Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia

FIT 青少年青少年纤维肌痛的多中心随机临床试验

• 批准号: 10689413
• 负责人: Susmita Kashikar-Zuck
• 金额: $ 100万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-21 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10689413
• 关键词: Administrative Supplement; Adolescent; Aerobic Exercise; Affect; Age; Behavioral Medicine; Biomechanics; COVID-19; Childhood; Chronic; Clinic; Clinical; Complex; Data; Data Coordinating Center; Enrollment; Exercise; FarGo; Fibromyalgia; Functional disorder; Funding; Future; Infrastructure; Intervention; Investments; Medicine; Movement; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Pain; Participant; Patients; Persons; Public Health; Randomized, Controlled Trials; Rheumatology; Running; Safety; Sample Size; Science; Self Management; Site; Suspensions; Teenagers; Testing; Time; Training Programs; Vaccines; Work; Youth; arm; chronic pain; clinical efficacy; clinical research site; cost; debilitating pain; disability; effective therapy; follow-up; innovation; insight; juvenile onset fibromyalgia; multidisciplinary; neural; novel; pandemic disease; pre-pandemic; primary endpoint; public health emergency; randomized, clinical trials; safety and feasibility; telehealth; timeline; treatment effect

Juvenile-onset fibromyalgia (JFM) is a complex, chronic, and debilitating pain condition for which there is no cure and treatment options are limited. Our multidisciplinary team of experts in Behavioral Medicine, Rheumatology, Exercise Science and Pain Medicine have developed a novel non-pharmacologic intervention - the Fibromyalgia Integrative Training program for Teens (FIT Teens) which is currently being tested in a rigorous 3-arm multi-site randomized controlled trial (RCT) to examine whether FIT Teens is more effective in reducing disability than CBT alone (CBT) or graded aerobic exercise alone (GAE) at the 3-month primary endpoint and whether treatment effects are sustained. The FIT Teens RCT is the largest (N=420) and most rigorous trial for JFM treatment to date and we have established a robust RCT infrastructure with a centralized Data Coordinating Center and Clinical Coordinating Center with six clinical sites. The trial was successfully launched in 2018 and was actively enrolling and treating patients until the COVID19 public health emergency was declared in March 2020. The disruption and delay that the pandemic caused for the trial went far beyond the typical lack of access to clinics and remote work that affected most trials due to circumstances unique to this trial – i.e., patients in a pediatric age range for whom vaccines were not available for an extended time, and the safety/feasibility concerns of implementing in- person group-based interventions. Therefore, we rapidly pivoted the entire trial to remote telehealth format and after a 6-month suspension of new enrollment, were able to successfully re-launch the trial and establish an enrollment trajectory comparable to pre-pandemic levels. We have currently enrolled N=330 JFM participants (78.5% of the proposed sample size) and have excellent retention (>80%) and engagement. The DSMB and the NIAMS have approved an extension of the trial timeline to May 2024 to complete enrollment, treatment and follow-up. The trial is currently in No-Cost Extension Year 1 (06/01/2022 – 05/31/2023). With carry-over funds, we are able to mitigate some of the impact of the delay caused by the pandemic but we can only implement the trial until 10/31/2022, after which funds run out. We are submitting this urgent Administrative Supplement Request as a result of the critical need for funds (from 11/1/2022-5/31/2024) to successfully complete the trial. Without additional funds, the enormous investment into this important trial will be in jeopardy because we will not have sufficient endpoint data to test our primary aims. Completion of the trial would definitively show if non- pharmacologic treatment is truly safe and effective long-term solution to the problem of chronic pain and disability in youth with JFM. Additionally, we will have the unique opportunity to examine the acceptability, safety and preliminary effect sizes for implementing the FIT Teens intervention in remote format. This could inform dissemination efforts for the FIT Teens treatment via telehealth which would be an incredible advance for the field. Ancillary projects are already yielding important insights into the neural pathophysiology of JFM and movement biomechanics that could be paradigm-shifting for JFM treatment in the future.

少年发作的纤维肌痛（JFM）是一种复杂，慢性和使人衰弱的疼痛状况，无法治愈 和治疗方案有限。我们的多学科行为医学专家，风湿病学专家， 运动科学和止痛药已经开发了一种新型的非药物干预 - 纤维肌痛 青少年（适合青少年）的综合培训计划目前正在严格的3臂多站点中进行测试 随机对照试验（RCT）检查适合青少年是否比CBT更有效地减少残疾 单独（CBT）或单独的有氧运动（GAE）在3个月的主要终点以及是否治疗 效果持续。适合的青少年是迄今为止最大的（n = 420），最严格的试验 我们已经建立了具有集中数据协调中心和临床的强大RCT基础架构 与六个临床部位协调中心。该试验于2018年成功启动，正在积极注册 并治疗患者，直到2020年3月宣布COVID19公共卫生紧急情况。 延迟对试验造成的大流行远远超出了典型的诊所和远程访问 由于此试验所特有的情况，影响大多数试验的工作 - 即儿科年龄范围的患者 谁在很长一段时间内无法使用疫苗，并且安全/可行性的问题是实施内置的问题 基于人群的干预措施。因此，我们迅速将整个试验转向远程远程医疗格式 经过6个月的新入学率暂停后，能够成功重新启动审判并建立一个 入学轨迹与流行前水平相当。我们目前已注册n = 330 JFM参与者 （占建议样本量的78.5％），具有出色的保留率（> 80％）和参与度。 DSMB和 NIAMS已批准将审判时间表延长至2024年5月，以完成入学，治疗和 后续。该试验目前处于第1年（06/01/2022 - 05/31/2023）中。有背负资金， 我们能够减轻大流行造成的延迟的某些影响，但我们只能实施 试用直到10/31/2022，此后资金用完了。我们正在提交这种紧急行政补充 由于至关重要的资金需要（从11/1/2022-5/31/2024）要求成功完成试验。 没有额外的资金，对这项重要试验的巨额投资将危及，因为我们将 没有足够的端点数据来测试我们的主要目标。审判的完成将明确显示是否非 药理治疗是解决慢性疼痛和问题的真正安全有效的长期解决方案 JFM青年的残疾。此外，我们将有独特的机会检查可接受性， 安全和初步效果大小，用于以远程格式实施适合的青少年干预。可以 通过远程医疗为适合青少年待遇的传播工作提供信息，这将是令人难以置信的进步 领域。辅助项目已经在对JFM和 将来可能会用于JFM治疗的运动生物力学。

项目成果

Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.

• DOI: 10.1016/j.cct.2021.106321
• 发表时间: 2021-04
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 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
• 通讯作者: Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators

Clinical Characterization of Juvenile Fibromyalgia in a Multicenter Cohort of Adolescents Enrolled in a Randomized Clinical Trial.

参加随机临床试验的多中心青少年队列中青少年纤维肌痛的临床特征。

• DOI: 10.1002/acr.25077
• 发表时间: 2023
• 期刊: Arthritis care & research
• 影响因子: 4.7
• 作者: Lynch-Jordan,AnneM;Connelly,Mark;Guite,JessicaW;King,Christopher;Goldstein-Leever,Alana;Logan,DeirdreE;Nelson,Sarah;Stinson,JenniferN;Ting,TracyV;Wakefield,EmilyO;Williams,AmyE;Williams,SaraE;Kashikar-Zuck,Susmita;Fibromy
• 通讯作者: Fibromy