Fibromyalgia Integrative Training for Teens

Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Age Range:12 - 18
Start Date:November 2013
End Date:December 2016

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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).

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.

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,

- documented developmental delay

- any medical condition determined by their physician to be a contraindication for

- on stable medications for 4 weeks prior to enrollment

- currently in CBT or structured physical therapy program
We found this trial at
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Principal Investigator: Susmita Kashikar-Zuck, PhD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Cincinnati, OH
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