| Study characteristics |
| Methods |
Study design: RCT
Setting: Israel, healthcare
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 45 (E1 = 25, C1 = 20)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Not specified
Mean age (years): 56
Sex (female): 100% |
| Interventions |
Exercise Group 1 (E1): Rotation exercises were conducted in 5 different weight bearing and non‐weight bearing positions including standing, sitting, supine/crook lying, side‐lying (left and right) and prone; type = stretching; duration = 4 weeks; dose = low; design = standardised; delivery = group; additional intervention = advice/education
Comparison Group 1 (C1): Other conservative treatment (education) |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); work (number of hours worked during study period)
Follow‐up time periods available for syntheses: 4 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: Not reported
Other: None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Article stated that the process was random, but did not explicitly report the method used; allocations were delivered in sealed envelopes. |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelopes |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
1. Impossible to blind patient to the allocation, since the interventions were so different (exercise versus guidance only); 2. Patient blinding likely did not cause deviations from intervention protocol because exercise group received control treatment plus exercises, and control group could not do exercises without physiotherapist. |
| 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. Therapists had no contact with control; lack of blinding for care providers unlikely to cause deviations because control patients were wait‐listed |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
1. Outcomes in question were pain and function which were assessed by the non‐blinded patients; 2. Treatment groups were very different, so patients may have had different expectations of treatment group effectiveness when assessing self‐reported outcomes; 3. Outcomes in an exercise versus no treatment study likely to be altered by knowledge of intervention assignment |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1. Unacceptable dropout rate (more than 20%); treatment group: 20%, control group: 25%; 2. Study dropped missing data since it occurred before intervention; 3. All control group dropouts were logistic in nature, while 4 of intervention group dropouts were medical including severe low back pain attacks; 4. 5 from each group |
| Participants analysed in group allocated (attrition bias) |
Low risk |
1. Paper cited that intention‐to‐treat was not done, however it seemed it was done just with the exclusion of missing data. Included patients were analysed in arm they were randomised to. |
| Selective reporting (reporting bias) |
Low risk |
1. No linked protocol or statistical analysis plan found: within this publication all outcomes and analyses fully reported; no obvious omissions |
| Groups similar at baseline (selection bias) |
Low risk |
No statistically significant differences between treatment groups on baseline characteristics except lumbar extension |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Patients asked to record co‐interventions for treatment period; five intervention and six control patients used medications; two intervention and six control did physical activity; three each worked. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
100% attendance reported for both treatment groups |
| Timing of outcome assessment similar in all groups (detection bias) |
High risk |
1. All outcomes assessed the same way for all participants except for experimental group outcome measures were compared among time points with ANOVA, and control group used paired t‐test; 2. Used well known scales, no reason to think outcome measures were invalid or unsuitable |
| Other bias |
Low risk |
Inadequate follow‐up time but no other apparent sources of bias |
