Cincinnati Children’s Receives $7.7 Million NIH Grant To Study Best Treatment for Chronic Debilitating Pain

Monday, July 31, 2017

Cincinnati Children’s Hospital Medical Center has received a five-year, $7.7 million grant from the National Institutes of Health (NIH) to conduct what is believed to be the largest and most rigorous clinical trial for patients with juvenile-onset fibromyalgia (JFM).

Fibromyalgia is a chronic and debilitating disorder involving musculoskeletal pain accompanied by mood changes and fatigue. It’s estimated that JFM affects up to 6 percent of school children, mostly teen girls. 

In recent years, a team of experts in behavioral medicine, rheumatology, sports medicine and pain medicine developed a novel program – the Fibromyalgia Integrative Training program for Teens (FIT Teens). This program provides specialized neuromuscular exercise training along with cognitive behavioral therapy -- a common type of psychotherapy in which a patient works with a mental health therapist in a highly-structured way. In this case, cognitive behavioral therapy is used to enhance psychological coping skills and decrease fear of movement.

“Our pilot work shows that this intensive group-based 8-week (16-session) intervention is safe, produces excellent patient engagement, has no adverse effects, reduces fear of movement and reduces pain-related disability,” says Susmita Kashikar-Zuck, PhD, a pediatric psychologist at Cincinnati Children’s and director of research for the Division of Behavioral Medicine and Clinical Psychology. 

“Moreover, these improvements are accompanied by objective improvements in strength and movement documented via a sophisticated 3-D motion capture technology – indicating greater capacity for safely engaging in physical exercise. 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.”

The grant, from the NIH’s National Institutes of Arthritis and Musculoskeletal and Skin Diseases, is a rigorous multi-site randomized clinical trial to test whether the FIT Teens intervention is more effective than either cognitive behavioral therapy or exercise alone in reducing disability, and whether treatment effects are sustained over the course of a year. “Results of the study will provide clear direction for the best clinical care for JFM patients,” says Kashikar-Zuck.