Kool 2007.
| Methods | RCT conducted in Switzerland | |
| Participants | Patients referred to work rehabilitation centre with age 20‐55 years, non acute NSLBP, >6 weeks sick leave in the last 6 months. 174 patients randomised, 21.3% female, average age 42.1 years, mean duration of pain not reported | |
| Interventions |
MBR (FCT): 6 days/week for 3 weeks, 4 hours/day. Time contingent: work simulation, endurance training, strengthening, aerobic training. Counselling, education, self‐efficacy, analgesic medication Physical (PCT): 6 days/week for 3 weeks, 2.5 hours/day. All activity was pain‐contingent: Passive and active mobilisation, stretching, strengthening, min‐back school (education), heat, electrotherapy, massage, progressive relaxation, analgesic medication |
|
| Outcomes | Pain (NRS), Work (% at work), Overall Improvement (Likert Scale), Medication (% taking medication), Self‐Efficacy (PACT) Follow‐ups: ST (3 months), LT (12 months) | |
| 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.1080 Design. "Randomization was concealed" |
| Allocation concealment (selection bias) | Unclear risk | pg.1080 Design. "Randomization was concealed" |
| 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. 166/174 randomized patients followed up |
| Intention to treat analysis | Low risk | pg.1091 Statistics. "Analysis was based on the intention‐to‐treat principle" |
| 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 | Low risk | pg.1091 Protocol compliance. "All patients attended at least 90% of the scheduled treatments, and treatment duration was comparable" |
| Cointerventions | Low risk | pg.1093 Health Care use. "Interventions after rehabilitation were comparable in the FCT and PCT group" |
| Timing of assessment | Low risk | pg.1090 Outcome measurement. Follow‐up 1 year |