Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that persists into adulthood for the majority of patients. The previous research has demonstrated that cognitive-behavioral therapy (CBT) is effective in reducing functional disability in adolescents with JFM. However, in order to achieve stronger and clinically meaningful improvement in functional disability and reduce pain, changing sedentary behavior and increasing engagement in moderate-vigorous physical activity is a crucial component of JFM pain management. Incorporation of physical exercise has emerged as a logical next step to enhance CBT, yet regular participation in any physical activity is difficult to initiate and maintain in JFM patients.

The multidisciplinary team of experts in Behavioral Medicine, Rheumatology, Exercise Science and Pain Medicine have developed a novel intervention - the Fibromyalgia Integrative Training program for Teens (FIT Teens), which enhances established CBT techniques with specialized neuromuscular exercise training derived from evidence-based pediatric injury prevention research. Innovative features include progressive neuromuscular training designed to limit delayed-onset muscle soreness and seamless integration with CBT to enhance psychological coping skills and decrease fear of movement. This treatment approach is extremely promising in its wide-ranging impact on treatment of JFM as well as other chronic musculoskeletal pain conditions in children.

ELIGIBILITY CRITERIA:

Inclusion Criteria:

  • Juvenile Fibromyalgia diagnosis by pediatric rheumatologist or pain physician and confirmed by 2010 American College of Rheumatology (ACR) criteria modified for pediatric use
  • 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
  • Stable medications prior to enrollment

Exclusion Criteria:

  • Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematous)
  • Untreated major psychiatric diagnoses (e.g. bipolar disorder, psychoses, symptoms of major depression) or documented developmental delay
  • Any medical condition determined by their physician to be a contraindication for physical exercise
  • Taking opioid pain medication

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Double (Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Study Location(s):

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

University of Louisville, Louisville, Kentucky, United States, 40202

Boston Chilldren's Hospital, Boston, Massachusetts, United States, 02116

Children's Mercy Hospital, Kansas City, Missouri, United States, 64108

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Hospital for Sick Children, Toronto, Ontario, Canada, M5G 1X8

Study Website:

https://clinicaltrials.gov/ct2/show/NCT03268421?term=NCT03268421&rank=1

Last Reviewed: 05/06/2019