Fibromyalgia Integrative Training Program for Teens (FIT Teens)

描述(申请人提供)：青少年纤维肌痛(JFM)是青少年的一种慢性和衰弱的疼痛状况，特征是广泛的疼痛、压痛点、疲倦，并经常伴随情绪障碍。目前还没有治愈JFM的方法，药物只能提供有限的短期症状缓解。在最近的一项多点随机试验中，我们证明认知行为疗法(CBT)显著改善了患有JFM的青少年的功能障碍和抑郁症状。[尽管功能有所改善，但患有JFM的青少年在CBT后继续出现中度疼痛症状。有很有希望的证据表明，CBT和体育锻炼相结合可以减轻纤维肌痛(FM)疼痛。不幸的是，众所周知，FM患者很难开始和维持定期参加中等强度的体育活动，这可能是由于久坐的生活方式加上缺乏适当的身体力学教育。在这个项目中，我们建议开发和测试一种新的青少年纤维肌痛综合训练计划(Fit Teens)，该计划将通过与从儿科运动医学/损伤预防方案修改而来的新的神经肌肉计划相结合，加强已建立的CBT干预。该计划包括综合神经肌肉训练，重点是提高安全从事更多体力活动所需的基本运动技能。该计划的创新特点包括1)专门为限制延迟性肌肉酸痛而设计的神经肌肉训练，这种疼痛可以模仿JFM的症状；2)与CBT无缝集成，以提高对增加的体力活动的依从性和参与度。这个跨学科项目的主要目标是开发一种专门和持久的自我管理干预措施，以影响患有JFM的青少年疼痛、功能残疾和抑郁症状的关键结果。目标1是测试Fit Teens计划的可行性和可接受性。我们将试行为期8周(16 对8名患有JFM的青少年(年龄12-18岁)进行小组干预，以获得有关可行性、安全性、耐受性的信息，以及关于方案格式和内容的定性反馈，以帮助改进方案。目标2是进行一项先导性双臂试验(N=48)，以评估Fit Teens计划在降低JFM青少年疼痛强度方面是否优于单独使用CBT。评估将在基线、治疗后和3个月的随访时进行。我们假设，通过3个月的随访，Fit青少年组的疼痛减轻程度将显著高于CBT组。预计这两组患者在功能障碍和抑郁症状方面都会有显著改善。在探索性目标中，我们将测试改进的身体生物力学(3-D运动分析、测力)、坚持性、增加体力活动(加速法)、减少灾难和对体力活动更有信心在解释疼痛结果方面的作用。如果FIT青少年在这项探索性试验中显示出比CBT更好的疗效，这些措施将被用于大规模的机械试验。

DESCRIPTION (provided by applicant): Juvenile fibromyalgia (JFM) is a chronic and debilitating pain condition in adolescents characterized by widespread pain, tender points, fatigue, and is often accompanied by mood disturbances. There is no cure for JFM and medications offer limited and short-term symptom relief. In a recent multi-site randomized trial, we demonstrated that cognitive-behavioral therapy (CBT) dramatically improved both functional disability and depressive symptoms in adolescents with JFM. [Despite improvements in functioning, adolescents with JFM continued to suffer from moderate pain symptoms after CBT. There is promising evidence that combined CBT and physical exercise reduce fibromyalgia (FM) pain. Unfortunately, regular participation in moderate-vigorous physical activity is notoriously difficult to initiate and maintain in FM patients, potentially due to sedentary lifestyes combined with lack of education in proper body mechanics. In this project, we propose to develop and test a new Fibromyalgia Integrative Training program for Teens (FIT Teens), which will enhance the established CBT intervention through integration with a novel neuromuscular program modified from pediatric sports medicine/injury prevention protocols. The program consists of integrative neuromuscular training focused on improving fundamental movement skills needed to safely engage in more physical activity. The program's innovative features include1) neuromuscular training specifically designed to limit delayed muscle soreness which could mimic the symptoms of JFM and 2) seamless integration with CBT to enhance adherence and engagement in increased physical activity. The primary goal of this interdisciplinary project is to develop a specialized and durable self-management intervention to impact the key outcomes of pain, functional disability and depressive symptoms in adolescents with JFM. Aim 1 is to test the feasibility and acceptability of the FIT Teens program. We will pilot the 8-week (16 session), group-based intervention with 8 adolescents with JFM (ages 12-18) to obtain information about feasibility, safety, tolerability, and qualitative feedback about the format and content of the program that will aid in protocol refinements. Aim 2 is to conduct a pilot two-arm trial (N=48) to evaluate whether the FIT Teens program is superior to CBT-alone in reducing pain intensity in adolescents with JFM. Assessments will occur at baseline, post-treatment and 3- month follow-up. We hypothesize that the FIT Teens group will have significantly greater pain reduction than the CBT group by the 3-month follow-up. Both groups are expected to show significant improvement in functional disability and depressive symptoms. In exploratory aims, we will test the role of improved body biomechanics (3-D motion analysis, dynamometry), adherence, increased physical activity (accelerometry), lower catastrophizing and greater confidence in physical activity in explaining pain outcomes. These measures will then be used in a large-scale mechanistic trial if FIT Teens shows greater efficacy compared to CBT in this exploratory trial].