Juvenile fibromyalgia (JFM) is a chronic and debilitating pain condition in adolescents characterized by widespread pain, tender points, fatigue, and is often accompanied by mood disturbances. There is no cure for JFM and medications offer limited and short-term symptom relief. In a recent multi-site randomized trial, we demonstrated that cognitive-behavioral therapy (CBT) dramatically improved both functional disability and depressive symptoms in adolescents with JFM. [Despite improvements in functioning, adolescents with JFM continued to suffer from moderate pain symptoms after CBT. There is promising evidence that combined CBT and physical exercise reduce fibromyalgia (FM) pain. Unfortunately, regular participation in moderate-vigorous physical activity is notoriously difficult to initiate and maintain in FM patients, potentially due to sedentary lifestyes combined with lack of education in proper body mechanics. In this project, we propose to develop and test a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which will enhance the established CBT intervention through integration with a novel neuromuscular program modified from pediatric sports medicine/injury prevention protocols. The program consists of integrative neuromuscular training focused on improving fundamental movement skills needed to safely engage in more physical activity. The program's innovative features include1) neuromuscular training specifically designed to limit delayed muscle soreness which could mimic the symptoms of JFM and 2) seamless integration with CBT to enhance adherence and engagement in increased physical activity. The primary goal of this interdisciplinary project is to develop a specialized and durable self-management intervention to impact the key outcomes of pain, functional disability and depressive symptoms in adolescents with JFM.
Aim 1 is to test the feasibility and acceptability of the FIT Teens program. We will pilot the 8-week (16 session), group-based intervention with 8 adolescents with JFM (ages 12-18) to obtain information about feasibility, safety, tolerability, and qualitative feedback about the format and content of the program that will aid in protocol refinements.
Aim 2 is to conduct a pilot two-arm trial (N=48) to evaluate whether the FIT Teens program is superior to CBT-alone in reducing pain intensity in adolescents with JFM. Assessments will occur at baseline, post-treatment and 3- month follow-up. We hypothesize that the FIT Teens group will have significantly greater pain reduction than the CBT group by the 3-month follow-up. Both groups are expected to show significant improvement in functional disability and depressive symptoms. In exploratory aims, we will test the role of improved body biomechanics (3-D motion analysis, dynamometry), adherence, increased physical activity (accelerometry), lower catastrophizing and greater confidence in physical activity in explaining pain outcomes. These measures will then be used in a large-scale mechanistic trial if FIT Teens shows greater efficacy compared to CBT in this exploratory trial].

Public Health Relevance

The development of this innovative self-management (FIT Teens) intervention that incorporates cognitive- behavioral strategies with specialized neuromuscular training has the potential to radically alter clinical care for adolescents with fibromyalgia who are vulnerable to long-term pain and disability. The new intervention will specifically target improvements in pain, functional disability and depressive symptoms using a novel paradigm combining principles of pediatric behavioral and exercise science.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21AR063412-01A1
Application #
8517421
Study Section
Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Serrate-Sztein, Susana
Project Start
2013-09-20
Project End
2015-08-31
Budget Start
2013-09-20
Budget End
2014-08-31
Support Year
1
Fiscal Year
2013
Total Cost
$198,900
Indirect Cost
$71,400
Name
Cincinnati Children's Hospital Medical Center
Department
Type
DUNS #
071284913
City
Cincinnati
State
OH
Country
United States
Zip Code
45229
Kashikar-Zuck, Susmita; Black, William R; Pfeiffer, Megan et al. (2018) Pilot Randomized Trial of Integrated Cognitive-Behavioral Therapy and Neuromuscular Training for Juvenile Fibromyalgia: The FIT Teens Program. J Pain 19:1049-1062
Tran, Susan T; Guite, Jessica W; Pantaleao, Ashley et al. (2017) Preliminary Outcomes of a Cross-Site Cognitive-Behavioral and Neuromuscular Integrative Training Intervention for Juvenile Fibromyalgia. Arthritis Care Res (Hoboken) 69:413-420
Kashikar-Zuck, Susmita; Tran, Susan T; Barnett, Kimberly et al. (2016) A Qualitative Examination of a New Combined Cognitive-Behavioral and Neuromuscular Training Intervention for Juvenile Fibromyalgia. Clin J Pain 32:70-81
Tran, Susan T; Thomas, Staci; DiCesare, Christopher et al. (2016) A pilot study of biomechanical assessment before and after an integrative training program for adolescents with juvenile fibromyalgia. Pediatr Rheumatol Online J 14:43
Sil, Soumitri; Thomas, Staci; DiCesare, Christopher et al. (2015) Preliminary evidence of altered biomechanics in adolescents with juvenile fibromyalgia. Arthritis Care Res (Hoboken) 67:102-11