| Study characteristics |
| Methods |
Study design: Cluster‐RCT (NCT00439764)
Setting: Spain, healthcare
Exercise groups: 1
Comparison groups: 2 |
| Participants |
Number of participants: 348 (E1 = 100, C1 = 109, C2 = 139)
Chronic LBP duration: Not specified (moderate)
Neurological/radicular symptoms: Some participants
Mean age (years): 51
Sex (female): 67% |
| Interventions |
Exercise Group 1 (E1): Stretching and active exercises for abdominal, lumbar and thoracic back extensors, psoas, ischiotibial, and pelvic muscles; type = core strengthening & stretching; duration = 1 week; dose = low; design = partially individualised; delivery = group; additional intervention = advice/education & relaxation
Comparison Group 1 (C1): Usual care/no treatment (healthy nutrition booklet and 15‐minute group talk)
Comparison Group 2 (C2): Other conservative treatment (education) |
| Outcomes |
Core outcomes reported: Pain (Visual Analogue Scale); function (Roland‐Morris Disability Questionnaire); HRQoL (12‐Item Short Form Survey); Global Perceived Health or Recovery (Global Perceived Health or Recovery (global assessment pain/disability (4 categories))
Follow‐up time periods available for syntheses: 12 weeks (short); 26 weeks (moderate) |
| Notes |
Conflicts of interest: None to declare
Funding source: Regional Government of Castilla‐Leon; Kovacs Foundation
Other: SDs imputed |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation to the three groups was performed blindly according to a random numbers table. |
| Allocation concealment (selection bias) |
Low risk |
Primary care physicians were not informed about which group they had been allocated to. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Authors said there was blinding, however, we believe this was not possible. |
| Blinding of care provider (performance bias) |
Unclear risk |
Primary care physicians were not informed about which group they had been allocated to. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
All questionnaires were self‐administered and completed by the patients on their own, unaccompanied by healthcare staff or third parties. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
There were no losses to follow‐up. |
| Participants analysed in group allocated (attrition bias) |
Low risk |
There were no losses to follow‐up. |
| Selective reporting (reporting bias) |
Low risk |
Yes |
| Groups similar at baseline (selection bias) |
Low risk |
Groups were very similar |
| Co‐interventions avoided or similar (performance bias) |
Low risk |
All patients received the usual treatment for low back pain in the Spanish National Health Service as provided by their primary care physician. |
| Compliance acceptable in all groups (performance bias) |
Low risk |
In order to reduce the number of losses to follow‐up, a treatment co‐ordinator blinded to the kind of intervention patients had received, was in charge. |
| Timing of outcome assessment similar in all groups (detection bias) |
Low risk |
Post‐treatment, follow‐up the same |
