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. 2021 Sep 28;2021(9):CD009790. doi: 10.1002/14651858.CD009790.pub2

Moreschi‐Guastala 2016.

Study characteristics
Methods Study design: RCT
Setting: Brazil, healthcare
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 43 (E1 = 23, E2 = 20)
Chronic LBP duration: 82.62 months (long)
Neurological/radicular symptoms: Not specified
Mean age (years): 51
Sex (female): 79%
Interventions Exercise Group 1 (E1): Global posture re‐education: patients hold 3 different positions (statically) for 15 minutes each; type = core strengthening; duration = 6 weeks; dose = low; design = individualised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): Isostretching: cycles of holding 9 different postures for 9 breaths each, with 60‐second rest between each cycle; type = stretching; duration = 6 weeks; dose = low; design = individualised; delivery = individual; additional intervention = none
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 6 weeks (short)
Notes Conflicts of interest: Not reported
Funding source: Not reported
Other: None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was done through computer‐generated numbers and delivered in sealed, opaque envelopes numbered in sequence.
Allocation concealment (selection bias) Low risk Sealed, opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk 1. Impossible for patients to be blinded to different exercise protocols; 2. Two treatments were similar; patients likely did not have expectations about which treatment would be more effective and thus their expectations of effectiveness would be unbiased.
Blinding of care provider (performance bias) Low risk 1. Care providers could not be blinded to allocation due to the nature of the treatments; 2. Same care provider conducted both active treatments; protocol was explicit, no decision‐making by personnel; opinion may have transferred to patients but no clear better intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk 1. Outcomes in question were pain and function which were assessed by the patients who were not blinded; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Neither treatment was obviously better than the other; no reason to alter patient response
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. Dropout rate was = > 0% in both treatment groups; one dropout was due to a change of address.
Participants analysed in group allocated (attrition bias) Unclear risk 1. Explicitly stated that intent‐to‐treat analysis was not performed; It was deemed unnecessary due to the low dropout rate; 2. No mention of patients switching groups; dropout rate was sufficiently small that the missing data (and lack of intention‐to‐treat analysis) was unlikely to have affected overall conclusions.
Selective reporting (reporting bias) Low risk 1. All study outcomes were fully analysed according to trial registration (NCT01468298).
Groups similar at baseline (selection bias) Low risk A few characteristics were collected and similar; no indication of problematic randomisation
Co‐interventions avoided or similar (performance bias) High risk Co‐interventions not reported; no mention of medications and whether or not participants were allowed to use other forms of treatment during treatment
Compliance acceptable in all groups (performance bias) High risk No adherence reporting but limitations listed compliance as a difficulty; all treatment sessions were supervised, and thus compliance could have been reported.
Timing of outcome assessment similar in all groups (detection bias) Low risk 1. All outcomes assessments were performed identically for participants in both treatment groups; data collection was performed at the same time for both treatment groups and with the same tools; 2. Visual Analogue Scale and Roland‐Morris Disability Questionnaire are very commonly used in low back pain studies and have been validated in this context.
Other bias Low risk Under‐reported, no other apparent sources of bias