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. 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.
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.
Authors: James W Varni; Brian D Stucky; David Thissen; Esi Morgan Dewitt; Debra E Irwin; Jin-Shei Lai; Karin Yeatts; Darren A Dewalt Journal: J Pain Date: 2010-06-02 Impact factor: 5.820
Authors: S van Koulil; M Effting; F W Kraaimaat; W van Lankveld; T van Helmond; H Cats; P L C M van Riel; A J L de Jong; J F Haverman; A W M Evers Journal: Ann Rheum Dis Date: 2006-08-17 Impact factor: 19.103
Authors: Susmita Kashikar-Zuck; Stacy R Flowers; Robyn Lewis Claar; Jessica W Guite; Deirdre E Logan; Anne M Lynch-Jordan; Tonya M Palermo; Anna C Wilson Journal: Pain Date: 2011-03-31 Impact factor: 6.961
Authors: Susan T Tran; Jessica W Guite; Ashley Pantaleao; Megan Pfeiffer; Gregory D Myer; Soumitri Sil; Staci M Thomas; Tracy V Ting; Sara E Williams; Barbara Edelheit; Sylvia Ounpuu; Jennifer Rodriguez-MacClintic; Lawrence Zemel; William Zempsky; Susmita Kashikar-Zuck Journal: Arthritis Care Res (Hoboken) Date: 2017-03 Impact factor: 4.794