| Study characteristics |
| Methods |
Study design: RCT
Setting: United Kingdom, healthcare
Exercise groups: 2
Comparison groups: 2 |
| Participants |
Number of participants: 758 (E1 = 185, E2 = 173, C1 = 190, C2 = 210)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 43
Sex (female): 56% |
| Interventions |
Exercise Group 1 (E1): "Back to fitness": initial individual assessment then group classes incorporating cognitive behavioural principles and a mix of exercises; type = mixed; duration = 12 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education & psychological therapy
Exercise Group 2 (E2): "Back to fitness": Initial individual assessment then group classes incorporating cognitive behavioural principles and a mix of exercises; type = mixed; duration = 12 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education & psychological therapy & manual therapy
Comparison Group 1 (C1): Other conservative treatment (education)
Comparison Group 2 (C2): Other conservative treatment (physical therapy) |
| Outcomes |
Core outcomes reported: Pain (Graded Chronic Pain Scale (Von Korff)); Function (Roland‐Morris Disability Questionnaire); HRQoL (36‐Item Short Form Survey; EuroQol 5D)
Follow‐up time periods available for syntheses: 4 weeks (short); 12 weeks (short); 52 weeks (long) |
| Notes |
Conflicts of interest: LL, JM, MU, MV, and KW have received salaries from the MRC. MU has received fees for speaking from Menarini Pharmaceuticals, the manufacturers of dexketoprofen and ketoprofen, and Pfizer, the manufacturers of celecoxib and valdecoxib.
Funding source: Medical Research Council (research costs); National Health Service in England, Northern Ireland, Scotland, and Wales (excess treatment and service support costs)
Other: Information modified for author contact |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
After consenting and participants had completed baseline assessments, nurses contacted the remote randomisation service. |
| Allocation concealment (selection bias) |
Low risk |
Author contact: Changed to yes |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Patients not blinded |
| Blinding of care provider (performance bias) |
High risk |
Care providers not blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Support for judgement was not available. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
At three months, 1029 (77%) returned questionnaires; at 12 months, 995 (75%) returned questionnaires. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
Used two‐sided significance tests to analyse the primary outcome, Roland disability questionnaire score, after three or 12 months by intention‐to‐treat |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
The mean (SD) age of participants at randomisation was 43 (11) years; 56% were female, and 9% were not working because of poor health. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
They agreed to avoid physical treatments, other than trial treatments, for three months. |
| Compliance acceptable in all groups (performance bias) |
High risk |
Author contact: 47% did not attend Ax + one session. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
