| Study characteristics |
| Methods |
Study design: RCT (NCT0028108728)
Setting: England, healthcare
Exercise groups: 4
Comparison groups: 4 |
| Participants |
Number of participants: 579 (E1 = 72, E2 = 72, E3 = 71, E4 = 71, C1 = 72, C2 = 75, C3 = 73, C4 = 73)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): Not reported
Sex (female): Not reported |
| Interventions |
Exercise Group 1 (E1): Doctor prescription for aerobic exercises (predominantly walking); type = aerobic; duration = 12 weeks; dose = high; design = not specified; delivery = independent; additional intervention = psychological therapy
Exercise Group 2 (E2): Doctor prescription for aerobic exercises (predominantly walking); type = aerobic; duration = not specified weeks; dose = high; design = not specified; delivery = independent; additional intervention = psychological therapy & manual therapy
Exercise Group 3 (E3): Doctor prescription for aerobic exercises (predominantly walking); type = aerobic; duration = not specified weeks; dose = high; design = not specified; delivery = independent; additional intervention = advice/education & psychological therapy
Exercise Group 4 (E4): Doctor prescription for aerobic exercises (predominantly walking); type = aerobic; duration = not specified weeks; dose = high; design = not specified; delivery = independent; additional intervention = advice/education & psychological therapy
Comparison Group 1 (C1): Usual care/no treatment ("normal care")
Comparison Group 2 (C2): Other conservative treatment (manual therapy)
Comparison Group 3 (C3): Other conservative treatment (physical therapy)
Comparison Group 4 (C4): Other conservative treatment (physical therapy) |
| Outcomes |
Core outcomes reported: Pain (Number of Pain Days); function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (overall improvement (health transitions))
Follow‐up time periods available for syntheses: 12 weeks (short); 52 weeks (long) |
| Notes |
Conflicts of interest: None to declare
Funding source: Medical Research Council (grant number G0001104)
Other: Sufficient data not available for inclusion in meta‐analyses |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
At the baseline appointment, after informed written consent had been obtained, participants were randomised to one of eight groups by the practice nurse. |
| Allocation concealment (selection bias) |
Unclear risk |
At the baseline appointment, after informed written consent had been obtained, participants were randomised to one of eight groups by the practice nurse. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Not described |
| Blinding of care provider (performance bias) |
High risk |
Not described |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
A total of 579 people were randomised and completed the baseline questionnaires. |
| Participants analysed in group allocated (attrition bias) |
High risk |
Not described |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
Baseline characteristics were similar for all variables (Table 2) except there were fewer women in the Alexander technique groups. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Not described |
| Compliance acceptable in all groups (performance bias) |
Unclear risk |
Good adherence was defined by the trial management group as attending five out of six massage sessions, five out of six lessons in the other group. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
One session a week for six weeks. Two lessons a week for two weeks then one lesson a week for two weeks. Twenty two lessons over five months |
