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Coping Skills Training for Adolescents With Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086047
First Posted: June 23, 2004
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
Results First Submitted: August 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Behavioral: Coping Skills Training
Behavioral: Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients diagnosed with juvenile fibromyalgia (ages 11-18 years)were recruited from four pediatric rheumatology clinics in the Midwestern United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened to determine eligibility for the study. if they met eligibility criteria, they were enrolled in the study and immediately randomized to one of the treatment arms.

Reporting Groups
  Description
Coping Skills Patients will receive 8 weeks of behavioral training in pain coping strategies
Education Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.

Participant Flow:   Overall Study
    Coping Skills   Education
STARTED   57   57 
COMPLETED   50   50 
NOT COMPLETED   7   7 
Lost to Follow-up                7                6 
Physician Decision                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Coping Skills Patients will receive 8 weeks of behavioral training in pain coping strategies
Education Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
Total Total of all reporting groups

Baseline Measures
   Coping Skills   Education   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   57   114 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      57 100.0%      57 100.0%      114 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.2  (1.8)   14.9  (1.7)   15.0  (1.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      54  94.7%      51  89.5%      105  92.1% 
Male      3   5.3%      6  10.5%      9   7.9% 
Region of Enrollment 
[Units: Participants]
     
United States   57   57   114 


  Outcome Measures

1.  Primary:   Change in FDI (Functional Disability Inventory) Scores at End of Study   [ Time Frame: Baseline and 6 months (end of study) ]

2.  Secondary:   Pain Intensity   [ Time Frame: 9 weeks and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Depressive Symptoms   [ Time Frame: 9 weeks and 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Susmita Kashikar-Zuck, PhD
Organization: Cincinnati Children's Hospital Medical Center
phone: 513 636 6337
e-mail: Susmita.Kashikar-Zuck@cchmc.org


Publications of Results:
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: R01AR050028 ( U.S. NIH Grant/Contract )
First Submitted: June 22, 2004
First Posted: June 23, 2004
Results First Submitted: August 12, 2011
Results First Posted: November 6, 2013
Last Update Posted: September 20, 2017