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

 描述(由申请人提供)：青少年起病纤维肌痛(JFM)是一种慢性、衰弱的疼痛状况，对大多数患者来说通常会持续到成年。虽然药物对JFM提供了有限和短期的症状缓解，但我们的研究小组已经证明，认知行为疗法(CBT)在减少患有这种疾病的青少年的功能残疾和抑郁症状方面是安全、有效和持久的。然而，60%接受CBT的患者在功能残疾方面没有表现出临床上的显著改善，尽管总体上疼痛程度有所减轻，但仍保持在中等范围内。客观测量的久坐活动在CBT治疗后也没有显著改善。纳入体育锻炼成分是增强CBT的合乎逻辑的下一步，然而，已证明在FM患者中很难开始和维持定期参加任何体育活动。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育活动的恐惧作为变量，这些变量可能是患有JFM的青少年日常身体活动不足的基础。因此，我们组建了行为医学、风湿病学、运动医学/运动科学和疼痛医学的多学科专家团队，以开发和测试新的青少年纤维肌痛综合训练计划(Fit Teens)，该计划通过源自循证儿童运动医学/损伤预防研究的新型神经肌肉运动训练计划，加强了已建立的CBT干预。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；以及2)与CBT无缝结合，以增强心理应对技能，减少对运动的恐惧，并增加体力活动的参与度。我们通过试点测试改进了这项为期8周(16节)的强化小组干预措施，发现患者参与度很高，没有不良反应，非常有希望的早期结果表明，这种治疗方法对残疾和疼痛结果的影响甚至比单独使用CBT更强。因此，我们现在建议进行一项严格的三臂多点随机临床试验(RCT)，以测试Fit青少年干预是否比单独进行CBT或单独进行分级有氧运动更有效，以及治疗效果是否可持续超过一年的随访。我们还将评估应对、对运动的恐惧以及客观测量的体力活动、运动能力和健康状况的变化如何预测残疾和疼痛结果的变化。拟议的随机对照试验将是JFM迄今规模最大(N=415)和最复杂的试验，这需要与多学科合作者进行多地点研究，这些合作者的互补专业知识确保了研究目标的成功。目前的U34申请申请为为期一年的规划拨款申请资金，以建立RCT的行政、监管和可行性方面的明确里程碑，以支持向U01临床试验的简化过渡。计划中的项目将为JFM患者提供最佳临床护理的明确方向，并为专注于JFM病理生理研究的潜在辅助项目提供最大规模的特征良好的JFM患者登记。

 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.