Roche 2007.
| Methods | RCT | |
| Participants | 132 workers with chronic low‐back pain and on sick leave or at risk of work disability for more than 3 months. Mean age 39.8, 65.1% men | |
| Interventions | Intervention: Functional restoration programme: 5 weeks, 6 hrs a day The group performed exercises supervised by a physiotherapist who adjusted the exercise intensity to each participant every week. Patients performed work simulations during occupational therapy sessions. They were referred to the psychologist at least once in the first week and for further treatment if requested. Dietary advice was given. The schedule of interventions was standardized for all patients. Control: Active individual therapy: 5 weeks 3x1 hr a week. only active exercises supervised directly by the physiotherapist. The last week focused on functional exercises and endurance training. The programme included 50 minutes of individual home exercises 2 days a week (these could include stretching, jogging, and swimming). In both groups, patients were off work during the 5 weeks of treatment. |
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| Outcomes | Measurement directly after treatment: % self perceived ability to return to work, % return‐to‐work, % full‐time return‐to‐work | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | block randomisation using an 8 element permutation table |
| Allocation concealment (selection bias) | High risk | according to author |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | High risk | according to author |
| Blinding (performance bias and detection bias) All outcomes ‐ patients? | High risk | patients aware of allocation and intervention content |
| Blinding (performance bias and detection bias) All outcomes ‐ care provider? | High risk | care providers aware of allocation and intervention content |
| Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs? | Low risk | return‐to‐work data missing on 1 subject from each group |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | ITT analysis |
| Selective reporting (reporting bias) | Low risk | no such suggestions found |
| Similarity of baseline characteristics? | Low risk | no significant differences found |
| Co‐interventions avoided or similar? | Unclear risk | according do author |
| Compliance acceptable? | Unclear risk | according to author |
| Timing of the outcome assessment similar? | Low risk | all subjects assessed at the end of treatment period of 5 weeks |