| Study characteristics |
| Methods |
Study design: RCT
Setting: USA, mixed
Exercise groups: 1
Comparison groups: 1 |
| Participants |
Number of participants: 235 (E1 = 112, C1 = 123)
Chronic LBP duration: Not specified (not specified)
Neurological/radicular symptoms: Some participants
Mean age (years): 42
Sex (female): 37% |
| Interventions |
Exercise Group 1 (E1): Strength, flexibility, and cardiovascular exercises to strengthen muscles and improve trunk flexibility; type = mixed; duration = 4 weeks; dose = low; design = standardised; delivery = group; additional intervention = none
Comparison Group 1 (C1): Other conservative treatment (manual therapy) |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire)
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: Not reported
Funding source: Health Resources and Services Administration (Grant #R18 AH 10001)
Other: SDs imputed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Subjects were randomised to one of two forms of treatment. |
| Allocation concealment (selection bias) |
Low risk |
Used manilla envelopes |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Not described |
| Blinding of care provider (performance bias) |
High risk |
Assumed not possible |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Support for judgement was not available. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Overall, 61 subjects withdrew from the study: 38 during the trial intervention (13 flexion distraction and 25 exercise program) and 23 during the follow‐up (14 flexion distraction, 9 exercise program). |
| Participants analysed in group allocated (attrition bias) |
Low risk |
Support for judgement was not available. |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
Patient demographics and baseline characteristics of the two groups were compared. |
| Co‐interventions avoided or similar (performance bias) |
High risk |
Subjects were asked not to take any pain‐reducing medication prior to data collection at weeks zero and five. |
| Compliance acceptable in all groups (performance bias) |
Unclear risk |
Not described |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
