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NCT03268421 · ClinicalTrials.gov registry record · NA

Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

A NA study of Fibromyalgia and Rheumatic Diseases, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
NA
Development phase
389
Enrollment target
7
Study locations

NCT03268421: Completed NA study of Fibromyalgia and Rheumatic Diseases, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT03268421 is a NA study of Fibromyalgia and Rheumatic Diseases that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 389 participants, above the 174-participant average among 76 other Fibromyalgia trials with a reported enrollment target (124% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03268421, a NA study of Fibromyalgia and Rheumatic Diseases, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
NA
Development phase
389 participants
Enrollment target
7
Study locations

Study Summary

This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.

Primary Outcome

Functional Disability Inventory (FDI) is a validated 15-item self-report measure, developed to assess perceived difficulty in the performance of daily activities in home, school, recreational, and social domains due to pain. Total sum scores are calculated and range from 0 - 60, with higher scores indicating greater functional disability. Clinical reference points are: No/Minimal disability (0 to 12), Mild disability (13 to 20), Moderate disability (21 to 29) and Severe disability (≥30). For thi

Conditions Studied

Fibromyalgia Rheumatic Diseases Muscular Diseases Musculoskeletal Disease Myofascial Pain Syndrome

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy
  • BEHAVIORAL Fibromyalgia Integrative Training for Teens
  • BEHAVIORAL Graded Aerobic Exercise

Study Locations (7)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • Nationwide Children's Hospital - Columbus

Connecticut

  • Connecticut Children's Medical Center - Hartford

Indiana

  • Riley Children's Hospital-University of Indiana - Indianapolis

Massachusetts

  • Boston Chilldren's Hospital - Boston

Missouri

  • Children's Mercy Hospital - Kansas City

Ontario

  • Hospital for Sick Children - Toronto

Trial Details

FieldValue
Enrollment Target 389 participants
Start Date 2018-01-02
Est. Completion 2023-12-21
Phase NA
Children's Hospital Medical Center, Cincinnati

571 total trials

What the finished NCT03268421 record still lists

NCT03268421 is an interventional study that assigns participants to a tested intervention. The registered 389 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 76 other Fibromyalgia trials with a reported enrollment target (124% higher).

The record links to 5 conditions, with Fibromyalgia appearing as the primary indexed condition, and to 3 interventions - of which Cognitive Behavioral Therapy is the first listed.

NCT03268421 lists 7 locations in 6 states (Ohio, Connecticut, Indiana).

Frequently Asked Questions

What is clinical trial NCT03268421 about?

NCT03268421 is a clinical study titled "Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia". This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therap...

What is the current status of trial NCT03268421?

This trial is currently completed. It is a NA study. The enrollment target is 389 participants. The study started on 2018-01-02. Estimated completion is 2023-12-21.

What conditions does trial NCT03268421 study?

This clinical trial studies the following conditions: Fibromyalgia, Rheumatic Diseases, Muscular Diseases, Musculoskeletal Disease, Myofascial Pain Syndrome.

What interventions are being tested in trial NCT03268421?

The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Fibromyalgia Integrative Training for Teens (BEHAVIORAL), Graded Aerobic Exercise (BEHAVIORAL).

Who is sponsoring clinical trial NCT03268421?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03268421 being conducted?

This trial has 7 study locations across Connecticut, Indiana, Massachusetts, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Fibromyalgia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03268421's enrollment target sits among peer trials

389 9th of 76 higher than 68 of 76 other Fibromyalgia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Fibromyalgia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03268421, the US trial registry maintained by the National Library of Medicine. NCT03268421 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.