Linton 2005.
| Methods | RCT conducted in Sweden | |
| Participants | Patients referred to primary care facilities at risk of developing long‐term disability, employed, with back or neck pain (back pain 85%), <4 months of sick leave over the past year. 185 patients randomised, 83% female, average age 49 years, mean duration of pain not reported | |
| Interventions |
MBR (PT+CBT): Physical Therapy (unconstrained volume of treatment); information on prevention, cause of LBP, activity advice, functional training, personalised programs. 6 weeks, 1 session/week, 2 hours/session plus homework. CBT intervention (groups n=6‐10); pain education, problem solving, coping skills, increase in function, graded activity, stress management, relaxation, dealing with exacerbations. Minimal intervention (1 session), education, actvity advice, booklet, patients free to seek any medical care MBR‐2 (CBT, Control 1): 6 weeks, 1 session/week, 2 hoursr/session plus homework, CBT intervention (groups = 6‐10 persons); pain education, problem solving, coping skills, increase in function, graded activity, stress management, relaxation, dealing with exacerbations. Minimal intervention (1 session), education, actvity advice, booklet, patients free to seek any medical care Usual (Control 2): Minimal intervention (1 session), education, actvity advice, booklet, patients free to seek any medical care |
|
| Outcomes | Pain (NRS), Disability (RMDQ), Work (% sick leave), Health Care Utilisation (number of visits), Medication (number of days of consumption), Fear Avoidance (TSK), Anxiety (HADS subscale), Depression (HADS subscale), Pain Catastrophising (PCS) Follow‐ups: LT (12 months) | |
| Notes | Subgroup analyses: Low 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 | Participants. "randomly assigned to 1 of the 3 groups using a computer‐generated block randomization" |
| Allocation concealment (selection bias) | Unclear risk | Unclear |
| 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 | Completion and participation rates. Differential dropout between groups |
| Intention to treat analysis | Low risk | Completion and participation rates. "An “intention to treat” approach was used" |
| 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 | Low risk | Completion and participation rates. High attanedance rates across the groups |
| Cointerventions | High risk | Minimal treatment group. Patients free to seek any care |
| Timing of assessment | Low risk | Measures and Procedures. 1 year follow‐up |