Tavafian 2008.
Methods | RCT conducted in Iran | |
Participants | Adult women recruited from outpatient rheumatology clinics with age >18 years, LBP >3 months. 102 patients randomised, 100% female, average age 42.9 years, mean duration of pain 9.1 months | |
Interventions |
MBR (Education): 4 days, 5 sessions, based on Back school. Education: anatomy, physiology, pathology of LBP, self‐care, health behaviours, biomechanics, lifestyle factors, prevention. Psychologist: coping skills, anger management, relaxation. Physiotherapist: stretching, strengthening, posture, functional movement advice (HEP) Usual (Control): medical management, mostly medication prescription (analgesics, muscle relaxants, NSAIDs, anti‐depressants) |
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Outcomes | Pain (SF‐36 bodily pain), General Health (SF‐36) Follow‐ups: ST (3 months), MT (6 months), LT (12 months) |
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Notes | Subgroup analyses: Mid‐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) | High risk | pg.1618 1st column. "The treatment allocation was not concealed" |
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.1618 Fig 1. 74/102 randomized patients followed up |
Intention to treat analysis | Unclear risk | Unclear |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Comparability of groups at baseline | Low risk | Table 1. Groups comparable on relevant demographic and clinical variables |
Compliance | Unclear risk | No stated |
Cointerventions | Low risk | pg.1618 1st column. "cointerventions were avoided for both group" |
Timing of assessment | Low risk | pg 1617 Study Design. "This was a blind randomized controlled trial with a 3, 6, and 12 months follow up" |