| Study characteristics |
| Methods |
Study design: RCT
Setting: Iran, not specified
Exercise groups: 2
Comparison groups: 1 |
| Participants |
Number of participants: 36 (E1 = 12, E2 = 12, C1 = 12)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Not specified
Mean age (years): Not reported
Sex (female): 0% |
| Interventions |
Exercise Group 1 (E1): Pilates, with a stretching and walking cool‐down portion; type = Pilates; duration = 6 weeks; dose = low; design = standardised; delivery = individual; additional intervention = none
Exercise Group 2 (E2): McKenzie programme, performed extension and flexion exercises in supine and sitting positions; type = McKenzie; duration = 6 weeks; dose = high; design = individualised; delivery = individual; additional intervention = none
Comparison Group 1 (C1): Usual care/no treatment (control group: no intervention) |
| Outcomes |
Core outcomes reported: Pain (McGill Pain Score Pain Questionnaire)
Follow‐up time periods available for syntheses: 6 weeks (short) |
| Notes |
Conflicts of interest: None to declare
Funding source: No funding received
Other: None |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Random number was used to randomly enrol, but no mention of randomisation to group made other than the vague "randomly assigned" |
| Allocation concealment (selection bias) |
High risk |
No information on treatment allocation concealment |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
1. Patients could not be blinded to allocation due to the nature of the treatments; 2. Patients in the control group were likely to seek out an exercise as they received no treatment in the study; they would be able to access at least one of the interventions (Pilates); 3. No information on deviations from protocol; 4. Control group seeking exercise interventions could improve their low back pain and disability. |
| 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 |
High 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 functional questionnaires are subjective, and responses could be altered by awareness of intervention; 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 |
High risk |
1. No description of dropout rate 2. ANOVA does not handle missing data; no sensitivity analyses were conducted; 3. Missingness could be caused by increased disability from low back pain; 4. No information on dropout rate in either group; 5. No information on reasoning for any dropouts |
| 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. Mentioned study protocol but could not be found: within this publication, no pre‐planned outcomes were indicated in methods, but standard outcomes reported analyses in methods were fully reported. |
| Groups similar at baseline (selection bias) |
High risk |
At baseline, groups had significantly different pain and general health; no information on duration of symptoms (age was balanced, all patients were male) |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Study excluded patients who were undergoing other therapies during the study period (co‐interventions). |
| Compliance acceptable in all groups (performance bias) |
High risk |
No information on compliance, adherence or attendance 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. McGill Pain Score Questionnaire (for pain) is a well‐validated tool in the low back pain context. |
| Other bias |
Low risk |
No other sources of bias noticed; generally very poorly reported |
