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）：青少年发作的纤维肌痛（JFM）是一种慢性、使人衰弱的疼痛状况，大多数患者通常持续到成年。虽然药物治疗为JFM提供了有限的短期症状缓解，但我们的研究小组已经证明，认知行为疗法（CBT）在减少青少年功能障碍和抑郁症状方面是安全，有效和持久的。然而，60%接受CBT的患者在功能障碍方面没有表现出临床显著的改善，尽管总体上有所降低，但疼痛水平仍在中度范围内。客观测量的久坐活动也没有显着改善CBT。纳入体育锻炼的组成部分出现作为一个合乎逻辑的下一步，以加强CBT，但定期参加任何体育活动已被证明是难以启动和维持FM患者。在我们之前的研究中，我们已经记录了运动能力差，运动信心不足和对体力活动的恐惧，这些变量可能是JFM青少年日常体力活动不足的原因。因此，我们组建了一个由行为医学，流变学，运动医学/运动科学和疼痛医学专家组成的多学科团队，以开发和测试一种新的青少年纤维肌痛综合训练计划（FIT Teens），该计划通过基于循证的儿科运动医学/损伤预防研究的新型神经肌肉运动训练计划增强了既定的CBT干预。创新功能包括：1）专门设计用于限制延迟性肌肉酸痛的神经肌肉训练; 2）与CBT无缝集成，以增强心理应对技能，减少对运动的恐惧，并增加身体活动的参与。我们已经通过试点测试完善了这种密集的基于小组的8周（16次）干预，发现患者参与度很高，没有不良反应，并且非常有希望的早期结果表明这种治疗对残疾和疼痛结果的影响甚至比单独的CBT更强。因此，我们现在提出了一项严格的3臂多中心随机临床试验（RCT），以测试FIT Teens干预是否比单独的CBT或单独的分级有氧运动更有效，以及治疗效果是否可持续超过1年随访。我们还将评估如何应对的变化，运动恐惧，客观测量的身体活动，运动能力和健身预测残疾和疼痛结果的变化。拟议的RCT将是迄今为止JFM中最大（N=415）和最复杂的试验，需要多学科合作者的多中心研究，其互补的专业知识确保研究目标的成功。目前的U34申请要求提供1年规划补助金，以建立RCT的行政、监管和可行性方面，并具有明确的里程碑，以支持向U 01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提供明确的方向，并为集中研究JFM病理生理学的潜在辅助项目提供最大的充分表征的JFM患者登记。