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 |