Clinical trial NCT01981096: Fibromyalgia Integrative Training for Teens
Official title: Fibromyalgia Integrative Training for Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Fibromyalgia
Keywords: juvenile fibromyalgia
pain in children
musculoskeletal pain
cognitive behavioral therapy
coping skills training
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2013-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Pain Intensity
timeFrame: Baseline, post-treatment and 3-month follow-up
Secondary outcomes:
measure: Functional Disability
timeFrame: Baseline, post-treatment and 3-month follow-up
measure: Depressive Symptoms
timeFrame: Baseline, Post-treatment, 3-month follow-up
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinati Children's Hospital Medical Center
name: Susmita Kashikar-Zuck, PhD
role: PRINCIPAL_INVESTIGATOR
References: