Thieme 2003.
Methods | RCT; 2 arms; assessed at pre‐treatment, post‐treatment, 6 months, 15 months | |
Participants | End of treatment n = 61 Start of treatment n = 83 Sex: 61 F, 0 M Mean age = 47.3 (SD 8.3) Source = hospital for rheumatic disorders Diagnosis = fibromyalgia Mean years of pain = 16.5 |
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Interventions | "operant treatment" "standard physical treatment" |
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Outcomes |
Primary pain outcome: MPI pain Primary disability outcome: MPI interference Primary mood outcome: MPI affective distress Catastrophising outcome: none Diary pain intensity Multidimensional Pain Inventory: pain Multidimensional Pain Inventory: interference Multidimensional Pain Inventory: life control Multidimensional Pain Inventory: affective distress Multidimensional Pain Inventory: social support Multidimensional Pain Inventory: self efficacy Multidimensional Pain Inventory: punishing responses, solicitous responses, distracting responses Multidimensional Pain Inventory: total activities Doctor visits (from medical records) Hospital days (from medical records) Sleep hours diary Medication diary Tubingen pain behaviour scale |
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Notes | BT versus TAU, post‐treatment and follow‐up: analyses 7.1, 7.2, 7.3, 8.1, 8.2, 8.3 Yates quality scale: total quality = 15/35, design quality = 11/26, treatment quality = 4/9 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | “randomly assigned” |
Allocation concealment (selection bias) | High risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition reported; no test for differences |
Selective reporting (reporting bias) | Low risk | Fully reported |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not reported |