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（由适用提供）：少年发作的纤维肌痛（JFM）是一种慢性，令人衰弱的疼痛状况，大多数患者通常会持续成年。尽管药物为JFM提供有限的短期症状缓解，但我们的研究小组表明，认知行为疗法（CBT）在减少这种情况的青少年的功能障碍和抑郁症状方面是安全，有效且持久的。但是，接受CBT的患者中有60％的功能障碍没有显示出临床上的显着改善，并且总体上降低了中等范围的疼痛水平。 CBT客观测量的久坐活动也没有显着改善。纳入体育锻炼成分是增强CBT的逻辑下一步，但经常参与任何体育活动已被证明很难在FM患者中启动和维持。在我们先前的研究中，我们已经记录了运动能力不佳，将运动信心定义为对体育活动的恐惧，这是变量可能是JFM青少年日常体育锻炼缺陷的基础。因此，我们组建了一个由行为医学，风湿病学，运动医学/运动科学和止痛药的专家组成的多学科团队，以开发和测试针对青少年（FIT Teens）的新的纤维肌痛整合培训计划，从而增强了既定的CBT干预，从而通过基于循证的基于循证的神经肌肉运动训练计划从基于循证的Neuromuscular运动培训计划中获得了基于循证的踏步踏板医学/受伤的运动医学研究。创新功能包括-1）专门设计用于限制延迟肌肉酸痛的神经肌肉训练； 2）与CBT无缝整合，以提高心理应对能力，减少对运动的恐惧和增加，我们通过试验测试来完善了这种基于组的8周（16个课程）干预措施，并发现出色的患者参与，没有不良的患者参与，非常有希望的早期结果表明，这种治疗对残疾和疼痛的影响比单独使用更强大。因此，我们现在提出了一项严格的3臂多站点随机临床试验（RCT），以测试合适的青少年干预是否比单独使用CBT或单独进行分级有氧运动更有效，以及在1年随访中治疗效果是否可持续。我们还将评估应对，对运动的恐惧以及客观测量的体育锻炼，运动能力和适应性如何预测残疾和疼痛结果的变化。拟议中的RCT将是迄今为止JFM中最大的（n = 415）和最复杂的试验，这必需与多学科合作者进行多站点研究，其完善专业知识可确保其目标的成功。当前的U34申请要求提供一项为期1年计划赠款的资金，以建立RCT的行政，监管和可行性方面，并具有明确的里程碑，以支持简化的U01临床试验过渡。该计划的项目将为JFM患者以及最大的特征性JFM患者注册表提供明确的方向，以针对潜在的辅助项目进行研究，以研究JFM的病理生理学。