Bendix 'C' 2000.
| Methods | RCT conducted in Denmark | |
| Participants | Patients referred to a back centre with threatened job situation due to LBP. 127 patients randomised, 65.4% female, median age 41 years, mean duration of pain not reported | |
| Interventions |
MBR (FR): 39 hours/week for 3 weeks inpatient, in groups (7/group), plus 1x 6 hour session/week for 3 weeks). Aerobic exercise, strength, stretching, simulated work tasks, biofeedback, pan coping, goal setting, cognitive appraisal, relaxation, job seeking skills, recreation, ball games, running, swimming. Physical (OIT): 1.5 hour sessions, 3x/week for 8 weeks; aerobic and strengthening exercises |
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| Outcomes | Pain (NRS), disability (LBP rating scale), work (working or able to return to work, days of sick leave), improvement (global rating of change), utilisation (contacts with health care system, admission to hospital due to LBP, LBP surgery) Follow‐up: LT (5 years) |
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| Notes | Subgroup analyses: High intensity intervention, Low baseline symptom intensity (<60% of maximum scale score) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Pg.2495 "Randomization, or rather stratification by minimization, 24 was intended to equalize age, gender, days of sick leave in 3 years, Manniche’s rating scale score19 (reflecting pain, disability, and physical measures), and smoking across the two treatments" |
| Allocation concealment (selection bias) | Unclear risk | Unclear |
| Blinding of participants | High risk | Not possible |
| Blinding of clinicians | High risk | Not possible |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not possible; patient reported outcome |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Fig 1. "For the participants starting FR and OIT, the dropout rate during treatment was 14% and 19%, respectively" |
| Intention to treat analysis | Low risk | pg.2497 Statistical Methods. "intention‐to‐treat analyses were performed to account for dropouts at different phases of the study" |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Comparability of groups at baseline | Low risk | Table 1. Groups comparable on relevant demographic and clinical variables |
| Compliance | Unclear risk | Not stated |
| Cointerventions | Unclear risk | Not stated |
| Timing of assessment | Low risk | pg.2497 Outcome Evaluation. "The 1‐year follow‐up evaluation was carried out at a meeting in the Back Cente" |