Cochrane Pilates
Cochrane Pilates
Cochrane Pilates
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Cochrane Database of Systematic Reviews
Yamato TP, Maher CG, Saragiotto BT, Hancock MJ, Ostelo RWJG, Cabral CMN, Menezes Costa LC,
Costa LOP
Yamato TP, Maher CG, Saragiotto BT, Hancock MJ, Ostelo RWJG, Cabral CMN, Menezes Costa LC, Costa LOP.
Pilates for low back pain.
Cochrane Database of Systematic Reviews 2015, Issue 7. Art. No.: CD010265.
DOI: 10.1002/14651858.CD010265.pub2.
www.cochranelibrary.com
TABLE OF CONTENTS
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 9
OBJECTIVES.................................................................................................................................................................................................. 10
METHODS..................................................................................................................................................................................................... 10
RESULTS........................................................................................................................................................................................................ 12
Figure 1.................................................................................................................................................................................................. 13
Figure 2.................................................................................................................................................................................................. 16
Figure 3.................................................................................................................................................................................................. 17
Figure 4.................................................................................................................................................................................................. 18
DISCUSSION.................................................................................................................................................................................................. 19
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 20
ACKNOWLEDGEMENTS................................................................................................................................................................................ 20
REFERENCES................................................................................................................................................................................................ 21
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 25
DATA AND ANALYSES.................................................................................................................................................................................... 45
Analysis 1.1. Comparison 1 Pilates versus minimal intervention, Outcome 1 Pain.......................................................................... 46
Analysis 1.2. Comparison 1 Pilates versus minimal intervention, Outcome 2 Disability.................................................................. 47
Analysis 1.3. Comparison 1 Pilates versus minimal intervention, Outcome 3 Function................................................................... 47
Analysis 1.4. Comparison 1 Pilates versus minimal intervention, Outcome 4 Global impression of recovery................................ 47
Analysis 2.1. Comparison 2 Pilates versus other exercises, Outcome 1 Pain.................................................................................... 48
Analysis 2.2. Comparison 2 Pilates versus other exercises, Outcome 2 Disability............................................................................ 48
Analysis 2.3. Comparison 2 Pilates versus other exercises, Outcome 3 Function............................................................................. 49
ADDITIONAL TABLES.................................................................................................................................................................................... 49
APPENDICES................................................................................................................................................................................................. 50
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 61
DECLARATIONS OF INTEREST..................................................................................................................................................................... 61
SOURCES OF SUPPORT............................................................................................................................................................................... 61
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 61
INDEX TERMS............................................................................................................................................................................................... 62
[Intervention Review]
Tiê P Yamato1, Christopher G Maher1, Bruno T Saragiotto1, Mark J Hancock2, Raymond WJG Ostelo3, Cristina MN Cabral4, Luciola C
Menezes Costa4, Leonardo OP Costa4,5
1Musculoskeletal Division, The George Institute for Global Health, Sydney Medical School, The University of Sydney, Sydney, Australia.
2Faculty of Human Sciences, Macquarie University, Sydney, Australia. 3Department of Health Sciences, EMGO Institute for Health and
Care Research, VU University, Amsterdam, Netherlands. 4Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de
São Paulo, São Paulo, Brazil. 5Faculty of Medicine, The University of Sydney, Australia, The George Institute for Global Health, Sydney,
Australia
Contact: Leonardo OP Costa, Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário
Galeno,448, São Paulo, 03071-000, Brazil. lcosta@george.org.au, lcos3060@gmail.com.
Citation: Yamato TP, Maher CG, Saragiotto BT, Hancock MJ, Ostelo RWJG, Cabral CMN, Menezes Costa LC, Costa LOP. Pilates for low back
pain. Cochrane Database of Systematic Reviews 2015, Issue 7. Art. No.: CD010265. DOI: 10.1002/14651858.CD010265.pub2.
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Non-specific low back pain is a major health problem worldwide. Interventions based on exercises have been the most commonly used
treatments for patients with this condition. Over the past few years, the Pilates method has been one of the most popular exercise
programmes used in clinical practice.
Objectives
To determine the effects of the Pilates method for patients with non-specific acute, subacute or chronic low back pain.
Search methods
We conducted the searches in CENTRAL, MEDLINE, EMBASE, CINAHL, PEDro and SPORTDiscus from the date of their inception to March
2014. We updated the search in June 2015 but these results have not yet been incorporated. We also searched the reference lists of eligible
papers as well as six trial registry websites. We placed no limitations on language or date of publication.
Selection criteria
We only included randomised controlled trials that examined the effectiveness of Pilates intervention in adults with acute, subacute or
chronic non-specific low back pain. The primary outcomes considered were pain, disability, global impression of recovery and quality of
life.
Main results
The search retrieved 126 trials; 10 fulfilled the inclusion criteria and we included them in the review (a total sample of 510 participants).
Seven studies were considered to have low risk of bias, and three were considered as high risk of bias.
A total of six trials compared Pilates to minimal intervention. There is low quality evidence that Pilates reduces pain compared with minimal
intervention, with a medium effect size at short-term follow-up (less than three months after randomisation) (MD -14.05, 95% confidence
interval (CI) -18.91 to -9.19). For intermediate-term follow-up (at least three months but less than 12 months after randomisation), two trials
provided moderate quality evidence that Pilates reduces pain compared to minimal intervention, with a medium effect size (MD -10.54, 95%
CI -18.46 to -2.62). Based on five trials, there is low quality evidence that Pilates improves disability compared with minimal intervention,
with a small effect size at short-term follow-up (MD -7.95, 95% CI -13.23 to -2.67), and moderate quality evidence for an intermediate-term
effect with a medium effect size (MD -11.17, 95% CI -18.41 to -3.92). Based on one trial and low quality evidence, a significant short-term
effect with a small effect size was reported for function (MD 1.10, 95% CI 0.23 to 1.97) and global impression of recovery (MD 1.50, 95% CI
0.70 to 2.30), but not at intermediate-term follow-up for either outcome.
Four trials compared Pilates to other exercises. For the outcome pain, we presented the results as a narrative synthesis due to the high
level of heterogeneity. At short-term follow-up, based on low quality evidence, two trials demonstrated a significant effect in favour of
Pilates and one trial did not find a significant difference. At intermediate-term follow-up, based on low quality evidence, one trial reported a
significant effect in favour of Pilates, and one trial reported a non-significant difference for this comparison. For disability, there is moderate
quality evidence that there is no significant difference between Pilates and other exercise either in the short term (MD -3.29, 95% CI -6.82 to
0.24) or in the intermediate term (MD -0.91, 95% CI -5.02 to 3.20) based on two studies for each comparison. Based on low quality evidence
and one trial, there was no significant difference in function between Pilates and other exercises at short-term follow-up (MD 0.10, 95%
CI -2.44 to 2.64), but there was a significant effect in favour of other exercises for intermediate-term function, with a small effect size (MD
-3.60, 95% CI -7.00 to -0.20). Global impression of recovery was not assessed in this comparison and none of the trials included quality of
life outcomes. Two trials assessed adverse events in this review, one did not find any adverse events, and another reported minor events.
Authors' conclusions
We did not find any high quality evidence for any of the treatment comparisons, outcomes or follow-up periods investigated. However,
there is low to moderate quality evidence that Pilates is more effective than minimal intervention for pain and disability. When Pilates was
compared with other exercises we found a small effect for function at intermediate-term follow-up. Thus, while there is some evidence for
the effectiveness of Pilates for low back pain, there is no conclusive evidence that it is superior to other forms of exercises. The decision to
use Pilates for low back pain may be based on the patient's or care provider's preferences, and costs.
Review question
To determine the effects of the Pilates method for patients with non-specific acute, subacute or chronic low back pain.
Background
Low back pain is an important health problem around the world. One of the most common treatments is exercise and in recent years Pilates
has been a common option for treating low back pain.
Search date
We conducted searches up to March 2014. We updated the search in June 2015 but these results have not yet been incorporated.
Study characteristics
This review included 10 studies and 510 patients. All studies included a similar population of people with non-specific low back pain. The
studies only included participants with chronic low back pain. The duration of the treatment programmes in the included trials ranged
from 10 days to 90 days. The duration of follow-up varied from four weeks to six months. None of the included studies measured follow-
up beyond six months. The sample sizes ranged from 17 to 87 participants.
Key results
The included studies demonstrated that Pilates is probably more effective than minimal intervention in the short and intermediate term
for pain and disability outcomes, and more effective than minimal intervention for improvement in function and global impression of
recovery in the short term. Pilates is probably not more effective than other exercises for pain and disability in the short and intermediate
term. For function, other exercises were more effective than Pilates at intermediate-term follow-up, but not at short-term follow-up. Thus,
while there is some evidence for the effectiveness of Pilates for low back pain, there is no conclusive evidence that it is superior to other
forms of exercise. Minor or no adverse events were reported for the interventions in this review.
Pilates for low back pain (Review) 2
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Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
Quality of evidence
The overall quality of the evidence in this review ranged from low to moderate.
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Pilates compared with minimal intervention for low back pain
Better health.
Informed decisions.
Trusted evidence.
Intervention: Pilates
Outcomes Illustrative comparative risks* (95% CI) Relative effect No of partici- Quality of the Comments
(95% CI) pants evidence
Assumed risk Corresponding risk (studies) (GRADE)
Pain The mean pain at The mean pain at short- Mean difference 265 partici- ⊕⊕⊝⊝ This is a moderate ef-
short-term follow-up term follow-up in the in- -14.05 (-18.91 to pants low 1,2 fect that is clinical-
NRS: scale from 0 to 100 (worse pain) ranged across con- tervention groups was -9.19) (6 studies) ly relevant in this pa-
trol groups from 14.05 lower tient group
Follow-up: short-term (less than 3
months from randomisation) 33.9 to 52 points (18.9 to 9.2 lower)
Pain The mean pain at in- The mean pain at in- Mean difference 146 partici- ⊕⊕⊕⊝ This is a moderate ef-
termediate-term fol- termediate-term fol- -10.54 (-18.46 to pants moderate 1 fect that is clinical-
NRS: scale from 0 to 100 (worse pain) low-up ranged across low-up in the interven- -2.62) ly relevant in this pa-
control groups from tion group was (2 studies) tient group
Follow-up: intermediate-term (more
than 3 months and less than 12 53 to 58.3 points 10.5 lower
Disability The mean disabili- The mean disability at Mean difference 248 partici- ⊕⊕⊝⊝ This is a small effect
ty at short-term fol- short-term follow-up in -7.95 (-13.23 to pants low 1,4 that may be clinical-
Multiple scales: scale from 0 to 100 low-up ranged across the intervention groups -2.67) ly relevant in this pa-
(worse disability) control groups from was (5 studies) tient group
Follow-up: short-term (less than 3 13.3 to 44.1 points 7.95 lower
months from randomisation)
(13.2 to 2.7 lower)
4
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Pilates for low back pain (Review)
Disability The mean disabil- The mean disability at Mean difference 146 partici- ⊕⊕⊕⊝ This is a moderate ef-
ity at intermedi- intermediate-term fol- -11.17 (-18.41 to pants moderate 1 fect that is clinical-
Multiple scales: scale from 0 to 100 ate-term follow-up low-up in the interven- -3.92) ly relevant in this pa-
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(worse disability) ranged across con- tion groups was (2 study) tient group
trol groups from 11.2lower
Follow-up: intermediate-term (more
than 3 months and less than 12 27.9 to 44.4 points (18.4 to 3.9 lower)
months)
Function The mean function at The mean function at Mean difference 86 participants ⊕⊕⊝⊝ This is a small effect
Better health.
Informed decisions.
Trusted evidence.
short-term follow-up short-term follow-up in 1.10 (0.23 to low 1,3 that may be clinical-
Patient Specific Functional Scale: in the control group the intervention group 1.97) (1 study) ly relevant in this pa-
used in a 11-point scale from 0 to 10 was was tient group (results
(greater functional ability) from 1 single study)
6.4 points 1.1 higher
Follow-up: short-term (less than 3
months from randomisation) (0.2 to 2.0 higher)
Function The mean function The mean function at Mean difference 86 participants ⊕⊕⊝⊝ The difference is not
at intermediate-term intermediate-term fol- 0.80 (-0.00 to low 1,3 statistically or clini-
Patient Specific Functional Scale: follow-up in the con- low-up in the interven- 1.60) (1 study) cally significant (re-
used in a 11-point scale from 0 to 10 trol group was tion group was sults from 1 single
(greater functional ability) study)
6.1 points 0.8 higher
Follow-up: intermediate-term (more
than 3 months and less than 12 (0.0 lower to 1.6 higher)
months)
Global impression of recovery The mean global im- The mean global impres- Mean difference 86 participants ⊕⊕⊝⊝ This is a small effect
pression of recov- sion of recovery at short- 1.50 (0.70 to low 1,3 that may be clinical-
Global Perceived Effect Scale: scale ery at short-term fol- term follow-up in the in- 2.30) (1 study) ly relevant in this pa-
from -5 to +5 (greater recovery) low-up in the control tervention group was tient group (results
group was from 1 single study)
Follow-up: short-term (less than 3 1.5 higher
months from randomisation) 1.7 points
Global impression of recovery The mean global im- The mean global im- Mean difference 86 participants ⊕⊕⊝⊝ The difference is not
pression of recovery pression of recovery at 0.70 (-0.11 to low 1,3 statistically or clini-
Global Perceived Effect Scale: scale at intermediate-term intermediate-term fol- 1.51) (1 study) cally significant (re-
from -5 to +5 (greater recovery) follow-up in the con- low-up in the interven- sults from 1 single
trol group was tion group was study)
Follow-up: intermediate-term (more
than 3 months and less than 12 1.7 points 0.7 higher
months)
(0.1 lower to 1.5 higher)
5
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Pilates for low back pain (Review)
Adverse events See comment See comment Not estimable See comment Only 1 included tri-
al assessed adverse
events and none
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were reported
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is
based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio
Better health.
Informed decisions.
Trusted evidence.
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: 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.
Very low quality: We are very uncertain about the estimate.
1Downgraded one level due to imprecision (fewer than 400 participants, total).
2 Downgraded one level due to risk of bias (> 25% of the participants were from studies with a high risk of bias).
3Downgraded one level due to clear inconsistency of results.
4Downgraded one level due to inconsistency (I2 > 50%).
Summary of findings 2.
Intervention: Pilates
Pain Not estimated Not estimated Not estimated 181 partici- ⊕⊕⊝⊝ Pooled results not esti-
pants low 1,2 mated due to high het-
NRS: scale from 0 to 100 (worse erogeneity
pain) (3 studies)
6
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Pilates for low back pain (Review)
Follow-up: short-term (less than 3
months from randomisation)
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Pain Not estimated Not estimated Not estimated 151 partici- ⊕⊕⊝⊝ Pooled results not esti-
pants low 1,2 mated due to high het-
NRS: scale from 0 to 100 (worse erogeneity
pain) (2 studies)
Follow-up: intermediate-term
(more than 3 months and less than
Better health.
Informed decisions.
Trusted evidence.
12 months)
Disability The mean disabili- The mean disability at Mean difference 149 partici- ⊕⊕⊕⊝ The difference is not
ty at short-term fol- short-term follow-up in -3.29 (-6.82 to pants moderate 1 statistically or clinical-
Multiple scales: scale from 0 to 100 low-up ranged across the intervention groups 0.24) ly significant
(worse disability) control groups from was (2 studies)
3.3 lower
Follow-up: short-term (less than 3 17.1 to 20 points
months from randomisation) (6.8 lower to 0.2 higher)
Disability The mean disabil- The mean disability at Mean difference 151 partici- ⊕⊕⊕⊝ The difference is not
ity at intermedi- intermediate-term fol- -0.91 (-5.02 to pants moderate 1 statistically or clinical-
Multiple scales: scale from 0 to 100 ate-term follow-up low-up in the interven- 3.20) ly significant
(worse disability) ranged across con- tion groups was (2 studies)
trol groups from 0.9 lower
Follow-up: intermediate-term
(more than 3 months and less than 13 to 18.1 points (5.0 lower to 3.2 higher)
12 months)
Function The mean function at The mean function at Mean difference 87 participants ⊕⊕⊝⊝ The difference is not
short-term follow-up short-term follow-up in 0.10 (-2.44 to low 1,3 statistically or clinical-
Patient Specific Functional Scale: in the control group the intervention group 2.64) (1 study) ly significant (results
scale from 0 to 30 (greater func- was was from 1 single study)
tional ability)
18.9 points 0.1 lower
Follow-up: short-term (less than 3
Function The mean function The mean function at Mean difference 87 participants ⊕⊕⊝⊝ This is a small effect
at intermediate-term intermediate-term fol- -3.60 (-7.00 to low 1,3 that may be clinically
Patient Specific Functional Scale: follow-up in the con- low-up in the interven- -0.20) (1 study) relevant in this patient
scale from 0 to 30 (greater func- trol group was tion group was group (results from 1
tional ability) single study)
22.8 points 3.6 lower
Follow-up: intermediate-term
(more than 3 months and less than (7 to 0.2 lower)
12 months)
7
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Pilates for low back pain (Review)
Adverse events See comment See comment Not estimable See comment 1 trial assessed ad-
verse events and re-
ported minor events
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*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is
based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio
Better health.
Informed decisions.
Trusted evidence.
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: 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.
Very low quality: We are very uncertain about the estimate.
1Downgraded one level due to imprecision (fewer than 400 participants, total).
2Downgraded one level due to inconsistency (I2 > 50%).
3Downgraded one level due to clear inconsistency of results.
Pilates approach aim to target these two factors (i.e. improving the • The therapists who provided the interventions had previous
stability of the spine by improving the motor control of the deep training in Pilates exercises or the therapists were described as
muscles and reducing the activity of superficial muscles), as well certified Pilates instructors.
as to improve posture and body awareness. These factors have the
potential to improve pain, disability and quality of life in patients Types of outcome measures
with LBP. We included any type of clinically relevant measure that could
be considered patient-centred. We did not consider physiological
Why it is important to do this review and biomechanical variables (e.g. range of motion, motor control,
Over the last decade, the popularity of the Pilates method as muscle endurance) for this review.
an intervention for patients with LBP and other musculoskeletal
conditions has steadily increased worldwide. There are published Primary outcomes
trials (Curnow 2009; Fonseca 2009; Gladwell 2006; Rajpal 2008; • Pain intensity measured by any reliable and valid self report
Rydeard 2006) and systematic reviews (Lim 2011; Miyamoto 2013; outcome measure.
Posadzki 2011; Wells 2014) available on this topic. However, • Disability measured by any reliable and valid self report
we are aware of new existing trials on this topic. Therefore, outcome measure.
a well-conducted systematic review is needed to better inform
• Global impression of recovery measured by any reliable and
clinicians, patients and policy-makers about the effectiveness of
valid type of Global Perceived Effect Scale.
this intervention in patients with non-specific LBP.
• Quality of life (measured by any reliable and valid instrument).
OBJECTIVES
Secondary outcomes
To determine the effects of the Pilates method for patients with • Return to work (measured by any reliable and valid instrument).
non-specific acute, subacute or chronic low back pain.
• Adverse effects.
METHODS
Search methods for identification of studies
Criteria for considering studies for this review Electronic searches
Types of studies We searched for randomised controlled trials from the following
We only included randomised controlled trials in this review. We did electronic databases without restrictions on language or date
not consider trials that used quasi-random allocation procedures of publication. We used the search strategies developed by the
in this review to avoid biased estimates of treatment effects across Cochrane Back Review Group. We searched all databases from the
the included studies (Higgins 2011). date of their inception to March 2014.
• The study explicitly stated that the intervention was based upon We also searched the reference lists of eligible papers as well as
the Pilates principles (i.e. centering, concentration, control, trial registry websites: Australian and New Zealand Clinical Trials
precision, flow, breathing and posture) or at least three of these Registry (ANZCTR), National Research Registry, ClinicalTrials.gov,
elements (Wells 2012). metaRegister of Controlled Trials (mRCT), Brazilian Registry
of Clinical Trials (ReBEC) and the World Health Organization Two review authors (BTS and TPY) independently performed this
International Clinical Trials Registry Platform (WHO ICTRP). The 'Risk of bias' assessment and resolved possible disagreements
search strategies for ClinicalTrials.gov and WHO ICTRP are between review authors by discussion, or arbitration by a third
described in Appendix 7. review author (CM) when consensus could not be reached. We
scored each of the 12 items of the 'Risk of bias' assessment as 'high',
Data collection and analysis 'low' or 'unclear' risk. We defined a study with an overall low risk of
bias as having low risk of bias on six or more of these items.
Selection of studies
Two pairs of review authors (CMNC and LCMC, BTS and TPY) We assessed clinical relevance by scoring five questions related
independently screened titles and abstracts for potentially eligible to this domain as 'yes', 'no' or 'unclear' (Appendix 10). Two
studies. We used full-text papers to determine the final inclusion independent authors performed this and resolved possible
in the review. We resolved disagreements between review authors disagreements by discussion, or arbitration by a third review author
through discussion or by the arbitration of a third review author when consensus could not be reached.
(LOPC or CM) when consensus could not be reached. We included
only full-text papers, written in any language, regardless of the date Measures of treatment effect
of publication. We included papers written in English, Portuguese, We expected to deal mostly with continuous outcome measures to
Spanish, Italian and Dutch as the review team includes authors determine the treatment effect, such as pain intensity, disability or
who are able to read these languages. We sent all remaining papers quality of life scales. For all continuous outcomes we quantified the
that were written in languages other than these to translators. We treatment effects with the mean difference (MD). To accommodate
also scanned the reference lists from previous published reviews on the different scales used for these outcomes, we converted
Pilates as well as the reference lists from the eligible randomised outcomes to a common 0 to 100 scale. We also expected to
trials. encounter dichotomous outcomes such as recovery or return to
work and in such cases we calculated the risk ratios (RR) for
Data extraction and management experiencing the positive outcome. We used effect sizes and 95%
Two independent review authors (TPY and BTS) extracted the confidence intervals (CI) as a measure of treatment effect. We
following data from each of the eligible papers using a standardised considered between-group differences of at least 20% as clinically
data extraction form (Appendix 8). We resolved disagreements important (Ostelo 2008). We used Review Manager 5 for all analyses.
between review authors through discussion or by the arbitration of For effect sizes, we defined three levels as: small (MD < 10% of the
a third review author (CM). scale), medium (MD 10% to 20% of the scale) or large (MD > 20% of
the scale) (Rubinstein 2011) (Appendix 10).
• Bibliometric data (authors, year of publication, language).
• Study characteristics (study design, sample size, description of Unit of analysis issues
the sample, country, recruitment modality, funding). We did not encounter any cross-over or cluster-randomised trials.
• Characteristics of the participants (gender, age, duration of To deal with repeated observations on participants we followed
symptoms, severity of the condition at baseline). the advocated strategy of defining the outcomes (already stated
• Description of the interventions (both experimental and control previously) as well as the time points a priori (Higgins 2011).
interventions), including dose (number of sessions, duration of The time points were short-term (less than three months after
each session of treatment, etc) and co-interventions. randomisation), intermediate-term (at least three months but less
• Duration of follow-up assessments. than 12 months after randomisation) and long-term (12 months
or more after randomisation) follow-up. When there were multiple
• Outcomes assessed (converted to a common 0 to 100 scale when
time points that fell within the same category we used the one
different scales were used).
that was closer to the end of the treatment (short-term), six
• Study results. months (intermediate-term) and 12 months (long-term). If studies
• Time periods for outcome assessment: short-term (less than included multiple treatment arms, we formed multiple treatment
three months after randomisation), intermediate-term (at least comparisons but if there was a shared group we split this in order
three months but less than 12 months after randomisation) and to be able to include two (reasonably independent) comparisons.
long-term (12 months or more after randomisation) follow-up.
When there were multiple time points that fell within the same Dealing with missing data
category we used the one that was closer to the end of the Firstly, review authors emailed the authors of each study requesting
treatment, six months and 12 months. any necessary data that was not comprehensively reported in the
We pilot tested the data extraction form using two RCTs on back manuscript. In cases where data were reported as a median and
pain. interquartile range (IQR), we assumed that the median is equivalent
to the mean and the width of the IQR is equivalent to 1.35 times
Assessment of risk of bias in included studies the standard deviation (Higgins 2011). We also estimated data
from graphs in cases where this information was not presented in
We assessed the risk of bias in the included studies using the tables or text. If any information regarding standard deviations was
'Risk of bias' assessment tool as recommended by The Cochrane missing, we calculated these from confidence intervals or standard
Collaboration (Higgins 2011) and the Cochrane Back Review Group errors (if available) of the same study. Finally, if no measure of
(Furlan 2009) (Appendix 9). variability was presented anywhere in the text, we estimated the
standard deviation from the most similar trial in the review, taking
the risk of bias of individual studies into consideration.
Assessment of heterogeneity evidence' if there were further limitations on the quality of evidence
(Rubinstein 2012). We reduced the quality of the evidence for a
The assessment of heterogeneity was based upon visual
specific outcome by a level, according to the performance of the
inspections of the forest plots (e.g. overlapping confidence
studies against these five factors and we described them as follows.
intervals) and more formally by the Chi2 test and the I2 statistic as
recommended in the Cochrane Handbook for Systematic Reviews High quality evidence: there are consistent findings among at
of Interventions (Higgins 2011). We combined results in a meta- least 75% of RCTs with low risk of bias, consistent, direct and
analysis using a random-effects model if I2 < 50%. If substantial precise data and no known or suspected publication biases. Further
heterogeneity was present, we did not combine the results but research is unlikely to change either the estimate or our confidence
instead presented them as a narrative synthesis. If I2 values were in the results.
slightly higher than 50% but we identified no clear heterogeneity
by visual inspection, we combined the results into a meta-analysis. Moderate quality evidence: one of the domains is not met. Further
research is likely to have an important impact on our confidence in
Assessment of reporting biases the estimate of effect and may change the estimate.
We performed comprehensive searches in order to reduce the Low quality evidence: two of the domains are not met. Further
possibility of reporting biases. We also planned to generate funnel research is very likely to have an important impact on our
plots (if we retrieved at least 10 trials) in order to determine possible confidence in the estimate of effect and is likely to change the
reporting biases. estimate.
Data synthesis Very low quality evidence: three of the domains are not met. We
We combined the results from individual trials through meta- are very uncertain about the results.
analysis. This pooling of the data was dependent on the level
No evidence: no RCTs were identified that addressed this outcome.
of statistical heterogeneity of the retrieved studies. We combined
results in a meta-analysis using a random-effects model if the I2 Subgroup analysis and investigation of heterogeneity
value was less than 50%. If substantial statistical heterogeneity was
present, we did not quantitatively pool the results but presented We stratified some of the analyses based upon a number of factors
them as a narrative synthesis. If the I2 value was slightly higher when necessary (Higgins 2011):
than 50% but no clear clinical heterogeneity was detected by visual
• types of control groups (e.g. minimal intervention, placebo,
inspection we combined the results in a meta-analysis.
another type of treatment, wait-and-see groups);
Regardless of whether there were sufficient data available to use • duration of follow-up (i.e. short-term, intermediate-term and
quantitative analyses to summarise the data, we assessed the long-term);
overall quality of the evidence for each outcome. To accomplish • risk of bias (i.e. low and high risk of bias studies.
this, we used the GRADE approach, as recommended in the
Cochrane Handbook for Systematic Reviews of Interventions (Higgins Sensitivity analysis
2011) and adapted in the updated Cochrane Back Review Group We did not plan to perform any sensitivity analyses as we
method guidelines (Furlan 2009). Factors that may decrease anticipated that the number of studies and comparisons would be
the quality of the evidence are: study design and risk of low. This turned out to be the case.
bias (downgraded if more than 25% of the participants were
from studies with a high risk of bias); inconsistency of results RESULTS
(downgraded if significant heterogeneity was present by visual
inspection or if the I2 value was greater than 50%); indirectness Description of studies
(generalisability of the findings; downgraded if more than 50%
of the participants were outside the target group); imprecision See: Characteristics of included studies; Characteristics of
(downgraded if fewer than 400 participants were included in excluded studies; Characteristics of studies awaiting classification;
the comparison for continuous data and there were fewer than Characteristics of ongoing studies.
300 events for dichotomous data (Mueller 2007)) and other
Results of the search
factors (e.g. reporting bias, publication bias). We considered
single studies with fewer than 400 participants for continuous or The search retrieved 126 trials, of which nine fulfilled the inclusion
dichotomous outcomes inconsistent and imprecise, providing 'low criteria and were included in the review (a total pooled sample of
quality evidence', which could be downgraded to 'very low quality 510 participants) (Figure 1).
Figure 1. (Continued)
A search for unpublished trials in ClinicalTrials.gov and the World evaluating two types of Pilates (e.g. mat Pilates versus equipment-
Health Organization International Clinical Trials Registry Platform based Pilates) as the aim of this review was to provide evidence on
(WHO ICTRP) search portal revealed 13 records of trials evaluating the effectiveness of the Pilates method for low back pain; thereby
Pilates for low back pain (LBP). Three records were for studies we focused our comparisons on no intervention, placebo or other
already included in this review (Marshall 2013; Miyamoto 2013; interventions.
Wajswelner 2012) and eight were ineligible (three compared
different forms of Pilates (NCT01533805, PACTR201211000443397, Study population
RBR-7tyg5j), two were from populations not included in this Most participants in the included trials were middle-aged (mean: 38
review (e.g. military settings, children) (ACTRN12607000471482, years), ranging from 22 to 50 years of age. Two trials included only
NCT01711203), one included both groups performing Pilates women participants (Quinn 2011; Rajpal 2008), and all the other
exercise (NCT01919268), one included cervical pain (NCT01999283) trials included both men and women. All trials included exclusively
and one is not a RCT (ACTRN12609000927224). Two registered trials chronic participants (low back pain persisting for 12 weeks or
appeared potentially eligible for this review (NCT01502059 and more), except for one trial that included participants with LBP for
RBR-7yhzym). We were able to find the published study for one at least six weeks (Rydeard 2006).
of these records (NCT01502059) and we included the study in the
review (Natour 2014). We did not find any publicly available report Technique: number and duration of treatments
for the other record (RBR-7yhzym), and the authors did not reply to
our email contact attempts. For the additional updated search, one The duration of the treatment programmes in the included trials
study fulfilled the inclusion criteria (Anand 2014) and we added it ranged from 10 days to 90 days. One trial provided treatment
to the awaiting classification section to be incorporated in the next twice a week for a total of 90 days (Natour 2014). In four trials,
review update. the participants received an eight-week programme. In two of the
four trials the frequency of treatment was three times per week
The 10 trials included in the review were conducted in five different (Brooks 2012; Marshall 2013), one trial provided treatment twice
countries: three were conducted in Australia (Brooks 2012; Marshall a week (Fonseca 2009), and the other one provided treatment
2013; Wajswelner 2012), three in Brazil (Fonseca 2009; Miyamoto once a week (Quinn 2011). In three trials the treatment duration
2013; Natour 2014), two in the United Kingdom (Gladwell 2006; was six weeks, with two trials evaluating treatment provided
Quinn 2011), and one in each of Hong Kong (Rydeard 2006), and twice a week (Miyamoto 2013; Wajswelner 2012), and one trial
India (Rajpal 2008). All trials were published in English. evaluating treatment delivered once a week (Gladwell 2006). Two
trials performed the treatment for four weeks, one included daily
Included studies sessions (Rajpal 2008), and the other provided treatment three
times per week (Rydeard 2006). The duration of all sessions was
A total of 510 participants were enrolled in the 10 included trials, of
approximately one hour for all included studies. The mean number
which we included data from 478 participants in the meta-analyses.
of sessions in the included studies was 15.3, ranging from six to 30
The study sample sizes ranged from 17 to 87 participants (median
sessions.
(IQR) = 41 (31.5)). One study was not included in the meta-analysis
because we found substantial heterogeneity in the comparison in Primary outcomes
which this study was included (Rajpal 2008).
Pain intensity
The assessment of clinical relevance for each study is described in
All studies measured pain intensity. In most cases, pain intensity
Table 1.
was measured with a visual analogue scale (VAS) or numerical
Types of studies rating scale (NRS), and one study used the 0 to 5 point Roland
Morris pain rating visual analogue scale (RMVAS) (Gladwell 2006).
We identified the following comparisons in this review: (i) six trials We converted all scales to a 0 to 100-point scale.
compared the Pilates method with minimal intervention or no
intervention (Fonseca 2009; Gladwell 2006; Miyamoto 2013; Quinn Disability
2011; Rydeard 2006; Natour 2014), and (ii) four trials compared Seven studies measured disability (Brooks 2012; Gladwell 2006;
the Pilates method with other types of exercises, including general Marshall 2013; Miyamoto 2013; Quinn 2011; Rydeard 2006;
exercise (Brooks 2012; Marshall 2013; Wajswelner 2012), and Wajswelner 2012). Four studies measured disability with the
the McKenzie method (Rajpal 2008). We did not include studies
Pilates for low back pain (Review) 14
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
Figure 2. 'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figure 3. Forest plot of comparison: 1 Pilates versus minimal intervention, outcome: 1.1 Pain.
We considered disability for the meta-analysis as we did not find Higgins 2011). Based on five trials, there is low quality evidence
considerable heterogeneity (I2 = 56%), but we downgraded the (downgraded due to imprecision and inconsistency) that Pilates
quality of the evidence due to inconsistency (Borenstein 2009; improves disability at short-term follow-up compared with minimal
intervention, with a small effect size (MD –7.95, 95% CI –13.23 to the meta-analysis (Brooks 2012; Marshall 2013; Wajswelner 2012).
–2.67; P value = 0.003) (Analysis 1.2). At intermediate-term follow- Two trials compared Pilates with general exercise (Brooks 2012;
up, two trials, Miyamoto 2013 and Natour 2014, provided moderate Wajswelner 2012), and one trial compared Pilates with stationary
quality evidence (downgraded due to imprecision) of a significant cycling exercise (Marshall 2013). Most of the trials included in the
effect in favour of Pilates, with a medium effect size (MD –11.17, 95% comparisons between Pilates and other exercises had small sample
CI –18.41 to –3.92) (Analysis 1.2). sizes (ranging from 32 to 87 participants).
Based on one trial, Miyamoto 2013, and low quality evidence Primary outcomes
(downgraded due to imprecision and inconsistency), we found a
significant short-term effect, with a small effect size for global Due to the high level of heterogeneity, we did not combine the
impression of recovery (MD 1.50, 95% CI 0.70 to 2.30) (Analysis 1.4), results for pain intensity at short-term and intermediate-term
but not for intermediate-term follow-up. One trial (Natour 2014) follow-up in a meta-analysis (I2 = 74% for short-term and I2 = 86%
evaluated quality of life but the estimates for the physical and for intermediate-term follow-up), but we report these descriptively.
mental components were not available in the publication and the For pain intensity, based on low quality evidence (downgraded
authors did not provide this information on request. due to imprecision and inconsistency), at short-term follow-up
two trials demonstrated significant effect in favour of Pilates
Secondary outcomes (Brooks 2012; Rajpal 2008), and one trial did not find significant
difference (Wajswelner 2012). At intermediate-term follow-up,
Only one trial assessed adverse events, but none were reported based on low quality evidence (downgraded due to imprecision
(Miyamoto 2013). None of the included trials evaluated return to and inconsistency), one trial reported a significant effect in favour
work. of Pilates (Marshall 2013), and one trial reported a non-significant
difference in pain intensity (Wajswelner 2012).
Other outcomes
In the meta-analysis for disability there is moderate quality
Based on one trial, Miyamoto 2013, and low quality evidence
evidence (downgraded due to imprecision) that there is no
(downgraded due to imprecision and inconsistency), there is a
significant difference between Pilates and other exercise at short-
significant short-term effect, with a small effect size, for function
term (MD –3.29, 95% CI –6.82 to 0.24) or intermediate-term follow-
(MD 1.10, 95% CI 0.23 to 1.97) (Analysis 1.3). No differences was
up (MD –0.91, 95% CI –5.02 to 3.20), based on two studies for each
found for an intermediate-term follow-up.
comparison (Analysis 2.2; Figure 4). One trial (Wajswelner 2012)
Effect of Pilates versus other exercises evaluated quality of life but the estimates for the physical and
mental components were not available in the publication and the
Four trials were included in this comparison (Brooks 2012; Marshall authors did not provide this information on request.
2013; Rajpal 2008; Wajswelner 2012), and three were included in
Figure 4. Forest plot of comparison: 2 Pilates versus other exercises, outcome: 2.2 Disability.
Secondary outcomes participants reported back spasms but were able to continue the
programme, and two reported worsening back pain causing them
One trial reported minor adverse events in both groups (Wajswelner to cease the exercise. None of the included trials evaluated return
2012). In the Pilates group two participants reported minor to work.
shoulder pain and one reported knee pain, but they were all
able to continue the exercises. In the general exercise group, two Other outcomes
Pilates for low back pain (Review) 18
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
Based on low quality evidence (downgraded due to imprecision three reported a clinically important effect for disability (Miyamoto
and inconsistency) from one trial (Wajswelner 2012), there was 2013; Natour 2014; Quinn 2011).
no significant difference between Pilates and other exercises in
function at short-term follow-up (MD 0.10, 95% CI -2.44 to 2.64). Quality of the evidence
However, there was a significant effect in favour of other exercises
In general, most included trials demonstrated a low risk of bias
(general exercise) in intermediate-term function, with a small effect
(427 participants were from studies with low risk of bias out of
size (MD -3.60, 95% CI -7.00 to -0.20) (Analysis 2.3).
510 participants in total). The most affected items were blinding
of participants and care providers, which is understandable for
DISCUSSION
exercise intervention trials. However, only 10 trials could be
Summary of main results included in this review, which compromises the quality of the
evidence provided. Also, the sample sizes in general were small
The evidence on the effectiveness of Pilates for chronic non-specific (ranging from 17 to 87 participants); therefore, our results cannot
low back pain (LBP) is of low to moderate quality primarily because be considered robust.
there are only a few small studies (range 17 to 87 participants). Of
the 15 estimates of treatment effect we provide in this review, only Potential biases in the review process
eight are based on more than one study. None of the trials reported
The main limitation of this review is the low number of trials
long-term outcomes, which would be important to consider for
and small sample sizes per comparison, outcome and follow-
patients with chronic LBP. In addition, we did not find any studies
up period, which prevented us from conducting a sensitivity
that investigated the effectiveness of Pilates for acute and subacute
analyses. An additional limitation is the potential for publication
LBP.
bias in the trials included. In this review, it was not possible
A total of six trials (n = 265 participants) compared Pilates to to assess publication bias using funnel plots as too few studies
minimal intervention. At short-term follow-up Pilates is more were included. However, by inspecting registries we found one
effective than minimal intervention for improvement in pain completed trial (from 2011) that was not yet published, which
intensity, disability, function and global impression of recovery. At may indicate potential publication bias. Moreover, the source of
intermediate-term follow-up Pilates led to better pain intensity and funding should be considered due to potential financial conflicts
disability outcomes, but was not superior to minimal intervention from industry-sponsored research (Bekelman 2003; Okike 2008).
in terms of function and global impression of recovery. The effect One trial received funding from a Pilates clinic to conduct the study
sizes varied from small to medium for this comparison. (Wajswelner 2012). The remaining trials were not funded.
Four trials (n = 245 participants) compared Pilates to other Finally, we found eight conference abstracts and for these we could
exercises. Pilates appears not to be more effective than other not find a full publication. They were therefore not included in
exercises for pain intensity and disability outcomes. For function, the analysis. We also did not include two theses. As unpublished
one study found a small significant effect at intermediate-term, but studies are more likely to report negative findings, it is possible that
not at short-term follow-up. the review's conclusions are overly optimistic.
Pilates appears to be an effective treatment compared to minimal Agreements and disagreements with other studies or
intervention, but when compared to other types of exercises the reviews
effect sizes tend to be smaller or no difference in effectiveness is
In general, the results of this review are reasonably consistent with
observed. This is in accordance with clinical practice guidelines
previous reviews regarding pain intensity and disability outcomes
(European Guidelines 2006) and previous reviews of exercise for low
(Lim 2011; Miyamoto 2013; Wells 2014). In the most recent review,
back pain (Hayden 2005), which recommend exercise therapy for
the authors reported a statistically significant short-term effect
patients with low back pain but note that there seems to be no clear
for pain intensity and disability compared to usual care and/or
difference in effectiveness between the various forms of exercise.
physical activity (Wells 2014). For the comparison with other forms
We did not find any studies that reported return to work. Only
of exercises, the results were conflicting. The results of this review
two trials assessed adverse events: one trial found minor adverse
are partially consistent with our findings. The key limitation of this
effects in the Pilates group (shoulder and knee pain) (Wajswelner
review is that the authors did not perform a meta-analysis, limiting
2012); another trial did not find any adverse events (Miyamoto
the comparison with our review.
2013).
In the 2013 review of Miyamoto et al the authors found a small
Overall completeness and applicability of evidence short-term effect on pain intensity and disability when compared
The trials included in this review were conducted in Australia, South to minimal intervention but not compared to other types of
America, Europe or Asia, with adult participants from primary or exercises (Miyamoto 2013). This is consistent with our review
tertiary care with non-specific low back pain for at least 12 weeks in although we mostly found medium effect sizes for the comparison
most trials. The care providers were all experienced instructors or with minimal intervention and we considered the results for pain
physiotherapists trained in the Pilates method, except for one trial intensity compared to other exercises too heterogeneous to be
that did not provide information about the care provider (Rajpal combined in a meta-analysis. The 2011 review of Lim et al only
2008). Therefore, we can generalise the results of this review to found a small significant effect on pain intensity in the short term
a range of settings. Regarding our clinical relevance assessment, compared to minimal intervention but not on disability (Lim 2011).
most trials included provided a clear description of the patients, This previous review did not find any significant effect for the
outcomes and interventions used. However, none of the trials comparison with other exercises; however, the authors included
found a clinically important effect size for pain intensity and only only one trial (Donzelli 2006) and one thesis (Gagnon 2005) in
Pilates for low back pain (Review) 19
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
this comparison. Another systematic review concluded that no Implications for research
definite conclusions can be drawn except that further better quality
research is needed (Posadzki 2011). The authors only had four trials There is an urgent need for large, high quality trials to evaluate
available in their review, each one with a different control group, Pilates for low back pain. Most trials included fewer than 40
making any comparison or conclusions difficult. participants in total (Fonseca 2009; Gladwell 2006; Quinn 2011;
Rajpal 2008; Rydeard 2006), or were unregistered (Brooks 2012;
AUTHORS' CONCLUSIONS Fonseca 2009; Gladwell 2006; Quinn 2011; Rajpal 2008; Rydeard
2006). None of the trials included long-term follow-up. In addition,
Implications for practice including an economic evaluation alongside a clinical trial of the
Pilates method would be useful to guide clinical choices between
No definite conclusions or recommendations can be made competing treatment options. There is one study in the awaiting
as we did not find any high quality evidence for any of classification section for the next update of this review, which will
the treatment comparisons, outcomes or follow-up periods contribute to the results of this review in the future.
investigated. However, there is low to moderate quality evidence
that Pilates is more effective than minimal intervention in the ACKNOWLEDGEMENTS
short and intermediate term as the benefits were consistent
for pain intensity and disability, with most of the effect sizes Tiê Parma Yamato is supported by CAPES (Coordenação de
being considered medium. It was less clear whether Pilates was Aperfeiçoamento de Pessoal de Nível Superior), Brazil. Chris Maher
more effective than other exercises for pain intensity, disability is supported by National Health and Medical Research Council of
and function as the results across outcomes were contradictory. Australia. Bruno Tirotti Saragiotto is supported by CNPQ (Conselho
However, a small effect favouring other exercises was found for Nacional de Desenvolvimento Científico e Tecnológico), Brazil.
function at intermediate-term follow-up. The decision to use
Pilates for chronic low back pain may be based on the patient's or
care provider's preferences, and costs.
REFERENCES
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Miyamoto GC, Costa LOP, Galvanin T, Cabral CMN. Efficacy of the Anderson BD. Randomized Clinical Trial Comparing Active
addition of modified Pilates exercise to a minimal intervention Versus Passive Approaches to the Treatment of Recurrent and
in patients with chronic low back pain: a randomized controlled Chronic Low Back Pain [Thesis]. Miami, FL: University of Miami,
trial. Physical Therapy 2013;93:310-20. 2005.
Natour 2014 {published data only} Anderson 2006 {published data only}
Natour J, Cazotti LD, Ribeiro LH, Baptista AS, Jones A. Pilates Anderson BD, Butler MN, Roach KE. OPL44 - A randomized
improves pain, function and quality of life in patients with controlled study examining the effects of Pilates on pain and
chronic low back pain: a randomized controlled trial. Clinical disability in subjects with chronic and recurrent low back
Rehabilitation 2014 Jun 25 [Epub ahead of print]. pain (CSM 2006 Orthopaedic Section Platform Presentations).
Journal of Orthopaedic & Sports Physical Therapy 2006;36:A18.
Quinn 2011 {published and unpublished data}
Quinn K, Barry S, Barry L. Do patients with chronic low back Blum 2002 {published data only}
pain benefit from attending Pilates classes after completing Blum CL. Chiropractic and Pilates therapy for the treatment
conventional physiotherapy treatment?. Physiotherapy Ireland of adult scoliosis. Journal of Manipulative and Physiological
2011;32(1):5-12. Therapeutics 2002;25:E3.
Rajpal 2008 {published and unpublished data} Boden 2010 {published data only}
Rajpal N, Arora M, Chauhan V. A study on efficacy of Pilates Boden Scott D. Spinescope. Seminars in Spine Surgery
& Pilates & McKenzie exercise in postural low back pain - a 2010;22:103-8.
rehabilitative protocol. Physiotherapy and Occupational Therapy
Journal 2008;1(1):33-56. Cámara 2011 {published data only}
Montero CJ, Sierra SE, Monteagudo SAM, López FJ, López LA,
Rydeard 2006 {published and unpublished data} Barco PM. T643 - Active stretching based on Pilates against
Rydeard R, Leger A, Smith D. Pilates-based therapeutic exercise: passive analytical hamstring stretching in subacute and chronic
effect on subjects with nonspecific chronic low back pain and non-specific low back pain. Pilot trial. European Journal of Pain
functional disability: a randomized controlled trial. Journal of Supplements 2011;5:93.
Orthopaedic & Sports Physical Therapy 2006;36(7):472-84.
Curnow 2009 {published data only}
Wajswelner 2012 {published and unpublished data} Curnow D, Cobbin D, Wyndham J, Boris Choy ST. Altered
Wajswelner H, Metcalf B, Bennell K. Clinical Pilates versus motor control, posture and the Pilates method of exercise
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[DOI: 10.1249/MSS.0b013e318248f665]
CHARACTERISTICS OF STUDIES
Brooks 2012
Methods Randomised controlled trial
Country: Australia
Inclusion criteria: men and women aged between 18 and 50 years, with ongoing recurrent LBP (> 12
weeks) located between the costal margins and inferior gluteal folds
Exclusion criteria: presence of a severe postural abnormality, pain radiating below the knee, known
lumbar disc hernia or fracture, history of back surgery, diagnosed inflammatory joint disease, known
severe osteoporosis, known metabolic or neuromuscular disease, or recent (< 3 months) participation
in an exercise programme or any form of therapeutic treatment (i.e. manipulation, mobilisation, mas-
sage)
Interventions 1. Specific trunk exercise group (Pilates): the specific programme was based on a Pilates training mod-
el, which incorporated skilled contraction techniques, general trunk focused strengthening exercise,
whole-body movements, and stretching of the trunk and hip musculature. It was thought that this
model of training best represented the most utilised components of specific trunk exercise rehabilita-
tion programmes for LBP, with a strong focus on the use of skilled contraction techniques (abdominal
drawing-in and abdominal bracing)
2. General exercise group: the general exercise programme was indoor stationary cycle training. Inten-
sity of effort within each component was based on combinations of heart rate training zones (based on
percentage of maximal heart rate) and rate of perceived exertion scales
All participants were required to attend exercise classes 3 times per week for a total of 8 weeks. Every
exercise class was for a duration of 50 to 60 minutes and was supervised, with a participant-to-instruc-
tor ratio of 10:1. Exercise classes for the 2 groups were administered in different training rooms to min-
imise the likelihood of contact between participants in the different groups. Instructors for the exer-
cise classes were trained and experienced (minimum 5 years) in a particular intervention only and had
no contact with participants or instructors from the different group. Instructors for the exercise groups
had no involvement in the recruitment, allocation or assessment of participants in the trial
2. Pain: using a 100 mm visual analogue scale (VAS) (left anchor "no pain at all", right anchor "worst
pain imaginable") for back pain experienced in the last week, and current back pain (VAS)
Risk of bias
Random sequence genera- Unclear risk Review authors' comment: the sequence generation procedure or the method
tion (selection bias) of allocation were not mentioned. The title, abstract and flowchart indicate
that it is a RCT
Allocation concealment Unclear risk Reviewers comment: The sequence generation procedure or the method of al-
(selection bias) location were not mentioned. The title, abstract, and flowchart indicate that it
is a RCT
Blinding of participants Low risk "To control for expectation bias, participants were blinded to the use of differ-
and personnel (perfor- ent modalities in the trial by being informed that they were volunteering for
mance bias) an exercise trial to investigate how exercise programs work for people with
All outcomes chronic LBP."
Blinding of personnel/care High risk No mention of any attempts to blind the care providers
providers (performance
bias)
All outcomes
Blinding of outcome as- Low risk "Self-report outcome measures and APAs were assessed before and after the
sessment (detection bias) 8-week intervention by a blinded assessor."
All outcomes
Incomplete outcome data Low risk The percentage of withdrawals and dropouts was within the acceptable range
(attrition bias)
All outcomes
Intention-to-treat analysis Low risk "Analysis of self-report data (ODI and VAS scores) was conducted by “inten-
tion to treat” (i.e., all available data from all randomised participants were
analysed in the group to which the participant was allocated)."
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, based on the Table 2
line (selection bias)
Compliance (performance Low risk Compliance was acceptable, based on the reported intensity/dosage, dura-
bias) tion, number and frequency for both the intervention and control groups
Timing of outcome assess- Low risk All important outcomes for both groups were measured at the same time
ments (detection bias)
Fonseca 2009
Methods Randomised controlled trial
Settings: waiting list for physiotherapeutic treatment (intervention group), and students and staff of
the University (control group)
Inclusion criteria: independent gait execution without the use of any support device (crutch, walking
stick, etc), complaints of low back pain for at least 6 months (low back group), no complaints of low
back pain or musculoskeletal pain (control group), and aged between 18 and 59 years old
Exclusion criteria: neurological disease, major visual deficits, true leg-length discrepancy greater than
2 cm, and history of ankylosing spondylitis, disc herniation, tumour, infection or fracture, cauda equina
syndrome, spine-fusion surgery or any lower extremity orthopaedic surgery within 1 year of the begin-
ning of the study
Interventions 1. Pilates group: performed 15 sessions of Pilates exercises, 2 sessions per week. The sessions lasted for
an hour and were performed individually. The exercise programme was taught by a certified Pilates in-
structor. The programme of exercises consisted of 4 stages: (i) isolated contraction training of the core
muscles; (ii) co-contraction of the core muscles, that is, simultaneous contraction of the transversus
abdominis, multifidus and pelvic-floor muscles; (iii) co-contraction of the core muscles combined with
limb movements, keeping the spine static; and (iv) co-contraction of the core muscles during dynamic
functional movements of the trunk. The participants were instructed to recruit the core muscles during
the exercises and not to substitute them for global muscles. The exercise programme consisted of ba-
sic-level Pilates exercises, progressing from positions with low loads (supine position, prone position
and side-lying) to more functional body positions with gradually increasing external loads (box and sit-
ting positions). The participants were instructed to maintain aligned and symmetrical posture of the
spine and limbs and to perform the exercises with the spine neutral. The exercises were taught by ap-
propriate verbal instructions given by the instructor. The participants were instructed to inform the in-
structor if they experienced any pain, discomfort, cramps or inability to maintain the contraction of the
core muscles or neutral spine. In those cases, the exercise was interrupted and, if necessary, modified
by decreasing lever lengths for any individual participants who found the particular exercise too chal-
lenging to enable them to maintain a neutral spine. If participants felt loss of control for a movement,
they were advised to go back to a base position for that particular exercise. Until the seventh session,
homework was assigned so that co-contraction of the core muscles would become automatic and effi-
cient. Those exercises were indicated to be performed once a day. From the eighth session on, the par-
ticipants were encouraged to activate these muscles regularly during daily activities (while walking,
watching TV, etc)
2. No Pilates group: continued with their normal activities and did not undergo any other type of treat-
ment aside from medication taken for conditions not related to the study
Risk of bias
Random sequence genera- Unclear risk Review authors' comment: the sequence generation procedure or the method
tion (selection bias) of allocation were not mentioned. The title, abstract and flowchart indicate
that it is a RCT
Allocation concealment Unclear risk Review authors' comment: the sequence generation procedure or the method
(selection bias) of allocation were not mentioned. The title, abstract and flowchart indicate
that it is a RCT
Blinding of participants High risk No mention of any attempts to blind the participants
and personnel (perfor-
mance bias)
All outcomes
Blinding of personnel/care High risk No mention of any attempts to blind the care providers
providers (performance
bias)
All outcomes
Blinding of outcome as- Unclear risk The study is described as a single-blind RCT, but there is not enough informa-
sessment (detection bias) tion to know who was blinded
All outcomes
Incomplete outcome data Low risk Unclear, but the text suggest that there were no drop-outs
(attrition bias)
All outcomes
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk "There were no significant differences between the Pilates group and the no-
line (selection bias) Pilates group in baseline data for age, height, weight, visual analogue pain
scale (Pilates = 5.9 ± 2.0 and no Pilates = 6.1 ± 1.8), and present pain intensity
(Pilates = 2.8 ± 1.5 and no Pilates = 2.0 ± 0.7)."
Compliance (performance Unclear risk There was insufficient information about the control group
bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Gladwell 2006
Methods Single-blind randomised controlled trial
Participants 49 participants who had had non-specific chronic low back pain for more than 12 weeks (located below
the scapulae and above the cleft of the buttocks)
Settings: individuals living within the Colchester region were offered the chance to participate in this
study via posters and letters given to local doctors' clinics and via e-mailed information to staff and stu-
dents at the local university
Inclusion criteria: chronic low back pain for at least 12 weeks not attributable to any specific pathology
(see exclusions) located below the scapulae and above the cleft of the buttocks. Aged between 18 and
60 years old. Patient able to travel independently. Patient is otherwise medically fit to perform physical
training and able to consent and understand what the study entails
Exclusion criteria: back pain attributed to any specific pathology: e.g. disc herniation, tumour, infec-
tion or fracture, osteoporosis, structural deformity, inflammatory disorder, radicular syndrome or cau-
da equina. Patient is unable to walk without a walking aid. Patient already involved in regular Pilates
classes. Constant or severe back pain judged on clinical grounds due to nerve root irritation. Major
surgery within the past year
Interventions 1. Pilates group: performed 6 1-hour classes of Pilates exercise (maximum class size = 12), 1 class per
week. The Pilates exercise programme was taught by a certified Pilates Institute Instructor. In the first
class, the basic principles of Pilates were explained and a handout was provided to participants for
home reading. Basic principles were reiterated at the beginning of every class throughout the inter-
vention period with an increasing portfolio of relevant Pilates techniques. In each 1-hour class, an ed-
ucational aspect was provided followed by specific modified Pilates exercises. Educational aspects in-
cluded posture check (including neutral spine and pelvis), recruitment of "core muscles" and encour-
agement not to substitute from global muscles; all aspects were completed during controlled breath-
ing. The exercises were "cued" by appropriate verbal instructions given by the instructor. All exercis-
es started at the base level and were progressed by incorporating limb movement, when participants
were able to maintain control of the spine. Additional exercises were also added during each session.
The exercises taught within a class were also repeated individually during 2 30-minute sessions each
week performed at home without supervision. No progression of exercises was made during home ses-
sions. Compliance with home-based exercises was recorded in a diary
2. Control group: continued with their normal activities and pain relief
Outcomes 1. Pain: Roland Morris pain rating visual analogue scale (RMVAS)
Risk of bias
Random sequence genera- Unclear risk Review authors' comment: the sequence generation procedure or the method
tion (selection bias) of allocation were not mentioned. The title, abstract and flowchart indicate
that it is a RCT
Allocation concealment Unclear risk Review authors' comment the sequence generation procedure or the method
(selection bias) of allocation were not mentioned. The title, abstract and flowchart indicate
that it is a RCT
Blinding of participants High risk No mention of any attempts to blind the participants
and personnel (perfor-
mance bias)
All outcomes
Blinding of personnel/care High risk No mention of any attempts to blind the care providers
providers (performance
bias)
All outcomes
Blinding of outcome as- Low risk "...a functional assessment were performed by an assessor blinded to the allo-
sessment (detection bias) cation of individuals to the two groups"
All outcomes
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, based on Table 3
line (selection bias)
Compliance (performance Unclear risk There was not enough data for the control group
bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Marshall 2013
Methods Single-centre, single-blind, randomised controlled study conducted in Sydney, Australia
Settings: recruited from the community via newspaper advertising, letterbox leaflets, advertisements
placed on community notice boards and word-of-mouth communication
Country: Australia
Inclusion criteria: males and females aged 18 to 50 years with ongoing recurrent LBP (> 12 weeks) locat-
ed between the costal margins and inferior gluteal folds
Exclusion criteria: presence of a postural abnormality contributing to the diagnosis (as presented in
medical notes summarising orthopaedic surgeon or physiotherapist diagnosis; as accredited exercise
physiologists it was not within the industry scope of practice for the researchers in this study to specif-
ically diagnose abnormalities. If a postural abnormality was observed, for example, scoliosis more
than 20°, participants were referred to local medical practitioners for confirmation and thus exclusion
from the trial). Further exclusion criteria were pain radiating below the knee, known history of or cur-
rently symptomatic lumbar disc hernia or fracture (60% of participants had undergone magnetic reso-
nance imaging and/or radiography in the last 2 years), history of back surgery, diagnosed inflammato-
ry joint disease, known severe osteoporosis, known metabolic or neuromuscular disease (as assessed
by American College of Sports Medicine pre-exercise screening tool for cardiovascular risk factors prior
to entry into an exercise programme), pregnancy, recent (< 3 months) participation in an exercise pro-
gramme or any form of physical treatment (i.e. manipulation, mobilisation massage)
Interventions 1. Specific trunk exercise group: performed Pilates exercise. Pilates has been described as a system of
mind-body exercises requiring core stability, strength and flexibility, with attention to muscle control,
posture and breathing
2. Stationary cycling exercise group: participants were informed that they were performing a style of
cycling known as Pilates Pedal to reduce any expectation bias as to why they were prescribed an exer-
cise programme that did not include specific trunk exercise. Intensity of effort within each component
was based on combinations of heart rate training zones (based on % of maximal heart rate) and rate of
perceived exertion scales
All participants were required to attend exercise classes 3 times per week for a total of 8 weeks. Every
exercise class was between 50 and 60 minutes duration, and was supervised with a participant to in-
structor ratio of 10:1. Exercise classes for the 2 groups were administered in different training rooms to
minimise the likelihood of contact between participants. Instructors were trained and experienced (> 5
years) in that intervention only, and had no contact with participants or instructors from the different
group
Outcomes 1. Pain: 10 cm VAS with "no pain" on the left side and "worst pain" on the right side
Risk of bias
Random sequence genera- Low risk "Randomisation was conducted by a researcher with no involvement in the
tion (selection bias) assessment protocols or training programs. Participants were randomly as-
signed in blocks of 8 with equal number of participants assigned to each
group."
Allocation concealment Low risk "The allocation sequence was concealed from researchers involved in en-
(selection bias) rolling and assessing participants."
Blinding of participants Low risk "To reduce expectation bias, participants were blinded to the use of different
and personnel (perfor- modalities in the trial. Participants were informed that they were volunteering
mance bias) for a study to investigate how exercise programs work for people with LBP."
All outcomes
Blinding of personnel/care High risk No mention of any attempts to blind the care providers
providers (performance
bias)
All outcomes
Blinding of outcome as- Low risk "Self-report questionnaires were completed by participants at baseline, 8
sessment (detection bias) weeks, and 6 months, and were processed by blinded research assistants."
All outcomes
Incomplete outcome data Low risk The percentage of withdrawals and dropouts was within the acceptable range
(attrition bias)
All outcomes
Intention-to-treat analysis Low risk "Data were analysed using SPSS with "intention-to-treat" principles (i.e. all
available data collected from all randomised participants were analysed in the
group to which the participant was allocated)."
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, based on Table 2
line (selection bias)
Compliance (performance Low risk Compliance was acceptable, based on the reported intensity/dosage, dura-
bias) tion, number and frequency for both the intervention and control groups
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Miyamoto 2013
Methods Randomised controlled trial carried out at the outpatient physical therapy department of (Universi-
dade Cidade de Sao Paulo, Sao Paulo, Brazil)
Settings: patients who responded to an advertisement placed in a regional newspaper and on the uni-
versity website
Country: Brazil
Inclusion criteria: the study included patients with chronic non-specific low back pain with a duration
of at least 3 months and aged between 18 to 60 years
Exclusion criteria: any contraindication for physical exercise (assessed with the Physical Activity Readi-
ness Questionnaire), previous regular Pilates method training, pregnancy, serious spinal pathologies,
previous or scheduled spine surgery, low back pain due to nerve root compromise, physical therapy
treatment for CLBP in the previous 6 months, and inability to write or speak in Portuguese
Interventions 1. Booklet group: the participants allocated to the booklet group received an educational booklet con-
taining information about the anatomy of the spine and pelvis, low back pain and recommendations
regarding posture and movements involved in activities of daily living. The participants in this group
did not receive additional exercise, and they were instructed not to undergo treatment elsewhere dur-
ing the period of the study. However, they had direct access to the physical therapist overseeing the in-
tervention and, over the next 6 weeks, they received twice-weekly telephone calls for clarification re-
garding the booklet instructions
2. Pilates group (Modified Pilates Exercise + Educational Programme): participants allocated to the
Pilates group received the same educational booklet in the first session of treatment. In addition to
the educational booklet, they received an individual, supervised treatment using the modified Pilates
method. The Pilates group received a 1-hour session, twice a week, over 6 weeks. These exercises fol-
lowed the traditional Pilates principles of centering (contracting deep trunk muscles known as "power
house muscles"), concentration, control, precision, flow and breathing. All exercises aimed at improv-
ing breathing, core stability, motor control, posture, flexibility and mobility with the spine in a neutral
position. At the beginning of all treatment sessions, 5 warm-up exercises were performed. These exer-
cises were aimed at improving spine and pelvis mobility. Then participants received the modified Pi-
lates protocol that was based on 8 exercises aimed at improving breathing associated with core sta-
bility, posture, strengthening of specific muscles (such as abdominal wall muscles, multifidus, gluteal
muscles, and hip flexors, extensors, adductors and abductors), and flexibility of the lower limbs and
spinal muscles in all planes of movement. The number of repetitions for each exercise was individu-
alised for each patient and ranged from 5 to 10 repetitions. These exercises were tailored individually
and progressed in difficulty in 3 levels (basic, intermediate and advanced). The physical therapist who
provided the intervention was a certified Pilates instructor with 3 years of clinical experience
Risk of bias
Random sequence genera- Low risk "Simple randomisation was conducted using Microsoft Excel for Windows soft-
tion (selection bias) ware (Microsoft Corporation, Redmond, Washington) by a researcher who was
not involved in participant recruitment."
Allocation concealment Low risk "The allocation sequence was generated by one of the authors who was not in-
(selection bias) volved with participant recruitment and treatment. Allocation was concealed
by using consecutively numbered, sealed, opaque envelopes."
Blinding of participants High risk "it was not possible to blind the participants and the therapist involved in the
and personnel (perfor- study."
mance bias)
All outcomes
Blinding of personnel/care High risk "it was not possible to blind the participants and the therapist involved in the
providers (performance study."
bias)
All outcomes
Blinding of outcome as- Low risk "...a previously trained, blinded assessor conducted an evaluation..."
sessment (detection bias)
All outcomes
Incomplete outcome data Low risk The percentage of withdrawals and dropouts was within the acceptable range
(attrition bias)
All outcomes
Intention-to-treat analysis Low risk "The analyses followed the intention-to-treat principles"
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, described in Table 2
line (selection bias)
Compliance (performance Low risk Compliance was acceptable, based on the description for both groups
bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Natour 2014
Methods Randomised, controlled clinical trial
Country: Brazil
Inclusion criteria: diagnosis of chronic low back pain (defined as pain between the lower rib cage and
gluteal folds for more than 12 months); non-specific low back pain characterised by the absence of
signs of a serious underlying condition (such as cancer, infection or cauda equina syndrome), spinal
stenosis or radiculopathy, or another specific spinal cause (such as vertebral compression fracture or
Pilates for low back pain (Review) 33
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
Exclusion criteria: diagnosis of low back pain due to other causes; fibromyalgia; prior spine surgery;
lawsuit; having initiated or changed regular physical activity in the previous 3 months; body mass index
> 30; and having undergone treatment with physical therapy or acupuncture in the previous 3 months
Interventions 1. Experimental group: patients maintained medical treatment with the use of a non-steroidal anti-in-
flammatory drug and underwent treatment with the Pilates method
2. Control group: patients continued medical treatment with the use of a non-steroidal anti-inflamma-
tory drug and did not undergo any other intervention
Outcomes 1. Pain: measured with the patient indicating his/her current level of pain by marking a point on a 10
cm VAS
2. Function: measured with the Roland-Morris questionnaire
3. Quality of life: measured with the SF-36
4. Satisfaction with treatment: measured with a Likert scale used to determine patient satisfaction with
the treatment (patients answered the question 'How do you feel today in comparison with your last
evaluation?', for which the options were 'much better', 'a little better', 'the same', 'a little worse' and
'much worse')
5. Flexibility: measured with a sit and reach test, which is the maximal distance achieved in the Wells
bench
6. Non-steroidal anti-inflammatory drug intake; the sodium diclofenac intake was recorded on a chart
supplied to each patient
This study was funded by grants provided by Fundacao Amparo a Pesquisa do Estado de Sao Paulo
(2007/53423-5)
Risk of bias
Random sequence genera- Low risk "Patients were randomised using an electronically generated randomisation
tion (selection bias) table"
Allocation concealment Low risk "Sealed, opaque envelopes were used to ensure the confidentiality of the as-
(selection bias) signment. The envelopes were stored in a locked cupboard and only opened
after the initial evaluation by an individual who did not participate in the
study."
Blinding of participants High risk "One limitation of this study is that the treatment provider and participants
and personnel (perfor- could not be blinded to the interventions."
mance bias)
All outcomes
Blinding of personnel/care High risk "One limitation of this study is that the treatment provider and participants
providers (performance could not be blinded to the interventions."
bias)
All outcomes
Blinding of outcome as- Low risk "An examiner blind to the assignment of the patients performed all evalua-
sessment (detection bias) tions."
All outcomes
Incomplete outcome data Low risk The percentage of withdrawals and dropouts was within the acceptable range
(attrition bias)
All outcomes
Intention-to-treat analysis Low risk "Data for all patients were evaluated with intention-to-treat analysis"
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, based on the Table 1
line (selection bias)
Compliance (performance Low risk Compliance was acceptable, based on the description for both groups
bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Quinn 2011
Methods Single-blinded randomised controlled trial
Inclusion criteria: participants aged between 18 and 60 years, with chronic LBP (> 3 months duration)
with no pain radiating below the knee and willing to attend Pilates classes for 8 weeks. Participants
also had to have some residual pain (VAS > 18 mm) and have failed the Sahrmann Abdominal Test for
core stability
Exclusion criteria: significant other co-morbidity such as unstable cardiovascular system, uncontrolled
epilepsy, Modified Zung Depression Index score > 33/6914 or significant pain in other joints which
would affect their ability to participate in class. Participants were also excluded if they were pregnant,
had spinal surgery in the past 12 months or were diagnosed with significant disc prolapse on MRI, se-
vere scoliosis, inflammatory low back pain or had a high level of disability (Roland Morris Disability
Questionnaire < 16/24)
Interventions 1. Pilates group: the 1-hour class consisted of modified mat-based Pilates exercises and was based on a
Body Control Pilates exercise programme used by a previous study. All classes were run by the chief in-
vestigator who was a chartered physiotherapist and a qualified Body Control Pilates instructor. Partic-
ipants in the intervention group were also advised to complete 15 minutes of Pilates exercise 5 days of
the week at home. Compliance with home-based exercise was monitored by a self recorded diary
2. Control group: participants in the control group received no further intervention for the 8-week peri-
od
Risk of bias
Random sequence genera- Low risk "Randomisation and concealed allocation was carried out using sequentially
tion (selection bias) numbered, opaque sealed envelopes"
Allocation concealment Low risk "Randomisation and concealed allocation was carried out using sequentially
(selection bias) numbered, opaque sealed envelopes"
Blinding of participants High risk "The study design did not permit blinding of the participants or the treating
and personnel (perfor- physiotherapist"
mance bias)
All outcomes
Blinding of personnel/care High risk "The study design did not permit blinding of the participants or the treating
providers (performance physiotherapist"
bias)
All outcomes
Blinding of outcome as- Low risk "...Baseline and final outcome measures of subjects participating in the study
sessment (detection bias) were recorded at a separate appointment by another physiotherapist (LB)
All outcomes who was blinded to group allocation and was not involved in providing treat-
ment..."
Intention-to-treat analysis Low risk "Groups were analysed on an intention to treat basis. All subjects were includ-
ed to avoid bias by omitting non compliers."
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, based on the Table 1
line (selection bias)
Compliance (performance Unclear risk There were insufficient data for the control group
bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Rajpal 2008
Methods Randomised controlled trial performed in the outpatient department of Sardar Bhagwan Singh Post
Graduate Institute of Biomedical Sciences and Research, Balawala, Dehradun
Country: India
Inclusion criteria: patients with postural low back pain for 3 months; female; in the age range 20 to 30
years; standing pelvic tilt angle of 9º or more; reduced abdominal muscle strength
Exclusion criteria: sciatica or any neurological deficit; soft tissue injuries; spinal fractures; disc pro-
lapse; back pain due to structural deformity, infection, tumour
Interventions 1. Pilates group: participants were given Pilates exercises for 1 month. The exercises were done 10
times with 10 seconds hold in between, daily. The participants were made to lie in crook lying with hip
and knee flexed. In this position, the lumbar spine is neither arched up nor flattened against the floor,
but is aligned normally with a small gap between the floor and the back. The participants were asked
to breathe in deeply and relax all the stomach muscles. While breathing out, the participant draws the
lower abdomen inwards as if the umbilicus goes backwards and upwards.The contraction was held for
10 seconds and then relaxed. This exercise was done 10 times daily for 10 days. The participants were
made to lie in quadruped/4-point kneeling position and were allowed to do the same contractions for
10 times daily for next 10 days. The participants were made to sit on an exercise ball with both hands
over the pelvis and were made to perform the same contractions and, along with that, were made to
extend their leg simultaneously. This exercise was performed 10 times daily for the next 10 days
2. McKenzie group: participants were taught postural correction and re-education. The participants
were told that as a person sits, the spine sooner or later takes a relaxed posture and the lumbar spine
moves into a fully flexed position that places stress over the various ligamentous structures. This posi-
tion is painful if maintained for longer period.
The participants were taught how to obtain and maintain the sitting posture for longer periods. To ob-
tain the correct sitting posture, this includes 'slouch-overcorrect' procedure. The participants were
made to sit slouched on a backless chair or stool, allowing the lumbar spine to rest on the ligaments in
the fully flexed position and permit head and chin to protrude. Then, slowly moved into the erect sit-
ting posture with the lordosis at its maximum and the head held directly over the spine with the chin
pulled up. This sequence was repeated for 3 times daily, 15 to 20 times at each session
Once they had mastered this procedure, they were advise to follow this procedure whenever they feel
pain and maintain the position. To maintain the correct sitting position, the participants were taught
about maintaining the lumbar lordosis in 2 ways: a) actively by conscious control of the lordosis, when
sitting on a chair without back rest; and b) passively by using the lumbar support, when sitting on a
seat with a back rest. The lumbar roll was used to hold the lumbar spine in a good position while pro-
longed sitting. The roll was placed at or just above the belt line (area of L3 and L4 vertebrae). This pro-
cedure was repeated for 3 times daily, 15 to 20 times at each session. The participants were made to
stand and moving the lower part of the spine backwards by tightening the abdominal muscles and tilt-
ing the pelvis posteriorly, while at the same time move the upper spine forwards and raising the chest.
This procedure was repeated for 3 times daily, 15 to 20 times at each session
Risk of bias
Random sequence genera- Unclear risk Review authors' comment: the sequence generation procedure or the method
tion (selection bias) of allocation were not mentioned. The title, abstract and flowchart indicate
that it is a RCT
Allocation concealment Unclear risk Review authors' comment: the sequence generation procedure or the method
(selection bias) of allocation were not mentioned. The title, abstract and flowchart indicate
that it is a RCT
Blinding of participants High risk No mention of any attempts to blind the patients
and personnel (perfor-
mance bias)
All outcomes
Blinding of personnel/care High risk No mention of any attempts to blind the care providers
providers (performance
bias)
All outcomes
Blinding of outcome as- High risk No mention of any attempts to blind the assessors
sessment (detection bias)
All outcomes
Incomplete outcome data Low risk The percentage of withdrawals and dropouts was within the acceptable range
(attrition bias)
All outcomes
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, based on the Table 1
line (selection bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Rydeard 2006
Methods Randomised controlled trial
Settings: participants were recruited through notices posted to private and public physicians' and
physiotherapists' offices, notices posted to local sports clubs and universities, and by advertisement in
an English-language newspaper
Inclusion criteria: physically active adults between 20 and 55 years old, living in Hong Kong, with long-
standing, persistent LBP (with or without leg pain) of greater than 6 weeks duration or recurring LBP
(with at least 2 painful incidences per year) of sufficient intensity to restrict functional activity in some
manner
Exclusion criteria: participants were excluded from the study if they were pregnant, had a past history
of spinal surgery or spinal fracture, were diagnosed with inflammatory joint disease, systemic metabol-
ic disorder, rheumatic disease or chronic pain syndrome, showed evidence of overt neurological com-
promise or acute inflammatory process, or had difficulty understanding written or spoken English
Interventions 1. Specific exercise training group (SETG): the SETG received a treatment protocol consisting of train-
ing in specialised (Pilates) exercise apparatus in the clinic for 3 1-hour sessions per week, and training
in a 15-minute home programme performed 6 days per week for 4 weeks.The standardised, progressive
treatment protocol addressed targeted muscle activation strategies throughout a variety of movement
patterns involving hip extension. The participant was required to consciously recruit specific muscles
- the deep anterolateral abdominals (with co-activation of the pelvic floor and lumbar multifidus), fol-
lowed by activation of the gluteus maximus muscles. Static postures were initially trained, followed
by training a variety of movement patterns to stress the lumbar-pelvic region and involving hip exten-
sion. The training was progressed on the Pilates Reformer over the 4-week period as tolerated. Initially
movements were practised using weight-bearing patterns in supine, with the lumbar spine in the neu-
tral position. Gradually more upright postures and controlled movement of the lumbar-pelvic region
out of neutral posture were incorporated. Prescribed movements were performed slowly, smoothly
and without pain. Individualised facilitation strategies were provided by the physiotherapist to correct
technique, control speed, assist appropriate muscle activation or modify the exercise or the progres-
sion to suit the participants' needs
The home treatment protocol consisted of 2 parts: (1) floor exercises to specifically activate the deep
anterolateral abdominals and local stability synergists and the gluteus maximus muscle by moving the
leg in a manner similar to that utilised on the apparatus; and (2) skill drills in which difficult tasks were
broken down into movement components and practised in isolation incorporating correct abdominal
and gluteal control
2. Control group (CG): no specific exercise training and continued with usual care, defined as consulta-
tion with a physician and other specialists and healthcare professionals as necessary. They were not re-
stricted from seeking any other treatment if they so wished. Participants were instructed to continue to
do what they were previously doing, including regular physical activity
2. Disability: Roland Morris Disability questionnaire, Chinese version validated in a Hong Kong Chinese
population (RMDQ-HK)
Risk of bias
Random sequence genera- Low risk "Subjects randomly pulled a card from a box of concealed pre-marked cards to
tion (selection bias) obtain assignment to either the specific exercise group or control group."
Allocation concealment Low risk "Subjects randomly pulled a card from a box of concealed pre-marked cards to
(selection bias) obtain assignment to either the specific exercise group or control group."
Blinding of participants High risk No mention of any attempts to blind the patients
and personnel (perfor-
mance bias)
All outcomes
Blinding of personnel/care High risk No mention of any attempts to blind the care providers
providers (performance
bias)
All outcomes
Blinding of outcome as- Low risk "Data collection monitored both pain intensity and functional status and in-
sessment (detection bias) cluded 2 self-report questionnaires administered by the research assistant, an
All outcomes independent physiotherapist investigator blinded to group assignment."
Incomplete outcome data Low risk The percentage of withdrawals and dropouts was within the acceptable range
(attrition bias)
All outcomes
Intention-to-treat analysis Low risk Intention-to-treat analysis was used to analyse the data
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- High risk Differences at baseline regarding pain and disability
line (selection bias)
Co-interventions (perfor- Unclear risk Unclear, but it seems that co-interventions were not avoided
mance bias)
Compliance (performance Unclear risk There were insufficient data for the control group
bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Wajswelner 2012
Methods Parallel, single-assessor blinded randomised controlled trial
Settings: participants were recruited from the community via local newspaper advertisements in 2 in-
ner suburban areas of Melbourne, Australia, and via e-mail news items at the University of Melbourne
Country: Australia
Inclusion criteria: aged between 18 and 70 years, symptoms of pain or stiffness in the lower back with
or without lower limb symptoms on most days of the week for more than 3 months (defined as chron-
ic), average pain score in the past week at telephone screening Q4 on an 11-point numeric rating scale
(0 = no pain and 10 = worst pain possible), and good understanding of written and spoken English
Exclusion criteria: spinal surgery; fever, infection, night sweats or rigours; unexplained weight loss or
loss of appetite; history of cancer or malignancy; cauda equina lesion, loss of bladder or bowel control,
or saddle paraesthesia; pregnancy or the possibility of pregnancy in the next 6 months; spinal fractures
or diagnosed osteoporosis; spinal inflammatory disease such as ankylosing spondylitis, rheumatoid
arthritis; co-morbidities that would prevent exercise; previous participation in a clinical Pilates pro-
gramme or other regular therapeutic back exercise programme in the last 6 months; inability to comply
with trial requirements; or compensable back pain
Interventions 5 musculoskeletal physiotherapists located in 2 accredited private practices and with expertise in the
exercise-based treatment of CLBP prescribed and supervised both treatments. Both interventions com-
prised an initial 1-hour individual session with the physiotherapist whereby an exercise programme
was prescribed. The therapist could use up to 2 further 30-minute individual sessions to ensure that the
participant could perform all exercises safely and effectively. After this, the participant attended group
exercise sessions (maximum number of 4 people) at one of the trial clinics twice a week (60 minutes)
for the 6-week duration of the programme. All sessions were supervised by one of the project physio-
therapists. Participants were also requested to perform a smaller number of daily home exercises
1. Pilates group: the clinical Pilates group received a tailor-made, direction-specific exercise pro-
gramme prescribed by a physiotherapist based on history, aggravating factors and physical exami-
nation. The clinical Pilates exercise programme was a series of exercises performed on the reformer
and trapeze equipment. The equipment both supports the patient and guides the direction and type
Pilates for low back pain (Review) 40
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
2. General exercise group: participants of the general exercise group were taught a standardised gener-
ic set of exercises traditionally used by physiotherapists for the management of CLBP. These exercises
were chosen via consensus of 7 musculoskeletal physiotherapists with expertise in exercise prescrip-
tion as well as from previous studies of general exercise programmes for CLBP. The exercises included
stationary bike, leg stretches, upper body weights, theraband, Swiss ball and floor exercises that were
multidirectional and nonspecific in nature. 4 daily home exercises were given to the general exercise
group participants
Notes Funding for this trial was provided by Mr. Craig Phillips of DMA Clinical Pilates Physiotherapy in
South Yarra, Melbourne, Victoria, Australia, and Mr. Marcus Pain of Back in Motion Physiotherapy in
Brunswick, Melbourne, Victoria, Australia
Henry Wajswelner works at a physiotherapy and Pilates clinic that uses clinical Pilates exercises to treat
patients. He also teaches clinical Pilates to other physiotherapists
Adverse events: in the Pilates group, 2 participants reported minor shoulder pain, and 1 experienced
knee pain. In the general exercise group, 2 participants reported worsening back pain, and 2 experi-
enced some back spasms
Risk of bias
Random sequence genera- Low risk "participants were randomly allocated in permuted blocks of six and eight,
tion (selection bias) stratified by age (18–35,
35–55, and 55–70 years) and gender, to either the clinical Pilates group or the
general exercise group. The randomisation sequence was generated a priori
using a computer program by an independent investigator."
Allocation concealment Low risk "Allocation was sealed in opaque and consecutively numbered envelopes held
(selection bias) centrally. An independent administrator opened the envelopes in sequence
and then revealed the group allocation to the physiotherapist just before the
participant presented for treatment."
Blinding of participants High risk No mention of any attempts to blind the patients
and personnel (perfor-
mance bias)
All outcomes
Blinding of personnel/care High risk No mention of any attempts to blind the care provider
providers (performance
bias)
All outcomes
Blinding of outcome as- Low risk There was blinding of the assessor
sessment (detection bias)
All outcomes
Incomplete outcome data Low risk The percentage of withdrawals and dropouts was within the acceptable range
(attrition bias)
All outcomes
Intention-to-treat analysis Low risk "The primary analysis was by intention-to-treat and was performed in a blind-
ed manner."
Selective reporting (re- Low risk It was clear that the published report included all expected outcomes
porting bias)
Group similarity at base- Low risk Patients did not differ in their baseline characteristics, reported in Table 1
line (selection bias)
Co-interventions (perfor- High risk There were few reported co-interventions in the study
mance bias)
Compliance (performance Low risk Compliance was acceptable, based on the description for both groups
bias)
Timing of outcome assess- Low risk All important outcome assessments for both groups were measured at the
ments (detection bias) same time
Hides 2012 Mixed population of healthy participants and those who have LBP
Anand 2014
Methods Randomised controlled trial
Country: India
Inclusion criteria: participants with low back pain of not more than 5 on a visual analogue scale
(moderate pain level), age range from 18 years to 60 years, both sexes, pain of more than 3 months
duration, doing normal ADL activity, working population (since they do their routine activity), BMI
within normal limit, not taking part in any of the research studies and not receiving physiotherapy
for the past 2 months (to avoid a carry-over effect) and no psychological or yellow flag participants
Exclusion criteria: participants with prolapsed intervertebral disc, radiating pain, stenosis, severe
spondylosis and spondylolisthesis, cardiovascular problems, tumours, infection or fracture, osteo-
porosis, radicular syndrome, inflammatory disorder, structural deformity not optimal for exercises
or psychologically unstable
Interventions 1. Experimental group: underwent modified Pilates-based exercises for 45 minutes, prior to the
modified Pilates-based exercises session; the general flexibility exercises were given for 15 min-
utes. The modified Pilates-based exercises included modified side kick, modified one leg stretch,
modified shoulder bridge, the hundred (base level modification), swimming (a modification from a
4-point base), modified swan dive, modified roll up, modified spine twist, double arm stretch, mod-
ified one leg circle. The flexibility exercises included the gluteus, hip flexors and quadriceps and
hamstrings stretches were encouraged
2. Control group: participants received therapeutic exercises for 45 minutes, prior to the therapeu-
tic exercises session; the general flexibility exercises were given for 15 minutes. The back exercises
includes pelvic bridging, prone straight leg raise, prone cobra and prone arm rise (unilateral initial-
ly and bilateral later), dynamic strengthening exercises, stationary bicycle and Swiss ball co-ordi-
nation exercises
RBR-7yhzym
Trial name or title Comparison between Pilates and conventional physical therapy for treatment of patients with non-
specific chronic low back pain: randomized controlled trial
RBR-7yhzym (Continued)
Inclusion criteria: medical diagnosis of chronic low back pain, aged 18 to 55 years
Interventions Pilates method (mat and apparatus) is the experimental group (n=31). The activities will be prac-
tised twice a week, for 45 minutes (morning or afternoon, according to the convenience of the par-
ticipant). The exercises are those that strengthen the abdominal and and paraspinal muscles,
the mobility of the spine and stretching of the muscle chains and move on to trunk exercises and
balance. The control group (n=31) will undergo conventional physical therapy(electrotherapy,
heat, strength training, stretching, mobilisation and patient education) also twice a week, for 45
minutes (morning or afternoon, according to the convenience of the participant)
E-mail: jeffcar@uel.br
Notes
Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants
1.1 Short-term (< 3/12 months from 6 265 Mean Difference (IV, Random, -14.05 [-18.91,
randomisation) 95% CI) -9.19]
1.2 Intermediate-term (more than 3/12 2 146 Mean Difference (IV, Random, -10.54 [-18.46,
months, less than 12/12 months) 95% CI) -2.62]
Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants
2.1 Short-term (< 3/12 months from 5 248 Mean Difference (IV, Random, -7.95 [-13.23,
randomisation) 95% CI) -2.67]
2.2 Intermediate-term (more than 3/12 2 146 Mean Difference (IV, Random, -11.17 [-18.41,
months, less than 12/12 months) 95% CI) -3.92]
3.1 Short-term (< 3/12 months from 1 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
randomisation) 95% CI)
3.2 Intermediate-term (more than 3/12 1 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
months, less than 12/12 months) 95% CI)
4 Global impression of recovery 1 Mean Difference (IV, Random, Totals not select-
95% CI) ed
4.1 Short-term (< 3/12 months from 1 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
randomisation) 95% CI)
4.2 Intermediate-term (more than 1 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
3/12, less than 12/12 months) 95% CI)
1.1.2 Intermediate-term (more than 3/12 months, less than 12/12 months)
Miyamoto 2013 43 45 (22) 43 53 (23) 69.39% -8[-17.51,1.51]
Natour 2014 30 42 (27.8) 30 58.3 (28.8) 30.61% -16.3[-30.62,-1.98]
Subtotal *** 73 73 100% -10.54[-18.46,-2.62]
Heterogeneity: Tau2=0; Chi2=0.9, df=1(P=0.34); I2=0%
Test for overall effect: Z=2.61(P=0.01)
1.2.2 Intermediate-term (more than 3/12 months, less than 12/12 months)
Miyamoto 2013 43 18.8 (18.8) 43 27.9 (23.3) 65.58% -9.1[-18.05,-0.15]
Natour 2014 30 29.3 (22.7) 30 44.4 (26) 34.42% -15.1[-27.45,-2.75]
Subtotal *** 73 73 100% -11.17[-18.41,-3.92]
Heterogeneity: Tau2=0; Chi2=0.59, df=1(P=0.44); I2=0%
Test for overall effect: Z=3.02(P=0)
1.3.2 Intermediate-term (more than 3/12 months, less than 12/12 months)
Miyamoto 2013 43 6.9 (1.8) 43 6.1 (2) 0.8[-0,1.6]
Analysis 1.4. Comparison 1 Pilates versus minimal intervention, Outcome 4 Global impression of recovery.
Study or subgroup Pilates group Minimal intervention Mean Difference Mean Difference
N Mean(SD) N Mean(SD) Random, 95% CI Random, 95% CI
1.4.1 Short-term (< 3/12 months from randomisation)
Miyamoto 2013 43 3.2 (1.5) 43 1.7 (2.2) 1.5[0.7,2.3]
Outcome or subgroup title No. of studies No. of partici- Statistical method Effect size
pants
1.1 Short-term (< 3/12 months 3 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
from randomisation) 95% CI)
1.2 Intermediate-term (more than 2 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
3/12, less than 12/12 months) 95% CI)
2.1 Short-term (< 3/12 months 2 149 Mean Difference (IV, Random, -3.29 [-6.82, 0.24]
from randomisation) 95% CI)
2.2 Intermediate-term (more than 2 151 Mean Difference (IV, Random, -0.91 [-5.02, 3.20]
3/12, less than 12/12 months) 95% CI)
3.1 Short-term (< 3/12 months 1 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
from randomisation) 95% CI)
3.2 Intermediate-term (more than 1 Mean Difference (IV, Random, 0.0 [0.0, 0.0]
3/12, less than 12/12 months) 95% CI)
Study or subgroup Pilates group Other exercises Mean Difference Weight Mean Difference
N Mean(SD) N Mean(SD) Random, 95% CI Random, 95% CI
Brooks 2012 32 15 (10.8) 30 20 (10) 46.47% -5[-10.18,0.18]
Wajswelner 2012 44 15.3 (9.1) 43 17.1 (13.4) 53.53% -1.8[-6.62,3.02]
Subtotal *** 76 73 100% -3.29[-6.82,0.24]
Heterogeneity: Tau2=0; Chi2=0.79, df=1(P=0.38); I2=0%
Test for overall effect: Z=1.83(P=0.07)
ADDITIONAL TABLES
*Clinical importance: consider 30% on VAS/NRS for pain intensity as clinically significant, and 2 to 3 points (or 8% to 12%) on the Roland-
Morris Disability Questionnaire for disability.
1Disability (short and intermediate-term).
2Disability (short-term).
APPENDICES
#2 dorsalgia
#3 backache
#8 lumbago OR discitis OR disc near degeneration OR disc near prolapse OR disc near herniation
#9 spinal fusion
#13 postlaminectomy
#14 arachnoiditis
#24 #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21
or #22 or #23
1. Clinical Article/
2. exp Clinical Study/
3. Clinical Trial/
4. Controlled Study/
S49 "pilates"
S45 lumbago
S38 "coccyx"
S37 sciatica
S31 backache
S29 "dorsalgia"
S24 volunteer*
S23 prospectiv*
S22 control*
S11 random*
S10 "placebo*"
S9 (MH "Placebos")
S7 S1 or S2 or S3 or S4 or S5 or S6
S6 triple-blind
S5 single-blind
S4 double-blind
S3 clinical W3 trial
Abstract and Title: Pilates AND Body Part: Lumbar spine, sacroiliac joint or pelvis AND Method: Clinical trial
S18 TX pilates
S15 DE "SCIATICA"
S14 TX backache
S13 TX sciatica
S11 DE "BACKACHE"
S10 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8 OR S9
S9 TX single blind
S8 TX random allocation
S6 SU clinical trials
S5 TX clinical trials
S4 TX placebo
S2 TX double blind
RCT
Pilates intervention
1. _______________________________________________________________________________
___________________________________________________________________________________
2. _______________________________________________________________________________
___________________________________________________________________________________
3. _______________________________________________________________________________
___________________________________________________________________________________
4. _______________________________________________________________________________
____________________________________________________________________________________
Authors (year) Patients Interventions Duration of Pilates intervention Outcomes Risk of Bias score
Continuous outcomes
Library
Cochrane
Mean SD N Mean SD N Mean SD N
Outcome #1
Better health.
Informed decisions.
Trusted evidence.
Baseline
Short term
Intermediate
Long term
Outcome #2
Baseline
Intermediate-term
Long-term
Short-term
Long-term
Baseline
(Continued)
Appendix 9. Criteria for assessing risk of bias for internal validity (Higgins 2011)
Random sequence generation (selection bias)
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
There is a low risk of selection bias if the investigators describe a random component in the sequence generation process such as: referring
to a random number table, using a computer random number generator, coin tossing, shuffling cards or envelopes, throwing dice, drawing
of lots, minimisation (minimisation may be implemented without a random element, and this is considered to be equivalent to being
random).
There is a high risk of selection bias if the investigators describe a non-random component in the sequence generation process, such as:
sequence generated by odd or even date of birth, date (or day) of admission, hospital or clinic record number; or allocation by judgement
of the clinician, preference of the participant, results of a laboratory test or a series of tests, or availability of the intervention.
There is a high risk of bias if participants or investigators enrolling participants could possibly foresee assignments and thus introduce
selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment
envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered);
alternation or rotation; date of birth; case record number; or other explicitly unconcealed procedures.
Blinding of participants
Performance bias due to knowledge of the allocated interventions by participants during the study
There is a low risk of performance bias if blinding of participants was ensured and it was unlikely that the blinding could have been broken;
or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack
of blinding.
• for patient-reported outcomes in which the patient was the outcome assessor (e.g. pain, disability): there is a low risk of bias for outcome
assessors if there is a low risk of bias for participant blinding (Boutron 2005);
• for outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care
providers (e.g. co-interventions, length of hospitalisation, treatment failure), in which the care provider is the outcome assessor: there
is a low risk of bias for outcome assessors if there is a low risk of bias for care providers (Boutron 2005);
• for outcome criteria that are assessed from data from medical forms: there is a low risk of bias if the treatment or adverse effects of the
treatment could not be noticed in the extracted data (Boutron 2005).
the plausible effect size (difference in means or standardised difference in means) among missing outcomes was not enough to have a
clinically relevant impact on observed effect size, or missing data were imputed using appropriate methods (if dropouts are very large,
imputation using even "acceptable" methods may still suggest a high risk of bias) (van Tulder 2003). The percentage of withdrawals and
dropouts should not exceed 20% for short-term follow-up and 30% for long-term follow-up and should not lead to substantial bias (these
percentages are commonly used but arbitrary, not supported by literature) (van Tulder 2003).
There is a high risk of reporting bias if not all of the study's pre-specified primary outcomes have been reported; one or more primary
outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified; one or
more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected
adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis;
the study report fails to include results for a key outcome that would be expected to have been reported for such a study.
There is low risk of bias if groups are similar at baseline for demographic factors, value of main outcome measure(s), and important
prognostic factors (examples in the field of back and neck pain are duration and severity of complaints, vocational status, percentage of
patients with neurological symptoms) (van Tulder 2003).
Intention-to-treat-analysis
There is low risk of bias if all randomised patients were reported/analysed in the group to which they were allocated by randomisation.
Other bias
Bias due to problems not covered elsewhere in the table
There is a low risk of bias if the study appears to be free of other sources of bias not addressed elsewhere (e.g. study funding).
CONTRIBUTIONS OF AUTHORS
Conception, design and drafting of the protocol: Leonardo OP Costa, Luciola da Cunha Menezes Costa and Cristina Maria Nunes Cabral.
Critical revision of the protocol for important intellectual content: Chris G Maher, Raymond Ostelo and Mark Hancock.
Analysis and interpretation of the data: Tiê P Yamato, Bruno T Saragiotto and Chris G Maher.
Drafting of the article: Tiê P Yamato, Bruno T Saragiotto and Chris G Maher.
Critical revision of the article for important intellectual content: Leonardo OP Costa, Luciola da Cunha Menezes Costa, Chris G Maher,
Raymond Ostelo and Mark Hancock.
DECLARATIONS OF INTEREST
Tiê P Yamato has no conflict of interest.
Cristina MN Cabral conducted two randomised controlled trials that use Pilates as an intervention for patients with chronic non-specific
low back pain and she is also author of one of the included trials (Miyamoto 2013).
Leonardo OP Costa conducted two randomised controlled trials that use Pilates as an intervention for patients with chronic non-specific
low back pain and he is also author of one of the included trials (Miyamoto 2013).
SOURCES OF SUPPORT
Internal sources
• None, Other.
External sources
• None, Other.
• In Selection of studies, the screening for potentially eligible studies was conducted by two pairs of review authors instead of two review
authors as stated in the protocol.
• In Measures of treatment effect, we had pre-specified in our protocol that for different scales we were going to quantify effect using the
standardised mean difference (SMD) and the mean difference (MD) for studies using the same scale. However, we decided to quantify
the effects of treatments using the MD for all continuous outcomes. If different scales were used we converted the scales to a 0 to 100
point scale.
• We did not perform a sensitivity analysis by excluding trials where the definition of the intervention was not clear because all definitions
of Pilates exercise were consistent with our criteria.
• We did not perform a subgroup analysis for duration of symptoms as all trials included chronic patients.
• In Assessment of heterogeneity, we included an acceptable range of the I2 value (< 50%) to combine the results in a meta-analysis
when no clear heterogeneity was identified by visual inspection. We used the 50% cut-off as I2 values above this value may represent
substantial heterogeneity.
• The approach to GRADE has been clarified further since the protocol with more detail about downgrading.
Pilates for low back pain (Review) 61
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.
Library Better health. Cochrane Database of Systematic Reviews
• We found three potentially eligible studies in trial registries reported as completed at least two years ago, for which no publicly available
report was found. Additionally, we were unable to contact the authors for these trials. Thus, we considered that there was a possibility
of publication bias in this review and downgraded all studies regarding publication bias for the analysis of quality of evidence (GRADE).
This condition was not mentioned previously in the protocol.
• Two studies measured quality of life, but the data from the physical and mental components were not available in the text and the
authors did not provide this information on request (Natour 2014; Wajswelner 2012), so we were unable to analyse this primary outcome
cited in the protocol.
• We did not find any studies that reported return to work, so we were unable to analyse this secondary outcome cited in the protocol.
INDEX TERMS