Skouen 2002.
| Methods | RCT conducted in Norway | |
| Participants | Employees on National Health Insurance list were invited. Patients with LBP sick‐listed for >8 weeks or at least 2 months/year over the last 2 years. 195 patients randomised, 43.5% female, average age 43.6 years, mean duration of pain not reported | |
| Interventions |
MBR (Extensive MD): 4 weeks, 5 days/week, 6 hours/day. CBT (group sessions): fear avoidance, coping strategies. Education: pain mechanisms, anatomy, exercise advice. Workplace interventions. Graded exercise program: stretching, strengthening, mobility, coordination exercises, aerobic trainnig. Relaxation, body awareness training. HEP at the end of the intervention MBR‐2 (Light MD, Control 1): Unspecified number of consultations (average 3) with physiotherapist and sometimes nurse or psychologist if necessary. Education; exercise, lifestyle, fear avoidance, advice to reduce illness behaviours and anxiety. HEP program and advice to stay active and gradually increase activity levels Usual (Control 2): usual care under GP, involving pain medication, referral to physiotherapist or chiropractic |
|
| Outcomes | Work (% return to work) Follow‐ups: LT (1, 1.5 and 2 years) | |
| 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.902 2nd column. "patients were allocated at random by means of a sequence of prelabeled cards contained in sealed envelopes. The allocation sequence was prepared beforehand by a physician outside the clinic" |
| Allocation concealment (selection bias) | Low risk | pg.902 2nd column. "patients were allocated at random by means of a sequence of prelabeled cards contained in sealed envelopes. The allocation sequence was prepared beforehand by a physician outside the clinic" |
| 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 1A. 195/211 randomized patients followed up |
| Intention to treat analysis | Unclear risk | Not stated |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Comparability of groups at baseline | Unclear risk | Insufficient information reported |
| Compliance | Unclear risk | Not stated |
| Cointerventions | Low risk | pg 903. Acceptable levels across groups |
| Timing of assessment | Low risk | Fig 1B. 3, 6, 12 months follow‐up |