CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Fibromyalgia integrative training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01981096
NCT01981096N/ACompleted
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Fibromyalgia Integrative Training for Teens

Children's Hospital Medical Center, Cincinnati·interventional·Posted Nov 11, 2013·Updated Feb 11, 2022

In Brief

A clinical study evaluating Fibromyalgia integrative training and Cognitive Behavioral Therapy for Juvenile Fibromyalgia. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this pilot randomized trial is to determine whether the fibromyalgia integrative training (FIT Teens) intervention is superior to cognitive-behavioral therapy (CBT) alone in reducing pain among adolescents with juvenile fibromyalgia (JFM). Hypothesis 1: Patients in the FIT Teens group will show significantly greater reduction in pain intensity than the CBT group at final study assessment (i.e., 3-month follow up). Hypothesis 2: Patients in both the FIT Teens and CBT groups will show significant reductions in functional disability and depressive symptoms at final study assessment (i.e., 3-month follow up).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Fibromyalgia
CountriesUnited States
CollaboratorsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 11, 2013
Enrollment StartNov 1, 2013
Primary CompletionJul 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.6 years ago

Interventions

Fibromyalgia integrative trainingbehavioral

Combined intervention with neuromuscular exercise training and cognitive behavioral therapy

Cognitive Behavioral Therapybehavioral

Therapy focused on training in behavioral pain coping skills