Gatchel 2003.
| Methods | RCT | |
| Participants | 124 workers from orthopaedic practices with acute low‐back pain and decreased ability to perform normal job requirements because of pain for about 3.8 weeks. Mean age was 38.2 and 65% was male. | |
| Interventions | Intervention: a functional restoration early intervention of 3 weeks which consisted of four major components‐pscyhology, physical therapy, occupational therapy and case‐management. Contents were 3 physical evaluations, 1 physician evaluation, 18 physical therapy sessions (individual and group) 9 biofeedback/pain management sessions, 9 group didactic sessions, 9 case manager/occupational therapy sessions and 3 interdisciplinary team conferences. The number of sessions administered to patients was tailored to their specific needs, with most patients not needing all of the aforementioned number of sessions. Control: non‐intervention, care as usual |
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| Outcomes | measured at 1 year after first evaluation: % return‐to‐work | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | urn randomization procedure |
| Allocation concealment (selection bias) | Unclear risk | not stated |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | Low risk | 'by raters blind to study hypotheses' |
| 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 | no dropouts |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | ITT analysis |
| Selective reporting (reporting bias) | Low risk | no suggestion found |
| Similarity of baseline characteristics? | Low risk | 'these three groups matched for age, gender, race, and time since original injury based upon and urn randomization procedure' |
| Co‐interventions avoided or similar? | High risk | control group received various types of treatment initiated by themselves |
| Compliance acceptable? | Unclear risk | not stated |
| Timing of the outcome assessment similar? | Low risk | all subjects followed up at 3, 6, 9, 12 months |