Juvenile Fibromyalgia (JFM) Study for Children and Teens

Why are we doing this research?

Cincinnati Children’s is conducting a clinical research study to test whether coping skills training and/or exercise treatments are effective in reducing pain and improving physical function in teens with JFM.

Who can participate?

Youth 12 to 17 years old who have been diagnosed with chronic widespread pain/JFM may be eligible for this study.

Conditions

  • Bones - Joints - Muscles

What will happen in the study?

This study includes 8 weeks of treatment in which teens will attend training sessions twice a week, and complete assessments before treatment, after treatment and at follow-up visits. There are a total of 26 study visits (20 training sessions and 6 assessment visits) over 14 months. Parents are asked to attend some of the treatment sessions. Here are some of the things that will happen in this study:

Teens will:

  • Complete questionnaires about pain and the impact of pain on their lives
  • Complete measures of strength and fitness
  • Keep track of their pain, sleep and physical activity for one week on a smartphone app or paper diary at home for each assessment
  • Wear a small activity tracker for one week during each assessment
  • Be randomized if eligible (that is, assigned by chance - like flipping a coin), to be in 1 of the following 3 treatment groups:
    • Fibromyalgia integrative training (FIT) which combines coping skills training with specialized neuromuscular exercises
    • Coping skills training – also called cognitive behavioral therapy (CBT), or
    • Low-impact aerobic exercises (GAE) which is a type of fitness training
  • Attend 16 small-group sessions of 4 to 6 teens who also have JFM/chronic widespread pain (90 minutes each) held twice a week for 8 weeks
  • Attend 4 “booster” training sessions
  • Return for follow-up assessments at 3, 6, 9 and 12 months after treatment ends

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form and will make sure that the parents’ and teen’s questions are answered.

What are the good things that can happen from this research?

Teens may learn better ways to manage pain and their physical functioning may improve. Also, they will meet with other teens who have JFM and learn from their experiences. By completing this research, we hope to develop better treatments for teens with JFM so they can take part in their normal activities, feel stronger and cope better with their pain.

What are the bad things that can happen from this research?

The training in exercise and coping skills is usually quite safe, but possible risks and discomforts will be fully discussed before enrollment in the study.

Will you/your child be paid to be in this research study?

Families will receive up to $540 for time and effort to complete this study.

Contact

Contact Us.Megan Pfeiffer
513-636-1846
fitteens@cchmc.org
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Susmita Kashikar-Zuck, PhD
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center