Nicholas 1991.
| Methods | RCT conducted in Australia | |
| Participants | Patients referred from pain clinic, GPs or specialist with age 20‐60 years, LBP >6 months. 58 patients randomised, 51.7% female, average age 41.2 years, mean duration of pain 7 years | |
| Interventions |
MBR (Behavioural+Relaxation): 5 weeks, 2 sessions/week. Education (anatomy, back care, lifting, medication, diet/weight),Strengthening exercises, mobilisation exercises, hydrotherapy, HEP. Behavioural treatment; goal‐setting (social, home, work) and advice, medication reduction, pacing, given positive reinforcement plus relaxation treatment; progressive muscle relaxation Physical (Physiotherapy): 5 weeks, 2 sessions/week. Education (anatomy, back care, lifting, medication, diet/weight), strengthening exercises, mobilisation exercises, hydrotherapy, HEP Note: 6 treatment groups in total, only the above groups used for this review |
|
| Outcomes | Pain (PRC), Disability (SIP), Medication (number of types), Anxiety (STAI), Depression (BDI), Pain Beliefs (PBQ), Coping (CSQ) Follow‐ups: ST (post‐treatment), MT (6 months), LT (12 months) | |
| Notes | Subgroup analyses: Low intensity intervention, Low baseline symptom intensity (<60% of maximum scale score). Included in Guzman 2006 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unclear |
| Allocation concealment (selection bias) | Low risk | pg.226 Experimental design. "The random assignment was performed after the pretreatment assessment. Thus, the experiments did not know to which condition a subject would be assigned at the time the pretreatment assessments were conducted" |
| 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.232 Attrition. 39/58 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 | Unclear risk | Not stated |
| Timing of assessment | Low risk | pg.226 Experimental design. "repeated measurements were conducted on four occasions‐pretreatment, post‐treatment, 6 months and 12 months after the end of treatment" |