Morone 2011.
Methods | RCT conducted in Italy | |
Participants | Patients referred to a rehabilitation centre with age 18‐80 years and NSLBP >3 months. 73 patients randomised, 64.3% female, average age 60.2 years, mean duration of pain not reported | |
Interventions |
MBR (Back School): 4 weeks, 10 sessions in groups (4‐5), each session 1 hour. Education (anatomy, pain, stress management, workplace, sporting activities, posture), exercise prescription (ergonomics, ADLs, HEP), stretching, strengthening, core stability Usual (Control): medical care, mostly pharmacological |
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Outcomes | Pain (VAS), Disability (ODI), General Health (SF‐36) Follow‐ups: ST (post‐treatment and 3 months), MT (6 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) | Unclear risk | Unclear |
Allocation concealment (selection bias) | Low risk | pg.535 last sentence. "The othet physiatrist was involved in patients' randomization and was unaware of clinical features" |
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.538 Results. 70/74 ranodmized patients followed up |
Intention to treat analysis | High risk | pg.537 last sentence. "A per‐protocol analysis was performed on primary and secondary outcome measures" |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Comparability of groups at baseline | Low risk | Tables 1/3/4. Groups comparable on relevant demographic and clinical variables |
Compliance | Unclear risk | Not stated |
Cointerventions | Unclear risk | Not stated |
Timing of assessment | Low risk | pg.536 Outcome measures. Baseline, end of treatment, 3, 6 months |