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

Soundararajan 2016.

Study characteristics
Methods Study design: RCT
Setting: India, occupational
Exercise groups: 2
Comparison groups: 0
Participants Number of participants: 30 (E1 = 15, E2 = 15)
Chronic LBP duration: 3.77 months (moderate)
Neurological/radicular symptoms: Not specified
Mean age (years): 27
Sex (female): 40%
Interventions Exercise Group 1 (E1): Multifidus retraining programme: deep spine stabiliser; type = core strengthening; duration = 6 weeks; dose = low; design = standardised; delivery = not specified; additional intervention = none
Exercise Group 2 (E2): Traditional back exercises to strengthen back and core; type = core strengthening; duration = 6 weeks; dose = low; design = standardised; delivery = not specified; additional intervention = none
Outcomes Core outcomes reported: Pain (Visual Analogue Scale); function (Oswestry Disability Index)
Follow‐up time periods available for syntheses: 6 weeks (short)
Notes Conflicts of interest: None to declare
Funding source: Not reported
Other: SDs imputed
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Purposive random sampling with 15 subjects (9 males and 6 females) in each group
Allocation concealment (selection bias) High risk No information on treatment allocation concealment
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. Both groups were receiving exercise interventions, unlikely to deviate from 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 caused deviations from intended interventions
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk 1. Outcome assessors for pain and function were patients themselves, who could not be blinded to allocation due to the nature of the treatments; 2. Pain and functional questionnaires are subjective, and responses could be altered by awareness of intervention; 3. Both groups were receiving exercise programmes; unlikely for patient response to be significantly altered
Incomplete outcome data (attrition bias)
All outcomes Low risk 1. It was highly likely that the dropout rate in this case was zero because the trial was conducted in a specific workplace, encouraging participation and follow‐up.
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. Study was analysed and reported as described in the methods section.
Groups similar at baseline (selection bias) Low risk Both treatment groups were similar on all relevant baseline characteristics.
Co‐interventions avoided or similar (performance bias) High risk No information about co‐interventions and whether or not they were comparable
Compliance acceptable in all groups (performance bias) High risk No explicit reference in the study to compliance/adherence/attendance, but because this study was run within a workplace, it was likely quite high
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