Fibromyalgia Integrative Training for Teens (FIT Teens)

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Juvenile Fibromyalgia

Treatments

Behavioral: Cognitive Behavioral Therapy

Behavioral: Fibromyalgia integrative training

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01981096

R21AR063412 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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