? DESCRIPTION (provided by applicant): Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that typically persists into adulthood for the majority of patients. Whereas medications offer limited and short-term symptom relief for JFM, our research group has demonstrated that cognitive-behavioral therapy (CBT) is safe, effective and durable in reducing functional disability and depressive symptoms in adolescents with this condition. However, 60% of patients receiving CBT did not show clinically significant improvement in functional disability, and pain levels remained in the moderate range despite being reduced overall. Objectively measured sedentary activity also did not significantly improve with CBT. Incorporation of a physical exercise component emerged as a logical next step to enhance CBT, yet regular participation in any physical activity has been shown to be difficult to initiate and maintain in FM patients. In our prior research, we have documented poor movement competence, deficits in movement confidence and fear of physical activity as variables that likely underlie deficiencies in daily physical activity for teens with JFM. Therefore, we have assembled a multidisciplinary team of experts in Behavioral Medicine, Rheumatology, Sports Medicine/Exercise Science and Pain Medicine to develop and test a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances the established CBT intervention with a novel neuromuscular exercise training program derived from evidence-based pediatric sports medicine/injury prevention research. Innovative features include - 1) neuromuscular training specifically designed to limit delayed muscle soreness;and 2) seamless integration with CBT to enhance psychological coping skills, decrease fear of movement and increase physical activity participation. We have refined this intensive group- based 8-week (16 session) intervention through pilot testing and found excellent patient engagement, no adverse effects and very promising early results indicating this treatment to have even stronger effects on disability and pain outcomes than CBT alone. We therefore are now proposing a rigorous 3-arm multi-site randomized clinical trial (RCT) to test whether the FIT Teens intervention is more effective than CBT alone or graded aerobic exercise alone and whether treatment effects are sustainable over 1 year follow-up. We also will evaluate how changes in coping, fear of movement, and objectively measured physical activity, movement competence and fitness predict changes in disability and pain outcomes. The proposed RCT will be the largest (N=415) and most sophisticated trial in JFM to date which necessitates a multi-site study with multi-disciplinary collaborators whose complementary expertise ensures success with the study aims. The current U34 application requests funds for a 1-year planning grant to establish administrative, regulatory and feasibility aspects of the RCT with clear milestones to support a streamlined transition to a U01 clinical trial. The planned project will provide clear direction fo the best clinical care for JFM patients as well as the largest registry of well-characterized JFM patients for potential ancillary projects focused to investigate the pathophysiology of JFM.

U34AR067978

2015-04-13

2016-03-31