Fibromyalgia Integrative Training Program for Teens (FIT Teens)

青少年纤维肌痛综合训练计划（FIT Teens）

• 批准号: 8739146
• 负责人: Susmita Kashikar-Zuck
• 金额: $ 16.58万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8739146
• 关键词: 3-Dimensional; Adherence; Adolescent; Adult; Aerobic; Aftercare; Age; Anxiety; Behavioral; Behavioral Medicine; Biomechanics; Body measure procedure; Characteristics; Childhood; Chronic; Cognitive; Cognitive Therapy; Development; Education; Exercise; Fatigue; Feedback; Fibromyalgia; Flare; Goals; Guidelines; Intervention; Maintenance; Measures; Medicine; Modeling; Moods; Motion; Movement; Muscle; Musculoskeletal Pain; Outcome; Pain; Pain intensity; Pain interference; Pain management; Pain quality; Patients; Pharmaceutical Preparations; Physical activity; Preparation; Prevention Protocols; Protocols documentation; Quality of life; Rheumatology; Role; Safety; Science; Self Management; Site; Sleep; Sports Medicine; Symptoms; Techniques; Teenagers; Testing; Training; Training Programs; Treatment Protocols; United States National Institutes of Health; actigraphy; base; body mechanics; chronic pain; clinical care; clinically significant; comparative efficacy; coping; depressive symptoms; design; disability; disturbance in affect; effective intervention; experience; follow-up; functional disability; improved; injury prevention; innovation; meetings; neuromuscular; novel; novel strategies; pilot trial; programs; psychologic; public health relevance; randomized trial; sedentary; skills; skills training; social; two-arm study

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].

描述（由申请人提供）：青少年纤维肌痛（JFM）是一种青少年慢性衰弱性疼痛病症，其特征是广泛的疼痛、压痛点、疲劳，并且常常伴有情绪障碍。 JFM 无法治愈，药物只能有限且短期地缓解症状。在最近的一项多中心随机试验中，我们证明认知行为疗法 (CBT) 可以显着改善 JFM 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 后仍然遭受中度疼痛症状。有令人鼓舞的证据表明 CBT 和体育锻炼相结合可以减轻纤维肌痛 (FM) 疼痛。不幸的是，FM 患者很难开始并维持定期参加中等强度的体力活动，这可能是由于久坐的生活方式以及缺乏适当的身体力学教育所致。在这个项目中，我们建议开发和测试一项新的青少年纤维肌痛综合训练计划（FIT Teens），该计划将通过与根据儿科运动医学/伤害预防方案修改的新型神经肌肉计划相结合，增强现有的 CBT 干预措施。该计划包括综合神经肌肉训练，重点是提高安全地进行更多体育活动所需的基本运动技能。该计划的创新功能包括：1) 专门设计用于限制延迟性肌肉酸痛的神经肌肉训练，这种肌肉酸痛可以模仿 JFM 的症状；2) 与 CBT 无缝集成，以增强对增加体力活动的坚持和参与。这个跨学科项目的主要目标是开发一种专门且持久的自我管理干预措施，以影响 JFM 青少年疼痛、功能障碍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 会议），对 8 名 JFM 青少年（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，以及有关项目格式和内容的定性反馈，这将有助于方案的完善。目标 2 是进行一项试点双臂试验 (N=48)，以评估 FIT 青少年计划在减轻 JFM 青少年疼痛强度方面是否优于单独的 CBT。评估将在基线、治疗后和 3 个月随访时进行。我们假设，在 3 个月的随访中，FIT 青少年组的疼痛减轻效果明显优于 CBT 组。预计两组患者的功能障碍和抑郁症状都会有显着改善。在探索性目标中，我们将测试改进的身体生物力学（3D 运动分析、测力）、坚持、增加体力活动（加速测量）、降低灾难性和增强对体力活动的信心在解释疼痛结果方面的作用。如果 FIT Teens 在此探索性试验中显示出比 CBT 更有效的效果，那么这些措施将用于大规模机械试验]。