Kole‐Snijders 1999.
| Methods | RCT conducted in the Netherlands | |
| Participants | Patients referred to rehabilitation centre by GP or specialist with age 18‐65 years, LBP >6 months, discrepancy between objective findings and pain complaints, partner willing to participate in treatment. 148 patients randomised, 64% female, average age 39.8 years, mean duration of pain 10 years | |
| Interventions |
MBR (OPCO): Individual and group, 5 weeks inpatient plus 3 weeks outpatient. Operant behavioural treatment, quota‐based activities, standing and sitting tolerance, daily activity schedule for home, spouse group training (education and discussion). Cognitive coping skills, increasing pain control and self‐efficacy, education, biofeedback MBR‐2 (OPDI, Control 1): Individual and group, 5 weeks inpatient plus 3 weeks outpatient. Operant behavioural treatment, quota‐based activities, standing and sitting tolerance, daily activity schedule for home, spouse group training (education and discussion). Group discussion (attention control for cognitive coping training) Waiting list (Control 2) |
|
| Outcomes | Recovery (% improved) Follow‐ups: ST (2 months), MT (6 months), LT (12 months) | |
| Notes | Subgroup analyses: High intensity intervention, Baseline symptom intensity unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | pg.933 Study design. "Allocation to the three conditions occurred following a randomizationm procedure" |
| Allocation concealment (selection bias) | Low risk | pg.933 Study design. "a number that an indpendent researcher blindly drew and assigned" |
| 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.936 Attrition. 107/148 patients available at 12 month follow‐up |
| Intention to treat analysis | Low risk | pg.936 Intention to treat analysis. "intention to treat analysis was done" |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Comparability of groups at baseline | High risk | pg.937 Baseline comparisons. Between group differences on dependent variables |
| Compliance | Low risk | pg.937 Compliance. Similar compliance across conditions |
| Cointerventions | Unclear risk | Not stated |
| Timing of assessment | Low risk | Fig 3. Post‐treatment, 6, 12 months |