Henchoz 2010.
Methods | RCT conducted in Switzerland | |
Participants | Patients referred to a hospital rheumatology outpatient clinic with age 18‐60 years, LBP >6 weeks. 109 patients randomised, 32% female, average age 39.8 yers, mean duration of pain not reported | |
Interventions |
MBR (Multidisciplinary Rehabilitation): 3 weeks with sessions 5 days/week, 5‐7 hours/day, in groups (n=5) and individual. Intensive physical and ergonomic training, psychological pain management, back school, social and work‐related education, tailored medication programme Physical (Control): 18 physiotherapy sessions (45min) over 9 weeks. Active exercise and passive modalities to manage pain, improve mobility and increase activity level |
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Outcomes | Disability (ODI), Work (% working) Follow‐ups: LT (3 weeks), MT (6 weeks), LT (1 year) | |
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.2 Design. "allocated by a secretary not involved in the study to a functional multidisciplinary rehabilitation programme (FMR) or outpatient physiotherapy (OP) according to computer‐generated random numbers" |
Allocation concealment (selection bias) | Low risk | pg.2 Design. "...sealed in opaque envelopes with consecutive numbering" |
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 | Fig 1. 67/109 randomized patients followed up |
Intention to treat analysis | Low risk | Fig 1. "Included in ITT analysis" |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Comparability of groups at baseline | Low risk | Tables 1/2. Groups comparable on relevant demographic and clinical variables |
Compliance | Unclear risk | Not stated |
Cointerventions | Unclear risk | Not stated |
Timing of assessment | Low risk | pg.3 Outcomes. "ODI was recorded at the beginning of treatment (T0), at 3‐week (T3w), 9‐week (T9w), 6‐month (T6m), 9‐month (T9m) and 12‐month (T12m) follow‐up" |