Clinical trial NCT00086047: Coping Skills Training for Adolescents With Fibromyalgia
Official title: Randomized Clinical Trial in Juvenile Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Keywords: Juvenile Fibromyalgia Syndrome
JPFS
Fibromyalgia
Chronic Pain
Pediatric Pain
Juvenile Fibromyalgia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2004-06-23
Enrollment: 114
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities. The purpose of this study is to determine whether coping skills training, when combined with usual medical care, can reduce pain and disability in adolescents with fibromyalgia.

Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual medical care will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive fibromyalgia education with their usual medical care. 2) Adolescents who receive coping skills training with their usual medical care will show significantly lower levels of functional disability, pain, and depressive symptoms at the end of a six-month maintenance phase than adolescents who receive fibromyalgia education with their usual medical care.

Detailed description: Juvenile Primary Fibromyalgia Syndrome (JPFS) is a debilitating chronic pain condition that occurs in adolescence and is characterized by persistent pain, multiple tender points, sleep difficulty, and fatigue. The cause of JPFS is unknown and there is no known cure. Children and adolescents with JPFS have difficulty with daily functioning, miss a great deal of school, and experience increased emotional distress compared to their peers. Fibromyalgia syndrome appears to be resistant to treatment in adulthood, so early behavioral treatment for JPFS with long-term beneficial effects would be useful. This study will evaluate the efficacy of coping skills training (CST) when combined with usual medical care in reducing functional disability, pain intensity, and depressive symptoms in adolescents with JPFS. This study will also determine whether improvements can be sustained long-term.

This study will last 34 weeks. Participants will be recruited from three pediatric rheumatology clinics. Patients will be randomly assigned to one of two groups: CST plus usual medical care or education plus usual medical care. There will be 6 medical visits, spaced 4 to 5 weeks apart. In addition, patients will attend 8 individual sessions of CST or education over the first 8 weeks of the study. CST sessions will include training in cognitive-behavioral techniques of pain management for the adolescent and behavioral management techniques for their parents. Education sessions will include education on fibromyalgia and discussion about lifestyle issues, but no training in pain management procedures.

Patients will be evaluated at Week 9 and will be followed for an additional 6-month maintenance phase. During this maintenance phase, adolescents will continue to receive their usual medical care and will attend 2 additional sessions of CST or education. There will be one final evaluation at the end of the maintenance phase.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of JPFS based upon widespread pain for over 3 months, at least 5 tender points, and associated features such as sleep difficulty, fatigue, and abdominal discomfort
* Average pain intensity greater than 4 on the Visual Analog Scale
* Functional disability score greater than 7
* Stable medications for 8 weeks prior to study entry

Exclusion Criteria:

* Other chronic rheumatic diseases, such as juvenile rheumatoid arthritis or lupus
* Significant developmental delay or impairments, such as autism, cerebral palsy, or mental retardation
* Present or lifetime psychiatric diagnosis that meets DSM-IV criteria for panic disorder, bipolar disorder, major depressive disorder, or psychosis
* Opioid medications are disallowed when used on an ongoing basis for treatment of fibromyalgia pain

Primary outcomes:
measure: Change in FDI (Functional Disability Inventory) Scores at End of Study
timeFrame: Baseline and 6 months (end of study)
Secondary outcomes:
measure: Pain Intensity
timeFrame: 9 weeks and 6 months
measure: Depressive Symptoms
timeFrame: 9 weeks and 6 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Charities Pediatric Center
state: Kentucky
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation, Division of Pediatrics
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Susmita Kashikar-Zuck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kashikar-Zuck S, Ting TV, Arnold LM, Bean J, Powers SW, Graham TB, Passo MH, Schikler KN, Hashkes PJ, Spalding S, Lynch-Jordan AM, Banez G, Richards MM, Lovell DJ. Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial. Arthritis Rheum. 2012 Jan;64(1):297-305. doi: 10.1002/art.30644.
citation: Joffe NE, Lynch-Jordan A, Ting TV, Arnold LM, Hashkes PJ, Lovell DJ, Passo MH, Powers SW, Schikler KN, Kashikar-Zuck S. Utility of the PedsQL rheumatology module as an outcome measure in juvenile fibromyalgia. Arthritis Care Res (Hoboken). 2013 Nov;65(11):1820-7. doi: 10.1002/acr.22045.