Kashikar‐Zuck 2012.
| Methods |
Study setting: North America (USA). Multicentre paediatric university rheumatology centres, outpatient based Study design: Parallel Duration therapy: 8 weeks Follow‐up: 6 months Analysis: Mixed modelling for repeated measures with fixed factors being group, time and group‐by‐time interaction, intention‐to‐treat |
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| Participants |
Patients: Treatment Group: 57 patients; 95% female, 84% white, mean age 15.2 years; disease duration 3.3 (3.1) years Control Group: 57 patients; 90% female, 97% white, mean age 14.9 years; disease duration 2.5 (1.8) years Inclusion: Juvenile FM classification criteria determined by a paediatric rheumatologist, age 11 to 18, stable medication for 8 weeks, willing to continue receiving stable medication for the duration of the study, average pain severity ≥4 on VAS 0‐10 based on 1 week of daily pain diaries, score of >7 on FDI Exclusion: Other rheumatic disease (juvenile arthritis, lupus), documented developmental delay, current panic disorder or major depression or lifetime bipolar disorder or psychosis, use of opioids |
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| Interventions |
Treatment Group: CBT, individual: Education about rationale for behavioural pain management, training in relaxation, distraction, activity pacing, problem solving, using calming statements, relapse prevention strategies; parents included in 3 out of 8 sessions: training in behavioural management techniques (1x45min/week), total: 6h Control Group: Active control: FMS education, individual: education and discussion about FM, pain medications, general lifestyle issues (diet, sleep, exercise), impact of juvenile’s FM on patient’s lifestyle; parents attended 3 out of 8 sessions (1x45min/week), total: 6h Co‐medication allowed: Yes, 9 patients were prescribed new antidepressant medication Other Co‐therapies: Not reported |
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| Outcomes |
Primary Outcomes Self reported pain: VAS pain 0‐10 Self reported negative mood: CDI T score Self reported disability: Functional Disability Index (FDI) 0‐60 Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Not assessed Self reported fatigue: Not assessed Self reported sleep problems: VAS sleep 0‐10 Self reported disease‐specific health‐related quality of life: Not assessed |
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| Notes | 1. Reasons for dropout: ‐ Treatment group: 1x time constraints, 1x family reasons, 1x loss to follow‐up, 1x psychiatric hospitalisation for non‐study related reasons, 6 months follow‐up 3x lost to follow‐up; ‐Control group: 2x dropped out before attending any sessions, other reasons for drop‐out not reported, 6‐months follow‐up: 3x lost to follow‐up 2: Attendance rates: Not reported 3. Responder analysis: 14.0% in the CBT‐group and 8.6% in the control group reported a ≥30% pain reduction 4. Funding sources and declaration of interest of the primary researchers:Supported by the National Institute of Arthtitis and Musculoskeletal and Skin Diseases grant R01‐AR‐0500208 to Dr. Kashikar‐Zuck. Dr Passo received consulting fees, speaking fees and/or honoraria from Pfizer (less than 10 000$) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization based upon a computer generated randomisation list, stratified by site |
| Allocation concealment (selection bias) | Low risk | Treatment allocation by biostatistician |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Intention‐to‐treat‐analysis reported, but no imputation methods for dropouts used |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Blinding of outcome assessor | Low risk | Study uses a single‐blind design, assessment staff were all blinded to the patients' treatment condition |