Streibelt 2009.
Methods | RCT conducted in Germany | |
Participants | Patients referred to rehabilitation centre from work insurance provider, limited work ability due to chronic musculoskeletal disorder. 222 patients randomised, 16.7% female, average age 45.8 years, mean duration of pain not reported | |
Interventions |
MBR (FCEMR): 3 weeks inpatient program, 3‐4 hours treatment/day. Physical therapy, exercises, massage, education, relaxation. Focus on work‐specific skills and functional capacity with operant behavioural approach. Coping skills training Physical (MR, Control): 3 weeks inpatient program, 3‐4 hours treatment/day. Physical therapy, exercises, massage, education, relaxation |
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Outcomes | Disability (PDI), Work (weeks off‐work, % return to work) Follow‐ups: LT (1 year) | |
Notes | Subgroup analyses: Mid‐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.4 Study design. "A computer‐generated randomization list was created by a statistician" |
Allocation concealment (selection bias) | Low risk | pg.4 Study design. "Randomized allocation of the patients in either the treatment or the control group was done by an external institute" |
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 | High risk | pg.7 Sample. >50% dropout rate |
Intention to treat analysis | Low risk | pg.6 Analysis. "Cases were analysed as intended to treat" |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Comparability of groups at baseline | High risk | Baseline characteristics. Groups comparable on relevant demographic and clinical variables |
Compliance | Unclear risk | Not stated |
Cointerventions | Unclear risk | Not stated |
Timing of assessment | Low risk | Fig 1. 1 year follow‐up |