Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia (JFM)

FIT 青少年青少年纤维肌痛 (JFM) 随机临床试验

• 批准号: 8878576
• 负责人: Susmita Kashikar-Zuck
• 金额: $ 36.34万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-13 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8878576
• 关键词: Address; Adolescent; Adult; Adverse effects; Aerobic Exercise; Affect; Arthritis; Behavioral; Behavioral Medicine; Biomechanics; Childhood; Chronic; Clinical Trials; Cognitive; Cognitive Therapy; Collaborations; Communication; Competence; Consumer Advocates in Research and Related Activities; Coping Skills; Data; Data Coordinating Center; Education; Educational process of instructing; Effectiveness; Ensure; Equipment and supply inventories; Exercise; Fatigue; Female Adolescents; Fibromyalgia; Flare; Fright; Functional disorder; Funding; Gait; Goals; Grant; Impairment; Institutional Review Boards; Intervention; Maintenance; Measures; Medicine; Modeling; Monitor; Movement; Muscle; Musculoskeletal Pain; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Outcome; Pain; Pain intensity; Pain interference; Patients; Performance; Pharmaceutical Preparations; Physical activity; Posture; Prevention Research; Protocols documentation; Public Health; Randomized Clinical Trials; Registries; Request for Applications; Research; Research Personnel; Rheumatology; Safety; School-Age Population; Schools; Science; Self Management; Site; Sports Medicine; Symptoms; Teenagers; Testing; Time; Training; Training Programs; Treatment Protocols; United States National Institutes of Health; Visual; analog; arm; base; chronic pain; clinical care; clinically significant; coping; daily functioning; depressive symptoms; design; disability; evidence base; fitness; follow-up; functional disability; improved; indexing; injury prevention; innovation; multidisciplinary; neuromuscular; novel; pain behavior; programs; psychologic; public health relevance; randomized trial; sedentary; skills; skills training; social; success; treatment effect; uptake

 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.