The Incremental Effects of Manual

[ research report ]
J. HAXBY ABBOTT, DPT, PhD, FNZCP1 • CATHERINE M. CHAPPLE, PT, MManipPhty, PhD2 • G. KELLEY FITZGERALD, PT, PhD, FAPTA3
JULIE M. FRITZ, PT, PhD, ATC4 • JOHN D. CHILDS, PT, PhD5 • HELEN HARCOMBE, BPhty, MPH, PhD1,6 • KIRSTEN STOUT, RN1
The Incremental Effects of Manual

Therapy or Booster Sessions
in Addition to Exercise Therapy
for Knee Osteoarthritis:
Downloaded from www.jospt.org at on November 2, 2021. For personal use only. No other uses without permission.
A Randomized Clinical Trial

TTSTUDY DESIGN: A factorial randomized TTRESULTS: Of 75 participants recruited, 66
Copyright © 2015 Journal of Orthopaedic & Sports Physical Therapy®. All rights reserved.
controlled trial. (88%) were retained at 1-year follow-up. Factorial

TTOBJECTIVES: To investigate the addition of
analysis of covariance of the main effects showed
significant benefit from booster sessions
O
manual therapy to exercise therapy for the reduc-
(P = .009) and manual therapy (P = .023) over
tion of pain and increase of physical function in steoarthritis (OA) is a
exercise therapy alone. Group analysis showed that
people with knee osteoarthritis (OA), and whether
“booster sessions” compared to consecutive ses-
exercise therapy with booster sessions (WOMAC common disorder that
score, –46.0 points; 95% confidence interval [CI]:
sions may improve outcomes. –80.0, –12.0) and exercise therapy plus manual affects up to 40% of
TTBACKGROUND: The benefits of providing therapy (WOMAC score, –37.5 points; 95% CI: –69.7, adults and, according to
manual therapy in addition to exercise therapy, or –5.5) had superior effects compared with exercise
some sources, may affect more
Journal of Orthopaedic & Sports Physical Therapy®
of distributing treatment sessions over time using therapy alone. The combined strategy of exercise
periodic booster sessions, in people with knee OA therapy plus manual therapy with booster sessions than 80% of those over 65 years
are not well established. was not superior to exercise therapy alone. of age.4,12 Knee and hip OA
TTMETHODS: All participants had knee OA and TTCONCLUSION: Distributing 12 sessions of exer- are among the most common causes of
were provided 12 sessions of multimodal exercise cise therapy over a year in the form of booster ses-
pain and disability in older adults. Exer-
therapy supervised by a physical therapist. Par- sions was more effective than providing 12 consec-
utive exercise therapy sessions. Providing manual cise therapy is known to be effective19 and
ticipants were randomly allocated to 1 of 4 groups:
therapy in addition to exercise therapy improved is recommended as the first line of treat-
exercise therapy in consecutive sessions, exercise
treatment effectiveness compared to providing 12 ment for reducing pain and disability in
therapy distributed over a year using booster
consecutive exercise therapy sessions alone. Trial individuals with knee OA.13 However, re-
sessions, exercise therapy plus manual therapy
registered with the Australian New Zealand Clinical
without booster sessions, and exercise therapy cent systematic reviews indicate that these
Trials Registry (ACTRN12612000460808).
plus manual therapy with booster sessions. The benefits are generally modest for improve-
primary outcome measure was the Western Ontar- TTLEVEL OF EVIDENCE: Therapy, level 1b-.
ments in pain and function,19 and although
io and McMaster Universities Osteoarthritis Index J Orthop Sports Phys Ther 2015;45(12):975-983.
Epub 28 Sep 2015. doi:10.2519/jospt.2015.6015 similar to those of simple analgesics and
(WOMAC score; 0-240 scale) at 1-year follow-up.
TTKEY WORDS: arthralgia, OA, physical therapy
nonsteroidal anti-inflammatory drugs, ef-
Secondary outcome measures were the numeric
pain-rating scale and physical performance tests. techniques, randomized controlled trial fects are often short lived.8,19,22,30 Strategies
are needed to improve treatment effect.
Centre for Musculoskeletal Outcomes Research, Orthopaedic Surgery Section, Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
1
2
School of Physiotherapy, University of Otago, Dunedin, New Zealand. 3University of Pittsburgh, Pittsburgh, PA. 4University of Utah, Salt Lake City, UT. 5US Army-Baylor University, Schertz,
TX. 6Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand. The study protocol was approved by the Lower South Regional Ethics Committee of the New
Zealand Ministry of Health (LSR/10/11/055), and registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000460808). This research was supported in part by the
New Zealand Lottery Grants Board, the New Zealand Society of Physiotherapists Scholarship Trust, the Health Research Council of New Zealand, and a University of Otago Research Grant.
Dr Abbott was supported in part by a Sir Charles Hercus Health Research Fellowship from the Health Research Council of New Zealand. The funders have had no influence on the content
of that work or the current article. The authors certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject
matter or materials discussed in the article. Address correspondence to Dr J. Haxby Abbott, Centre for Musculoskeletal Outcomes Research, Department of Surgical Sciences, Dunedin
School of Medicine, University of Otago, PO Box 913, Dunedin, New Zealand. E-mail: haxby.abbott@otago.ac.nz t Copyright ©2015 Journal of Orthopaedic & Sports Physical Therapy®
journal of orthopaedic & sports physical therapy | volume 45 | number 12 | december 2015 | 975
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[ research report ]
Manual therapy is an intervention sions compared to no booster sessions. joint replacement surgery, and people
commonly combined with therapeutic Only 1 study testing this proposition has with knee OA on our clinical trials mail-
exercise in clinical practice,9 although the appeared in the literature, which found ing list. All participants provided written
research available to date cannot provide no benefit from booster sessions.10 There informed consent.
evidence as to whether it may improve is a pressing need to evaluate the effec- A research nurse screened each po-
the overall effectiveness of rehabilita- tiveness of regular follow-up via booster tential participant against the inclusion
tion for reducing pain and disability in sessions28,30 for maintaining the benefi- and exclusion criteria by chart review
patients with knee OA.1,14,15 A recent trial cial effect of interventions over longer- and telephone interview. Eligible partici-
that included patients with knee OA who term follow-up. pants had to be 40 years of age or older
were assigned exercise, manual therapy, In this randomized clinical trial, we and meet the American College of Rheu-
or a combination of exercise therapy plus investigated, in people with knee OA, matology clinical criteria for a diagnosis
manual therapy found that these inter- the effectiveness of providing manual of knee OA.5,6 Exclusion criteria were
ventions were superior to usual care with therapy in addition to exercise therapy rheumatoid arthritis; previous knee or
no additional therapy; however, no sig- as a strategy for increasing the ben- hip joint replacement surgery of the af-
nificant differences were found between eficial effects of exercise therapy, and fected joint; any other surgical proce-
the 3 intervention groups.1 In that trial, of regularly scheduled booster sessions dure on the lower limbs in the previous 6
the overall treatment contact time was as a strategy for optimizing the ben- months; surgical procedure on the lower
equivalent across treatments; however, eficial effects of interventions to 1-year limbs planned in the next 6 months; ini-
this meant that the participants in the follow-up. tiation of opioid analgesia or corticoste-
combined-therapy group did not receive The specific aims of the trial were roid or analgesic injection intervention
a comparable dose of supervised exercise (1) to investigate the effects of manual for hip or knee pain within the previous
therapy to that received by the exercise therapy combined with exercise therapy, 30 days; physical impairments unrelated
therapy group within the same allocated compared with exercise therapy alone, to the hip or knee that would prevent safe
time.1 There is a need to investigate the in improving pain, disability, and physi- participation in exercise, manual therapy,
incremental benefit of providing manual cal function; and (2) to compare the ef- walking, or stationary cycling; inability to
therapy in addition to exercise therapy fects of delivering the physical therapy comprehend and complete study assess-
for patients with knee OA compared with intervention using periodic booster ses- ments or comply with study instructions;
exercise therapy alone. sions versus not using booster sessions in or stated inability to attend or complete
A weakness of most studies of exer- improving pain, disability, and physical the proposed course of intervention and
cise therapy or manual therapy interven- function at 1-year follow-up. follow-up schedule.
tions has been the duration of follow-up, Potential participants attended an
such that most have only provided evi- METHODS appointment, at which an assessor con-
dence of short- to medium-term ef- firmed their eligibility and obtained
fectiveness. Few trials have followed Design written informed consent and baseline
T
participants beyond 3 to 6 months, and he present study was a random- measures. Baseline and follow-up testing
those that did have generally shown sig- ized controlled trial (RCT) with a was conducted by research staff blinded
nificant diminishment of effectiveness in parallel-group, factorial design and to group allocation. Eligible participants
the longer term.30 Strategies are needed a 1-year follow-up period. Data were col- were randomly allocated to each group
to facilitate longer-term maintenance of lected at the Outpatient Physiotherapy by a researcher who was not involved in
beneficial effects. Previous investigators and Orthopaedics Departments, Duned- participant assessment or treatment. The
and expert opinion14,17,18,30 recommend in Hospital, New Zealand. The study was random allocation sequence was gener-
that patients receive regular follow-ups approved by the Lower South Regional ated (by J.H.A.) with an online service
or “booster sessions” in the delivery of Ethics Committee of the New Zealand (http://www.randomization.com), in-
physical therapy. A recent systematic re- Ministry of Health (LSR/10/11/055) cluded randomly permuted blocks of 8
view heralded the benefits of booster ses- and registered with the Australian New and 12 participants per block, and was
sions in the delivery of exercise therapy Zealand Clinical Trials Registry (AC- concealed from recruitment staff, asses-
for people with OA of the hip or knee30; TRN12612000460808). Participants sors, and treatment providers. The allo-
however, critical examination of the were recruited in Dunedin, New Zea- cation ratio was 1:1:1:1.
studies from which these recommen- land from 3 sources: patients present-
dations were made reveals that most of ing to physical therapy with knee pain, Interventions
those primary studies did not, in fact, in- patients referred for orthopaedic consul- Following baseline testing, participants
vestigate the effectiveness of booster ses- tation for knee OA but not eligible for with knee OA were randomized to 1 of
976 | december 2015 | volume 45 | number 12 | journal of orthopaedic & sports physical therapy
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TABLE 1 Brief Description of the Exercise Therapy and Manual Therapy Interventions*
Therapy Type/Intervention Description

Exercise†
Mandatory interventions 1. Aerobic exercise: up to 10 minutes, cycle or walk
2. Strengthening: 3 sets of 10 repetitions of knee extension, hip extension, knee flexion. Resistance adjusted
as appropriate
3. Stretching: 60-second passive stretch of knee flexors, knee extensors, ankle plantar flexors
4. Neuromuscular coordination control exercises: 3 sets of 2 minutes of (choose from) standing weight shifting,
standing balance on uneven surfaces, sidestepping, forward/backward and shuttle walking drills, stair walking
Secondary (nonmandatory) interventions, prescribed when 1. Ankle plantar flexor strengthening, hip abductor strengthening, hip lateral rotator strengthening, hip flexor
indicated by assessment findings and knee extensor stretching, trunk muscle strengthening
Home exercise program 1. Prescribe up to 6 of the above activities to reinforce clinic interventions
Manual‡
Mandatory interventions 1. Knee flexion: nonthrust physiologic motion
2. Anteroposterior-directed force to the tibia, tibiofemoral joint: nonthrust
3. Knee extension: nonthrust physiologic motion

4. Posteroanterior-directed force to the tibia, tibiofemoral joint: nonthrust
5. Patellar gliding force: nonthrust
6. Manual stretch to quadriceps, hamstrings, triceps surae muscles
7. Soft tissue manipulation: quadriceps and peripatellar connective tissue, hamstrings, hip adductors, and triceps
surae muscles
Secondary (nonmandatory) interventions prescribed when 1. Long-axis hip distraction with thrust
indicated by assessment findings
2. Lateral hip distraction: nonthrust
3. Anteroposterior-directed force to proximal femur: nonthrust

4. Posteroanterior-directed force to proximal femur: nonthrust
5. Medial hip rotation: nonthrust
6. Soft tissue manipulation to hip and thigh musculature and fascia
7. Manual stretches to connective tissue of hip and thigh
8. Ankle and talocalcaneal joint distraction: thrust or nonthrust
9. Ankle talocrural anteroposterior-directed force: nonthrust
10. Anteroposterior-directed force to distal fibula, tibiofibular joint: nonthrust
11. Soft tissue manipulation: ankle plantar flexor muscle group
12. Lumbopelvic rotation: thrust manipulation
Home program of reinforcing activities 1. Prescribe up to 6 range-of-motion activities to reinforce clinic interventions
*A full description of the intervention protocol and procedures is available from the corresponding author.
†
Supervised exercise physical therapy. The exercise therapy protocol did not allow therapist-applied manual forces.
‡
Individualized manual physical therapy. Manual therapy was defined as skilled therapist–applied manual procedures intended to modify the quality
and range of motion of the target joint and associated soft tissue structures. The manual therapy protocol did not provide or prescribe aerobic, strengthening,
or neuromuscular control exercises. The home program of reinforcing activities did not include any exercise therapy exercises.
4 groups: (1) exercise therapy without booster sessions (ExB+MT). Factor 1 was warm-up/aerobic, muscle strengthening,
booster sessions (Ex), (2) exercise therapy therefore booster versus no booster; fac- muscle stretching, and neuromuscular
with booster sessions (ExB), (3) exercise tor 2 was exercise alone versus exercise control exercises (TABLE 1). Additional exer-
therapy plus manual therapy with no plus manual therapy. cise therapy interventions were prescribed
booster sessions (Ex+MT), or (4) exer- The exercise therapy protocol consisted individually for each participant, based on
cise therapy plus manual therapy with of a multimodal, supervised program of the physical examination findings, from a
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[ research report ]
limited list of interventions. In the case
of bilateral symptoms, the limb with the Characteristics of Participants
TABLE 2
greatest numeric pain-rating scale (NPRS) at Entry to the Trial*
score at baseline assessment was consid-
ered the affected limb, and treatment was ExB+MT
targeted to that limb. All participants were Ex (n = 19) ExB (n = 19) Ex+MT (n = 18) (n = 19)
provided twelve 45-minute sessions of ex- Demographic
ercise therapy, supervised and progressed Men, n (%) 8 (42) 8 (42) 6 (33) 7 (37)
by a physical therapist. The dose of exer- Women, n (%) 11 (58) 11 (58) 12 (67) 12 (63)
cise therapy was therefore balanced across
Age, y 64  10 65  10 61  12 64  10.2
all of the groups.
Body mass index, kg/m2 29.2  6.1 30.2  5.6 27.6  4.7 29.8  6.6
Participants randomized to the no-
booster condition received 12 consecutive Clinical
sessions of their assigned intervention in WOMAC score (0-240)† 70.9  45.1 108.4  54.8 71.1  42.8 93.5  50.1
the first 9 weeks of the study. We defined Pain-intensity score (0-10)‡ 2.1  1.2 3.4  2.1 2.8  1.9 2.5  1.5
booster sessions as sessions of supervised Timed up-and-go test, s 7.8  1.8 7.8  2.3 7.2  2.1 9.2  3.1
therapy provided at time intervals sepa-
40-meter self-paced walk time, s 31.7  5.8 32.2  7.3 30.1  7.3 35.7  10.1
rated from the consecutive sessions of the
30-second sit-to-stand test, n 10.8  5.1 10.8  3.1 12.2  4.7 8.3  5.0
initial episode of care, with intervening
periods of no supervised therapy provi- Bilateral symptoms, n (%) 10 (53) 12 (63) 6 (33) 13 (68)
sion. Participants randomized to receive Duration of symptoms, n
booster sessions had their assigned inter- Less than 1 y 3 4 4 5
vention distributed in the following man- 1-2 y 2 3 4 4
ner: 8 consecutive sessions in the first 9
3-5 y 3 3 1 3
weeks, 2 booster sessions at 5 months, 1
5-10 y 9 4 2 3
booster session at 8 months, and 1 boost-
er session at 11 months, also for a total More than 10 y 2 5 7 4
of 12 sessions. We selected 3-month in- Abbreviations: Ex, exercise therapy without booster sessions; Ex+MT, exercise therapy plus manual
therapy with no booster sessions; ExB, exercise therapy with booster sessions; ExB+MT, exercise
tervals between booster sessions because therapy plus manual therapy with booster sessions; MT, manual therapy; WOMAC, Western Ontario
it appears likely that benefits from exer- and McMaster Universities Osteoarthritis Index.
cise programs may diminish within this *Values are mean  SD unless otherwise indicated.
†
Lower scores represent less pain, stiffness, and disability.
period.30 ‡
Higher scores represent more pain.
The manual therapy protocol consist-
ed of procedures intended to modify the
quality and range of motion of the target ment records were conducted through- individuals with knee OA.25 Minimum
joint and associated soft tissue structures. out the trial to assess provider adherence important change has been shown to be
Additional manual therapy interventions and treatment progression. Due to the approximately 20% of baseline score.7
were prescribed individually for each nature of the interventions, it was not We also assessed treatment success,
participant randomized to this interven- possible to blind treatment providers to defined according to the Outcome Mea-
tion, based on the physical examination group allocation. sures in Rheumatoid Arthritis Clinical
findings, from a limited list of interven- Trials-Osteoarthritis Research Society
tions defined in our protocol (TABLE 1). Outcome Measures International (OMERACT-OARSI) re-
This manual therapy protocol has been The primary outcome variable was sponder criteria,29; as either (1) greater
shown to be effective in earlier research.1 change in the Western Ontario and Mc- than or equal to 50% improvement in the
Participants allocated to manual therapy Master Universities Osteoarthritis Index WOMAC pain or function subscales and
were provided twelve 30- to 45-minute (WOMAC) total score. We used WOMAC an absolute improvement of greater than
sessions of manual therapy in addition to Version NRS 3.1, in which each of the or equal to 20 points when transformed
the exercise therapy sessions. 24 items is rated on a 0-to-10 numeric to a 0-to-100 scale, or (2) at least 2 of
All interventions were provided by rating scale, for a total scale range of 0 the following: (a) pain reduction greater
physical therapists at Dunedin Hospi- to 240 points. The WOMAC is a well- than or equal to 20% from baseline and
tal, following training in delivery of the established, disease-specific measure of absolute change greater than or equal to
intervention protocols. Audits of treat- pain, stiffness, and physical function for 10 (WOMAC pain score, 0-100 scale), (b)
45-12 Abbott.indd 978 11/16/2015 6:50:30 PM

Assessed for eligibility, n = 134 Declined to participate, n = 3
Did not meet inclusion criteria, n = 4
• Less than 40 years of age, n = 3
• Did not meet ACR criteria, n = 1
Excluded, n = 52
• Unable to attend, n = 16
• Inflammatory arthritis, n = 10
• Prior TKR or TKR planned, n = 6
• Other prior surgery, n = 2
• Insufficient communication ability, n = 2
Randomized, n = 75 • Other reasons, n = 16
Allocation
Ex, n = 19 ExB, n = 19 Ex+MT, n = 18 ExB+MT, n = 19

Received allocated interven- Received allocated interven- Received allocated interven- Received allocated interven-
tion, n = 19 tion, n = 19 tion, n = 18 tion, n = 19
Lost to follow-up, n = 1 Lost to follow-up, n = 3 Lost to follow-up, n = 1 Lost to follow-up, n = 4

12-month
follow-up
• Unable to contact, n = 1 • Illness, n = 1 • Time commitments, n = 1 • Unable to contact, n = 1

• Personal reasons, n = 1 • Declined, n = 2
• Unknown, n = 1 • Declined due to pain, n = 1
Analysis
Included in complete case Included in complete case Included in complete case Included in complete case
analysis, n = 18 analysis, n = 16 analysis, n = 17 analysis, n = 15
FIGURE. Flow diagram. Abbreviations: ACR, American College of Rheumatology; Ex, exercise therapy without booster sessions; Ex+MT, exercise therapy plus manual therapy
with no booster sessions; ExB, exercise therapy with booster sessions; ExB+MT, exercise therapy plus manual therapy with booster sessions; TKR, total knee replacement.
functional improvement greater than or with paired baseline and follow-up val- variables as those of the primary analysis.
equal to 20% from baseline and abso- ues.32 We therefore used ANCOVA linear The appropriateness of imputed values
lute change greater than or equal to 10 regression as the primary analysis to as- was assessed. Multiple imputed (pri-
(WOMAC function score, 0-100 scale), or sess main effects and the interaction ef- mary) and complete case analyses were
(c) patient global assessment of change of fect between groups, adjusting for age, performed for the primary outcome,
4 or greater (scale, –7 to 7) assessed using sex, and bilateral symptoms at base- as recommended by CONSORT, with
the global rating of change instrument.21 line.24,27 To determine whether the data the imputed analysis performed for the
Secondary outcome measures in- violated statistical assumptions of linear intention-to-treat analysis and the com-
cluded the NPRS,2 the timed up-and-go regression, we used Shapiro-Wilk and plete case analysis to reveal any sensitiv-
test, the 30-second sit-to-stand test, and skewness/kurtosis tests of the regression ity to the imputed values.26
the 40-meter fast-paced walk test.16 As- residuals and residuals plots. An inten- We also reported the number needed
sessors were trained in the assessment tion-to-treat analysis, with 20 multiple to treat (NNT) by the trial intervention
methods and blinded to group allocation. imputations for each missing value,33 groups (groups 2-4) compared with the
was conducted with the “mi” suite of reference group (group 1, Ex) to achieve
Statistical Analysis commands in the Stata Version 13.1 sta- a gain of 1 additional OMERACT-OAR-
An analysis of covariance (ANCOVA) is tistical package (StataCorp LP, College SI responder, as well as mean change in
the preferred method of analyzing RCTs Station, TX), using the same explanatory the secondary outcome measures from
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[ research report ]
baseline to 1-year follow-up. Differences
in means were analyzed using an AN- Results of the Adjusted Analysis-of-
TABLE 3
COVA adjusted for age, sex, and bilateral Covariance Regression Models*
symptoms at baseline. Only the results of
complete case analyses were reported for Multiple Imputation, m = 20 (n = 75)† Complete Case Analysis (n = 66)
secondary outcomes.
Coefficient‡ P Value Coefficient‡ P Value
RESULTS Treatment groups

Ex Reference ... Reference ...
O
f 75 participants recruited ExB –46.0 (–80.0, –12.0) .009 §
–46.9 (–79.4, –14.4) .005§
from April 2011 to June 2012, 66 Ex+MT –37.5 (–69.7, –5.3) .023§ –37.3 (–68.8, –5.8) .021§
(88%) were retained at 1-year fol- ExB+MT –1.5 (–35.3, 32.3) .928 –2.0 (–34.9, 30.9) .905
low-up. The participants are described
Age 0.2 (–1.4, 1.0) .747 –0.2 (–1.3, 0.9) .727
in TABLE 2. The FIGURE shows the flow of

Sex
participants through the trial.
In the intention-to-treat ANCOVA fac- Male Reference ... Reference ...
torial model with multiple imputation of Female –5.2 (–29.2, 18.9) .669 –4.4 (–28.6, 19.7) .715
missing outcome data, the main effects Bilateral symptoms
for both manual therapy (WOMAC score, No Reference ... Reference ...
–37.49 points; 95% confidence interval

Yes 12.2 (–13.4, 37. 8) .342 12.7 (–11.3, 36.8) .293
[CI]: –69.72, –5.26; P = .023) and booster
Abbreviation: Ex, exercise therapy without booster sessions; Ex+MT, exercise therapy plus manual
sessions (WOMAC score, –46.02 points; therapy with no booster sessions; ExB, exercise therapy with booster sessions; ExB+MT, exercise
95% CI: –80.04, –11.99; P = .009) were therapy plus manual therapy with booster sessions; MT, manual therapy.
clinically and statistically significant. How- *Values are Western Ontario and McMaster Universities Osteoarthritis Index points (0-240 scale),
with lower scores (negative difference) indicating improvement.
ever, the factorial analysis also identified a †
Adjusted for age, sex, and bilateral symptoms at baseline.
statistically significant interaction effect (P ‡
Values in parentheses are 95% confidence interval.
= .001) between interventions of manual
§
Statistically significant at 2-sided P<.05.
therapy and booster sessions, which there-

fore required an analysis of all results by significant difference was seen for the studies showed conflicting results re-
group, with group 1 (Ex) as the reference 30-second sit-to-stand test, with ExB su- garding the effectiveness of combined
group.24,27 The results, reported in TABLE perior to Ex (TABLE 4). manual therapy plus exercise therapy
3, indicate that groups 2 and 3 (ExB and for knee OA.14,15,20,23 The present finding
Ex+MT) showed outcomes superior to DISCUSSION builds on a recent report that found both
those of the reference group (Ex), while the exercise therapy and manual therapy in
O
outcomes of group 4 (ExB+MT) were not ur results indicated that pro- addition to usual medical care to provide
superior to those of Ex. The model using viding either manual therapy or benefits superior to those of usual medi-
only complete cases was consistent with booster sessions, in addition to cal care alone.1 That trial also included
the imputed intention-to-treat model. exercise therapy, conferred incremental combined exercise therapy plus manual
Treatment success, as defined by the benefits over providing exercise therapy therapy, which did not provide signifi-
OMERACT-OARSI responder criteria, was alone. However, our results did not sup- cant benefits over either intervention
observed among 36 of 66 (54.5%) complete port the hypothesis that providing both alone. However, in that trial, all condi-
cases. The NNT, reported in TABLE 4, was manual therapy and booster sessions in tions received approximately the same
statistically significant for groups 2 and 3 addition to exercise results in incremental treatment contact time. Consequently,
(ExB and Ex+MT) compared with the ref- benefit. In fact, we detected a strong in- in the combined exercise therapy plus
erence group (Ex). Group 4 (ExB+MT) was teraction effect between manual therapy manual therapy condition the delivered
not superior to Ex. These results were con- and booster sessions that resulted in a di- dose was reduced compared with that in
sistent with the ANCOVA model. minished effect in that combined group. the separately delivered exercise therapy
Change in pain intensity (NPRS) These results indicate that benefits, and manual therapy conditions.1 This is
significantly favored the Ex+MT group in terms of pain and self-reported dis- an important distinction between that
(TABLE 4). While change in physical per- ability at 1-year follow-up, result from trial and the present trial, in which all
formance test scores generally favored providing 12 sessions of manual therapy exercise conditions were equivalent and
group 2 (ExB), the only statistically in addition to exercise therapy. Earlier the manual therapy sessions were addi-
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TABLE 4 Changes in Secondary Outcome Measures From Baseline to 1-Year Follow-up*
Secondary Outcome Ex ExB Ex+MT ExB+MT

Mean  SD (range) total treatment time, min 440  137 (60-570) 346  167 (0-555) 741  192 (227-960) 622  237 (180-970)
Total WOMAC score (0-240)† 5.0 (–14.2, 24.3) –51.1 (–82.2, –20.0)‡ –34.2 (–57.5, –11.0)‡ –3.3 (–30.9, 24.2)
Pain-intensity score (0-10)§ 1.0 (–0.3, 2.3) –1.0 (–2.3, 0.3) –1.3 (–2.5, –0.1)‡ 1.2 (–0.4, 2.8)
Timed up-and-go test, s ‖
0.4 (–0.4, 1.3) –0.6 (–1.9, 0.7) 0.4 (–0.8, 1.5) 0.3 (–1.4, 2.0)
40-meter self-paced walk time, s‖ –0.5 (–3.7, 2.7) –2.4 (–6.1, 1.5) –1.4 (–4.3, 1.6) –1.1 (–1.5, 3.6)
30-second sit-to-stand test, n¶ 0.2 (–1.8, 2.1) 2.7 (1.4, 3.9)‡ 2.1‡ (0.7, 3.4)‡ 1.2 (–0.9, 3.3)
Adverse events, n 1# 0 0 1**
NNT to gain 1 additional OMERACT-OARSI responder††

Reference 2.8 (1.7, 50.5) 2.7 (1.7, 23.4) NA‡‡
Abbreviations: Ex, exercise therapy without booster sessions; Ex+MT, exercise therapy plus manual therapy with no booster sessions; ExB, exercise therapy
with booster sessions; ExB+MT, exercise therapy plus manual therapy with booster sessions; MT, manual therapy; NA, not available; NNT, number needed
to treat; OMERACT-OARSI, Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International responder criteria;
WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.
*Complete case analysis (n = 66). Values are mean change (95% confidence interval) in test score (or time) from baseline to 1 year unless otherwise indicated.
†
A lower score (negative difference) is better.
‡
P<.05 compared with exercise therapy only (reference), adjusted for baseline value, age, sex, and bilateral symptoms at baseline.
§
Negative scores indicate reduced pain.
‖
Negative times represent shorter time to complete, indicating improvement.
¶
Positive values represent more repetitions, indicating improvement.
#
Possibly trial-related hip pain associated with exercise.
**Possibly trial-related fall onto knee associated with exercise.
††
As defined in Pham et al.29
‡‡
Unable to calculate (nonsignificantly less than reference).
tional. This trial indicates that, keeping group). The content of the booster ses- number of participants per group, and
content and dose of exercise equivalent, sions might have differed slightly. In the therefore greater uncertainty of treat-
the addition of manual therapy confers trial by Bennell et al,10 the home exercise ment effect and higher risk of chance
additional benefits. However, that in- program was reviewed and the patient findings compared with larger trials.
cremental benefit carries the additional was observed performing the home ex- An important difference between this
cost of providing the manual therapy in- ercises, whereas in the present trial the trial and the previous trial investigating
tervention, which required an additional full supervised intervention protocol was the effectiveness of booster sessions10 was
300 minutes per participant of therapist completed and the home exercises were that, in the present trial, the nonbooster
time (TABLE 4). reviewed. Also, the duration of follow-up and booster conditions had equal treat-
The results indicating benefit from was shorter in that trial (36 weeks) com- ment time, whereas in the study by Ben-
booster sessions are contrary to the re- pared to that of the current trial (1 year), nell et al,10 the booster condition had
cent findings of Bennell et al,10 who found while within-group treatment standard- 2 additional sessions. In this trial, all
that 2 booster sessions did not influence ized effect size (calculated from reported groups had 12 exercise therapy sessions,
pain or physical function outcomes in results) was greater in the trial by Bennell only distributed differently over the
patients with knee OA who completed et al10 (approximately 0.78 at 13 weeks11) 12-month duration of the trial. In fact,
a 12-week course of physical therapist– than it was in the present trial (0.1 for ex- the ExB group participants consumed
supervised exercise. The age of the par- ercise alone at 1 year). This indicates that 93 minutes less therapist contact time,
ticipants, the duration and severity of there was considerably more room for on average, over the 12 months. Yet, we
their symptoms, the content of the inter- improvement in treatment effect in the found superior benefits in terms of self-
vention, its intensity, and the number of current trial than there was in the study reported disability and the 30-second
visits were similar to those of the present by Bennell et al.10,11 It also reveals an sit-to-stand test from distributing ses-
study. However, the booster sessions were unexpectedly low treatment effect from sions over 12 months, to include booster
shorter in the trial by Bennell et al10 (30 the Ex intervention group in the current sessions, rather than providing all 12 ses-
minutes) compared to the present trial trial, compared with the previous trial on sions in the first 9 weeks.
(approximately 45 minutes in the ExB which its treatment protocol was based.1 The finding of an adverse interac-
group and 75 minutes in the ExB+MT However, the current trial had a lower tion effect between manual therapy and
45-12 Abbott.indd 981 11/16/2015 6:50:31 PM

[ research report ]
booster sessions, that is, lower WOMAC ous outcome (WOMAC) being skewed interaction effect seen in the ExB+MT
change in the combination condition at follow-up assessment, which risks group was contradictory. The dose of in-
compared with each intervention indi- violating the assumptions of common terventions delivered has differed among
vidually, was perplexing. The ExB+MT parametric statistical methods, such as trials in the literature and is very likely to
group did receive less therapist contact linear regression. Given that supervised be a factor determining treatment effect.
time than the Ex+MT group (622 min- exercise is a known effective therapy,13,19 The incremental effectiveness of these
utes compared with 740 minutes, on it was not surprising that improvement interventions therefore remains unre-
average), but more than the Ex and ExB in all groups at follow-up led to skewed solved, and further research will be nec-
groups (TABLE 4). This trial was not de- distribution of the WOMAC scores. This essary to resolve the aims of this trial. We
signed to reveal mechanisms, so potential is common following treatment in mus- are aware of a larger, recently completed
explanations are conjecture. The simplest culoskeletal conditions.3 However, AN- study (ClinicalTrials.gov; NCT01314183),
and therefore most likely explanation is COVA has been established as robust to the results of which provide further
that the interaction effect may be sim- nonnormally distributed data31 and is the evidence toward establishing whether
ply a chance finding due to the relatively preferred statistical analysis for RCTs,32 booster sessions and/or manual therapy
small individual group sizes (n = 18 or and our statistical analysis of the regres- provide incremental benefits in addition
19 per group) in this trial, which was sion residuals indicated acceptable con- to exercise therapy.
intended to test the main effects within formance to a normal distribution. The
the factorial design (ie, n = 37 or 38 per NNT analysis of difference in propor- CONCLUSION
factor). This might have introduced in- tions of responders between the groups
D
stability in the resulting per-group find- (TABLE 4) is not subject to distributional istributing supervised exercise
ings, leading to type II error in finding no assumptions and was consistent with therapy sessions over the course of
significant effect for the ExB+MT group. the ANCOVA. Another potential weak- 1 year, in the form of 8 initial ses-
This explanation may indicate that in- ness was the chance inequivalence in the sions in the first 2 months, then 4 booster
terpretation should rest with the pri- primary outcome (WOMAC) at baseline; sessions at 5, 8, and 11 months, improved
mary factorial analysis, which indicated however, the ANCOVA controls for base- outcomes at 1 year compared with deliv-
that providing either manual therapy or line, and all of our analyses resulted in ery of 12 consecutive sessions of super-
booster sessions, in addition to exercise the same interpretations for both self- vised exercise therapy within 2 months,
therapy, conferred incremental benefits reported disability and pain. Therefore, without additional therapist contact
over providing exercise therapy alone. If we believe that our results are statisti- time. The addition of 12 sessions of in-
the interaction results represent a real cally robust. Both the factorial and the dividually tailored manual therapy to 12
phenomenon, the mechanism cannot be per-group analyses showed statistically sessions of supervised exercise therapy,
determined and would require further significant results in favor of the booster delivered over 2 months, also improved
investigation. and manual therapy interventions. How- outcomes at 1 year, while also requiring
A strength of the present trial was ever, because we were forced to conduct additional therapist time. However, pro-
the use of exercise therapy and manual a per-group analysis following the facto- viding manual therapy distributed over
therapy protocols previously shown to be rial analysis, due to the adverse inter- 12 months using booster sessions in ad-
effective.1 Also, all participants were allo- action effect between the main factors, dition to supervised exercise therapy did
cated a standard dose of twelve 45-min- this resulted in a relatively small sample not provide incremental benefit at 1 year
ute sessions of standardized exercise size per group. Therefore, the data may compared with delivery of 12 consecutive
therapy, so all comparisons can be attrib- be variable and susceptible to chance sessions of supervised exercise therapy
uted to the allocated group conditions. findings, so we recommend further alone, and required additional thera-
We consider the results to be generaliz- investigation. pist time. Further research is required
able to clinical practice, as we excluded While the results of this trial indicate to establish the incremental benefits of
few patients with knee OA, the included that booster sessions or manual therapy booster sessions and/or manual therapy
patients represented a wide spectrum of provide incremental benefits in addition in addition to exercise therapy. t
symptom severity, the trial was set in a to exercise therapy, these results are not
busy hospital physical therapy clinic, and definitive: the booster session results in KEY POINTS
the clinicians providing the interventions this trial do not concur with the results FINDINGS: Providing manual therapy in
were not selected on the basis of special- of Bennell et al,10 the Ex group in the addition to exercise therapy improved
ist skills or qualifications and received current trial showed lower-than-expect- treatment effectiveness compared with
only in-service training. A potential ed treatment effect compared with the providing 12 consecutive exercise thera-
threat to the analysis was the continu- protocol on which it was based,1 and the py sessions only. Distributing 12 exercise
45-12 Abbott.indd 982 11/16/2015 6:50:31 PM

therapy sessions over a year in the form with hip osteoarthritis. Phys Ther. 2011;91:1525- 23. J ansen MJ, Viechtbauer W, Lenssen AF, Hen-
of booster sessions was more effective 1541. http://dx.doi.org/10.2522/ptj.20100430 driks EJ, de Bie RA. Strength training alone,
than providing consecutive exercise 10. Bennell KL, Kyriakides M, Hodges PW, Hinman exercise therapy alone, and exercise therapy
RS. Effects of two physiotherapy booster sessions with passive manual mobilisation each re-
therapy sessions. on outcomes with home exercise in people with duce pain and disability in people with knee
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11. Bennell KL, Kyriakides M, Metcalf B, et al. Neu- 24. McAlister FA, Straus SE, Sackett DL, Altman
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[ research report ]

The Incremental Effects of Manual

A Randomized Clinical Trial

controlled trial. (88%) were retained at 1-year follow-up. Factorial

journal of orthopaedic & sports physical therapy | volume 45 | number 12 | december 2015 | 975

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Therapy Type/Intervention Description

3. Knee extension: nonthrust physiologic motion

3. Anteroposterior-directed force to proximal femur: nonthrust

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Ex, n = 19 ExB, n = 19 Ex+MT, n = 18 ExB+MT, n = 19

Lost to follow-up, n = 1 Lost to follow-up, n = 3 Lost to follow-up, n = 1 Lost to follow-up, n = 4

• Unable to contact, n = 1 • Illness, n = 1 • Time commitments, n = 1 • Unable to contact, n = 1

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RESULTS Treatment groups

in TABLE 2. The FIGURE shows the flow of

–37.49 points; 95% confidence interval

therapy and booster sessions, which there-

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Secondary Outcome Ex ExB Ex+MT ExB+MT

NNT to gain 1 additional OMERACT-OARSI responder††

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tis of the knee: a randomized comparison of

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