BACKGROUND: Systematic reviews have confirmed the effectiveness of work-related rehabilitation with significant cognitive-behavioural components for patients with musculoskeletal disorders (MSDs). In Germany, however, work-related rehabilitation focuses mainly on functional capacity training and less on psychosocial work demands. OBJECTIVE: To evaluate the efficacy of multimodal work hardening (MWH) with a cognitive-behavioural approach. METHODS: Patients with MSDs resulting in severe restriction of work ability were randomly assigned to treatment by either MWH or conventional musculoskeletal rehabilitation (controls). The primary outcome was work status. The work status at 6 months of follow-up was defined as positive if the patient was working and had <= 6 weeks of sick leave, and that at 12 months was defined as positive if the patient was working and had <= 12 weeks of sick leave. Follow-up data were collected by postal questionnaires. RESULTS: 236 patients consented to participate. Follow-up data were obtained from 169 (71.6%) participants at 6 months and 146 (61.9%) participants at 12 months. At 6 months, participants in the MWH group had a 2.4 times higher chance of a positive work status than the controls (OR 2.363; 95% CI 1.266 to 4.410; p = 0.007). At 12 months, the chances of a positive work status were still higher, but this difference was not statistically significant (OR 1.914; 95% CI 0.849 to 4.317; p = 0.118). Significance of the interaction term of treatment and time indicated more favourable outcomes for depression and anxiety, mental and physical health-related quality of life, and pain management in the MWH group. CONCLUSIONS: MWH improves health-related quality of life and is able to enhance the mid-term chances of work-life participation.

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