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.

 描述（由申请人提供）：青少年发病的纤维肌痛 (JFM) 是一种慢性、使人衰弱的疼痛病症，通常会持续到大多数患者成年期，认知行为疗法 (CBT) 在减少功能障碍方面是安全、有效和持久的。然而，60% 接受 CBT 的患者并未表现出抑郁症状。尽管客观测量的久坐活动有所减少，但功能障碍的临床显着改善和疼痛水平仍保持在中等范围内，结合体育锻炼成分成为增强 CBT 的合理下一步。在我们之前的研究中，我们发现运动能力差、运动信心不足和对身体活动的恐惧可能是导致日常身体活动不足的变量。适合患有 JFM 的青少年。因此，我们组建了一个由行为医学、风湿病学、运动医学/运动科学和疼痛医学领域的多学科专家团队来开发和测试新的青少年纤维肌痛综合训练计划（FIT Teens），该计划以新颖的方式增强了现有的 CBT 干预措施源自循证儿科运动医学/损伤预防研究的神经肌肉运动训练计划，创新功能包括：1) 专门为限制延迟性肌肉酸痛而设计的神经肌肉训练；2) 无缝训练。与 CBT 相结合，以增强心理应对能力，减少对运动技能的恐惧，并增加身体活动参与度。我们通过试点测试完善了这种基于小组的强化干预，为期 8 周（16 次），发现患者参与度很高，没有不良影响，非常有前途。早期结果表明，这种治疗对残疾和疼痛结果的影响比单独的 CBT 更强，因此我们现在提议进行一项严格的 3 组多中心随机临床试验 (RCT)，以测试 FIT 青少年干预是否比 CBT 更有效。单独或分级有氧运动单独锻炼以及治疗效果是否可持续超过 1 年的随访时间。我们还将评估应对方式的变化、对运动的恐惧以及客观测量的身体活动、运动能力和健康状况如何预测残疾和疼痛结果的变化。是迄今为止 JFM 中规模最大（N=415）和最复杂的试验，需要与多学科合作者进行多地点研究，他们的互补专业知识可确保研究目标的成功当前的 U34 申请要求为 1 年规划提供资金。授予建立RCT 的管理、监管和可行性方面具有明确的里程碑，以支持向 U01 临床试验的简化过渡。计划中的项目将为 JFM 患者的最佳临床护理以及最大的特征明确的 JFM 患者登记提供明确的方向。致力于研究 JFM 病理生理学的潜在辅助项目。