# Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia

> **NIH NIH R01** · CINCINNATI CHILDRENS HOSP MED CTR · 2020 · $1,528,804

## Abstract

Abstract
Juvenile-onset fibromyalgia (JFM) is a chronic, debilitating pain condition that persists into adulthood for the
majority of patients. Our research group 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. Our 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 1) progressive neuromuscular training designed to limit delayed-onset muscle
soreness; and 2) seamless integration with CBT 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 has a greater impact on
pain-related disability than CBT alone. Moreover, these improvements are accompanied objective improvements
in strength and movement competence documented via 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. In
this U01, we propose a rigorous 3-arm multi-site randomized clinical trial (RCT) to test whether the FIT Teens
intervention is more effective in reducing disability than CBT alone or graded aerobic exercise alone at the 3-month
primary endpoint and whether treatment effects are sustained over 1 year. We will also explore how changes in
coping, fear of movement, and objectively measured physical activity, movement competence and physical fitness
predict changes in outcomes. The proposed RCT will be the largest (N=420) and most rigorous trial in JFM to date
which necessitates a multi-site study with multi-disciplinary collaborators whose complementary expertise ensures
success in accomplishing the study aims. Supported by a U34 planning agreement, we have established a robust
RCT infrastructure with a central Data Coordinating Center and seven clinical sites, accomplished key
administrative and regulatory milestones, completed feasibility assessment and developed standardized protocols
for a str...

## Key facts

- **NIH application ID:** 9952316
- **Project number:** 5R01AR070474-04
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Susmita Kashikar-Zuck
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,528,804
- **Award type:** 5
- **Project period:** 2017-06-21 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9952316

## Citation

> US National Institutes of Health, RePORTER application 9952316, Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia (5R01AR070474-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9952316. Licensed CC0.

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