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Coping Skills Training for Adolescents With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Coping Skills Training
Education
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Juvenile Fibromyalgia Syndrome, JPFS, Fibromyalgia, Chronic Pain, Pediatric Pain, Juvenile Fibromyalgia

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kosair Charities Pediatric Center
  • Cincinnati Children's Hospital Medical Center
  • Cleveland Clinic Foundation, Division of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coping Skills

Education

Arm Description

Patients will receive 8 weeks of behavioral training in pain coping strategies

Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.

Outcomes

Primary Outcome Measures

Change in FDI (Functional Disability Inventory) Scores at End of Study
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
Depressive Symptoms

Full Information

First Posted
June 22, 2004
Last Updated
August 23, 2017
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00086047
Brief Title
Coping Skills Training for Adolescents With Fibromyalgia
Official Title
Randomized Clinical Trial in Juvenile Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Juvenile Fibromyalgia Syndrome, JPFS, Fibromyalgia, Chronic Pain, Pediatric Pain, Juvenile Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coping Skills
Arm Type
Experimental
Arm Description
Patients will receive 8 weeks of behavioral training in pain coping strategies
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Intervention Type
Behavioral
Intervention Name(s)
Coping Skills Training
Other Intervention Name(s)
cognitive-behavioral therapy
Intervention Description
8 weekly sessions of behavioral treatment
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
8 weekly sessions of fibromyalgia education
Primary Outcome Measure Information:
Title
Change in FDI (Functional Disability Inventory) Scores at End of Study
Description
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)
Time Frame
Baseline and 6 months (end of study)
Secondary Outcome Measure Information:
Title
Pain Intensity
Time Frame
9 weeks and 6 months
Title
Depressive Symptoms
Time Frame
9 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susmita Kashikar-Zuck, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosair Charities Pediatric Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Cleveland Clinic Foundation, Division of Pediatrics
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22108765
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.
Results Reference
result
PubMed Identifier
23686969
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.
Results Reference
derived

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Coping Skills Training for Adolescents With Fibromyalgia

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