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

Susmita Kashikar-Zuck; Matthew S Briggs; Sharon Bout-Tabaku; Mark Connelly; Morgan Daffin; Jessica Guite; Richard Ittenbach; Deirdre E Logan; Anne M Lynch-Jordan; Gregory D Myer; Sylvia Ounpuu; James Peugh; Kenneth Schikler; Dai Sugimoto; Jennifer N Stinson; Tracy V Ting; Staci Thomas; Sara E Williams; William Zempsky; Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators

doi:10.1016/j.cct.2021.106321

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

Contemp Clin Trials. 2021 Apr:103:106321. doi: 10.1016/j.cct.2021.106321. Epub 2021 Feb 20.

Authors

Susmita Kashikar-Zuck¹, Matthew S Briggs², Sharon Bout-Tabaku³, Mark Connelly⁴, Morgan Daffin⁵, Jessica Guite⁶, Richard Ittenbach⁷, Deirdre E Logan⁸, Anne M Lynch-Jordan⁹, Gregory D Myer¹⁰, Sylvia Ounpuu¹¹, James Peugh⁹, Kenneth Schikler⁵, Dai Sugimoto¹², Jennifer N Stinson¹³, Tracy V Ting¹⁴, Staci Thomas¹⁵, Sara E Williams⁹, William Zempsky¹⁶; Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators

Affiliations

¹ Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. Electronic address: susmita.kashikar-zuck@cchmc.org.
² Sports Medicine Research Institute, and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
³ Department of Pediatric Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine, Doha, Qatar.
⁴ Division of Developmental and Behavioral Sciences, Children's Mercy Hospital, Kansas City, KS, USA.
⁵ Department of Pediatrics, University of Louisville, School of Medicine, Norton Children's Hospital, Louisville, KY, USA.
⁶ Department of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA.
⁷ Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
⁸ Division of Pain Medicine, Department of Anesthesia, Boston Children's Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
⁹ Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
¹⁰ Sports Performance and Research Center, Emory University School of Medicine, Atlanta, GA, USA.
¹¹ Center for Motion Analysis, Connecticut Children's Medical Center, Department of Orthopedic Surgery, University of Connecticut School of Medicine, Hartford, CT, USA.
¹² Sport Sciences, Waseda University, Tokyo, Japan; The Micheli Center for Sports Injury Prevention, Waltham, MA, USA.
¹³ Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Canada; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada.
¹⁴ Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
¹⁵ Division of Sports Medicine, SPORT Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
¹⁶ Department of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA; Division of Pain and Palliative Medicine, Connecticut Children's Medical Center, Hartford, CT, USA.

Abstract

Objective: 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.

Design/methods: 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.

Conclusions: 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. Clinical trials.gov registration: NCT03268421.

Keywords: Cognitive behavioral therapy; Juvenile fibromyalgia; Neuromuscular training; Pediatric chronic pain; RCT- randomized clinical trial.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Adaptation, Psychological
Adolescent
Cognitive Behavioral Therapy*
Exercise Therapy
Fibromyalgia* / therapy
Humans
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03268421

Abstract

Publication types

MeSH terms

Associated data

Grants and funding