Burckhardt 1994.
Methods |
Study setting: Europe (Sweden). Single‐centre, recruitment in occupational and primary health clinics, outpatient based Study design: Parallel Duration therapy: 6 weeks Follow‐up: 3 and 6 months Analysis: ANOVA (FIQ), MANOVA (QOLS‐S, FAI, SELF pain, SELF function, SELF other, 6‐min walk, chair test, myalgic score), if omnibus F significant ANOVA on individual outcomes, independent group t‐tests, paired different t‐tests for within group change |
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Participants |
Patients: Treatment group: 28 patients; Control group: 30 patients; Total sample:100% female, 99% white, mean age 46.5 years; Duration of symptoms not reported Inclusion: ACR 1990 criteria for FM, normal results in laboratory tests (haemoglobin, free thyroxine, erythrocyte sedimentation rate, antinuclear antibodies, rheumatoid factor, creatine phosphokinase), understand Swedish Exclusion: Other rheumatic diseases |
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Interventions |
Treatment Group: CBT, group: education, relaxation, assertiveness training, coping strategies, problem solving techniques (1x1.5h/week), total: 9h Control Group: Delayed treatment control Co‐medication allowed: Yes, not controlled for Other Co‐therapies: Not reported |
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Outcomes |
Primary Outcomes Self reported pain: FIQ pain 0‐10; SD not reported and not provided on request; SDs calculated by imputation method Self reported negative mood: FIQ depression 0‐10; SD not reported and not provided on request; SDs calculated by imputation method Self reported disability: FIQ physical impairment 0‐10; SD not reported and not provided on request; SDs calculated by imputation method Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Self‐Efficacy (SES) pain scale 500‐50; SD not reported and calculated by reported P‐value Self reported fatigue: FIQ fatigue 0‐10; SD not reported and not provided on request; SDs calculated by imputation method Self reported sleep problems: Not assessed Self reported disease‐specific health‐related quality of life: FIQ total 0‐80; SD not reported and not provided on request; SDs calculated by imputation method |
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Notes | 1. Study arm CBT plus physical therapy not used for comparison 2. Reasons for drop‐out ‐Total sample: 6x did not return for retesting (no separate data reported ‐Experimental groups: 7x did only attend 1 or 2 classes 3. Attendance rates: Not reported 4. Responder analysis: None 5. Funding sources and declaration of interest of the primary researchers: No details reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No detailed information |
Allocation concealment (selection bias) | Unclear risk | No detailed information |
Incomplete outcome data (attrition bias) All outcomes | High risk | No Intention‐to‐treat analysis |
Selective reporting (reporting bias) | High risk | Except FIQ‐subscale scores all other outcomes not reported in detail at follow‐up and not provided on request |
Blinding of outcome assessor | Unclear risk | No detailed information |