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. 2018 Oct 1;2018(9):CD003968. doi: 10.1002/14651858.CD003968.pub5

Kashikar‐Zuck 2012.

Study characteristics
Methods RCT. 2 arms. Assessed pretreatment, post‐treatment, 6‐month follow‐up
Participants End of treatment: n = 106; follow‐up 6 months n = 100
Start of treatment: n = 114
Sex: 105 F, 9 M
Mean age = 15.0 years (1.8)
Source = paediatric rheumatology centres in Midwestern USA
Diagnosis = fibromyalgia syndrome
Mean years of pain = 2 years, 10 months (2 years, 6 months)
Interventions "Cognitive behavioural therapy"
"Fibromyalgia education"
Outcomes Primary pain outcome: pain severity VAS (averaged over 7 days)
Primary disability outcome: Functional Disability Scale
Primary depression outcome: Children's Depression Inventory
Primary anxiety outcome: Pain Coping Questionnaire

  1. Pain severity VAS (averaged over 7 days)

  2. Functional Disability Scale

  3. Children's Depression Inventory

  4. Tender point sensitivity

  5. Pedatric Quality of Life Inventory

  6. Sleep quality VAS (averaged over 7 days)

  7. Physician's global assessment VAS
Notes COI: "Dr. Passo has received consulting fees, speaking fees, and/or honoraria from Pfizer (less than $10,000)."
Funding: "Supported by the NIH (National Institute of Arthritis and Musculoskeletal and Skin Diseases grant R01‐AR‐050028 to Dr. Kashikar‐Zuck)."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Eligible patients were randomly assigned to 1 of the 2 treatment arms based upon a computer‐generated randomisation list. Randomisation was stratified by site."
Comment: probably done
Allocation concealment (selection bias) Low risk "When a patient was enrolled, the study therapist contacted the biostatistician to obtain the subject identification number and treatment allocation."
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk "The principal investigator, study physicians, study coordinator, and assessment staff were all blinded to the patients' treatment condition throughout the trial. Patients were asked not to divulge what treatment they were receiving to the study physician."
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Low risk Attrition was described; no significant differences between completers and non‐completers were reported
Selective reporting (reporting bias) Low risk Data were fully reported