Randomized clinical trial of fibromyalgia integrative training (FIT teens) for adolescents with juvenile fibromyalgia – Study design and protocol.

Feb 25, 2021

Contributor: 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,

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. Clinical trials.gov registration: NCT03268421.

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About The Expert

Susmita Kashikar-Zuck

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.

Matthew S Briggs

Sports Medicine Research Institute, and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.

Sharon Bout-Tabaku

Department of Pediatric Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine, Doha, Qatar.

Mark Connelly

Department of Pediatric Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine, Doha, Qatar.

Morgan Daffin

Division of Developmental and Behavioral Sciences, Children’s Mercy Hospital, Kansas City, KS, USA.

Jessica Guite

Department of Pediatrics, School of Medicine & Center for Advancement in Managing Pain (CAMP), School of Nursing, University of Connecticut, Hartford, CT, USA.

Richard Ittenbach

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.

Deirdre E Logan

Division of Pain Medicine, Department of Anesthesia, Boston Children’s Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.

Anne M Lynch-Jordan

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.

Gregory D Myer

Division of Sports Medicine, The Human Performance Laboratory, Department of Pediatrics and Orthopedic Surgery, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.

Sylvia Ounpuu

Center for Motion Analysis, Connecticut Children’s Medical Center, Department of Orthopedic Surgery, University of Connecticut School of Medicine, Hartford, CT, USA.

James Peugh

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.

Kenneth Schikler

Department of Pediatrics, University of Louisville, School of Medicine, Norton Children’s Hospital, Louisville, KY, USA.

Dai Sugimoto

Sport Sciences, Waseda University, Tokyo, Japan; The Micheli Center for Sports Injury Prevention, Waltham, MA, USA.

Jennifer N Stinson

Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, Toronto, Canada; Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada.

Tracy V Ting

Department of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Rheumatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA.

Staci Thomas

Division of Sports Medicine, SPORT Center, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA.

Sara E Williams

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.

William Zempsky

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.

References

PubMed