Coping Skills Training for Adolescents With Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00086047
First received: June 22, 2004
Last updated: November 1, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Behavioral: Coping Skills Training
Behavioral: Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial in Juvenile Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Change in FDI (Functional Disability Inventory) Scores at End of Study [ Time Frame: Baseline and 6 months (end of study) ] [ Designated as safety issue: No ]
    Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 114
Study Start Date: July 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coping Skills
Patients will receive 8 weeks of behavioral training in pain coping strategies
Behavioral: Coping Skills Training
8 weekly sessions of behavioral treatment
Other Name: cognitive-behavioral therapy
Active Comparator: Education
Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Behavioral: Education
8 weekly sessions of fibromyalgia education

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

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086047

Locations
United States, Kentucky
Kosair Charities Pediatric Center
Louisville, Kentucky, United States, 40202
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation, Division of Pediatrics
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Susmita Kashikar-Zuck, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided by Children's Hospital Medical Center, Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00086047     History of Changes
Other Study ID Numbers: R01 AR050028, R01AR050028
Study First Received: June 22, 2004
Results First Received: August 12, 2011
Last Updated: November 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Juvenile Fibromyalgia Syndrome
JPFS
Fibromyalgia
Chronic Pain
Pediatric Pain
Juvenile Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014