Overview

This trial is active, not recruiting.

Condition juvenile fibromyalgia
Treatments fibromyalgia integrative training, cognitive behavioral therapy
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date November 2013
End date July 2016
Trial size 40 participants
Trial identifier NCT01981096, R21AR063412

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
8 week (16 sessions) combined intervention with cognitive-behavioral therapy and neuromuscular training
fibromyalgia integrative training
Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
(Active Comparator)
8 week (16 session) cognitive-behavioral therapy treatment.
cognitive behavioral therapy
Therapy focused on training in behavioral pain coping skills

Primary Outcomes

Measure
Average Pain Intensity
time frame: One week

Secondary Outcomes

Measure
Functional Disability
time frame: Past 2 weeks
Depressive Symptoms
time frame: Past 2 weeks

Eligibility Criteria

Male or female participants from 12 years up to 18 years old.

Inclusion Criteria: - Males and females ages 12-18 - Juvenile fibromyalgia (JFM) diagnosed by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology (ACR) criteria and confirmation with a tender point exam of ≥ 11 of 18 tender points upon palpation - Functional Disability Score ≥13 indicating at least moderate disability - Average pain intensity in the past week ≥ 4 on a 0-10 cm Visual Analog Scale Exclusion Criteria: - Comorbid rheumatic disease (e.g., juvenile arthritis, systemic lupus erythematous) - untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses) - documented developmental delay - any medical condition determined by their physician to be a contraindication for participation - on stable medications for 4 weeks prior to enrollment - currently in CBT or structured physical therapy program

Additional Information

Official title Fibromyalgia Integrative Training for Teens
Principal investigator Susmita Kashikar-Zuck, PhD
Description CBT has been found to have beneficial effects on improving coping among adolescents with JFM and increasing patients' ability to engage in daily activities. The purpose of this study is to evaluate whether CBT can be enhanced with specialized neuromuscular training, in the new fibromyalgia integrative training (FIT Teens) intervention, to produce stronger pain reduction than CBT alone. Neuromuscular training originates from the field of pediatric sports medicine and has been successfully used for injury prevention but has never before been utilized for pain management in JFM. This type of training emphasizes education and proper training in fundamental movement skills prior to the initiation of more vigorous physical activity and exercise. It is expected that the neuromuscular training integrated with established CBT techniques will enhance patients' ability to engage in exercise and to achieve better JFM pain control. Adolescents with JFM will be randomly assigned to receive either the 8-week FIT Teens intervention or an 8-week CBT program with assessments at baseline, post-treatment and 3-month follow-up.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.