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

Bhadauria 2017.

Study characteristics
Methods Study design: RCT
Setting: India, healthcare
Exercise groups: 3
Comparison groups: 0
Participants Number of participants: 45 (E1 = 15, E2 = 15, E3 = 15)
Chronic LBP duration: 9.8 months (moderate)
Neurological/radicular symptoms: No participants
Mean age (years): 35
Sex (female): 33%
Interventions Exercise Group 1 (E1): Pilates: majority of exercises are abdominal or back focussed with warm‐up and cool‐down stretching exercises; type = Pilates; duration = 1.43 weeks; dose = low; design = standardised; delivery = individual; additional intervention = electrotherapy & heat/ice
Exercise Group 2 (E2): Lumbar stabilisation: photographs of all exercises performed focussed on trunk‐strength, warm‐up and cool‐down stretching exercises; type = core strengthening; duration = 1.43 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = electrotherapy & heat/ice
Exercise Group 3 (E3): Lumbar dynamic strengthening focussed on abdominals and lumbar muscles; type = core strengthening; duration = 1.43 weeks; dose = low; design = partially individualised; delivery = individual; additional intervention = electrotherapy & heat/ice
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 1.43 weeks (short)
Notes Conflicts of interest: None to declare
Funding source: Not reported
Other: SDs imputed, sufficient data not available for inclusion in meta‐analyses
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Patients were "randomly allocated".
Allocation concealment (selection bias) Low risk "Randomly allocated in three groups by envelop method"
Blinding of participants and personnel (performance bias)
All outcomes Low risk 1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Unlikely that lack of patient blinding caused deviation from intended interventions because patients had no control over the delivery of intervention.
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. Unlikely that lack of care provider blinding led to deviation from intended intervention because interventions were all quite distinct.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk 1. Outcome assessors for pain were the patients themselves, who could not be blinded due to the nature of the treatments; 2. Pain and function questionnaires require judgement which could be susceptible to a lack of blinding; 3. No treatment was obviously better than the others; no reason to alter patient response.
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. 8 of 44 dropped out, 18%.
Participants analysed in group allocated (attrition bias) Low risk 1. Appeared that all patients were analysed according to the allocation to which they were randomised
Selective reporting (reporting bias) Low risk 1. No linked protocol or statistical analysis plan found: within this publication all outcomes and analyses were fully reported.
Groups similar at baseline (selection bias) High risk Pilates group had significantly longer duration of symptoms (1 year longer than other two groups), and almost significantly higher average body mass index (3‐4 points higher).
Co‐interventions avoided or similar (performance bias) High risk No information presented about co‐interventions
Compliance acceptable in all groups (performance bias) High risk No information on compliance, adherence or attendance presented in this study
Timing of outcome assessment similar in all groups (detection bias) Low risk 1. Outcome assessments were identical for all patients, regardless of treatment group; 2. Visual Analogue Scale (for pain) and Oswestry Disability Index (for function) are well‐validated tools in the low back pain context.
Other bias Low risk Appeared free from other sources of bias