer to:
Menstrual-Associated
Migraine algorithm
Perimenopausal or 53
Menopausal Migraine
algorithm yes Is this a Adjunctive therapy #32, 36, 39, 44
On Estrogen-Containing hormone-related Rest in quiet, dark room
Contraceptives or migraine? IV rehydration
Considering Estrogen- Antiemetics **
Containing no - Hydroxyzine
Contraceptives with - Metoclopramide
Migraine algorithm - Prochlorperazine
55
- Promethazine
Is patient 56 Caffeine
candidate for no Continue acute
prophylactic treatment
treatment?
yes
57
Refer to
Treatment algorithm
Return to Table of Contents www.icsi.org


Tension-Type Headache Algorithm

58
Tension-type
headache
The patient would enter this
algorithm from box 17 of the
Diagnosis algorithm.
59
60
Text in blue in this algorithm Patient meets
indicates a linked corresponding criteria for tension- no Return to Diagnosis
annotation. type headache? algorithm
yes
62
61
Acute treatment:
Does patient Acetaminophen
yes Aspirin
currently have a
headache? NSAIDs
Midrin
Adjunctive therapy
no
63
64 65
Consider referral no Is patient candidate yes Therapy

Out of guideline for prophylactic successful?
treatment?
no
yes
66
Prophylactic treatment:
Adjunctive therapy #62, 66 Amitriptyline
Stress management Other TCAs
Physiotherapy Venlafaxine XR
Adjunctive therapy
68
67 Consider other acute or

prophylactic treatment
Therapy no Reconsider diagnosis
successful? Consider medication
overuse
Consider specialty referral
yes
69
Continue therapy


Cluster Headache Algorithm

70
Cluster headache The patient would enter this

algorithm from box 18 of the
Diagnosis algorithm.
71

72
Patient meets
criteria for cluster no Return to Diagnosis
Algorithm
headache?
annotation.
yes
73 74
Reinforce patient
Is patient currently no education
in a cluster cycle? Consider pre-cluster
cycle specialty consult
yes
75
Acute treatment:
Oxygen
Sumatriptan SQ and
intranasal
Zolmatriptan intranasal
DHE
Start prophylactic
treatment
76
Bridging treatment
Corticosteroids
Occipital nerve block
77
Maintenance prophylaxis
Verapamil (first-line)
Avoid alcohol consumption
during cluster cycle
Verapamil - high doses

Steroids and others
Lithium
Depakote (valproic acid)
Topiramate
79
78 Continue and modify acute
treatment
Therapy no
Continue and modify
successful?
prophylactic therapy
Consider referral
yes
81 80 82
Continue therapy yes Therapy no Consider referral/
through cycle, then
successful? Out of guideline
taper

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Dihydroergotamine Mesylate (DHE) Algorithm

83 The patient would enter
this algorithm from box 46
DHE protocol algorithm of the Migraine Treatment
algorithm.

84 annotation.
Intravenous metoclopramide
10 mg IV
85
Begin continuous DHE
2 mg/1,000 mL IV at
42 ml/hour
Metoclopromide 10 mg IV
every 8 hours as needed
for nausea
86
Return to Migraine
Treatment algorithm,
box 48
Caution: Dihydroergotamine mesylate must not be given to or continued in patients who develop the following
conditions:
Pregnancy
History of ischemic heart disease
History of Prinzmetal's angina
Severe peripheral vascular disease
Onset of chest pain following administration of test dose
Within 24 hours of receiving any triptan or ergot derivative
Elevated blood pressure
Patients with hemiplegic or basilar-type migraines*
Cerebrovascular disease
* Basilar-type migraine is defined as three of the following features: diplopia, dysarthria, tinnitus, vertigo, transient
hearing loss or mental confusion (Headache Classification Subcommittee of the International Headache Society, 2004
[Guideline]).


Menstrual-Associated Migraine Algorithm

87
The patient would Patient meets criteria for Menstrual only

enter this algorithm menstrual-only or menstrual- Headache occurs exclusively
from box 54 of the associated migraine 2 days before and first 2 days
Migraine Treatment of menstrual cycle
algorithm. Associated but not limited to
menstruation
88 Occurs > 6-8 days/month
Initiate treatment for OR
Text in blue in this algorithm migraine (algorithm Occurs > 3 days/month when
indicates a linked corresponding boxes 32, 36, 39) optimally treated and still
annotation. debilitating
89
90
Therapy yes
Continue therapy
successful?
no
91
Consider cyclic
prophylaxis
NSAIDs
Triptans
94
Consider hormone prophylaxis:
Transdermal estradiol
92 Estrogen-containing
93
contraceptives
yes no GnRH agonists with "add back"
Continue therapy Patient improves?
therapy
Refer to On Estrogen-Containing
Contraceptives or Considering
Estrogen-Containing Contraceptives
with Migraine algorithm
95
96
yes
Continue therapy Patient improves?
no
97
Consider consult
with headache
specialist


Perimenopausal or Menopausal Migraine Algorithm

98
Perimenopausal or HT: newer terminology for HRT.

menopausal with active In this guideline, HT indicates
migraine history and is a treatment with one of several
potential candidate for HT available estrogens, with or
without progestin.
99
The patient would enter 100
Attempt treatment with
this algorithm from box 54 Patient is no
willing to start
of the Migraine Treatment HT? Treatment algorithm
algorithm.
yes
101
102
yes
1 03 Continue therapy Successful?
Hormone therapy
Oral, transvaginal or transdermal
estrogen
Progestin if indicated no
Estrogen-containing
contraceptives
Refer to the On Estrogen-Containing
Contraceptives or Considering
Estrogen-Containing Contraceptives
with Migraine algorithm
104
105
Consider changing delivery
no
Successful? system or formulation of
estrogen and progestin
yes
107 108
106
yes Specialty consultation

Continue with therapy no
Successful? Return to Migraine
and follow-up
Treatment algorithm
Text in blue in this algorithm Return to Table of Contents

annotation.
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On Estrogen-Containing Contraceptives or Considering Estrogen-

Containing Contraceptives with Migraine Algorithm
109
On estrogen-containing contraceptives
or considering estrogen-containing
contraceptives with migraine
The patient would enter
this algorithm from box 54
Text in blue in this algorithm of the Migraine Treatment
indicates a linked corresponding algorithm.
annotation.
110
no Patient prefers yes

non-estrogen
birth control?
111 112
Evaluate vascular risk factors: Progestin methods
Risk factors for CAD - Progestin-only contraceptives
Migraine aura - Depo-Provera
Existing laboratory evidence of - IUD
hypercoagulability Non-hormonal contraceptive methods
Prior thromboembolic disease
Current tobacco use
118
113 Headaches worsen?

no Increase in frequency yes
no yes
At risk? Increase in severity
Develop an aura
114
119 120
Low-estrogen
contraceptives Continue therapy Consider discontinuing progestin
Reassess causes for concern
Consider specialty consultation
Return to Migraine Treatment
115 algorithm
Headaches worsen?
no Increase in frequency yes
Increase in severity
Develop an aura
116
117
Continue therapy Consider adding oral or transdermal
estrogen during placebo week or
continuous or extended cycle
contraceptive regimens
Discontinue estrogen-containing
contraceptives
Consider progestin methods or
nonhormonal contraceptive methods
Reassess causes for concern
Consider specialty consultation
Return to Migraine Treatment algorithm
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Migraine Prophylactic Treatment Algorithm

121 Text in blue in this algorithm
Patient meets criteria for indicates a linked corresponding
migraine headache
annotation.
122
Prophylactic treatment Patients enter this algorithm
Assess factors that may from box 57 of the Migraine
trigger migraine Treatment algorithm.
Treatment:
Medication
- Beta-blocker
- Tricyclic antidepressants
- Ca++ channel blockers
- Antiepileptic drugs
Divalproex
Topiramate
Gabapentin
Reinforce education and
lifestyle management
Consider other therapies
(biofeedback, relaxation)
Screen for depression and
generalized anxiety
12 3 124
*123, 126, 129. Successful?
yes Continue treatment for Success as determined by:
Successful? * 6-12 months, then Headaches decrease by
reassess 50% or more
An acceptable side effect
no profile
125
Try different first-line

medication or different
drug of different class
126 127
yes Continue treatment for

Successful? * 6-12 months, then
reassess
no
128
Try combination of
beta-blockers and
tricyclics
12 9 130
yes Continue treatment for

Successful? * 6-12 months, then
reassess
no
131
Third-line prophylaxis
treatment or consultation
with headache specialist


Table of Contents
Algorithms and Annotations........................................................................................................1-45
Work Group Leader Algorithm (Main)..........................................................................................................................................1
John Beithon, MD Algorithm (Diagnosis)..................................................................................................................................2
Family Medicine, Lakeview Algorithm (Migraine Treatment)..................................................................................................................3
Clinic Algorithm (Tension-Type Headache)............................................................................................................4
Algorithm (Cluster Headache)......................................................................................................................5
Work Group Members
Algorithm (Dihydroergotamine Mesylate [DHE])........................................................................................6
Affiliated Community
Algorithm (Menstrual-Associated Migraine)................................................................................................7
Medical Center Algorithm (Perimenopausal or Menopausal Migraine)................................................................................8
Jane Schmidt, NP Algorithm (On Estrogen-Containing Contraceptives or Considering
Nursing Estrogen-Containing Contraceptives with Migraine)..............................................................................9
HealthPartners Medical Algorithm (Migraine Prophylactic Treatment)...........................................................................................10
Group and Regions Evidence Grading...................................................................................................................................12-13
Hospital Foreword
Pamela Kildahl, RPh Introduction...........................................................................................................................................14
Pharmacy Scope and Target Population................................................................................................................15
Hutchinson Medical Aims......................................................................................................................................................15
Center Clinical Highlights...........................................................................................................................15-16
Julie Krenik, MD Implementation Recommendation Highlights......................................................................................16
Family Medicine Related ICSI Scientific Documents......................................................................................................16
Definition..............................................................................................................................................16
Mayo Clinic Special Circumstances..........................................................................................................................17
Mary Gallenberg, MD
Annotations............................................................................................................................................18-45
Gynecology Annotations (Diagnosis)..................................................................................................................18-28
Mark Liebow, MD Annotations (Migraine Treatment)..................................................................................................28-34
Internal Medicine Annotations (Tension-Type Headache)...........................................................................................34-35
Linda Linbo, RN Annotations (Cluster Headache)......................................................................................................35-37
Nursing Annotations (Dihydroergotamine Mesylate [DHE])............................................................................37
Jerry Swanson, MD Annotations (Menstrual-Associated Migraine)...............................................................................38-40
Neurology Annotations (Perimenopausal or Menopausal Migraine)................................................................40-41
Annotations (On Estrogen-Containing Contraceptives or Considering
OSI Physical Therapy
Estrogen-Containing Contraceptives with Migraine)..................................................................41-42
Steven Peterson, PT
Annotations (Migraine Prophylactic Treatment).............................................................................42-45
Physical Therapy
Quality Improvement Support...............................................................................................................46-62
ICSI
Aims and Measures................................................................................................................................47-48
Kari Johnson, RN Measurement Specifications............................................................................................................49-59
Clinical Systems Implementation Recommendations.............................................................................................................60
Improvement Facilitator Implementation Tools and Resources.........................................................................................................60
Cassie Myers Implementation Tools and Resources Table...........................................................................................61-62
Clinical Systems
Supporting Evidence.................................................................................................................................63-83
Improvement Facilitator
Conclusion Grading Worksheet Summary..................................................................................................64
Conclusion Grading Worksheets............................................................................................................65-67
Conclusion Grading Worksheet A Annotation #91
(Non-Steroidal Anti-Inflammatory Drugs).................................................................................65-66
Conclusion Grading Worksheet B Annotation #111 (Risk of Stroke)...............................................67
References..............................................................................................................................................68-75
Appendices.............................................................................................................................................76-83
Appendix A Drug Treatment for Headache..................................................................................76-79
Appendix B Drug Treatment for Adjunctive Therapy.......................................................................80
Appendix C Headache Clinical Summary....................................................................................81-83
Disclosure of Potential Conflicts of Interest.......................................................................................84-86
Acknowledgements....................................................................................................................................87-88
Document History and Development...................................................................................................89-90
Document History.......................................................................................................................................89
ICSI Document Development and Revision Process..................................................................................90
www.icsi.org

Evidence Grading
Literature Search
A consistent and defined process is used for literature search and review for the development and revi-
sion of ICSI guidelines. The literature search was divided into two stages to identify systematic reviews,
(stage I) and randomized controlled trials, meta-analysis and other literature (stage II). Literature search
terms used for this revision are below and include diagnosis of headache, migraine treatment, tension-type
headache treatment, cluster headache treatment, menstrual-associated migraine treatment, perimenopause
or menopause migraine treatment, pharmacologic treatment of headache, Botox and headache from June
2010 through July 2012
GRADE Methodology
Following a review of several evidence rating and recommendation writing systems, ICSI has made a decision
to transition to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.
GRADE has advantages over other systems including the current system used by ICSI. Advantages include:
developed by a widely representative group of international guideline developers;
explicit and comprehensive criteria for downgrading and upgrading quality of evidence ratings;
clear separation between quality of evidence and strength of recommendations that includes a
transparent process of moving from evidence evaluation to recommendations;
clear, pragmatic interpretations of strong versus weak recommendations for clinicians, patients and
policy-makers;
explicit acknowledgement of values and preferences; and
explicit evaluation of the importance of outcomes of alternative management strategies.
This document is in transition to the GRADE methodology
Transition steps incorporating GRADE methodology for this document include the following:
Priority placed upon available Systematic Reviews in literature searches.
All existing Class A (RCTs) studies have been considered as high quality evidence unless specified
differently by a work group member.
All existing Class B, C and D studies have been considered as low quality evidence unless specified
differently by a work group member.
All existing Class M and R studies are identified by study design versus assigning a quality of
evidence. Refer to Crosswalk between ICSI Evidence Grading System and GRADE.
All new literature considered by the work group for this revision has been assessed using GRADE
methodology.
www.icsi.org

Evidence Grading Eleventh Edition/January 2013
Crosswalk between ICSI Evidence Grading System and GRADE

ICSI GRADE System Previous ICSI System
High, if no limitation Class A: Randomized, controlled trial
Low Class B: [observational]
Cohort study
Class C: [observational]
Non-randomized trial with concurrent or
historical controls
Low Case-control study
Low Population-based descriptive study
*Low Study of sensitivity and specificity of a
diagnostic test
* Following individual study review, may be elevated to Moderate or High depending upon study design
Class D: [observational]
Low Cross-sectional study
Case series
Case report
Meta-analysis Class M: Meta-analysis
Systematic Review Systematic review
Decision Analysis Decision analysis
Cost-Effectiveness Analysis Cost-effectiveness analysis
Low Class R: Consensus statement
Low Consensus report
Low Narrative review
Guideline Class R: Guideline
Low Class X: Medical opinion
Evidence Definitions:
High Quality Evidence = Further research is very unlikely to change our confidence in the estimate of effect.
Moderate Quality Evidence = Further research is likely to have an important impact on our confidence in the
estimate of effect and may change the estimate.
Low Quality Evidence = Further research is very likely to have an important impact on our confidence in the
estimate of effect and is likely to change the estimate or any estimate of effect is very uncertain.
In addition to evidence that is graded and used to formulate recommendations, additional pieces of
literature will be used to inform the reader of other topics of interest. This literature is not given an
evidence grade and is instead identified as a Reference throughout the document.
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Foreword
Introduction
This guideline discusses the headache disorders most commonly seen in primary care offices. It is not a
comprehensive discussion of diagnosis and treatment of all headache syndromes, since many headaches
are rare and felt best treated by headache specialists or neurologists with specialization in headache. It is
intended for primary care clinicians to help with their diagnosis and treatment of four main types of headache:
migraine, tension-type headache, cluster headache and chronic daily headache. This guideline is necessarily
long and may be considered by some to be cumbersome. However, extensive information pertaining to
headaches is covered, along with the typical medications. As there are multiple easy-to-access information
sources available containing current detailed drug information, drug tables in the appendices highlight only
selected drugs whose dosing, side effects and contraindications might otherwise be challenging to locate.
For most headaches, diagnosis is made on the basis of history and physical exam with no imaging or labora-
tory assistance. There are, however, causes for concern listed in the algorithms, which may direct clinicians
to specific testing or referral.
Headache is a very common problem presenting to primary care clinicians, with about 3% of emergency
department visits and 1.3% of outpatient visits for headaches. While tension-type headache is the most
common type of headache overall, migraine is the most common headache type seen in clinical practice,
with visits for tension-type headache and cluster headaches being much less common in clinician's offices.
Therefore migraine is the first and primary headache type reviewed.
Migraine is a genetically influenced chronic brain condition marked by paroxysmal attacks of moderate to
severe throbbing headache. About 324 million persons suffer from migraine worldwide according to the
World Health Organization. Nearly 18% of women and 8% of men in the United States suffer from migraine
in any given year. Typically the disorder begins in adolescence and young adults but the lifetime cumula-
tive incidence is 43% for women and 18% for men. Over 25% of migraine sufferers have more than three
headache days per month (Loder, 2010 [Low Quality Evidence]).
Women headache sufferers may present with a hormonal component to the course of headaches over their
lifetime, and an algorithm for treatment of hormone-related headache is also included. Headaches over three
times a month are often treated with prophylactic treatment as overuse of medication for acute migraine
may actually cause chronic headache.
Because headache is such a common disorder that is often misdiagnosed and undertreated or mistreated,
improved diagnosis of headache syndromes will improve the patient's experience of care, notably quality of
and satisfaction with care. Morbidity due to headaches is substantial, so improved diagnosis and treatment
will improve the health of the population. Reducing office visits, emergency department visits, and inpatient
admissions for uncontrolled headache syndromes along with reducing unnecessary tests and procedures
for headache diagnosis is likely to reduce total costs of care even if there are more visits for diagnosis of
headache and increased costs for headache-specific drugs.
www.icsi.org

Foreword Eleventh Edition/January 2013
Scope and Target Population

Patients age 12 years and older who present with headache. For the purpose of this guideline, pain that
primarily involves the back of the neck and only involves the head to a limited extent is not considered a
headache. This guideline does not specifically address occipital neuralgia.
Aims
1. Increase the accurate diagnosis of primary headaches in patients age 12 years and older. (Annotation
#11)
2. Increase the percentage of patients with primary headache diagnosis who receive educational materials
about headache. (Annotation #15)
3. Increase the percentage of patients with primary headache syndrome who receive prophylactic treatment.
(Annotations #66, 77, 91, 94, 122, 131)
4. Increase the percentage of patients with migraine headache who have improvement in their functional
status. (Annotation #15)
5. Increase the percentage of patients with migraine headache who have a treatment plan or report adher-
ence to a treatment plan. (Annotations #32, 33, 36, 42, 43, 44)
6. Decrease the percentage of patients with migraine headache who are prescribed opiates and barbiturates
for the treatment of migraines to less than 5%. (Annotations #36, 49)
7. Increase the percentage of patients with migraine headache who have appropriate acute treatment.
(Annotations #30, 32, 36)
Clinical Highlights
Headache is diagnosed by history and physical examination with limited need for imaging or laboratory
tests. (Annotation #11; Aim #1)
Warning signs of possible disorder other than primary headache are (Annotation #12; Aim #1):
- Subacute and/or progressive headaches that worsen over time (months)
- A new or different headache
- Any headache of maximum severity at onset
- Headache of new onset after age 50
- Persistent headache precipitated by a Valsalva maneuver
- Evidence such as fever, hypertension, myalgias, weight loss or scalp tenderness suggesting a systemic
disorder
- Presence of neurological signs that may suggest a secondary cause
- Seizures
Migraine-associated symptoms are often misdiagnosed as "sinus headache" by patients and clinicians.
Most headaches characterized as "sinus headaches" are migraines. (Annotation #15; Aim #1).
Early treatment of migraines with effective medications improves a variety of outcomes including dura-
tion, severity and associated disability. (Annotations #32, 36; Aim #7)

Drug treatment of acute headache should generally not exceed more than two days per week on a regular
basis. More frequent treatment other than this may result in medication-overuse chronic daily headaches.
(Annotations #32, 36; Aim #7)
Inability to work or carry out usual activities during a headache is an important issue for migraineurs.
(Annotation #30; Aim #4)
Prophylactic therapy should be considered for all patients. (Annotations #66, 77, 91, 94, 122, 131; Aim
#3)
Migraines occurring in association with menses and not responsive to standard cyclic prophylaxis
may respond to hormonal prophylaxis with the use of estradiol patches, creams or estrogen-containing
contraceptives. (Annotation #94; Aim #3)
Women who have migraines with aura have a substantially higher risk of stroke with the use of estrogen-
containing contraceptive compared to those without migraines. Headaches occurring during perimeno-
pause or after menopause may respond to hormonal therapy. (Annotations #109, 111; Aim #5)
Most prophylactic medications should be started in a low dose and titrated to a therapeutic dose to mini-
mize side effects and maintained at target dose for 8-12 weeks to obtain maximum efficacy. (Annotation
#122; Aims #3, 5, 7)
Implementation Recommendation Highlights

The following system changes were identified by the guideline work group as key strategies for health care
systems to incorporate in support of the implementation of this guideline.
Develop a system for assessment of headache based on history and functional impairment.
Develop a system for results of this assessment to be used for identification of treatment options/
recommendations.
Develop systems that allow for consistent documentation and montoring based on type of headache.
Develop a system for follow-up assessment that identifies success in management of headache in
the primary care setting.
Develop a process that will remove barriers to referral to a specialist if indicated.
Develop a system for consistent documentation and monitoring of medication administration.
Related ICSI Scientific Documents

Guidelines
Assessment and Management of Chronic Pain
Definition
Clinician All health care professionals whose practice is based on interaction with and/or treatment of a
patient.
www.icsi.org

Special Circumstances
Adolescents
At this time the majority of the adolescent literature supports a strong placebo effect in this age group.
Success of triptans and prophylactic medications in patients age 12-17 yield similar positive outcomes as in
adult studies, but placebo administered in blinded, controlled studies has a similar effect. There has been a
recent study that supports the use of almotriptan with statistically significant efficacy over placebo. As an
acute treatment, almotriptan in the dose of 12.5 mg was effective in relieving pain and associated symptoms
and was well tolerated (Linder, 2008 [High Quality Evidence]).
As a prophylactic treatment, topiramate 100 mg/day was effective in reduction of the number of migraine
headaches a month (Lewis, 2009 [High Quality Evidence]).
Psychological treatments, principally relaxation and cognitive behavioral therapies are effective treatments
of childhood headache (Eccleston, 2009 [Meta-analysis/Systematic Review]).
Pregnancy and Breastfeeding
Special consideration should be given to medication selection and management during pregnancy and
breastfeeding, considering the risks and benefits of selected drugs and their efficacy.
www.icsi.org

Algorithm Annotations
Diagnosis Algorithm Annotations
10. Patient Presents with Complaint of a Headache

Recommendation:
Clinicians should perform an appropriate prompt evaluation of the patient who presents
with headache and initiate acute treatment.
Migraine is the most common headache disorder seen by primary care clinicians (Tepper, 2004 [Low Quality
Evidence]).
A patient may present for care of headaches during an attack or during a headache-free period. If a patient
presents during a headache, appropriate evaluation (history, examination, appropriate testing) needs to be
in a timely fashion. Once the diagnosis of primary headache is established, acute treatment is instituted.
If the patient has a history of recurrent headaches, a plan for treatment (acute and prophylactic) needs to
be established.
Return to Algorithm Return to Table of Contents
11. Critical First Steps

Recommendation:
Clinicians should gather a detailed history, including a focused physical and neurological
exam, of the patient who presents with headache.
Headache is one of the most frequent diseases seen in clinics by health care clinicians.
Clinicians, minimal general physical examination is performed at the first consultation of patient presenting
with a headache.
Symptoms and signs with the use of criteria can diagnose headache. The International Classification of
Headache Disorders, second edition (ICHD-II) system presently provides the gold standard. As empirical
evidence and clinical experience accumulate, criteria for diagnosing headaches will be revised (Olsen, 2006
[Reference]).
Detailed History
Inquire about functional disabilities at work, school, housework or leisure activities during the past three
months (informally or using well-validated disability questionnaire).
Assessment of the headache characteristics requires determination of the following:
Temporal profile:
Time from onset to peak
Usual time of onset (season, month, menstrual cycle, week, hour of day)
Frequency and duration
Stable or changing over past six months and lifetime
Return to Algorithm Return to Table of Contents www.icsi.org

Algorithm Annotations Eleventh Edition/January 2013
Autonomic features:
Nasal stuffiness
Rhinorrhea
Tearing
Eyelid ptosis or edema
Descriptive characteristics: pulsatile, throbbing, pressing, sharp, etc.
Location: uni- or bilateral, changing sides
Severity
Precipitating features and factors that aggravate and/or relieve the headache
Factors that relieve the headache
History of other medical problems
Pharmacological and non-pharmacological treatments that are effective or ineffective
Aura (present in approximately 15% of migraine patients)
Focused physical examination
Vital signs (blood pressure, pulse, respirations and temperature)
Extracranial structure evaluation such as carotid arteries, sinuses, scalp arteries, cervical paraspinal
muscles
Examination of the neck in flexion versus lateral rotation for meningeal irritation. (Even a subtle limita-
tion of neck flexion may be considered an abnormality.)
Focused neurological examination
A focused neurological examination may be capable of detecting most of the abnormal signs likely to
occur in patients with headache due to acquired disease or a secondary headache.
This examination should include at least the following evaluations:
Assessment of patient's awareness and consciousness, presence of confusion, and memory
impairment
Ophthalmological examination to include pupillary symmetry and reactivity, optic fundi, visual
fields, and ocular motility
Cranial nerve examination to include corneal reflexes, facial sensation and facial symmetry
Symmetry of muscle tone, strength (may be as subtle as arm or leg drift), or deep tendon reflexes
Sensation
Plantar response(s)
Gait, arm and leg coordination
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12. Causes for Concern?

Headache features beyond that of International Classification of Headache Disorders, second edition (ICHD-
II) system criteria should raise concern of a more sinister underlying cause (Pryse-Phillips, 1997 [Guideline]).
Causes for concern in the diagnosis of headaches may alter a diagnosis of migraine to a secondary diagnosis
of headache, which can be more serious and/or life-threatening (Dalessio, 1994 [Guideline]; Edmeads,
1988 [Low Quality Evidence]).
Causes for concern must be evaluated irrespective of the patient's past history of headache. Warning signs
of possible disorder other than primary headache are:
Subacute and/or progressive headaches that worsen over time (months).
A new or different headache or a statement by a headache patient that "this is the worst headache
ever."
Any headache of maximum severity at onset.
Headaches of new onset after the age of 50 years old.
Persistent headache precipitated by a Valsalva maneuver such as cough, sneeze, bending or with
exertion (physical or sexual).
Evidence such as fever, hypertension, myalgias, weight loss or scalp tenderness suggesting a systemic
disorder.
Neurological signs that may suggest a secondary cause. For example: meningismus, confusion,
altered levels of consciousness, changes or impairment of memory, papilledema, visual field defect,
cranial nerve asymmetry, extremity drifts or weaknesses, clear sensory deficits, reflex asymmetry,
extensor plantar response, or gait disturbances.
Seizures.
13. Consider Secondary Headache Disorder

The presence of the symptoms or signs listed above suggests a secondary cause for the headache and could
be indicative of an underlying organic condition. Alternate diagnoses include subarachnoid hemorrhage,
tumor, meningitis, encephalitis, temporal arteritis, idiopathic intracranial hypertension and cerebral venous
thrombosis, among others.
Secondary Headaches
Subacute and/or progressive, worsening headaches over weeks to months:
Headaches that worsen with time may be due to a progressive intracranial lesion such as tumor, subdural
hematoma, or hydrocephalus. While the neurologic examination may reveal abnormalities that suggest
a sinister process, this is not always the case. Accordingly, a history of a progressive headache is an
indication for head imaging. For most processes, magnetic resonance imaging with and without gado-
linium contrast will be more sensitive than a computed tomography head scan. Note: in patients who
receive gadolinium contrast media used in MRI, there is the potential for renal toxicity and the rare
complication (3-5% risk in patients with moderate to end-stage renal disease) of life-threatening neph-
rogenic systemic fibrosis. It is recommended that gadolinium use be avoided when possible in patients
with advanced renal disease.
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A new or different headache or a statement by a headache patient that "this is the worst headache
of my life":
Primary headache disorders (mainly tension-type headache and migraine) are exceedingly common. A
history of a primary headache disorder does not confer protection against a new, serious process that
presents with headache. The acuteness of a headache will largely define the differential diagnosis.
Headache that presents suddenly, "like a thunderclap," can be characteristic of several serious intrac-
ranial processes, including subarachnoid hemorrhage, venous sinus thrombosis, bacterial meningitis,
spontaneous cerebral spinal fluid leak, carotid dissection, and rarely, pituitary apoplexy and hypertensive
encephalopathy. The first investigation is a computed tomography head scan without contrast. If there
is no evidence of a subarachnoid hemorrhage, a lumbar puncture should be performed. If both studies
are normal and the suspicion of subarachnoid hemorrhage is still high, a magnetic resonance imaging
with and without gadolinium should be obtained. Neurological consultation is indicated and further
tests for consideration include magnetic resonance angiogram and magnetic resonance venogram.
If the headache is more subacute in onset, chronic meningitis may need to be considered along with
a space-occupying intracranial lesion or hydrocephalus. Again, neuroimaging should be performed.
Whether a lumbar puncture is done will be guided by the index of suspicion regarding a meningeal
process (e.g., meningitis).
Headache of sudden onset:
This refers mainly to thunderclap headache (see above). It should be treated as an emergency since
the possible presence of aneurysmal subarachnoid hemorrhage needs to be assessed as outlined above.
Other secondary causes of headache will be found less commonly.
Headache precipitated by a Valsalva maneuver such as cough, sneeze, bending or with exertion:
Valsalva headaches, while often representing primary cough headache, can signal an intracranial
abnormality, usually of the posterior fossa. The most commonly found lesion is a Chiari malformation,
although other posterior fossa lesions are sometimes found. Less commonly there are intracranial lesions
located elsewhere. A magnetic resonance imaging needs to be obtained to appropriately investigate for
these possibilities. Exertional headache, such as with exercise or during sexual activity, may represent
a benign process such as migraine. However, if the headache is severe or thunderclap in onset, inves-
tigations will be necessary as already outlined above.
Headaches of new onset after the age of 50 years:
The large majority of individuals who are destined to develop a primary headache disorder do so prior
to age 50 years. Of course, this is not universal, and migraine or other primary headache disorders may
begin even at an advanced age. Nevertheless, care should be taken before a diagnosis of a primary
headache disorder is assigned. Many patients who do have the onset of a new headache disorder after
age 50 years will merit brain imaging. In addition, after the age of 50 years, a new headache disorder
should evoke suspicion of possible giant cell arteritis. Obviously, symptoms of polymyalgia rheumatica,
jaw claudication, scalp tenderness or fever will increase the likelihood of this diagnosis. Findings of
firm, nodular temporal arteries and decreased temporal pulses will increase the suspicion, as will an
elevated sedimentation rate.
Symptoms suggestive of a systemic disorder such as fever, myalgias, weight loss or scalp tender-
ness or a known systemic disorder such as cancer or immune deficiency:
Systemic disorders, while not incompatible with a coexistent primary headache disorder, should signal
caution. Patients should be carefully evaluated. Obviously, the differential diagnosis will be long, and
the index of suspicion for any given process will largely depend on the clinical setting.
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Presence of subtle neurological signs suggests a secondary cause for headache. For example,
meningismus, confusion, altered level of consciousness, memory impairment, papilledema, visual
field defect, cranial nerve abnormalities, pronator drift, extremity weakness, significant sensory
deficits, reflex asymmetry, extensor plantar response, or gait disturbance when accompanying a
headache should elicit caution:
While neurological signs may be unrelated to a headache, previously undocumented neurological
findings that are presumably new need to be carefully considered. Usually cranial imaging will be the
initial study. Depending on the index of suspicion, lumbar puncture and blood studies may be indicated.
Seizures:
While seizures can occasionally be a manifestation of a primary headache disorder such as migraine, this
is the exception and not the rule; it is a diagnosis of exclusion. Other etiologies for seizures including
space-occupying lesions, infection, stroke and metabolic derangements will need to be considered.
Again, magnetic resonance imaging is the imaging procedure of choice unless there is an issue of acute
head trauma, in which case a computed tomography head scan should be obtained initially.
Diagnosis to be included in secondary headache:
- subdural hematoma - giant cell arteritis
- epidural hematoma - acute hydrocephalus
- tumor - obstructive hydrocephalus
- other metabolic disorders - cerebral spinal fluid leaks
- craniocervical arterial dissection - cerebral venous sinus thrombosis
This list is not intended to be all-inclusive but rather to represent the most commonly seen diagnosis for
secondary headache by the primary care clinician.
14. Meets Criteria for Primary Headache Disorder?

The International Classification of Headache Disorders, second edition (ICHD-II) system for migraine
has been studied in a community population sample without consideration of treatment. Findings suggest
that the best criteria differentiating migraine from other headache types are the presence of nausea and/or
vomiting in combination with two of the following three symptoms: photophobia, phonophobia and osmo-
phobia (Olesen, 2006 [Reference]).
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Modified Diagnostic Criteria

Episodic Headaches
Migraine: with and without Aura Episodic Tension-Type Headache
A. At least two of 1-4, plus one of 5 or 6: A. Headache less than 15 days per month.
1. Unilateral location B. Lasts 30 minutes to 7 days
2. Pulsating/throbbing quality C. At least two of the following characteristics:
3. Moderate or severe intensity (inhibits or 1. Pressing/tightening (non-pulsating)
prohibits daily activities) quality
4. Aggravation by routine activity 2. Mild to moderate intensity (may inhibit, but does not
5. Nausea and/or vomiting prohibit activities)
6. Photophobia and phonophobia 3. Bilateral location
B. Aura criteria 4. Not aggravated by routine physical activity
1. One or more fully reversible aura symptoms D. Both of the following:
2. At least one aura symptom develops over more 1. No nausea or vomiting (anorexia may occur)
than 4 minutes or two or more symptoms occur in 2. Photophobia and phonophobia are absent, or only one of
succession the two is present
3. Symptoms do not last more than 60 minutes E. Organic disorder is ruled out by the initial evaluation or by
4. Attack follows within 60 minutes diagnostic studies. If another disorder is present, the
C. Previous similar attacks headaches should not have started in close temporal
relationship to the disorder.
D. Organic disorder is ruled out by the initial evaluation
or by diagnostic studies. If another disorder is
present, the headaches should not have started in
close temporal relationship to the disorder.
Cluster Headache
A. Severe unilateral orbital, supraorbital and/or temporal pain lasting 15 to 180 minutes untreated
B. Attack is associated with at least one of the following signs on the side of the pain:
1. Conjunctival injection
2. Lacrimation
3. Nasal congestion
4. Rhinorrhea
5. Forehead and facial swelling
6. Miosis
7. Ptosis
8. Eyelid edema
9. Agitation, unable to lie down
C. Frequency from one every other day to eight per day
D. Organic disorder is ruled out by the initial evaluation or by diagnostic studies. If another disorder is present, the
headaches should not have started in close temporal relationship to the disorder.

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Chronic Headaches
Chronic Migraine Chronic Tension-Type Headache
A. Headache (tension type and/or migraine) on greater A. Average frequency of greater than 15 attacks per
than or equal to 15 days per month for at least three month
months* B. At least two of the following pain characteristics:
B. Occurring in a patient who has had at least five 1. Pressing/tightening quality
attacks fulfilling criteria for 1.1 Migraine without 2. Mild to moderate intensity (may inhibit, but
aura does not prohibit activities)
C. On greater than or equal to eight days per month for 3. Bilateral location
at least three months headache has fulfilled C1
and/or C2 below, that is, has fulfilled criteria for 4. Not aggravated by routine physical activity
pain and associated symptoms of migraine without C. Both of the following:
aura 1. No vomiting
1. Has at least two of a-d 2. No more than one of the following: nausea,
(a) unilateral location photophobia or phonophobia
(b) pulsating quality D. Organic disorder is ruled out by the initial
(c) moderate or severe pain intensity evaluation or by diagnostic studies. If another
disorder is present, the headaches should not have
(d) aggravation by or causing avoidance of started in close temporal relationship to the
routine physical activity (e.g., walking or disorder.
climbing stairs)
and at least one of a or b
(a) nausea and/or vomiting
(b) photophobia and phonophobia
2. Treated and relieved by triptan(s) or ergot
before the expected development of C1 above
D. No medication overuse and not attributed to another
causative disorder
*Characterization of frequently recurring headache generally
requires a headache diary to record information on pain and
associated symptoms day by day for at least one month.
Sample diaries are available at
http://www.headache.org/for_Professionals/Headache_Dairy.
Medication Overuse Headache Hemicrania Continua
A. Headache greater than or equal to 15 A. Headache for more than three months fulfilling
days/month criteria B-D
B. Regular overuse for greater than three months B. All of the following characteristics:
of one or more acute/symptomatic treatment unilateral pain without side-shift
drugs as defined under one or more treatment daily and continuous, without pain-free
drugs as noted below:
periods
1. Ergotamine, triptans, opioids or
combination analgesic medications on moderate intensity, but with exacerbations
greater than or equal to 10 days/month on of severe pain
a regular basis for greater than three C. At least one of the following autonomic features
months occurs during exacerbations and ipsilateral to the
2. Simple analgesic or any combination of side of pain:
ergotamine, triptans, analgesic opioids on conjunctival injection and/or lacrimation
greater than or equal to 15 days/month on nasal congestion and/or rhinorrhoea
a regular basis for greater than three ptosis and/or miosis
months without overuse of any single
D. Complete response to therapeutic doses of
class alone
indomethacin
C. Headache has developed or markedly worsened
during medication overuse E. Not attributed to another disorder
The table "Modified Diagnostic Criteria" has been modified from the International Classification of Headache
Disorders, second edition (ICHD-II) system criteria and describes the differentiating criteria applicable for
the diagnosis of migraine and other primary headache disorders.
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15. Evaluate Type of Primary Headache. Initiate Patient Education and

Lifestyle Management
Recommendations:
Clinicians should provide patient education and lifestyle management options to patients
with headache.
Clinicians should instruct patients with headache to maintain a diary to clarify the
frequency, severity, triggers and treatment responses to their headaches.
Migraine-associated symptoms are often misdiagnosed as "sinus headache" by patients and clinicians. This
has led to the under diagnosis and treatment of migraine.
While education is of paramount importance in managing any condition, it is especially important in the
ongoing management of headache. Patients may have to make lifestyle changes, are often required to make
self-management choices in the treatment of individual headaches, and should maintain a diary to clarify the
frequency, severity, triggers and treatment responses. Most patients should be educated on the following:
Headache is due to physiologic disorders, to which individuals may be genetically predisposed.
Identifiable food or alcohol triggers are present in a minority of patients.
Most patients will benefit from stress reduction, regular eating and sleeping schedules, and regular
aerobic exercise.
Chronic daily headache, including transformed migraine, is associated with overuse of analgesics
or acute treatment drugs. Use of NSAIDs for acute treatment of headache for more than nine days
per month or use of aspirin more than 15 days is associated with an increased risk of chronic daily
headaches.
Keeping a headache diary has the potential benefit of monitoring treatment effect upon severity,
frequency and disability.
Acute treatment has the goal of shortening individual headaches, while prophylaxis can reduce
frequency and possibly severity.
It is often not possible to eliminate primary headache completely.
The presentation of four clinical characteristics and duration can help clinicians determine if the migraine
headache is likely, possible or unlikely by using the simple mnemonic POUNDing (Pulsatile quality; dura-
tion of 4 to 72 hours; Unilateral location; Nausea or vomiting; Disabling intensity) for the screening of
migraine headache (Detsky, 2006 [Decision Analysis]). See the table, "Modified Diagnostic Criteria" for
more information.
19. Chronic Daily Headache

Chronic daily headache refers to the presence of a headache more than 15 days per month for greater than
three months. Chronic daily headache is not a diagnosis but a category that may be due to disorders repre-
senting primary and secondary headaches. Secondary headaches are typically excluded with appropriate
neuroimaging and other tests. Chronic daily headache can be divided into those headaches that occur
nearly daily that last four hours or less and those that last more than four hours, which is more common.
The shorter-duration daily headache contains less-common disorders such as chronic cluster headache and
other trigeminal autonomic cephalgias. Only daily headaches of long duration are considered here.

Chronic daily headache has been estimated to occur in 2.5-4% of the general population with surveys showing
that chronic tension-type headache is a bit more common than chronic migraine (transformed migraine).
In the clinic setting, chronic migraine is much more common than chronic tension-type headache. As with
migraine, chronic daily headaches are more common in women than men. An associated factor for chronic
daily headache is medication overuse. As outlined below, the Headache Classification Committee of the
International Classification of Headache Disorders, second edition (ICHD-II) has provided revised guidelines
for chronic migraine and medication overuse headache (Olesen, 2006 [Low Quality Evidence]).
In diary studies, patients who fulfill criteria for a diagnosis of the older definition of transformed migraine
also fulfill criteria for a diagnosis of the revised definition of chronic migraine, which is presented below
(Liebenstein, 2007 [Low Quality Evidence]; Bigal, 2006 [Low Quality Evidence]).
Please see the Modified Diagnostic Criteria table for the revised International Classification of Headache
Disorders, second edition (ICHD II) criteria for chronic migraine.
Medication-overuse headache
When medication overuse is present, this is the most likely cause of chronic headache. However, if the
acute headache relieving medications are discontinued for an extended period (often two months) and the
headache symptoms persist, it is likely chronic headache, not medication overuse type headache, even though
the ICHD-II criteria do not require this for the diagnosis of medication overuse.
Please see the Modified Diagnostic Criteria table for the International Classification of Headache Disorders,
second edition (ICHD-II), system revised criteria for medication-overuse headache.
Chronic Tension-Type Headache
As noted, chronic tension-type headache is much less common than episodic-type headache; it is more likely
seen in clinical practice. Please see the Modified Diagnostic Criteria table for the International Classification
of Headache Disorders, second edition (ICHD-II) criteria for chronic tension-type headache.
Hemicrania Continua
A less common but not rare (and under recognized) cause for chronic daily headache is hemicrania continua.
Hemicrania continua description is a persistent, strictly unilateral headache responsive to indomethacin.
Please see the Modified Diagnostic Criteria table for the International Classification of Headache Disorders,
second edition (ICHD-II) criteria for hemicrania continua.
A much rarer disorder is that known as new daily persistent headache. This disorder is characterized by
its sudden onset, with the patient often able to note the date and time it began. There is no history of prior
significant headaches. It is typically bilateral and usually resembles migraine or tension-type headache.
Some individuals report an antecedent viral infection.
20. Other Headache

Other headaches include cervicogenic and persistent daily headaches.
21. Specialty Consultation Indicated?

Recommendation:
Clinicians may consider specialty consultation when the diagnosis or etiology cannot
be confirmed, warning signals exist or quality of life is impaired.
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The decision to seek a specialty consultation will depend upon the practitioner's familiarity and comfort
with headache and its management. Specialty consultation may be considered when:
The diagnosis cannot be confirmed
Etiology cannot be diagnosed or warning signals are present
Headache attacks are occurring with a frequency or duration sufficient to impair the patient's quality
of life despite treatment or the patient has failed to respond to the acute remedies, or is in status
migrainosus
22. Perform Diagnostic Testing If Indicated

Recommendation:
Clinicians should use a detailed headache history, that includes duration of attacks and
the exclusion of secondary causes, as the principal means to diagnose primary headache.
Additional testing in patients without atypical symptoms or an abnormal neurologic
examination is unlikely to be helpful.
There are, as yet, no tests that confirm the diagnosis of primary headache. The diagnosis of primary headache
is dependent on the clinician. The work group recommends careful consideration before proceeding with
neuroimaging (computed tomography or magnetic resonance imaging). It is uncommon for neuroimaging
to detect an abnormality in persistent headaches of longer duration versus new onset situations. Selective
testing including neuroimaging or electroencephalogram, lumbar puncture, cerebrospinal fluid and blood
studies may be indicated to evaluate for secondary headache if causes of concern have been identified in the
patient history or physical examination. (See Annotation #12, "Causes for Concern?") Diagnosis may be
complicated if several headache types coexist in the same patient. The following symptoms significantly
increased the odds of finding a significant abnormality on neuroimaging in patients with non-acute headache:
Rapidly increasing headache frequency
History of lack of coordination
History of localized neurologic signs or a history such as subjective numbness or tingling
History of headache causing awakening from sleep (although this can occur with migraine and
cluster headache) (Silberstein, 2000a [Guideline]).
In a study of 750 patients questioned, 47% had throbbing quality of headaches, while another study showed
30% of 1,000 cases of tension headache patients had pulsatile quality pain, 40% of all patients with migraine
have bilateral headaches. Duration of an attack is important. It is felt that pitfalls in interpreting diagnostic
criteria may lie in how questions are asked (Blau, 1993 [Low Quality Evidence]).
There is difficulty in developing an operational system to diagnose headaches with the lack of objective
diagnostic tests that identify various types of headache disorders absolutely. International Classification of
Headache Disorders, second edition (ICHD-II) criteria depend largely on a detailed headache history and
the exclusion of secondary cause for headache through a physical and neurological examination. Concern
of a secondary cause for headache may necessitate testing or further evaluation (Olesen, 1994 [Guideline]).
A total of 897 computed tomography scans or magnetic resonance images were done on migraine patients
with findings of three tumors and two arteriovenous malformations. At this time, there is evidence to define
the role of computed tomography and magnetic resonance imaging in the evaluation of headache patients.
1,800 computerized tomographic scans and magnetic resonance studies done on patients with headaches,
including those that were acute, progressively worsening, and chronic, found only 2.4% of those imaged

had arteriovenous malformation, aneurysms, subdural hematoma or hydrocephalus was found (American
Academy of Neurology Quality Standards Subcommittee, 1994 [Guideline]).
In a retrospective study, 592 patients with headaches and normal neurological exam were examined by
computed tomography scanning between 1990 and 1993 at a cost of $1,000 per scan. None of the patients
had any serious intracranial pathology identified. This technique is costly and unrewarding (Akpek, 1995
[Cost-analysis]).
In a case series study 52 migraineurs were evaluated by spinal taps, cerebral spinal fluid analysis and tap
pressure. Pressures of cerebral spinal fluid and the chemistry evaluation of the same bore no direct relation-
ship to the presence of headache diagnosis (Kovcs, 1989 [Low Quality Evidence]).
A summary statement reviewed articles from 1941 to 1994 with no study of electroencephalograms improving
diagnostic accuracy for the headache sufferer. Electroencephalography does not delineate subtypes or
screen for structural causes of headache effectively (American Academy of Neurology Quality Standards
Subcommittee, 1994 [Guideline]). In the absence of studies showing improved diagnostics with electroen-
cephalogram, there is no indication for routine use of electroencephalograms in the diagnosis of headache.
23. Findings Consistent with Secondary Headache?

If diagnostic evaluation leads to a diagnosis other than primary headache, subsequent care of the patient
would fall beyond the scope of this guideline.
Migraine Treatment Algorithm Annotations

27. Patient Meets Criteria for Migraine
Migraine is the most common headache disorder seen by primary care clinicians.
It is expected that a patient with headache will undergo a diagnostic workup (see the Diagnosis Algorithm)
establishing the diagnosis of migraine before initiating acute treatment.
28. Is Patient Experiencing a Typical Headache?

Each individual headache must be evaluated in the context of the patient's prior migraine headaches. The
practitioner must always remain alert to the possibility of secondary causes for headache, particularly when
there is a previously established history of a primary headache disorder such as migraine.
Migraine headache does not preclude the presence of underlying pathology (arterial dissection, intracranial
aneurysm, venous sinus thrombosis, ischemic or hemorrhagic stroke, temporal arteritis, etc.) that may also
present with "vascular headaches." If the history is scrutinized, ominous causes for headaches can often be
identified and treated with the potential to avoid catastrophe.
30. Categorize According to Peak Severity Based on Functional

Impairment, Duration of Symptoms, and Time to Peak Impairment
Recommendations:
Clinicians should categorize headache according to peak severity, duration of symptoms
and time to peak impairment.
Clinicians should treat according to severity.

Accurate categorization and characterization by both clinicians and patients is important. The categorization
of migraine influences choice of treatment method.
Severity levels:
Mild Patient is aware of a headache but is able to continue daily routine with minimal alteration.
Moderate The headache inhibits daily activities but is not incapacitating.
Severe The headache is incapacitating.
Status A severe headache that has lasted more than 72 hours.
There may be additional features that influence choice of treatment. For example, parenteral administration
(subcutaneous, nasal) should strongly be considered for people whose time to peak disability is less than
one hour, who awaken with headache, and for those with severe nausea and vomiting.
Determining functional limitations during migraine episodes is the key to determining the severity and
therefore the best treatment for a patient. Clinicians and patients should stratify treatment based on severity
rather than using stepped care, though patients will often use stepped care within an attack. This algorithm
uses a stratified-care model.
Factors That May Trigger Migraine

Certain influences can lead to a migraine attack. It is important to note that although a single trigger may
provoke the onset of a migraine, a combination of factors is much more likely to set off an attack.
Environmental:
Temperature (exposure to heat/cold) Bright lights or glare Noise
Head or neck injury Weather changes Motion
Odors (smoke, perfume) Flying/high altitude Physical strain
Lifestyle Habits:
Chronic high levels of stress Skipping meals and/or poor diet
Disturbed sleep patterns Smoking
Hormonal:
Puberty Menopause
Menstruation or ovulation Pregnancy
Using oral contraceptives or estrogen therapy
Emotional:
Anxiety Depression
Anger (including repressed anger) Excitement or exhilaration
"Let-down" response
Medications:
Nitroglycerin Nifedipine
Oral contraceptives Hormone therapy

Dietary:
Dietary triggers vary considerably from patient to patient, are overall a minor and infrequent trigger for
migraine headaches, and will not consistently precipitate a migraine headache in an individual for whom
they have been a trigger in the past.
Citrus fruit Aspartame
Caffeine Aged cheese
Chocolate Alcohol (red wine, beer)
Foods containing nitrites Foods containing monosodium glutamate
32. Mild Treatment

Recommendations:
Clinicians may manage mild migraines with over-the-counter medications.
Clinicians may use triptans for mild migraine pain levels.
The guideline work group presumes most mild migraine headaches will be managed by self-care, which
implies an emphasis on over-the-counter medications. However, since only 2-12% of initially mild migraine
episodes remain mild (with the remainder progressing), treatments effective for mild headaches may be
useful for only a short time. Studies on treatment of migraine headache at the mild level show that triptans
are more effective in abolishing pain at this stage than if the headache is more severe. It is acceptable to
use other symptomatic headache relief drugs, as well as triptans, for mild headache. However, current
retrospective analyses of mild pain treatment studies reveal triptan response to two-hour pain freedom to
be superior to any other comparator drug. Please see Appendix A, "Drug Treatment for Headache," and
Appendix B, "Drug Treatment for Adjunctive Therapy."
Use of NSAIDs for acute treatment of headache for more than nine days per month or use of aspirin for
more than 15 days is associated with an increased risk of chronic daily headache.
Early treatment of migraines with effective medications improves a variety of outcomes including duration,
severity and associated disability (Valade, 2009 [Meta-analysis]).
Given a longer half-life of naratriptan, headache response is delayed with naratriptan when compared with
other selective 5-hydroxy tryptamine (5-HT) receptor agonists. However, headache recurrence may be less
frequent.
Second doses of triptans have not been shown to relieve headache more if the first dose has been ineffective.
Studies show that sumatriptan and naproxen sodium in combination may be more effective than either drug
alone. However, there are no studies that demonstrate that sumatriptan 85 mg/naproxen sodium 500 mg
is more effective than sumatriptan and naproxen sodium taken together. Therefore, a dose of sumatriptan
100 mg and a dose of naproxen sodium 550 mg taken at the same time is recommended.
33. Successful?
Success for treatment of migraine is defined as complete pain relief and return to normal function within
two hours of taking medication. In addition, patients should not have intolerable side effects and should
find their medications reliable enough to plan daily activities despite migraine headache (Dowson, 2004a
[Low Quality Evidence]; Dowson, 2004b [Low Quality Evidence]).

Consider reasons for treatment failure and change treatment plan.

Common reasons for migraine treatment failure:
Acute medication or analgesic overuse
Medication dose too little or used too late
Inadequate medication for degree of disability. Medication not well matched with most disabling
symptoms (e.g., using oral agents for a patient with vomiting) or inappropriate route of administra-
tion (e.g., using oral agents for a headache where maximum disability occurs quickly)
Failure to use adjunctive medication (e.g., caffeine, antiemetics)
Inaccurate diagnosis
Patient adherence to therapy contributes to reaching treatment goals. The clinician-patient relationship plays
a key role in improving adherence. Clinicians should ask patients open-ended, non-threatening questions
regularly to assess adherence. Questions that probe for factors that contribute to non-adherence could include
those surrounding adverse reactions, misunderstandings of treatment, depression, cognitive impairment,
complex regimens and financial constraints.
Interventions to improve adherence include simplification of the drug regimen (frequency and complexity);
use of reminder systems; involvement of family or friends; a health care team approach including nurses,
pharmacists, and educators in addition to clinicians; written instructions; and educating the patient about
potential adverse effects, importance of therapy, and realistic treatment goals.
For example:
A. Assess the patient's knowledge of the condition and expectations for treatment:
"What is/will be the most difficult task for you in reaching your treatment goal?"
B. Assess the patient's medication administration process:
"How do you remember to take your medication each day? Do you use a reminder device such as
a pill box or alarm?"
C. Assess the patient's barriers to adherence:
"Do you have a difficult time opening medication bottles, swallowing pills or reading small print
on labels?"
"Are you comfortable with your ability to follow the treatment plan that we have designed
together?"
"Are you experiencing any unusual symptoms that you think may be due to your medication?"
(Nichols-English, 2000 [Low Quality Evidence])
36. Moderate Treatment

Recommendation:
Clinicians should avoid the use of opiates and barbiturates in the treatment of headache.
Early treatment of migraines with effective medications improves a variety of outcomes including duration,
severity, and associated disability (Valade, 2009 [Meta-analysis]).

The use of opiates and barbiturates should be avoided. This guideline emphasizes the use of other agents
over opiates and barbiturates, recognizing that many migraineurs are currently treated with drugs from the
latter two classes. In general, opiates are characterized by having a short pain-relief window, release inflam-
matory neurochemicals, and increase vasodilation; none of these addresses the currently known treatment
issues and pathophysiology of migraine.
Meperidine should be avoided. The metabolite of meperidine, normeperidine, has a long half-life and
produces less analgesic effect, and there is an increased risk of seizures that cannot be reversed by naloxone.
We have specifically excluded butorphanol because of its high potential for abuse and adverse side-effect
profile.
If an opiate must be used, meperidine should not be the opiate selected.
See Appendix A, "Drug Treatment for Headache."
See Appendix B, "Drug Treatment for Adjunctive Therapy."
37. Successful?
See Annotation #33 for information.
42. Consultation with Headache Specialist

A headache specialist is a practitioner, often but not always, a neurologist who has extensive experience,
knowledge of, and demonstrated high standards of health care in the field of headache. There are advanced
training programs in headache medicine.
The American Headache Society has a membership directory of practitioners interested in the field of head-
ache and can be contacted if the name of a recommended specialist in a particular geographic location is
required. (American Headache Society can be reached by e-mail at AHSHQ@talley.com. The Web site:
http://www.americanheadachesociety.org)
43. Status (Greater Than 72 Hour Duration)

Recommendation:
It is recommended that the patient be hydrated prior to neuroleptic administration with
250-500 mL of 5% dextrose with 0.45% sodium chloride intravenously and advised
of the potential for orthostatic hypotension and acute extrapyramidal side effects. The
patient should be observed in a medical setting as clinically appropriate after adminis-
tration of a neuroleptic and should not drive for 24 hours.
44. Adjunctive Therapy

Recommendation:
Clinicians may consider adjunctive therapy as a treatment option for headache.
See Appendix B, "Drug Treatment for Adjunctive Therapy." As adjunctive therapy, any of the listed medica-
tions can be used singularly or in compatible combination. For intermittent, infrequent headache, caffeine
should be added as first choice when not contraindicated. The use of caffeine in patients with chronic

daily headache is to be discouraged. The prokinetic agent metoclopramide could be considered next. This
guideline has no other preferences.
45. Patient Meets Criteria for Dihydroergotamine Mesylate (DHE)?

Dihydroergotamine mesylate is effective in halting intractable migraine attacks or migraine status. Dihy-
droergotamine mesylate is also effective in halting the acute cycle of cluster headaches.
Dihydroergotamine mesylate must not be given to patients with the following conditions:
Pregnancy and breastfeeding
History of ischemic heart disease
History of Prinzmetal's angina
Onset of chest pain following administration of test dose
Within 24 hours of receiving any triptan or ergot derivative
Elevated blood pressure
Patients with hemiplegic or basilar-type migraine *
* Basilar-type migraine is defined as three of the following features: diplopia, dysarthria, tinnitus, vertigo, tran-
sient hearing loss or mental confusion (Headache Classification Subcommittee of the International Headache
Society, 2004 [Guideline]).
Intravenous dihydroergotamine mesylate is the method most frequently employed to terminate a truly
intractable migraine attack or migraine status. The protocol outlined in the dihydroergotamine mesylate
algorithm is effective in eliminating an intractable migraine headache in up to 90% of patients within 48
hours. This method of administration has also been found to be effective in terminating an acute cycle of
cluster headaches, as well as chronic daily headaches with or without analgesic/ergotamine rebound.
47. Chlorpromazine, Intravenous Valproate Sodium, Intravenous

Magnesium Sulfate or Prochlorperazine
Recommendations:
Clinicians should treat patients with migraine > 72 hours who do not meet criteria for
DHE, with chlorpromazine, intravenous valproate sodium, intravenous magnesium
sulfate or prochlorperazine.
Clinicians should premedicate patients with diphenhydramine or benztropine who have
migraine for > 72 hours, who do not meet criteria for DHE and who have a history of
dystonic reaction.
See Appendix A, "Drug Treatment for Headache," and Appendix B, "Drug Treatment for Adjunctive Therapy."
If chlorpromazine, valproate sodium or intravenous magnesium sulfate was used previously, one may not
wish to repeat.
www.icsi.org

48. Successful?
See Annotation #33 for more information.
49. Opiates
These are not drugs of first choice, and headache practice recommends against the use of meperidine. Nor-
meperidine, the active metabolite of meperidine, has a long half-life and is neuroexcitatory and neurotoxic.
There is inconsistent absorption of opiates, at least with meperidine, when injected intramuscularly, and they
are less effective than when given intravenously. Opiates release inflammatory neurochemicals and increase
vasodilation that are mechanistically counterproductive to currently known migraine pathophsiology and
can exacerbate headaches. Studies have been done using meperidine, but the effects are likely due to class
effect, and other opiates are likely to be just as effective (Duarte, 1992 [High Quality Evidence]). However,
it should be noted that there are no studies to support opiate effectiveness.
51. Dexamethasone
See Appendix A, "Drug Treatment for Headache," and Appendix B,"Drug Treatment for Adjunctive Therapy."
Migraine Treatment Annotations #32, 36, 39, 44, 47, 49, 51

Adolescents
At this time the majority of the adolescent literature supports a strong placebo effect in this age group.
Success of triptans and prophylactic medications in patients age 12-17 yield similar positive outcomes as in
adult studies, but placebo administered in blinded, controlled studies has a similar effect. There has been a
recent study that supports the use of almotriptan with statistically significant efficacy over placebo. As an
acute treatment, almotriptan in the dose of 12.5 mg was effective in relieving pain and associated symptoms
and was well tolerated (Linder, 2008 [High Quality Evidence]).
Refer to Appendix A, "Drug Treatment for Headache," for more information.
Tension-Type Headache Algorithm Annotations

59. Patient Meets Criteria for Tension-Type Headache?
Tension-type headache is one of the most common primary headaches. See Annotation #14, "Meets Criteria
for Primary Headache Disorder?" for episodic (less than 15 days per month) and chronic tension-type head-
ache (more than 15 days per month).
It is important to evaluate the patient who comes to the office for tension-type headache for the possibility
of migraine. While the International Classification of Headache Disorders, second edition (ICHD-II) system
suggests migraine and tension-type headaches are distinct disorders, there is evidence to suggest that for the
migraineur, tension-type headache is actually a low-intensity migraine.
(Torelli, 2004 [High Quality Evidence]; Ashina, 2003 [Low Quality Evidence]; Zhao, 2003 [Low Quality
Evidence])
www.icsi.org

62. Acute Treatment

Recommendation:
Clinicians may utilize over-the-counter analgesics or prescription NSAIDs for tension-
type headache treatment.
Analgesics offer a simple and immediate relief for tension-type headache. Medication overuse is potentially
a concern that can lead to chronic daily headache. Use of drugs for acute treatment of headache for more
than nine days per month is associated with an increased risk of chronic daily headache.
Evidence])
Electromyography biofeedback has been found to have an effect on tension-type headaches. The goal is to
help patients recognize muscle tension. Fifty-three studies have shown medium to large effect (Bendtsen,
2010 [Guideline]).
66. Prophylactic Treatment

Recommendation:
Prophylactic treatment, including the use of tricyclic antidepressants, may be used for
chronic tension-type headaches.
Prophylactic therapy is reserved for patients with chronic tension-type headache (more than 15 headaches
per month).
Tricyclic antidepressants are effective in reducing the frequency and severity of tension-type headache.
Evidence])
Cluster Headache Algorithm Annotations

71. Patient Meets Criteria for Cluster Headache?
There is no more severe pain than that sustained by a cluster headache sufferer. This headache is often termed
"suicide headache." Cluster headache is characterized by repeated short-lasting but excruciating intense
attacks of strictly unilateral peri-orbital pain associated with local autonomic symptoms or signs. The most
striking feature of cluster headache is the unmistakable circadian and circannual periodicity. Many patients
typically suffer daily (or nightly) from one or more attacks over a period of weeks or months.
(Dodick, 2000 [Low Quality Evidence]; Goadsby, 1997 [Low Quality Evidence]; Lipton, 1998 [High Quality
Evidence])
75. Acute Treatment

Recommendations:
Clinicians should utilize inhaled oxygen for the treatment of cluster headaches at a rate
of 7-15 L/min.
www.icsi.org

Clinicians should consider using subcutaneous sumatriptan or intranasal zolmitriptan

as a first line option for the treatment of cluster headaches.
Oxygen inhalation is highly effective when delivered at the beginning of an attack with a non-rebreathing
facial mask (7-15 L/min). Most patients will obtain relief within 15 minutes. Acute drugs may be difficult
to obtain in adequate quantity.
Subcutaneous sumatriptan and intranasal zolmitriptan are the most effective self-administered medication
for the relief of cluster headaches. Sumatriptan is not effective when used before the actual attack nor is
it useful as a prophylactic medication (Law, 2010 [Systematic Review]. Intranasal sumatriptan can also be
considered for acute treatment (Francis, 2010 [Moderate Quality Evidence]).
Dihydroergotamine mesylate provides prompt and effective relief from cluster headaches in 15 minutes, but
due to the rapid peak intensity and short duration of cluster headaches, dihydroergotamine mesylate may be
a less feasible option than sumatriptan.
(Dodick, 2000 [Low Quality Evidence]; Goadsby, 1997 [Low Quality Evidence]; Lipton, 1998 [High Quality
Evidence])
76. Bridging Treatment

Recommendation:
Clinicians should initiate bridging treatment or transitional prophylaxis simultaneously
with maintenance prophylactic treatment after acute treatment has suppressed the initial
attack for cluster headaches.
Bridging treatment allows for the rapid suppression of cluster attacks in the interim until the maintenance
treatment reaches therapeutic levels.
Options for bridging treatment are:
Corticosteroids
Occipital nerve block
(Capobianco, 2006 [Guideline]; Husid, 2006 [Low Quality Evidence]; Sandrini, 2006 [Low Quality
Evidence]; Ambrosini, 2005 [High Quality Evidence]; Peres, 2002 [Low Quality Evidence]; Dodick, 2000
[Low Quality Evidence])
77. Maintenance Prophylaxis

Recommendation:
Clinicians should initiate maintenance prophylaxis to provide sustained suppression of
cluster headaches over the expected cluster period.
Effective prevention cannot be overemphasized in these patients. Maintenance prophylaxis is critically
important since cluster headache sufferers typically experience one or more daily (or nightly) attacks for a
period of weeks or months. The goal of transitional therapy is to induce rapid suppression of attacks while
maintenance prophylaxis is intended to provide sustained suppression over the expected cluster period.
If the patient has intractable headache or is unresponsive to prophylactic treatment, consider referral to a
headache specialist.

(Dodick, 2000 [Low Quality Evidence]; Olesen, 1999 [Reference]; Goadsby, 1997 [Low Quality Evidence];
Lipton, 1998 [High Quality Evidence])
Dihydroergotamine Mesylate (DHE) Algorithm Annotations
84. Intravenous Metoclopramide 10 mg Intravenous

Metoclopramide (10 mg) is given either by direct intavenous injection over two-three minutes, or infused
intravenously in 50 mL of normal saline over 15 minutes. Each dose of metoclopramide should be admin-
istered 15 minutes prior to each dihydroergotamine mesylate injection. Although uncommon, acute extra-
pyramidal side effects such as dystonia, akathisia, and oculogyric crisis may occur after administration of
metoclopramide. Benztropine mesylate is effective in terminating this unusual adverse event, given as a 1
mg injection (intravenous or intramuscular). Often after five doses of metoclopramide, it may be given as
needed every eight hours for nausea (Ellis, 1993 [High Quality Evidence]).
85. Begin Continuous Dihydroergotamine Mesylate (DHE)

Begin dihydroergotamine mesylate 2 mg in 1,000 mL normal saline at 42 mL/hr. Limit the dose of DHE
to no more than 2 mg/24 hours.
Continue intravenous metoclopramide 10 mg IV every eight hours as needed for nausea.
Side effects:
If significant nausea occurs at any time, reduce the rate of dihydroergotamine mesylate to 21 to 30
mL/hr.
If diarrhea occurs, give diphenoxylate with atropine, one or two tablets, three times daily as
needed.
If excessive anxiety, jitteriness (akathisia) or dystonic reaction occurs, give intravenous benztropine
1 mg.
It may be continued up to seven days. Opioid analgesics should not be used since these are likely to prolong
the headache via analgesic rebound.
This is an adjusted Ford modification of the Raskin protocol. This is a continuous protocol as this is the
preferred method. This approach is an alternative to the intermittent dosing of dihydroergotamine mesylate
as outlined in the Raskin protocol, and some practitioners may prefer it rather than the intermittent dihydro-
ergotamine mesylate protocol. Continuous dihydroergotamine mesylate, like the intermittent administration,
can be continued for seven days, although 72 hours is more typical. Opioid analgesics should not be used
with either protocol since these are likely to prolong the headache via analgesic rebound.
Ford, et al. described results of an open trial comparison between intermittent intravenous dihydroergota-
mine mesylate and continuous infusion dihydroergotamine mesylate. Success in treating migraine status
was virtually the same with each protocol. The Ford variation may be preferred by some clinicians. This
protocol should be used only with an intravenous pump (Ford, 1997 [Low Quality Evidence]; Queiroz, 1996
[Low Quality Evidence]; Raskin, 1986 [ Low Quality Evidence]).
www.icsi.org

Menstrual-Associated Migraine Algorithm Annotations
87. Patient Meets Criteria for Menstrual-Only or Menstrual-

Associated Migraine
Recommendation:
Clinicians should advise women who meet criteria for menstrual-associated migraine to
keep a continuous daily record of headache occurrence, severity, duration and menstrual
flow for at least two months.
"Menstrual migraine," a term misused by both patients and clinicians, lacks precise definition. The
International Classification of Headache Disorder, second edition (ICHS-II) system has proposed that
menstrual-only migraine be defined as attacks exclusively starting two days before and first two days
of the menstrual cycle (Pringsheim, 2008 [Meta-analysis]; Headache Classification Subcommittee of
the International Headache Society, 2004 [Guideline]). The woman should be free from attacks at all
other times of the cycle.
Many women who do not have attacks exclusively with menses are considered to have menstrual-
associated migraines (MacGregor, 1996 [Low Quality Evidence]).
The clinician and patient need to discuss diary documentation. The patient should keep a continuous
daily record for at least two months to include the following:
Day/time of headache Duration
Severity of headache Onset of menstrual flow
91. Consider Cyclic Prophylaxis

Recommendation:
Clinicians may consider non-hormonal cyclic prophylactic treatment with NSAIDs and
triptans for patients with menstrual-associated migraine.
Non-steroidal anti-inflammatory drugs
Non-steroidal anti-inflammatory drugs should be considered approaches of first choice in the
prophylactic treatment of migraine associated with menses. Many clinicians consider triptans to
be equally effective, but there are no comparative studies. [Conclusion Grade III: See Conclusion
Grading Worksheet A Annotation #91 (Non-Steroidal Anti-Inflammatory Drugs)]
Naproxen sodium has been used as a preventive agent, although other non-steroidal anti-inflammatory
drugs may also be effective. Typically, the agent is initiated two to three days before anticipated
onset of the headache and continued through the at-risk period.
Virtually every review paper supports the use of non-steroidal anti-inflammatory drugs for cyclic
prophylaxis. There are almost no controlled studies in this setting, with two smaller studies supporting
prophylaxis with naproxen sodium (Boyle, 1999 [Low Quality Evidence]; Silberstein, 1999 [High
Quality Evidence]; Kornstein, 1997 [Low Quality Evidence]).
www.icsi.org

Triptans
There are good placebo studies supporting the use of triptans (sumatriptan, naratriptan, frovatriptan
and zolmitriptan) for cyclic prophylaxis (Tuchman, 2008 [High Quality Evidence]; Silberstein,
2000b [High Quality Evidence]; Newman, 1998 [Low Quality Evidence]).
94. Consider Hormone Prophylaxis

Recommendation:
Clinicians may consider hormone prophylaxis treatment for patients with menstrual-
associated migraines.
Transdermal estradiol
Estrogen levels decrease during the late luteal phase of the menstrual cycle, likely triggering migraine.
Estrogen replacement prior to menstruation has been used to prevent migraine.
Estradiol patches, 50-100 mcg, are applied 48 hours prior to expected onset of migraine and used for
one week.
The 50 mcg estradiol patch, applied 48 hours before anticipated onset of menses and continuing for
seven days, was effective in relieving headaches in a subgroup of women with menstrual migraines
confirmed by neurophysiological testing. Others have shown a better clinical outcome with 100 mcg
estradiol patches than with lower dose patches. Oral estrogen has been less effective than transdermal
estrogen in prophylaxis of menstrual migraine.
(Becker, 1999 [Low Quality Evidence]; Cupini, 1995 [Low Quality Evidence]; Larsson-Cohn, 1970
Estrogen-containing contraceptives
Estrogen-containing contraceptives have a variable effect on migraines, causing worsening of headaches
in some patients, improvement of headaches in a small percentage of patients, and no change in migraines
in other patients. We are not aware of any population-based studies on this topic.
The effect of estrogen-containing contraceptives on migraines is unpredictable. In one study, migraines
worsened in 39% of patients, improved in 3%, and remained unchanged in 39%. Another author reported
improvement in migraines in 35% of patients when estrogen-containing contraceptives were started.
(Becker, 1999 [Low Quality Evidence]; Cupini, 1995 [Low Quality Evidence]; Larsson-Cohn, 1970
In a contraceptive containing drospirenone, an extended 168-day placebo-free oral contraceptive regimen
showed a significant decrease in duration, severity of headaches and loss of function due to headache
compared with a standard 21/7 oral contraceptive cycle (Sulak, 2007 [Low Quality Evidence]). In 2011,
the Food and Drug Administration concluded that drospirenone may be associated with a higher risk for
blood clots than other progestin-containing pills. http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm.
GnRH agonists with "add back" therapy
For patients with severe menstrual migraine unrelieved by other therapies, suppression of the menstrual
cycle with a gonadotropin-releasing hormone agonist and "add back" therapy may be effective.
Suppression of ovarian steroid production followed by a constant estrogen-progestin milieu was studied
in five women with severe menstrual migraine. All patients reported dramatic improvement in

functioning and quality of life and a decrease in analgesic medications used for headache relief. Two
patients discontinued therapy and had increased headache frequency. The monthly cost of GnRH agonist
therapy is about 10 times the cost of conventional hormone therapy. GnRH agonists and "add back"
therapy may also be associated with erratic bleeding. This therapy should probably be managed by a
gynecologist or endocrinologist in concert with a headache specialist.
Tamoxifen, danazol and bromocriptine have shown limited efficacy in treatment of menstrual migraine.
Whether oophorectomy is an effective treatment for refractory migraines is not settled at this time.
(Herzog, 1997 [Low Quality Evidence]; Murray, 1997 [Low Quality Evidence]; Lichten, 1991 [Low
Quality Evidence]; O'Dea, 1990 [Low Quality Evidence])
Perimenopausal or Menopausal Migraine Algorithm Annotations
98. Perimenopausal or Menopausal with Active Migraine History and

Is a Potential Candidate for Hormone Therapy
Recommendation:
Clinicians should not prescribe hormone therapy for perimenopausal or menopausal
migraine treatment in patients who are pregnant or have unexplained bleeding.
Menopause is the permanent cessation of menses.
Perimenopause is the span of time from the reproductive to the post-reproductive interval.
Hormone therapy may worsen, improve or leave migraines unchanged.
In a study of 112 women taking hormone therapy, 52 reported worsening of migraines, 50 reported improve-
ment, and 10 reported no change in migraine headaches. More women improved with transdermal than
oral estrogen (Wang, 2003 [Low Quality Evidence]; Nappi, 2001 [High Quality Evidence]; MacGregor,
1997 [Low Quality Evidence]).
Women with these conditions are not candidates for hormone therapy:
Pregnancy or unexplained bleeding: these are temporary but absolute contraindications to hormone
therapy.
Past history of breast cancer or endometrial cancer: while usually considered contraindications to
hormone therapy, short-term use for severe menopausal symptoms may be considered with proper
precautions.
103. Hormone Therapy

Transdermal, transvaginal or oral estrogen
Progestin if indicated
Estrogen-containing contraceptives
(Fettes, 1999 [Low Quality Evidence]; de Lignieres, 1996 [Low Quality Evidence]; Silberstein, 1993
www.icsi.org

104. Successful?
Successful is commonly defined as a 50% reduction in frequency in headache days and/or severity of
headaches.
105. Consider Changing Delivery System or Formulation of Estrogen

and Progestin
Success is achieved through trial and error.
On Estrogen-Containing Contraceptives or Considering

Estrogen-Containing Contraceptives with Migraine Algorithm
Annotations
109. On Estrogen-Containing Contraceptives or Considering
Estrogen-Containing Contraceptives with Migraine
Migraine patients who do not have absolute contraindications to estrogen-containing contraceptives
should consider that estrogen-containing contraceptives may have unpredictable effects on the severity
and/or frequency of headaches. In addition, evidence exists that the risk of ischemic stroke increases
for migraineurs using estrogen-containing contraceptives (International Headache Society Task Force
on Combined Oral Contraceptives & Hormone Replacement Therapy, The, 2000 [Guideline]; Becker,
1999 [Low Quality Evidence]; Cupini, 1995 [Low Quality Evidence]).
111. Evaluate Vascular Risk Factors

Recommendation:
Clinicians should evaluate for vascular risk factors before prescribing estrogen
containing contraceptives for treatment of migraine.
Risk factors for coronary artery disease
Prior thromboembolic disease
Migraine aura
Smoking
Women who have migraine with an aura probably have significantly increased ischemic stroke risk if
estrogen-containing contraceptives are used. This risk probably increases with age as baseline stroke
rates increase, so that the increased risk may be acceptable to the younger patient (i.e., under age 30),
but not to the older patient. It is probably too simplistic to say that no patient with migraine with aura
should use estrogen-containing contraceptives. The decision should be individualized and should be
made with the patient.
It appears reasonable that women who have prolonged migraine auras (certainly those beyond 60 minutes),
multiple aura symptoms, or less common aura symptoms (i.e., dysphasia, hemiparesis) should be strongly
discouraged from using estrogen-containing contraceptives.

Patients who develop a migraine aura for the first time while using estrogen-containing contraceptives, or
whose previous typical migraine aura becomes more prolonged or complex should discontinue estrogen-
containing contraceptives.
Use of oral contraceptives in patients with a history of migraine increases the risk of stroke. [Conclusion
Grade II: See Conclusion Grading Worksheet B Annotation #111 (Risk of Stroke)]
Women with migraine aura who smoke and are hypertensive further increase their risk. Additional risk is
also noted if they are taking estrogen-containing contraceptives.
Migraine Prophylactic Treatment Algorithm Annotations

122. Prophylactic Treatment
Recommendation:
Clinicians may prescribe prophylactic treatment for patients with migraine history
after realistic goals and expectations have been established with the patient.
Criteria for prophylactic treatment
- Three or more severe migraine attacks per month that fail to respond adequately to symptomatic
therapy.
- Less frequent but protracted attacks that impair the patient's quality of life.
- Patient is interested in prophylactic treatment.
Prophylactic therapy
Prior to instituting prophylactic therapy for migraine, it is imperative that realistic goals and expecta-
tions be established. Patients should have a clear understanding that the goals of preventive therapy
are to:
Decrease migraine attack frequency by 50% or more
Decrease pain and disability with each individual attack
Enhance response to acute, specific, anti-migraine therapy
One or more of these goals may be achieved.
Medications
The choice of prophylactic agent depends upon:
Side-effect profile
Comorbid conditions
Medication interactions
Evidence-based efficacy
Patient preference (weight loss or gain)
Patients should also understand that there is usually a latency of at least three to six weeks between
the initiation of medication and recognizable efficacy. Often, an 8- to 12-week trial is necessary,
allowing an adequate period for drug titration to a dosage likely to attain efficacy. It is also not

uncommon for initial side effects to subside after continued therapy, and patients should be made
aware of this so as to avoid premature discontinuation of a potentially effective medication.
The choice of prophylactic medication should be individualized according to the side-effect profile,
the presence of comorbid conditions and risk of medication interactions. For example, a tricyclic
antidepressant may be especially useful with a migraineur with depression, while sodium valproate
may be ideal for a patient with epilepsy.
Reinforce education and lifestyle management. Refer to Annotation #15, "Evaluate Type of Primary
Headache. Initiate Patient Education and Lifestyle Management."
Adolescents
As a prophylactic treatment topiramate, 100 mg/day was effective in reduction of the number of
migraine headaches a month (Lewis, 2009 [High Quality Evidence]).
Medications
The following references pertain to the medications used in prophylactic treatment.
Antiepileptics Beta-Blockers Ca++ Channel Blockers Tricyclics

Valproate sodium Atenolol Verapamil Amitriptyline
(Hering, 1992 [High Quality (Johannsson, 1987 [Low (Solomon, 1983 (Couch, 1979 [High
Evidence]; Quality Evidence]) [High Quality Quality Evidence])
Klapper, 1997 [High Quality Evidence])
Evidence])
Gabapentin Metoprolol Doxepin
(Mathew, 2002 [High Quality
Evidence])
Topiramate Nadolol Nortiptyline
(Brandes, 2004 [High Quality
Evidence]; Silberstein, 2004
[High Quality Evidence])
Nebivolol
(Schellenberg, 2008 [High
Quality Evidence])
Propranolol
(Carroll, 1990 [High
Quality Evidence])
Timolol
Other Therapies
The treatment therapies listed below are in alphabetical order and do not indicate work group preference
or scientific support.
Acupuncture
A systematic (Cochrane) review of acupuncture in migraine prophylaxis demonstrated that adding
acupuncture to patients getting only acute treatment for headaches reduced the number of headaches
patients had. When true and sham acupuncture were compared, they both reduced the number of
headaches. There was no difference in benefit between true and sham acupuncture groups when
results for all trials were pooled. Acupuncture demonstrated slightly better outcomes and fewer
adverse effects than drugs shown to be helpful for prophylaxis (Linde, 2009 [Systematic Review]).
Biofeedback
Various methods of biofeedback have been used as adjunctive therapy for migraine and tension-
type headaches. A meta-analysis of 53 studies of biofeedback in combination with relaxation for
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tension-type headache demonstrated these to be more effective than headache monitoring, placebo
or relaxation, especially in reducing headache frequency. Most of these studies were randomized
controlled trials. Effects were most pronounced in adolecents (Nestoriuc, 2008 [Meta-analysis]).
Butterbur root (petasites hybridus)
An extract from the plant Petasites hybridus is effective for migraine prevention. It should be used
to reduce severity and frequency of migraine attacks (Holland, 2012 [Guideline]; Lipton, 2004
[Moderate Quality Evidence]; Grossman, 2000 [High Quality Evidence]).
Coenzyme Q10
In one randomized placebo-controlled trial, coenzyme Q10 was superior to placebo for attack
frequency, headache days and days with nausea (Sndor, 2005 [High Quality Evidence]).
Cognitive behavioral therapy
This therapy is based on the premise that anxiety and distress aggravate an evolving migraine,
and it has the potential for helping the patient recognize maladaptive responses that may trigger a
headache (Campbell, 2003 [Guideline]; Andrasik, 1996 [Low Quality Evidence]; Reid, 1996 [Low
Quality Evidence]).
Psychological treatments, principally relaxation and cognitive behavioral therapies, are effective
treatments of childhood headache (Eccleston, 2009 [Meta-analysis/Systematic Review]).
Feverfew
This herbal therapy is made from crushed chrysanthemum leaves. 250 mcg of the active ingre-
dient, parthenolide, is considered necessary for therapeutic effectiveness. Because these are herbal
preparations, the quantity of active ingredient varies with the producer (Vogler, 1998 [Systematic
Review]; Johnson, 1985 [High Quality Evidence]).
Magnesium
Daily oral dosages of 400 to 600 mg of this salt have been shown to be of benefit to migraineurs in
European studies (Peikert, 1996 [High Quality Evidence]).
Onabotulinum toxin
Onabotulinum toxin has been approved by the Food and Drug Administration for the treatment
of chronic migraine. Since this approach would be used by headache specialists or others trained
specifically for use of this product, onabotulinum toxin is beyond the scope of this discussion.
Physical therapy
Individuals unable to take medication or interested in other nonpharmacological headache manage-
ment, may benefit from physical therapy including craniocervical exercises. Craniocervical exercises
designed to correct postural faults by retraining and strengthening craniocervical flexion, cervico-
thoracic extension, scapular retraction, thoracic extension and normalization of lumbar lordosis
have been shown to significantly reduce tension-type and cervicogenic headaches over a prolonged
time frame (van Ettekoven, 2006 [High Quality Evidence]; Jull, 2002 [High Quality Evidence]).
Relaxation training
Relaxation training includes progressive muscular relaxation, breathing exercises and directed
imagery. The goal is to develop long-term skills rather than to treat individual events. Repetitive
sessions and practice by the patient increase the success of these therapies in reducing headache
frequency (Reich, 1989 [High Quality Evidence]).
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Riboflavin
A randomized, placebo-controlled study has found daily supplements of 400 mg moderately effec-
tive in reducing the frequency and severity of migraine (Schoenen, 1998 [High Quality Evidence]).
Several additional treatment modalities are available. The modalities listed below lack sufficient
scientific support to be recommended as therapies of proven value.
Cervical manipulation
Previous studies suggested potentially high levels of risk associated with improper application of
this modality. Although some studies report few complications, the scientific evidence of signifi-
cant benefit is not convincing. There is well-documented evidence of cerebral infarction and death
from cervical manipulation (Haldeman, 2002 [Low Quality Evidence]; Krueger, 1980 [Low Quality
Evidence]; Parker, 1980 [High Quality Evidence]). A systematic review demonstrates that numerous
deaths have been associated with high-velocity, short-lever thrusts of the upper spine with rotation
(Ernst, 2010 [Meta-analysis]).
Transcutaneous electrical stimulation units
Transcutaneous electrical stimulation units units for migraine or muscle contraction headache have
not been found to be more beneficial than placebo when evaluated in a controlled study (Solomon,
1985 [High Quality Evidence]).
124. Continue Treatment for 6-12 Months, Then Reassess

Recommendation:
After 6-12 months, a gradual taper of prophylactic migraine treatment is recom-
mended unless headaches become more frequent or more severe.
125. Try Different First-Line Medication or Different Drug of Different

Class
Recommendation:
Monotherapy is recommended with dose increasing until patient receives benefit,
maximum recommended dose is reached or unacceptable side effects occur. If
failure with one medication, try another from the same class.
128. Try Combination of Beta-Blockers and Tricyclics

A beta-blocker and tricyclic antidepressant may be more effective and produce fewer side effects in
combination than a single drug at a higher dose from either class.
131. Third-Line Prophylaxis Treatment or Consultation with Headache

Specialist
Please see Annotation #42, "Consultation with Headache Specialist."
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Quality Improvement Support:
The Aims and Measures section is intended to provide protocol users with a menu
of measures for multiple purposes that may include the following:
population health improvement measures,
quality improvement measures for delivery systems,
measures from regulatory organizations such as Joint Commission,
measures that are currently required for public reporting,
measures that are part of Center for Medicare Services Physician Quality
Reporting initiative, and
other measures from local and national organizations aimed at measuring
population health and improvement of care delivery.
This section provides resources, strategies and measurement for use in closing
the gap between current clinical practice and the recommendations set forth in the
guideline.
The subdivisions of this section are:
Aims and Measures
Implementation Recommendations
Implementation Tools and Resources
Implementation Tools and Resources Table

Aims and Measures

1. Increase the accurate diagnosis of primary headaches in patients age 12 years and older. (Annotation
#11)
Measure for accomplishing this aim:
a. Percentage of patients diagnosed with primary headache using the appropriate diagnostic criteria.
2. Increase the percentage of patients with primary headache diagnosis who receive educational materials
about headache. (Annotation #15)
a. Percentage of patients with primary headache who received educational materials on headache.
3. Increase the percentage of patients with primary headache syndrome who receive prophylactic treatment
when appropriate. (Annotations #66, 77, 91, 94, 122, 131)
a. Percentage of patients with primary headache syndrome who are prescribed prophylactic treatment
when appropriate.
4. Increase the percentage of patients with migraine headache who have improvement in their functional
status. (Annotation #15)
Measures for accomplishing this aim:
a. Number of days per month with migraine headache.
b. Percentage of patients with migraine headache who are showing improvement in functional status
shown by using one of the following disease-specific tools or questionnaires (e.g., MIDAS, Head-
ache Impact Test (HIT), Migraine Specific Quality of Life [MSQ])*.
c. Percentage of patients with migraine headache seen for migraine in the emergency department/
urgent care.
d. Percentage of patients with decreased headache shown by using calendar or diary.
* While general functional status/quality-of-life assessment tools are easier to administer, disease-specific
measures may be easier to interpret for disease-specific disability.
5. Increase the percentage of patients with migraine headache who have a treatment plan or report adher-
ence to a treatment plan for mild, moderate and severe migraine headaches. (Annotations #32, 33, 36,
42, 43, 44)
Measures for accomplishing this aim:
a. Percentage of patients with migraine headache with treatment plans.
b. Percentage of patients with migraine headache with treatment plan who report adherence to their
treatment plan.
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Aims and Measures Eleventh Edition/January 2013
6. Decrease the percentage of patients with migraine headache who are prescribed opiates and barbiturates
for the treatment of migraines to less than 5%. (Annotations #36, 49)
a. Percentage of patients with migraine headache with a prescription for opiates or barbiturates for
the treatment of migraine.
7. Increase the percentage of patients with migraine headache who have appropriate acute treatment.
(Annotations #30, 32, 36)
a. Percentage of patients with migraine headache prescribed appropriate acute treatment.
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Measurement Specifications
Measure #1a
Percentage of patients diagnosed with primary headache using the appropriate diagnostic criteria.
Population Definition
Patients age 12 years and older diagnosed with a primary headache.
Data of Interest
# of patients for which appropriate diagnostic criteria were used
# of patients diagnosed with a primary headache
Numerator/Denominator Definitions
Numerator : Number of patients age 12 years and older for which appropriate diagnostic criteria were used.
Denominator: Number of patients age 12 years and older diagnosed with a primary headache.
Method/Source of Data Collection

Review electronic medical records for patients age 12 years and older with one of headache diagnoses:
migraine, tension-type, cluster, sinus or chronic daily headache. Determine whether appropriate diagnostic
criteria were used to determine diagnosis.
Time Frame Pertaining to Data Collection

Monthly.
Notes
This is a process measure, and improvement is noted as an increase in the rate.
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Measure #2a
Percentage of patients with a primary headache who received educational materials on headache.
Patients age 12 years and older with a primary headache.
Data of Interest
# of patients who received educational materials on headache
# of patients with a primary headache
Numerator : Number of patients age 12 years and older with primary headache, who received educational
materials on headache. This can include information about:
Genetic predisposition to migraine
Role of lifestyle changes
Stress reduction, regular eating and sleeping schedules, and regular aerobic exercise
Results of overuse of analgesics and acute migraine drugs
Benefit of keeping a headache diary
Treatment approaches
Denominator: Number of patientsage 12 years and older with a primary headache.

Review electronic medical records for patients age 12 years and older with a primary headache. Review
records to determine whether patients received written educational materials on headache.

Monthly.
Notes
Providing education is of paramount importance in managing any chronic illness; it is especially important
in the ongoing management of migraine. Patients may have to make lifestyle changes and are often required
to make self-management choices in the treatment of individual headaches and to maintain a diary to clarify
the frequency, severity, triggers and treatment responses to their headaches.
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Measure #3a
Percentage of patients with primary headache syndrome who are prescribed prophylactic treatment when
appropriate.
Patients age 12 years and older with primary headache syndrome.
Data of Interest
# of patients who are prescribed prophylactic treatment when appropriate
# of patients with headache diagnosis
Numerator : Number of patients age 12 years and older with primary headache syndrome who are prescribed
prophylactic treatment when appropriate.
Denominator: Number of patients age 12 years and older with primary headache diagnosis syndrome.

Review electronic medical records for patients age 12 years and older with primary headache syndrome.
Review records to determine whether patients were prescribed prophylactic treatment when appropriate.

Monthly.
Notes
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Measure #4a
Number of days per month with migraine headache.
Patients age 12 years and older with diagnosis of migraine headache.
Data of Interest
Number of days per month with migraine for patients who are diagnosed with migraine headache.

Review electronic medical records for patients age 12 years and older with diagnosis of migraine headache.
Review records to determine the number of days per month the patients had migraine.

Monthly.
Notes
This is an outcome measure, and the goal is a decerease in days with migraine.
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Measure #4b
Percentage of patients with migraine headache who are showing improvement in functional status shown
by using one of the following disease-specific tools or questionnaires (e.g., MIDAS, Headache Impact Test
(HIT), Migraine Specific Quality of Life [MSQ])*.
* While general functional status/quality of life assessment tools are easier to administer, disease-specific
measures may be easier to interpret for disease-specific disability. Tools can be found at http://www.head-
aches.org.
Data of Interest
# of patients who are assessed for functional status using disease-specific tools
# of patients with migraine headache diagnosis
Numerator : Number of patients age 12 years and older and migraine headache diagnosis, who are showing
improvement in functional status shown by using one of the following disease-specific tools
or questionnaires (e.g., MIDAS, Headache Impact Test, Migraine Specific Quality of Life).
Denominator: Number of patients age 12 years and older with migraine headache diagnosis.

Review electronic medical records for patients age 12 years and older with migraine headache diagnosis.
Review records to determine whether patients were assessed for functional status using disease-specific
tools or questionnaires such as MIDAS, HIT or MSQ.

Monthly.
Notes
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Measure #4c
Percentage of patients with migraine headache seen for migraine in the emergency department/urgent care.
Data of Interest
# of patients seen for migraine in the emergency department/urgent care
Numerator : Number of patients age 12 years and older and migraine headache diagnosis who are seen for
migraine in the emergency department/urgent care.

Review records to determine whether patients were seen for migraine in the emergency department/urgent
care.

Monthly.
Notes
This is an outcome measure, and improvement is noted as a decrease in the rate.
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Measure #4d
Percentage of patients with decreased migraine headache shown by using a calendar or diary.
Data of Interest
# of patients who have a headache calendar or diary
Numerator : Number of patients age 12 years and older and migraine headache diagnosis, who have head-
ache calendar or diary.

Review electronic medical records for atients age 12 years and older with migraine headache diagnosis.
Review records to determine whether patients reported having headache calendar or diary.

Monthly.
Notes
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Measure #5a
Percentage of patients with migraine headache with treatment plans.
Patients ages 12 years and older with diagnosis of migraine headache.
Data of Interest
# of patients who have a treatment plan
Numerator : Number of patients age 12 years and older and migraine headache diagnosis, who have a
treatment plan.
Denominator: Number of patients age 12 years and older with a migraine headache diagnosis.

Review records to determine whether patients had treatment plan.

Monthly.
Notes
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Measure #5b
Percentage of patients with migraine headache with a treatment plan who report adherence to their treat-
ment plan.
Patients age 12 years and older with diagnosis of migraine headache and have a treatment plan.
Data of Interest
# of patients who report adherence to their treatment plan
# of patients with migraine headache diagnosis and treatment plan
Numerator : Number of patients age 12 years and older and migraine headache diagnosis and treatment
plan who report adherence to their treatment plan.
Denominator: Number of patients age 12 years and older with migraine headache diagnosis and treatment
plan.

Review electronic medical records for patients age 12 years and older with migraine headache diagnosis
and treatment plan. Review records to determine whether patients report adherence to their treatment plan.

Monthly.
Notes
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Measure #6a
Percentage of patients with migraine headache with a prescription for opiates or barbiturates for the treat-
ment of migraine.
Data of Interest
# of patients prescribed opiates or barbiturates for the treatment of migraine
Numerator : Number of patients age 12 years and older and migraine headache diagnosis who are prescribed
opiates or barbiturates for the treatment of migraine.

Review records to determine whether patients were prescribed opiates or barbiturates for the treatment of
migraine.

Monthly.
Notes
This is a process measure, and improvement is noted as a decrease in the rate to less than 5% usage in a
facility. This measure is intended to address overuse in prescription on opioids and narcotics for the treat-
ment of migraine headache.
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Measure #7a
Percentage of patients with migraine headache prescribed appropriate acute treatment.
Data of Interest
# of patients prescribed appropriate acute treatment
Numerator : Number of patients age 12 years and older and migraine headache diagnosis who are prescribed
appropriate acute treatment.

Review records to determine whether patients were prescribed appropriate acute treatment.

Monthly.
Notes
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Implementation Recommendations
Prior to implementation, it is important to consider current organizational infrastructure that address the
following:
System and process design
Training and education
Culture and the need to shift values, beliefs and behaviors of the organization.
The following system changes were identified by the guideline work group as key strategies for health care
systems to incorporate in support of the implementation of this guideline:
Develop a system for assessment of headache based on history and functional impairment.
Develop a system for results of this assessment to be used for identification of treatment options/
recommendations.
Develop systems that allow for consistent documentation and montoring based on type of headache.
Develop a system for follow-up assessment that identifies success in management of headache in
the primary care setting.
Develop a process that will remove barriers to referral to a specialist if indicated.
Develop a system for consistent documentation and monitoring of medication administration.
Implementation Tools and Resources

Criteria for Selecting Resources
The following tools and resources specific to the topic of the guideline were selected by the work group.
Each item was reviewed thoroughly by at least one work group member. It is expected that users of these
tools will establish the proper copyright prior to their use. The types of criteria the work group used are:
The content supports the clinical and the implementation recommendations.
Where possible, the content is supported by evidence-based research.
The author, source and revision dates for the content are included where possible.
The content is clear about potential biases and when appropriate conflicts of interests and/or
disclaimers are noted where appropriate.
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Implementation Tools and Resources Table

Author/Organization Title/Description Audience Web Sites/Order Information
American Academy of General health information on various Patients and http://familydoctor.org/family-
Family Physicians topics. Families doctor/en.html
American Headache This Web site is an excellent resource for Health Care http://
Society (AHS) patients and clinicians to learn more about Professionals; www.americanheadachesociety.
Committee for Headache headaches and resources to help manage Patients and org
Education them, including prevention and treatment. Families
This site also has information on migraine
assessments and headache diaries.
Headache Care This Web site is designed for viewers to Patients and http://www.headachecare.com
educate themselves on types of headaches, Families
treatment and prevention techniques. This
site contains a complete migraineur's guide
to migraine that will help patients under-
stand migraines and how they can become
an active participant in their care program
to gain control over migraines.
Healthfinder General health information on various top- Patients and http://www.healthfinder.gov
ics. Spanish link available. Families
HealthPartners General overview on various topics and Patients and http://www.healthpartners.com
Medical Group health information. (Need to register prior Families
to accessing information.)
ICSI ICSI Shared Decision-Making Model Providers http://www.icsi.org
Mayo Clinic General health information on various top- Patients and http://www.mayoclinic.com
ics and interactive "Ask a Specialist" and Families
Headache Center: A Complete Guide to
Managing Headaches.
National Library of MedlinePlus is the National Institutes of Health Care http://www.nlm.nih.gov/medlin-
Medicine's MEDLINE Health's Web site for patients and their Professionals; eplus
plus National families and friends. Produced by the Patients and
Institutes of Health National Library of Medicine, it provides Families
information about diseases, conditions and
wellness issues.
National Women's Government resource for women's health Patients and http://www.4woman.org
Health Information information and referrals. Spanish Families
Center language link.
National Headache Educational and informational resources on Patients and http://headaches.org
Foundation headache. Families;
Health Care
Professionals
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Implementation Tools and Resources Table Eleventh Edition/January 2013
Author/Organization Title/Description Audience Web Sites/Order Information

Primary Care Patient-centered strategies for Health Care http://www.primarycarenet.org
Network effective management of migraine Professionals
headaches.
Quality Metric General health assessment tools includ- Health Care http://www.amihealthy.com
Incorporated ing the Headache Impact Test (HIT). Professionals;
(Need to register prior to Patients and
accessing information.) Families
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Supporting Evidence:
The subdivisions of this section are:

Conclusion Grading Worksheet Summary
- Conclusion Grading Worksheets
References
Appendices

Conclusion Grading Worksheet Summary

Grade I: The evidence consists of results from studies of strong design for answering the question addressed.
The results are both clinically important and consistent with minor exceptions at most. The results are free
of any significant doubts about generalizability, bias, and flaws in research design. Studies with negative
results have sufficiently large samples to have adequate statistical power.
Grade II: The evidence consists of results from studies of strong design for answering the question
addressed, but there is some uncertainty attached to the conclusion because of inconsistencies among the
results from the studies or because of minor doubts about generalizability, bias, research design flaws, or
adequacy of sample size. Alternatively, the evidence consists solely of results from weaker designs for the
question addressed, but the results have been confirmed in separate studies and are consistent with minor
exceptions at most.
Grade III: The evidence consists of results from studies of strong design for answering the question
addressed, but there is substantial uncertainty attached to the conclusion because of inconsistencies among
the results from different studies or because of serious doubts about generalizability, bias, research design
flaws, or adequacy of sample size. Alternatively, the evidence consists solely of results from a limited
number of studies of weak design for answering the question addressed.
Grade Not Assignable: There is no evidence available that directly supports or refutes the conclusion.
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Work Group's Conclusion: Non-steroidal anti-inflammatory drugs should be considered approaches of first choice in the
prophylactic treatment of migraine associated with menses. Many clinicians consider triptans to be equally effective, but there
are no comparative studies.
Conclusion Grade: III

Author/Year Design Quality Population Studied/Sample Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/
Type Size confidence interval, relative risk, odds ratio, likeli- Work Group's Comments (italicized)
hood ratio, number needed to treat)
Sargent, Sol- RCT High -Ages 18 to 65 years with -129 patients were included in the efficacy analysis -NS and PH appeared to reduce headache
bach, Damasia, confirmed diagnosis of com- (42 in NS group, 44 in PH group, and 43 in PL frequency, headache severity, nausea and
et al. (1985) mon or classical migraine, or group); groups were comparable (demographic and visual disturbances relative to placebo al-
combination of migraine and clinical data) at baseline though the differences were not significant.
muscle contraction headache -Median outcomes (Patient daily improvement re- PH was better tolerated than NS. Women
(history of migraines for 1 cord): treated with NS experienced the greatest
yr, average of 12 migraine NS PH PL decrease in headache severity during the pre-
headache days over 6 mi- Headache days per week -0.05 0.33 -0.25* menstrual period.
Institute for Clinical Systems Improvement

graine attacks in 3 months Headache severity 0.83 1.00 0.66*
prior to entry) Nausea 1.42 1.66 1.37* NOTES: 12-week full-dose phase (III) (all
-Excluded: pregnant, major Vomiting 1.88 1.92 1.72* received PL) followed a 2-week washout
medical illness, active ulcers Visual disturbances 1.80 1.30 1.18* phase (I) and 2 weeks where PH group re-
in previous year, bleeding *No significant differences among groups ceived 40 mg bid (II) (NS group received
problems, sensitivity to -Data from 30 patients who reported at least 2 men- full dose); 170 were enrolled, 161 entered
NSAIDs, rebound ergotamine strual periods during the study period: frequency of washout (I), 149 entered phase II, and 129
migraine, contraindications to migraine before start of menses was lower than after completed phase III (efficacy data phase);
propranolol hydrochloride start of menses in both treatment groups (compari- excluded 20 who had entered phase III from
-Randomized to naproxen sons with placebo group were not significant, how- analysis (14 with fewer than 4 wks of treat-
sodium (NS) (550 mg bid), ever); NS reduced severity of migraine before start ment, 6 with protocol violations)
propranolol hydrochloride of menses (relative to after start of menses) more
(PH) (40 mg tid) or placebo than placebo (p=0.01) or PH (p=0.054) Work Groups Comments: no explanation
(PL) -More gastrointestinal complaints in NS group than given for why 170 were enrolled but 149
-Patients could not take other PH group (p=0.02) entered active treatment phase; compliance
NSAIDs, anticoagulants, or with medication was not reported; little de-
alpha-adrenergic antagonists tail about measurement tools used
(Non-Steroidal Anti-Inflammatory Drugs)
during study period

Conclusion Grading Worksheet A Annotation #91

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65

Author/Year Design Quality Population Studied/Sample Primary Outcome Measure(s)/Results (e.g., p-value, Authors' Conclusions/
Type Size confidence interval, relative risk, odds ratio, likeli- Work Group's Comments (italicized)
hood ratio, number needed to treat)
Sances, Mar- Non Low -Ages 19 to 45 years; -35 completed the study (of 40 enrolled); 18 with -In comparison with placebo, NS is effective
tignoni, Ran- migraine without aura; NS for 6 mos, 17 with PL for 3 mos and NS for 3 in reducing headache intensity and duration
Fioroni, et al. dom menstrual-related periodicity months; 2 groups comparable (age, history of dis- as well as days of headache and analgesic
(1990) of migraine for 2 to 30 years ease, and migraine attack features); estradiol, pro- consumption. Good tolerability and few side
(headaches every cycle); free gesterone and prolactin levels normal for all patients effects were observed.
from endocrinological, meta- in each cycle in which they were tested
bolic or other organic abnor- -Percentage of response to treatment did not signifi-
malities; no prophylactic cantly differ between NS and PL groups in double- NOTES: 3 dropped out for reasons unrelated
treatment for migraine or no blind phase; response was almost equal in open to treatment; 2 dropped out due to severe
oral contraceptives for 6 phase; absence of migraine reported in 16.7% of NS gastralgia and nausea; non-significant differ-
months prior to study group in 1st month of treatment and 33% in 2nd and ences in PTI between NS and PL were at-
-2-month observation period 3rd months (compared to none in PL group) tributed to high variability of scores and high
-3-month (3 cycles) double- -NS group had significant change in PTI (relative to standard deviations
blind treatment with naproxen baseline) throughout study period (p=0.05 at month
sodium (NS) or placebo (PL); 2, others p0.01); PL group had significant change
Conclusion Grading Worksheet A
treatment from 7th day before in PTI at 1st month (p<0.05) and at months 3-6 (all

expected menses through 6th p<0.01); overall no difference between NS and PL
day of flow -Days of headache: decreased throughout study
-3 additional cycles with all period for NS group (all p<0.005) and at months 1,
women treated with active 2, 4, 5 & 6 for PL group (p=0.05 at month 2, others
drug p0.005); NS group differed from PL group at
-Calculated Pain Total Index month 3 (p<0.05)
(PTI) from daily diaries based -Analgesic consumption: decreased throughout
on number of attacks, dura- study period for NS group (all p0.01) and at
tion and severity months 1, 4, 5 & 6 for PL group (all p0.01); NS
group significantly different from PL group at
months 1 (p<0.02), 2 and 3 (both p<0.05)
Annotation #91 (Non-Steroidal Anti-Inflammatory Drugs)
-Menstrual Distress Questionnaire: significant im-

provement (p<0.006) in premenstrual and menstrual
pain during NS treatment but not PL treatment

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66

Work Group's Conclusion: Use of oral contraceptives in patients with a history of migraine increases the risk of stroke.
Conclusion Grade: II
Author/Year Design Quality Population Studied/Sample Size Primary Outcome Measure(s)/Results (e.g., p- Authors' Conclusions/
Type value, confidence interval, relative risk, odds Work Group's Comments (italicized)
ratio, likelihood ratio, number needed to treat)
Tzourio, Case- Low -Cases: 72 women under age 45 -Baseline characteristics: no differences in age, -Migraine is strongly associated with
Tehindrazana- Control years hospitalized for first BMI, history of diabetes, educational back- ischemic stroke in young women inde-
rivelo, Iglsias, et ischemic stroke ground, or hormonal content of oral contracep- pendent of main vascular risk factors.
al. (1995) -Controls: 173 women who tives; smoking status, oral contraceptive use The risk of ischemic stroke was par-
agreed to participate from status, and history of hypercholesterolemia dif- ticularly increased for migrainous
among 225 randomly selected fered between groups women who were currently using oral
patients hospitalized in same -No association between migraine and present contraceptives.
(Risk of Stroke)
centers during same time for use of oral contraceptives in cases or controls
acute orthopedic or benign -Migraine and ischemic stroke were strongly NOTE: used a group of 57 women
rheumatological illness associated (60% of cases vs. 30% of controls; under age 45 hospitalized for orthope-
-Interviewed (telephone) cases p<0.001); association persisted after controlling dic conditions to determine expected
and controls about history of for age, history of hypertension, use of oral con- prevalence of migraine in controls
headaches and vascular risk traceptives, and smoking (since non-response in controls might
factors; subjects were not aware -In migrainous women using oral contraceptives be an issue); 73% of the stroke patients

of aim of study (at time of stroke for cases, at time of interview and 74% of the controls using oral con-
for controls), risk of stroke was 13.9 (OR=13.9; traceptives were taking 30-40 g (mi-
95%CI: 5.5-35.1) compared to those without crograms) of estrogen.
migraine not using oral contraceptive
Work Groups Comments: investiga-
tors used a structured interview to re-
duce potential for classification bias;
recall bias is possible
Becker (1999) Review Low -Assumptions: -Risk for ischemic stroke associated
a. Women with migraine with aura have relative with migraine without aura is probably
stroke risk of approximately 6 low enough that it is not a major con-
b. Low-dose oral contraceptives with estrogen sideration in prescribing oral contra-
content below 50 g have increased ischemic ceptives unless the patient has other
stroke risk of approximately 2 major risk factors or unless headaches
c. If a patient with migraine with aura uses oral become substantially exacerbated
contraceptives and if the odds ratios are multipli- when oral contraceptives are started
cative, the expected relative ischemic stroke risk -For patients with migraine with aura
might be 6*2=12 or who develop migraine while taking
-Expected incidence of ischemic stroke per oral contraceptives, the additional
100,000 women per year: ischemic stroke risk should be consid-
Age Without Migraine Migraine with ered in clinical practice
Aura No OC use OC use No OC use OC use
15-19 0.4 0.8 2 5
20-24 1.4 3 8 16
25-29 1.9 4 11 23
30-34 2.4 5 14 29
35-39 3.4 7 20 41
40-44 11.6 23 70 139

Conclusion Grading Worksheet B Annotation #111
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67

References Links are provided for those new references added to

this edition (author name is highlighted in blue).
Adelman JU, Von Seggern R. Cost considerations in headache treatment. Part 1: prophylactic migraine
treatment. Headache 1995;35:479-87. (Low Quality Evidence)
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www.icsi.org

Appendix A Drug Treatment for Headache

Note: As there are multiple, easy-to-access information sources available that contain current
detailed drug information, the tables on the following pages highlight only those selected
drugs, their dosing, side effect and contraindications that may be otherwise challenging to
locate. Therefore, this is not intended as an inclusive listing of medication treatment options.
All drugs are listed in alphabetical order, not in order of work group preference. Drugs are
listed by their generic names and include brand names only where the generic name may not
be well recognized. These drug treatment tables have been compiled from package inserts,
PDR.net and Micromedex.
When viewing the following Drug Treatment tables, please consider the following key for the
symbols used in each table:
* Patient, lying down supine, head extended 45 degrees and rotated 30 degrees, drips 0.4 mL of 4% lido-
caine solution in the nostril ipsilateral to headache when unilateral, or most clear nostril when headache
is bilateral.
** Please note use of parenteral corticosteroids should be considered as treatment of last resort and
initiated only after careful consideration of the risks as they pertain to each individual. Their use is
empiric and based upon anecdotal evidence. The rationale for the use of corticosteroids is uncertain,
but they may reduce perivascular inflammation or sensitize the blood vessels to the vasoconstrictive
effect of circulating catecholamines and specific anti-migraine agents.
*** Ergotamine is not commonly used and not recommended as a first-line treatment.
www.icsi.org

Appendix A Drug Treatment for Headache Eleventh Edition/January 2013
The following references pertain to medications used in migraine treatment.
Almotriptan: Magnesium Sulfate: (Demirkaya, 2001 [Low Quality

(Spierings, 2001 [High Quality Evidence]) Evidence])
Acetaminophen, aspirin, caffeine Meperidine: (Duarte, 1992 [High Quality Evidence])

combination:
Because there is no good evidence to support the
use of acetaminophen for treatment of mild
migraine, the work group has replaced it with
acetaminophen, aspirin and caffeine (Lipton,
1998 [High Quality Evidence]; Stang, 1994
[Low Quality Evidence]).
Chlorpromazine IM: (McEwen, 1987 [High Metoprolol: (Gerber, 1991 [High Quality Evidence];
Quality Evidence]) Srensen, 1991 [High Quality Evidence])
Chlorpromazine IV: (Lane, 1989 [High Nadolol: (Ryan, 1983 [High Quality Evidence]; Ryan,
Quality Evidence]) 1982 [High Quality Evidence])
Dexamethasone IM: (Gallagher, 1986 [Low Naproxen: (Krymchantowski, 2000 [Low Quality
Quality Evidence]) Evidence]; Nestvold, 1985 [High Quality Evidence])
Dichloralphenazone: (Diamond, 1976 [High Naratriptan: (Mathew, 1997 [High Quality
Quality Evidence]) Evidence])
Dihydroergotamine: (Callaham, 1986 [High Nortriptyline: (Adelman, 1995 [Low Quality
Quality Evidence]) Evidence])
Dihydroergotamine nasal: (Gallagher, 1996 Prochlorperazine IV: (Coppola, 1995 [High
[High Quality Evidence]) Quality Evidence])
Dihydroergotamine- IM: (Weisz, 1994 [Low Prochlorperazine rectal: (Jones, 1994 [High
Quality Evidence]) Quality Evidence])
Dihydroergotamine- SQ: (Winner, 1996 [High Promethazine: (Capobianco, 1996 [Guideline])
Quality Evidence])
Doxepin: (Adelman, 1995 [High Quality Rizatriptan: (Kramer, 1998 [High Quality Evidence];
Evidence]) Teall, 1998 [High Quality Evidence])
Eletriptan: (Stark, 2002 [High Quality Sumatriptan nasal: (Francis, 2010 [Moderate
Evidence]) Quality Evidence]; Ryan, 1997 [High Quality
Evidence])
Hydroxyzine: (Duarte, 1992 [High Quality Sumatriptan oral: (Cutler, 1995 [High Quality
Evidence]) Evidence]; Sargent, 1995 [High Quality Evidence])
Ibuprofen: (Kloster, 1992 [High Quality Sumatriptan SQ:
Evidence]) (Wendt, 2006 [High Quality Evidence]; Visser, 1992
[High Quality Evidence]; Subcutaneous Sumatriptan
International Study Group, 1991 [High Quality
Evidence])
Isometheptene: (Diamond, 1976 [High Quality Sumatriptan/Naproxen:
Evidence]) (Brandes, 2007 [High Quality Evidence])
Ketorolac: (Duarte, 1992 [High Quality Valproate Sodium: (Mathew, 2000 [Low Quality
Evidence]) Evidence]; Norton, 2000 [Low Quality Evidenc])
Lidocaine nasal: (Maizels, 1996 [High Zolmitriptan:
Quality Evidence]) (Charlesworth, 2003 [High Quality Evidence];
Dowson, 2003 [High Quality Evidence]; Rapoport,
1997 [High Quality Evidence]; Solomon, 1997 [High
Quality Evidence])
www.icsi.org

Drug Dose Side Effects Contraindications

Chlorpromazine (CPZ) Dilute 1 mL CPZ (25 mg) Drowsiness, Hypotension, previous adverse
Injection with 4 mL normal saline extrapyramidal reaction
(1 mL = 5 mg CPZ) symptoms
0.1 mg/kg IV every 15
minutes, up to 3 doses.
Dilute to 1 mg/mL with
normal saline and
administer via IV infusion
at rate to greater than 1
mg/min.
Stop when headache
relieved; not to exceed 25
mg/dose
Dexamethasone 4-20 mg IM once per month Cushingoid
Injection**
DHE 0.5-1 mg subcutaneous, IM Nausea, vomiting, Pregnancy, history of ischemic
(dihydroergotamine or IV, may repeat in 1 hour; diarrhea, abdominal heart disease, history of
mesylate) not to exceed 3 mg in 24 cramps, dizziness, Prinzmetals angina, severe
Injection hours IM or 2 mg IV paresthesia and leg peripheral vascular disease,
pain onset of chest pain following
administration of test dose,
within 24 hours of receiving
any triptan or ergot derivative,
elevated blood pressure,
patients with hemiplegic or
basilar-type migraines,
cerebrovascular disease
Nasal spray 0.5 mg in each nostril; Nasal congestion, See DHE injection
repeat 0.5 mg in each nostril throat discomfort,
in 15 min; not to exceed 6 nasal irritation,
sprays (3 mg) in 24 hours nausea, chest
tightness, tingling,
vomiting
Hydrocortisone 100-250 mg IM
Injection** Repeat parenteral or oral
equivalent may be given
within 24 hrs
Isometheptene Mucate 2 by mouth at onset; 1 every Drowsiness, Ischemic heart disease, severe
65 mg hr as needed; not to exceed dizziness renal disease, ischemic
Dichloralphenazone 100 5 in 12 hrs; not to exceed 2 cerebrovascular disease
mg treatment days per week or
Acetaminophen 325 mg 40 caps per month
Midrin CIV
Lidocaine 4% Solution* 0.4 ml-0.5 mL intranasally Burning or numbness
over 30 seconds in nose or pharynx
Refer to the first page of Appendix A for the key explaining the symbols.
Many of the medications listed are available in a variety of formulations for different routes of administration (e.g.,
oral, intravenous, rectal suppository).
Basilar-type migraine is defined as three of the following features: diplopia, diparthria, tennitus, vertigo, transient
hearing loss or mental confusion (Headache Classification Subcommittee of the International Headache Society, 2004
[Guideline])
www.icsi.org

Drug Dose Side Effects Contraindications

Magnesium Sulfate 1 gm IV Flushing, Heart block, severe renal
Injection hypotension, impairment
burning sensation
in the face and
neck
Prochlorperazine IV Dilute 1 mL (10 mg) Drowsiness, Hypotension
with 4 mL normal saline extrapyramidal
(1 mL = 2 mg) symptoms
Inject 1 mL /3-5 min;
stop when headache
relieved; not to exceed
10 mg/dose
Valproate Sodium Injection 300-500 mg IV in normal Nausea, vomiting, Liver disease, pregnancy
saline at a rate of 20 tremor, dizziness
mg/minute
Refer to the first page of Appendix A for the key explaining the symbols.
Many of the medications listed are available in a variety of formulations for different routes of administration (e.g.,
oral, intravenous, rectal suppository).
www.icsi.org

Appendix B Drug Treatment for Adjunctive Therapy

Drug Dose Side Effects
Caffeine Minimum 65 mg by mouth Tremors, nausea
Metoclopramide 10 mg IV Drowsiness, extrapyramidal
symptoms
Prochlorperazine 5-10 mg IV, IM, or rectal Drowsiness, extrapyramidal
suppository 25 mg symptoms
Promethazine 25 mg IV over 1 minute, IM, or Drowsiness, extrapyramidal
rectal suppository symptoms

www.icsi.org

Appendix C Headache Clinical Summary

Diagnosis of Headache Type*
Accurate diagnosis of primary headache requires a thorough physical exam and detailed headache history to rule out
secondary causes (e.g., hematoma, tumor, metabolic disorders, craniocervical arterial dissection, hydrocephalus, etc.).
Neuroimaging, EEG, lumbar puncture, or cerebrospinal fluid and blood studies may be indicated to evaluate for secondary
causes. These tests are not indicated for primary headache diagnosis.
Warning signs of possible disorder other than primary headache:
o Headaches that worsen over weeks or months o Persistent headache brought on by cough, sneeze,
o New or different headache or "worst headache ever" bending over, or physical or sexual exertion
o Sudden, severe onset or "thunderclap" headache o Neurological signs suggestive of secondary cause:
o New onset of headaches after age 50 confusion, altered level of consciousness, memory
o Seizures impairment, papilledema, visual field defect, cranial
o Symptoms suggestive of systemic disorder: fever, nerve asymmetry, extremity weaknesses, clear
hypertension, myalgia, scalp tenderness, or weight sensory deficits, reflex asymmetry, extensor plantar
loss response, or gait disturbances
Criteria for Primary Headache Types

**
Migraine with or without aura : Cluster headache**:
o Two or more of the following: o Frequency: one every other day to 8 per day
Unilateral location o Severe unilateral orbital, supraorbital and/or
Pulsating or throbbing quality temporal pain
Moderate to severe intensity o Pain lasting 15 to 180 minutes untreated
Aggravated by routine activity o One or more of the following occur on same side
o Plus 1 or both of the following: as the pain:
Nausea/vomiting Conjunctival injection
Photophobia and phonophobia Lacrimation (tearing)
o Previous similar headaches Nasal congestion
o Aura criteria: Rhinorrhea
One or more reversible aura symptoms Forehead and facial swelling
One or more aura symptoms develop over more than Miosis (constricted pupil)
4 minutes, or two or more symptoms occur in Ptosis (eyelid drooping)
succession Eyelid edema
Symptoms do not last more than 60 minutes Agitation, unable to lie down
Headache follows within 60 minutes
Tension-type headache (Chronic and Episodic)**: Chronic daily headache:
o Two or more of the following: o Frequency: more than 15 days per month for
Bilateral location more than 3 months
Pressing or tightening quality o Not a separate diagnosis
Mild to moderate intensity o A category of a primary or secondary headache
Not aggravated by routine activity disorder
o For Chronic, all of the following:
Frequency: average of 15 or more headache days per Medication overuse headache:
month for more than 3 months o Frequency: 15 or more days per month
No vomiting o Regular overuse for more than 3 months of one or
No more than one of nausea, photophobia, or more drugs for symptomatic treatment of
phonophobia headache:
o For Episodic, all of the following: Ergotamine, triptans, opioids or combination
Frequency: less than 15 headache days per month analgesic medications on 10 or more days/
No vomiting or nausea month
No more than one of photophobia or phonophobia Simple analgesics or any combination of
ergotamine, triptans, analgesic opioids on 15
or more days/month, without overuse of any
1 class alone
o Developed or worsened during medication
overuse
www.icsi.org

Appendix C Headache Clinical Summary Eleventh Edition/January 2013
Prophylactic Treatment of Primary Headache

Migraine prophylactic treatment:
o Criteria:
Three or more severe migraines/month with inadequate response to symptomatic therapy
Less frequent but protracted attacks that impair patient's quality of life
Patient is interested in prophylactic treatment
o First-line treatment:
Beta blockers, calcium channel blockers, tricyclic antidepressants
Antiepileptics (divalproex, topiramate, gabapentin)
Patient education and lifestyle management
Screen for depression/anxiety
Other therapies available, but with varying levels of scientific support. Refer to complete guideline for this
information
o Second-line treatment:
Different first-line med class or different drug of same class
Combination of beta blockers and tricyclics
o If menstrual-associated migraine:
Consider cyclic prophylaxis with NSAIDs (first choice), triptans, OR
Hormone prophylaxis (transdermal estradiol, estrogen-containing contraceptives)
Suppress menstrual cycle with GnRH agonist and "add back" therapy
o If menopausal or perimenopausal migraine:
Consider hormone therapy (oral or transdermal estrogen, progestin, or estrogen-containing contraceptives)
Therapy success defined as 50% reduction in headache frequency and/or severity
Hormone therapy may worsen migraines in some women
o If using or considering estrogen-containing contraceptives:
Evaluate vascular risk factors, such as risk for CAD, history of blood clots, migraine with aura, smoking
Risk of ischemic stroke increases with use of estrogen-containing contraceptives
Women with prolonged aura, or those who have an aura for the first time while using estrogen containing
contraceptives, should be discouraged from using them.
Tension-type headache prophylactic treatment (more than 15 headaches/month):
o Amitriptyline and other tricyclic antidepressants; Venlafaxine XR
Treatment of Primary Headache
Early treatment of migraines, using effective medications, improves a variety of outcomes, such as duration, severity, and
disability associated with chronic pain.
Long-term and first-line use of opiates and barbiturates should be avoided due to lack of studies to support effectiveness, side
effects, and potential for abuse.
Mild migraine treatment (self-management): Adjunctive therapy for all migraines:
o APAP/ASA/Caffeine o Rest in quiet, dark room
o ASA alone o IV rehydration
o Lidocaine nasal o Antiemetics:
o Midrin Hydroxyzine
o NSAIDs Metoclopramide
o Triptans Prochlorperazine
Promethazine
Moderate migraine treatment: o Caffeine
o DHE (dihydroergotamine mesylate)
Cluster headache treatment:
o Lidocaine nasal
o Acute treatment:
o Midrin
Oxygen
o NSAIDs Sumatriptan SQ (self-management)
o Triptans Zolmitriptan nasal (self-management)
Severe migraine treatment: DHE
o Prochlorperazine o Bridge treatment (for quick suppression of attacks until
o Chlorpromazine maintenance treatment reaches therapeutic level):
o DHE Corticosteroids
o Ketorolac IM Occipital nerve block
o Magnesium Sulfate IV o Maintenance treatment (for sustained suppression of
o Triptans attacks over the expected cluster cycle):
Avoid alcohol during cycle
Verapamil
Steroids
Lithium
Depakote
Topiramate

www.icsi.org

Appendix C Headache Clinical Summary Eleventh Edition/January 2013
Treatment of Primary Headache (Continued)
Status (lasting > 72 hrs) treatment: Tension-type headache treatment:

o DHE unless contraindicated. Must not be given within o Acute treatment:
24 hours of receiving any triptan or ergot derivative. Acetaminophen
Must not be used in patients with: Aspirin
Pregnancy NSAIDs
History of ischemic heart disease Midrin
History of variant angina Avoid overuse of treatment meds
Hemiplegic or basilar-type migraine
Onset of chest pain following DHE test dose
o If not DHE, then:
Chlorpromazine
Valproate sodium IV
Magnesium Sulfate IV
Prochlorperazine
o If treatment unsuccessful:
Opiates (not meperidine)
Dexamethasone
Self-Management of Primary Headache

Potential migraine triggers to be avoided:
o Environmental--heat or cold, weather changes, flying or high altitude, bright lights, head or neck injury, odors
o Lifestyle--chronic stress, disturbed sleep, skipping meals or poor diet, smoking
o Hormonal--puberty, menstruation, pregnancy, menopause, oral contraceptives, estrogen therapy
o Emotional--anxiety, anger, depression, excitement, or "let down" response
o Dietary--citrus fruit, chocolate, aspartame, aged cheese, beer or red wine, caffeine, foods containing nitrates or MSG
o Medications--oral contraceptives, estrogen therapy, nifedipine, nitroglycerin
Patient education is especially important in the ongoing management of headache
o Most patients benefit from stress reduction, regular eating and sleeping schedules, and regular aerobic exercise
o Keeping a headache diary can help identify frequency, severity, triggers, and response to treatment
o The risk of chronic daily headaches is increased if headache treatment meds are used more than nine days a month
o Adherence to prophylactic treatment medications can lead to less frequent and less severe headache attacks
o It may not be possible to eliminate the primary headache completely
*Note: All information provided in this summary is for non-pregnant persons age 12 and over. Due to fetal risk and the complications
of medication management, pregnant women, those who desire to become pregnant, or those who are breastfeeding should be treated
based on the appropriate chronic pain and obstetrical guidelines.
** Other disorders have been ruled out, or if another disorder is present, the headaches did not start around the same time as the
disorder.
Used with permission by McKesson Health Solutions, 2012. The information contained in this Summary is based on the ICSI
guideline and is not a comprehensive review.
www.icsi.org

Disclosure of Potential Conflicts of Interest:
ICSI has long had a policy of transparency in declaring potential conflicting and
competing interests of all individuals who participate in the development, revision
and approval of ICSI guidelines and protocols.
In 2010, the ICSI Conflict of Interest Review Committee was established by the
Board of Directors to review all disclosures and make recommendations to the board
when steps should be taken to mitigate potential conflicts of interest, including
recommendations regarding removal of work group members. This committee
has adopted the Institute of Medicine Conflict of Interest standards as outlined in
the report, Clinical Practice Guidelines We Can Trust (2011).
Where there are work group members with identified potential conflicts, these are
disclosed and discussed at the initial work group meeting. These members are
expected to recuse themselves from related discussions or authorship of related
recommendations, as directed by the Conflict of Interest committee or requested
by the work group.
The complete ICSI policy regarding Conflicts of Interest is available at
http://bit.ly/ICSICOI.
Funding Source
The Institute for Clinical Systems Improvement provided the funding for this
guideline revision. ICSI is a not-for-profit, quality improvement organization
based in Bloomington, Minnesota. ICSI's work is funded by the annual dues of
the member medical groups and five sponsoring health plans in Minnesota and
Wisconsin. Individuals on the work group are not paid by ICSI but are supported
by their medical group for this work.
ICSI facilitates and coordinates the guideline development and revision process.
ICSI, member medical groups and sponsoring health plans review and provide
feedback but do not have editorial control over the work group. All recommenda-
tions are based on the work group's independent evaluation of the evidence.

Disclosure of Potential Conflicts of Interest

John Beithon, MD (Work Group Leader)
Physician, Family Medicine, Lakeview Clinic
National, Regional, Local Committee Affiliations: None
Guideline Related Activities: None
Research Grants: None
Financial/Non-Financial Conflicts of Interest: Spouse owns Pfizer stock from employer
Mary Gallenberg, MD (Work Group Member)
Physician, Gynecology, Mayo Clinic
Financial/Non-Financial Conflicts of Interest: None
Pamela Kildahl, RPh (Work Group Member)
Pharmacist, HealthPartners Medical Group and Regions Hospital
Julie Krenik, MD (Work Group Member)
Medical Director, Family Medicine, Hutchinson Medical Center
Mark Liebow, MD (Work Group Member)
Medical Consultant, Internal Medicine, Mayo Clinic
National, Regional, Local Committee Affiliations: Employer receives program support from a National
Institute of Health grant for ovarian cancer research. Mark is also a chair for senate district 26 DFL Govern-
ment Council, and a member of the American College of Physicians, MN Chapter
Linda Linbo, RN (Work Group Member)
Neurology, Mayo Clinic
Steven Peterson, PT (Work Group Member)
Clinic Manager, Physical Therapy, OSI Physical Therapy
Guideline Related Activities: ICSI Adult Acute and Subacute Low Back Pain Guideline Work Group
www.icsi.org

Disclosure of Potential Conflicts of Interest Eleventh Edition/January 2013
Jane Schmidt, NP (Work Group Member)

Nurse Practitioner, Family Medicine, Affiliated Community Medical Center
Jerry Swanson, MD (Work Group Member)
Consultant and Chair of Headache Division, Neurology, Mayo Clinic
Financial/Non-Financial Conflicts of Interest: Receives compensation from UpToDate as a headache docu-
ment editor
www.icsi.org

Acknowledgements:
All ICSI documents are available for review during the revision process by
member medical groups and sponsors. In addition, all members commit to
reviewing specific documents each year. This comprehensive review provides
information to the work group for such issues as content update, improving
clarity of recommendations, implementation suggestions and more. The
specific reviewer comments and the work group responses are available to
ICSI members at http://www.icsi.org/Headache.
The ICSI Patient Advisory Council meets regularly to respond to any
scientific document review requests put forth by ICSI facilitators and work
groups. Patient advisors who serve on the council consistently share their
experiences and perspectives in either a comprehensive or partial review of a
document, and engaging in discussion and answering questions. In alignment
with the Institute of Medicine's triple aims, ICSI and its member groups are
committed to improving the patient experience when developing health care
recommendations.

Acknowledgements
ICSI Patient Advisory Council
The work group would like to acknowledge the work done by the ICSI Patient Advisory Council in reviewing
the Diagnosis and Treatment of Headache and thank them for their suggestions on shared decision-making
topics related to diagnosis, treatment options and side effects, and related patient education.
Invited Reviewers
During this revision, the following groups reviewed this document. The work group would like to thank
them for their comments and feedback.
HealthPartners Health Plan, Minneapolis, MN
Lakeview Clinic, Waconia, MN
Marshfield Clinic, Marshfield, WI
Mayo Clinic, Rochester, MN
Medica Health Plan, Hopkins, MN
www.icsi.org

Document History and Development:
Document Drafted Original Work Group Members

Jan May 1997
John Beithon, MD Pamela Kildahl, RPh Wendy Milligan
First Edition Family Practice, Work Group Pharmacy Health Education
Aug 1998
Leader HealthPartners HealthPartners
Second Edition Lakeview Clinic Le Sedlacek, MN, CNS Chris Schroeder, RN
Jun 2000
Rick Carlson, MS Nursing Facilitator
Third Edition Measurement Advisor Minneapolis Clinic of ICSI
Jun 2001 HealthPartners Neurology Frederick Taylor, MD
Fourth Edition Elizabeth Detlie, MD Mark Liebow, MD Neurology
Aug 2002
Family Practice Internal Medicine Park Nicollet Clinic Health-
Fifth Edition North Suburban Family Mayo Clinic System Minnesota
Aug 2003 Clinicians Judy Mellesmoen Leonard Warren, MD
Sixth Edition David Dodick, MD Buyers Health Care Action Family Practice
Dec 2004 Neurology Group Representative Quello Clinic
Seventh Edition Mayo Clinic Carlson Companies
Feb 2006 Chris Hult, MD
Eighth Edition Family Practice
Feb 2007 HealthPartners
Ninth Edition
Apr 2009
Tenth Edition
Feb 2011
Eleventh Edition
Begins Feb 2013 The next revision will be no later than February 2018.
Contact ICSI at:

8009 34th Avenue South, Suite 1200; Bloomington, MN 55425; (952) 814-7060; (952) 858-9675 (fax)
Online at http://www.ICSI.org
ICSI Document Development and Revision Process

Overview
Since 1993, the Institute for Clinical Systems Improvement (ICSI) has developed more than 60 evidence-based
health care documents that support best practices for the prevention, diagnosis, treatment or management of a
given symptom, disease or condition for patients.
Audience and Intended Use

The information contained in this ICSI Health Care Guideline is intended primarily for health professionals and
other expert audiences.
This ICSI Health Care Guideline should not be construed as medical advice or medical opinion related to any
specific facts or circumstances. Patients and families are urged to consult a health care professional regarding their
own situation and any specific medical questions they may have. In addition, they should seek assistance from a
health care professional in interpreting this ICSI Health Care Guideline and applying it in their individual case.
This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical framework for the
evaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a
protocol for all patients with a particular condition.
Document Development and Revision Process

The development process is based on a number of long-proven approaches and is continually being revised
based on changing community standards. The ICSI staff, in consultation with the work group and a medical
librarian, conduct a literature search to identify systematic reviews, randomized clinical trials, meta-analysis,
other guidelines, regulatory statements and other pertinent literature. This literature is evaluated based on the
GRADE methodology by work group members. When needed, an outside methodologist is consulted.
The work group uses this information to develop or revise clinical flows and algorithms, write recommendations,
and identify gaps in the literature. The work group gives consideration to the importance of many issues as they
develop the guideline. These considerations include the systems of care in our community and how resources
vary, the balance between benefits and harms of interventions, patient and community values, the autonomy of
clinicians and patients and more. All decisions made by the work group are done using a consensus process.
ICSI's medical group members and sponsors review each guideline as part of the revision process. They provide
comment on the scientific content, recommendations, implementation strategies and barriers to implementation.
This feedback is used by and responded to by the work group as part of their revision work. Final review and
approval of the guideline is done by ICSI's Committee on Evidence-Based Practice. This committee is made up
of practicing clinicians and nurses, drawn from ICSI member medical groups.
Implementation Recommendations and Measures
These are provided to assist medical groups and others to implement the recommendations in the guidelines.
Where possible, implementation strategies are included that have been formally evaluated and tested. Measures
are included that may be used for quality improvement as well as for outcome reporting. When available, regu-
latory or publicly reported measures are included.
Document Revision Cycle
Scientific documents are revised every 12-24 months as indicated by changes in clinical practice and literature.
ICSI staff monitors major peer-reviewed journals every month for the guidelines for which they are responsible.
Work group members are also asked to provide any pertinent literature through check-ins with the work group
midcycle and annually to determine if there have been changes in the evidence significant enough to warrant
document revision earlier than scheduled. This process complements the exhaustive literature search that is done
on the subject prior to development of the first version of a guideline.
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*** Drug Safety Alert ***

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Migraine Treatment Tension-Type Headache Cluster Headache

Menstrual-Associated Perimenopausal or On Estrogen-Containing

Annotations: Pages 18-45

years old Causes for yes Consider secondary

Perform diagnostic Diagnosis of yes

Return to Table of Contents

Migraine Treatment Algorithm

Patient meets criteria

For information on adolescents The patient would enter this

Text in blue in this algorithm

indicates a linked corresponding

- 5 HT agonists others - 5 HT agonists

Consultation with no Successful?

Return to Table of Contents www.icsi.org

Tension-Type Headache Algorithm

Consider referral no Is patient candidate yes Therapy

67 Consider other acute or

Return to Table of Contents www.icsi.org

Cluster Headache Algorithm

Cluster headache The patient would enter this

Text in blue in this algorithm

Verapamil - high doses

Return to Table of Contents

Dihydroergotamine Mesylate (DHE) Algorithm

Text in blue in this algorithm

Return to Table of Contents www.icsi.org

Menstrual-Associated Migraine Algorithm

The patient would Patient meets criteria for Menstrual only

Return to Table of Contents www.icsi.org

Perimenopausal or Menopausal Migraine Algorithm

Perimenopausal or HT: newer terminology for HRT.

yes Specialty consultation

Text in blue in this algorithm Return to Table of Contents

On Estrogen-Containing Contraceptives or Considering Estrogen-

no Patient prefers yes

113 Headaches worsen?

Return to Table of Contents

Migraine Prophylactic Treatment Algorithm

Try different first-line

yes Continue treatment for

yes Continue treatment for

Return to Table of Contents www.icsi.org

Crosswalk between ICSI Evidence Grading System and GRADE

Return to Table of Contents

Scope and Target Population

Implementation Recommendation Highlights

Related ICSI Scientific Documents

10. Patient Presents with Complaint of a Headache

11. Critical First Steps

12. Causes for Concern?

13. Consider Secondary Headache Disorder

14. Meets Criteria for Primary Headache Disorder?

Modified Diagnostic Criteria

15. Evaluate Type of Primary Headache. Initiate Patient Education and

19. Chronic Daily Headache

20. Other Headache

21. Specialty Consultation Indicated?

* Drug Safety Alert *