Fibromyalgia Integrative Training for Teens

Juvenile Fibromyalgia Clinical Trial

— FIT Teens  

Official title:

Fibromyalgia Integrative Training for Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981096
• Other study ID #: R21AR063412
• Secondary ID: R21AR063412
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: February 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Juvenile Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Fibromyalgia integrative training
Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
• Cognitive Behavioral Therapy
Therapy focused on training in behavioral pain coping skills

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Pain Intensity	Average pain intensity in the past week marked on a paper-pencil Visual Analog Scale (Min = 0 {no pain} to Max = 10 {pain as bad as it can be}). Lower scores mean better outcomes.	Baseline, post-treatment and 3-month follow-up
Secondary	Functional Disability	Validated 15-item patient-report measure of difficulties in physical, social and recreational activities in the past 2 weeks (score Min = 0, Max = 60; Lower score means less disability/better outcome)	Baseline, post-treatment and 3-month follow-up
Secondary	Depressive Symptoms	Children's Depression Inventory: a 27-item validated patient-report measure of depressive symptoms in the past 2 weeks (scores 0 = no depressive symptoms to 54 = most severe symptoms; lower score means less depression/better outcomes)	Baseline, Post-treatment, 3-month follow-up