Juvenile Primary Fibromyalgia Syndrome (JPFS) is a chronic pain condition of unknown etiology and is associated with a great deal of pain, suffering and disability. There are currently no randomized clinical trials for the treatment of pediatric patients suffering from fibromyalgia. The current application is a randomized, placebo controlled clinical trial testing the efficacy of combined behavioral and pharmacological treatment in the treatment of JPFS. Treatments combining pharmacological interventions with behavior change have been found to be efficacious in the treatment of adults with chronic pain but have been understudied in pediatric populations. In this study, we will test whether a combination of pain coping skills training (CST) and low-dose amitriptyline (AMI) is efficacious in reducing functional disability, pain and depressive symptoms in adolescents with JPFS. We will test the hypothesis that coping skills training combined with low-dose amitriptyline (CST+AMI) will be superior to coping skills training + placebo (CST+placebo) or low-dose amitriptyline + attention (AMI+ATT). Further, we will test whether subjects who receive CST+AMI will have significantly less pain, disability and depressive symptoms after a six-month maintenance phase. Subjects (N=135) will be randomly assigned to one of the three treatment conditions. During the acute treatment phase, subjects assigned to CST will self-monitor using pain and sleep diaries for 8 weeks, followed by 8 weekly sessions of coping skills training. Sessions will focus on teaching the adolescent muscle relaxation techniques, distraction, activity pacing, problem solving and use of calming techniques using a treatment manual specifically developed for this age group. Subjects in the ATT condition will receive the same amount of therapist support and attention but not the active behavioral intervention. Amitriptyline dosage for subjects assigned to AMI will be stabilized at a maximum dose of 20 mg per day. Functional disability, pain intensity and depressive symptoms will be assessed before and after treatment. In the maintenance phase, subjects will continue to take their medication (or placebo) and return for either 2 CST booster sessions or 2 ATT sessions (depending on group assignment) at intervals of 8 weeks. Functional disability, pain intensity and depressive symptoms will be reassessed after the six-month maintenance phase. The long term objectives of this research are to establish effective treatments for JPFS that lead to sustained benefits in terms of improved pain control and functional abilities. ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Research Project (R01)
Project #
5R01AR050028-02
Application #
6903453
Study Section
Special Emphasis Panel (ZRG1-CFS (01))
Program Officer
Serrate-Sztein, Susana
Project Start
2004-07-01
Project End
2009-06-30
Budget Start
2005-07-01
Budget End
2006-06-30
Support Year
2
Fiscal Year
2005
Total Cost
$490,431
Indirect Cost
Name
Children's Hospital Med Ctr (Cincinnati)
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
Sil, Soumitri; Arnold, Lesley M; Lynch-Jordan, Anne et al. (2014) Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia. Pain 155:1206-12
Kashikar-Zuck, Susmita; Zafar, Marium; Barnett, Kimberly A et al. (2013) Quality of life and emotional functioning in youth with chronic migraine and juvenile fibromyalgia. Clin J Pain 29:1066-72
Sil, Soumitri; Kashikar-Zuck, Susmita (2013) Understanding why cognitive-behavioral therapy is an effective treatment for adolescents with juvenile fibromyalgia. Int J Clin Rheumtol 8:
Sil, Soumitri; Lynch-Jordan, Anne; Ting, Tracy V et al. (2013) Influence of family environment on long-term psychosocial functioning of adolescents with juvenile fibromyalgia. Arthritis Care Res (Hoboken) 65:903-9
Kashikar-Zuck, Susmita; Flowers, Stacy R; Strotman, Daniel et al. (2013) Physical activity monitoring in adolescents with juvenile fibromyalgia: findings from a clinical trial of cognitive-behavioral therapy. Arthritis Care Res (Hoboken) 65:398-405
Joffe, Naomi E; Lynch-Jordan, Anne; Ting, Tracy V et al. (2013) Utility of the PedsQL rheumatology module as an outcome measure in juvenile fibromyalgia. Arthritis Care Res (Hoboken) 65:1820-7
Kashikar-Zuck, Susmita; Sil, Soumitri; Lynch-Jordan, Anne M et al. (2013) Changes in pain coping, catastrophizing, and coping efficacy after cognitive-behavioral therapy in children and adolescents with juvenile fibromyalgia. J Pain 14:492-501
Kashikar-Zuck, Susmita; Ting, Tracy V; Arnold, Lesley M et al. (2012) Cognitive behavioral therapy for the treatment of juvenile fibromyalgia: a multisite, single-blind, randomized, controlled clinical trial. Arthritis Rheum 64:297-305
Kashikar-Zuck, Susmita; Flowers, Stacy R; Verkamp, Emily et al. (2010) Actigraphy-based physical activity monitoring in adolescents with juvenile primary fibromyalgia syndrome. J Pain 11:885-93
Kashikar-Zuck, Susmita; Johnston, Megan; Ting, Tracy V et al. (2010) Relationship between school absenteeism and depressive symptoms among adolescents with juvenile fibromyalgia. J Pediatr Psychol 35:996-1004

Showing the most recent 10 out of 11 publications