| Study characteristics |
| Methods |
Study design: RCT (ISRCTN56323917)
Setting: England, healthcare
Exercise groups: 3
Comparison groups: 0 |
| Participants |
Number of participants: 212 (E1 = 71, E2 = 72, E3 = 69)
Chronic LBP duration: 92 weeks (long)
Neurological/radicular symptoms: Some participants
Mean age (years): 44
Sex (female): 64% |
| Interventions |
Exercise Group 1 (E1): Trunk muscle retraining, stretches, and general spinal mobility for home practice (as part of physiotherapy); type = mixed; duration = not specified weeks; dose = low; design = individualised; delivery = individual; additional intervention = advice/education & manual therapy
Exercise Group 2 (E2): Transversus abdominis and lumbar multifidus muscle training, spinal stability exercises; type = core strengthening; duration = 26 weeks; dose = low; design = partially individualised; delivery = group; additional intervention = none
Exercise Group 3 (E3): General strengthening, stretching, and light aerobic exercises progressed according to pacing principles; type = mixed; duration = not specified weeks; dose = low; design = standardised; delivery = group; additional intervention = advice/education & psychological therapy |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); work (days not working due to back pain in the previous 6 months); HRQoL (EuroQol 5D)
Follow‐up time periods available for syntheses: 26 weeks (moderate); 52 weeks (long) |
| Notes |
Conflicts of interest: None to declare
Funding source: Arthritis Research Campaign
Other: Information modified for author contact; SDs imputed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Before the trial started, the randomisation protocol was computer‐generated and held by a trials unit independent of and distant from the trial setting. |
| Allocation concealment (selection bias) |
Low risk |
After clinical assessment, participants were assigned to their intervention by clinic staff telephoning the trials unit. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Masking of participants or clinicians was neither possible nor desirable. |
| Blinding of care provider (performance bias) |
High risk |
Masking of participants or clinicians was neither possible nor desirable. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Author contact: unmasking appears to have occurred at six months. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Randomised 212 participants between March 2002 and September 2003; reassessed 169 participants at six months, 154 at 12 months and 160 at the final time point. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
Clinical outcomes were analysed on both intention‐to‐treat and complete case basis according to a previously prepared data analysis plan. |
| Selective reporting (reporting bias) |
Low risk |
Support for judgement was not available. |
| Groups similar at baseline (selection bias) |
Low risk |
The three treatment groups had similar characteristics and baseline values of outcome measures. |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
Author contact: only 4% of exercise group had manual treatment. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
Retention tended to be lowest in pain management (47 of 69, 68%) and highest in individual physiotherapy (59 of 71, 83%). |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Support for judgement was not available. |
