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Coping Skills Training for Adolescents With Fibromyalgia
This study is currently recruiting participants.
Study NCT00086047   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: June 22, 2004   Last Updated: April 24, 2009   History of Changes

June 22, 2004
April 24, 2009
July 2004
December 2009   (final data collection date for primary outcome measure)
Functional disability [ Time Frame: 9 weeks and 6 months ] [ Designated as safety issue: No ]
Functional disability
Complete list of historical versions of study NCT00086047 on ClinicalTrials.gov Archive Site
  • Pain intensity [ Time Frame: 9 weeks and 6 months ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 9 weeks and 6 months ] [ Designated as safety issue: No ]
  • Pain intensity
  • depressive symptoms
 
Coping Skills Training for Adolescents With Fibromyalgia
Randomized Clinical Trial in Juvenile Fibromyalgia

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.

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.

Phase III
Interventional
Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Fibromyalgia
  • Behavioral: Coping Skills Training
  • Behavioral: Education
  • Experimental: Patients will receive 8 weeks of behavioral training in pain coping strategies
  • Active Comparator: Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
116
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
11 Years to 18 Years
No
Contact: Susmita Kashikar-Zuck, PhD 513-636-6337 Susmita.Kashikar-Zuck@cchmc.org
United States
 
NCT00086047
Susmita Kashikar-Zuck, PhD./Associate Professor, Cincinnati Children's Hospital Medical Center
R01 AR050028, NIAMS-120
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
 
Principal Investigator: Susmita Kashikar-Zuck, PhD Children's Hospital Medical Center, Cincinnati
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP