Evidence map›Paper›PMID 33618033›Full record

ArticleContemporary clinical trials2021

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 and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03268421 (Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03268421 nacompletednot on this map

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

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2018 to 2023Enrolled389ConditionsFibromyalgia, Myofascial Pain Syndrome, Muscular Diseases, Musculoskeletal DiseaseArmsFibromyalgia Integrative Training for Teens, Cognitive Behavioral Therapy, Graded Aerobic Exercise
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Observational
  9. Neurophysiology of Resilience in Juvenile Fibromyalgia.medRxiv : the preprint server for health sciences · 2024
    Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 12 institutions in 4 countries.

Susmita Kashikar-ZuckDepartment 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 BriggsSports Medicine Research Institute, and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Sharon Bout-TabakuDepartment of Pediatric Medicine, Sidra Medicine, Doha, Qatar; Weill Cornell Medicine, Doha, Qatar.
Mark ConnellyDivision of Developmental and Behavioral Sciences, Children's Mercy Hospital, Kansas City, KS, USA.
Morgan DaffinDepartment of Pediatrics, University of Louisville, School of Medicine, Norton Children's Hospital, Louisville, KY, USA.
Jessica GuiteDepartment of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA.
Richard IttenbachDepartment 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 LoganDivision 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-JordanDepartment 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 MyerSports Performance and Research Center, Emory University School of Medicine, Atlanta, GA, USA.
Sylvia OunpuuCenter for Motion Analysis, Connecticut Children's Medical Center, Department of Orthopedic Surgery, University of Connecticut School of Medicine, Hartford, CT, USA.
James PeughDepartment 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 SchiklerDepartment of Pediatrics, University of Louisville, School of Medicine, Norton Children's Hospital, Louisville, KY, USA.
Dai SugimotoSport Sciences, Waseda University, Tokyo, Japan; The Micheli Center for Sports Injury Prevention, Waltham, MA, USA.
Jennifer N StinsonChild 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 TingDepartment of Pediatrics, College of Medicine, University of Cincinnati, Cincinnati, OH, USA; Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Staci ThomasDivision of Sports Medicine, SPORT Center, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Sara E WilliamsDepartment 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 ZempskyDepartment of Pediatrics and Nursing, University of Connecticut, Hartford, CT, USA; Division of Pain and Palliative Medicine, Connecticut Children's Medical Center, Hartford, CT, USA.
Childhood Arthritis and Rheumatology Research Alliance (CARRA) Pain Workgroup Investigators
University of Cincinnati Medical Center · USCincinnati Children's Hospital Medical Center · USConnecticut Children's Medical Center · USKosair Children's Hospital · USBoston Children's Hospital · USChildren's Mercy Hospital · USEmory University · USHospital for Sick Children · CAThe Micheli Center for Sports Injury Prevention · USThe Ohio State University Wexner Medical Center · USUniversity of Connecticut · USWeill Cornell Medical College in Qatar · QA

Funding

Multi-site Randomized Clinical Trial of FIT Teens for Juvenile FibromyalgiaR01AR070474 · NIAMS · CINCINNATI CHILDRENS HOSP MED CTR · PI KASHIKAR-ZUCK, SUSMITA · 2017 to 2023
$8.7M
Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia (JFM)U34AR067978 · NIAMS · CINCINNATI CHILDRENS HOSP MED CTR · PI KASHIKAR-ZUCK, SUSMITA · 2015 to 2015
$363k
NIAMS NIH HHS R01 AR070474NIAMS NIH HHS U34 AR067978
6 · The paper itself

Abstract

objectiveJuvenile-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/

methodsThis 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.

conclusionsThis 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.

Indexed as

Cognitive Behavioral TherapyFibromyalgiaAdaptation, PsychologicalAdolescentExercise TherapyHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTreatment OutcomeCognitive behavioral therapyJuvenile fibromyalgiaNeuromuscular trainingPediatric chronic painRCT- randomized clinical trial

Identifiers

PMID33618033
PMCPMC8089039
OpenAlexW3131210889

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.