Skouen 2002.
| Methods | RCT | |
| Participants | 211 chronic low‐back pain patients of which 90% were on sick leave and 10% had been sick listed at least 2 months per year for last 2 years. Mean age 43.5, % male 35 | |
| Interventions | Intervention: light multidisciplinary treatment consisting of 3‐4 hours of evaluation, consultation and lecture at the start of intervention period with encouragement to gradually increase activity level. Topics were exercise, lifestyle, and fear avoidance. Intervention: extensive multidisciplinary treatment consisting of 4 wks of 6 hr per day group sessions with education, exercises, and occasional workplace interventions. |
|
| Outcomes | Measurement after 12, 18 and 24 months after treatment: information on sick leave status via National Health Insurance | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | random by means of a sequence of pre‐labelled cards contained in sealed envelopes; block randomisation |
| Allocation concealment (selection bias) | Low risk | prepared beforehand by physician outside clinic |
| Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors? | Low risk | data from national health insurance register |
| 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 | 3 patients dropped out (out of 195) |
| Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis? | Low risk | all subjects analysed (in terms of return‐to‐work) in the group to which they were allocated |
| Selective reporting (reporting bias) | Low risk | no suggestion found |
| Similarity of baseline characteristics? | Low risk | only age and gender provided |
| Co‐interventions avoided or similar? | Low risk | control group could seek other medical advice via GP |
| Compliance acceptable? | Low risk | only 3 patients did not comply with treatment programme |
| Timing of the outcome assessment similar? | Low risk | all subjects followed up once a month during the 26 follow‐up period |