Nicholas 1992.
| Methods | RCT conducted in Australia | |
| Participants | Patients referred from pain clinic, GPs or specialist with age 20‐60 years, LBP >6 months. 20 patients randomised, 45% female, average age 43.7 years, mean duration of pain 5.5 years | |
| Interventions |
MBR (CBT): 5 weeks, 2 sessions/week. Education (anatomy, back care, lifting, medication, diet/weight), strengthening exercises, mobilisation exercises, hydrotherapy, HEP, chronic pain education, coping, attentional porcesses, challenging and altering unhelpful cognitions, distraction techniques. Relaxation treatment: progressive muscle relaxation Physical (Control): 5 weeks, 2 sessions/week. Education (anatomy, back care, lifting, medication, diet/weight), strengthening exercises, mobilisation exercises, hydrotherapy, HEP. Attention control, general group discussion about living with back pain, no advice or information provided |
|
| Outcomes | Pain (PRC), Disability (SIP), Medication (% using), Depression (BDI), Coping (CSQ), Self‐Efficacy (PSEQ) Follow‐ups: ST (post‐treatment), MT (6 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.341 1st paragraph. "The random assignment was conducted after the pretreatment assessment and before the program started. Thus, neither the psychologist nor the physiotherapist knew 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 | Low risk | Pg.340 Subjects. 18/20 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 | Table 1. Post‐treatment, 6 months |