Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.
Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.
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DOI：
10.1016/j.cct.2021.106321
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发表时间：
2021-04
影响因子：
2.2
通讯作者：
Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators
中科院分区：
文献类型：
--
作者：
Kashikar-Zuck S;Briggs MS;Bout-Tabaku S;Connelly M;Daffin M;Guite J;Ittenbach R;Logan DE;Lynch-Jordan AM;Myer GD;Ounpuu S;Peugh J;Schikler K;Sugimoto D;Stinson JN;Ting TV;Thomas S;Williams SE;Zempsky W;Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators
青少年纤维肌痛（Juvenile-onset fibromyalgia，JFM）是一种慢性衰弱性疼痛，对身体，社会和学术功能产生负面影响。认知行为疗法（CBT）有助于减少青少年JFM患者的功能障碍，但对减轻疼痛的影响不大，并且不能提高体育锻炼的参与度。这项随机对照试验（RCT）旨在测试将CBT与专门的神经肌肉运动训练（青少年纤维肌痛综合训练计划“FIT Teens”）相结合的新型干预措施是否上级单独的CBT或分级有氧运动（GAE）计划。这项3组多中心RCT将检查FIT Teens干预相对于CBT或GAE在减少功能残疾（主要结局）和疼痛强度（次要结局）方面的疗效。所有干预措施持续8周（16次会议），并在4-6名患有JFM的青少年的小组中进行。预计在7个研究中心共招募420名受试者，每个治疗组的分配大致相同。将在基线、治疗后以及3个月、6个月、9个月和12个月随访时评估过去一周的功能障碍和平均疼痛强度。3个月随访是评价治疗疗效的主要终点;纵向评估将确定治疗获益的维持。还将评估应对方式、运动恐惧、生物力学变化和体能的变化。这项多中心随机对照试验旨在评估对于患有JFM的青少年，FIT Teens联合干预是否会比CBT或GAE单独对残疾和疼痛减轻产生更大的影响。
Juvenile-onset fibromyalgia (JFM) is a chronic debilitating pain condition that negatively impacts physical, social and academic functioning. Cognitive-behavioral therapy (CBT) is beneficial in reducing functional disability among adolescents with JFM but has only a modest impact on pain reduction and does not improve physical exercise participation. This randomized controlled trial (RCT) aims to test whether a novel intervention that combines CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program for Teens “FIT Teens”) is superior to CBT alone or a graded aerobic exercise (GAE) program. This 3-arm multi-site RCT will examine the efficacy of the FIT Teens intervention in reducing functional disability (primary outcome) and pain intensity (secondary outcome), relative to CBT or GAE. All interventions are 8-weeks (16 sessions) in duration and are delivered in small groups of 4–6 adolescents with JFM. A total of 420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm. Functional disability and average pain intensity in the past week will be assessed at baseline, post-treatment and at 3-, 6-, 9- and 12-month follow-up. The 3-month follow-up is the primary endpoint to evaluate treatment efficacy; longitudinal assessments will determine maintenance of treatment gains. Changes in coping, fear of movement, biomechanical changes and physical fitness will also be evaluated. This multi-site RCT is designed to evaluate whether the combined FIT Teens intervention will have significantly greater effects on disability and pain reduction than CBT or GAE alone for youth with JFM.
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