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

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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.