Falcao 2008.
Methods | RCT; 2 arms; assessed at pre‐treatment, post‐treatment, 3 months | |
Participants | End of treatment n = 51 Start of treatment n = 60 Sex: 60 F, 0 M Mean age = 45.7 (SD 2.3) Source = Rheumatology outpatients Diagnosis = fibromyalgia Mean years of pain = 3.6 |
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Interventions | "Cognitive behavioral therapy" "Routine medical visits" |
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Outcomes |
Primary pain outcome: VAS Primary disability outcome: FIQ (no data for SF‐36) Primary mood outcome: BDI Catastrophising outcome: none 1. Visual analogue scale for pain 2. Verbal improvement scale (5 categories) 3. Fibromyalgia Impact Questionnaire (FIQ) 4. SF‐36 physical capacity (function) 5. SF‐36 physical aspects (role) 6. SF‐36 pain 7. SF‐36 general health 8. SF‐36 vitality 9. SF‐36 social aspects 10. SF‐36 emotional aspects 11. SF‐36 mental health 12. Beck Depression Inventory (BDI) 13. Spielberger State‐Trait Anxiety Inventory (STAI State) 14. Number of paracetamol tablets |
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Notes | December 2009 search: analyses 3.1, 3.2, 3.3 Yates quality scale: total quality = 16/35, design quality = 14/26, treatment quality = 2/9 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomized by drawing lots" |
Allocation concealment (selection bias) | High risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition partially reported; statement that dropouts were not different |
Selective reporting (reporting bias) | Low risk | Fully reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Evaluation by clinician blind to treatment allocation |