Physical Activity Pain Resilience

NCT ID: NCT07049029

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-29
• Study Completion Date: 2026-12-01

Brief Summary

The purpose of this research study is to test a new program called Pain REsilience Promotion for Youth (PREP-Y). This program is designed to help adolescents with chronic musculoskeletal pain (pain in muscles, bones, or joints that lasts more than 3 months) become more physically active and better able to manage their pain. The program includes four weekly virtual sessions that teach skills related to resilience, such as how to stay motivated, build confidence, and cope with pain.

Participants will complete surveys and physical activity tests before and after the program. Participants will also wear physical activity monitors to track their activity levels. The goal of this study is to learn whether the program is practical, helpful, and acceptable to participants, and to prepare for a future larger study.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PREP-Y

Group Type: EXPERIMENTAL

PREP-Y

Intervention Type: BEHAVIORAL

The intervention is a series of behavioral health/psychoeducational modules that the participant will learn from. Participants will use the information discussed and overall impact on physical activity engagement, chronic pain management, and quality of life will be measured

Interventions

PREP-Y

The intervention is a series of behavioral health/psychoeducational modules that the participant will learn from. Participants will use the information discussed and overall impact on physical activity engagement, chronic pain management, and quality of life will be measured

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between the ages of 12 and 17
• History of chronic musculoskeletal pain for more than 3 months assessed by a pediatric rheumatologist or pain physician
• Diagnosis of a primary pain disorder (e.g., juvenile fibromyalgia and other widespread pain conditions, lower back pain, complex regional pain and amplified pain syndrome)
• Speaks English as primary language

Exclusion Criteria

• Chronic pain secondary to disease (e.g., sickle cell disease or rheumatic disease such as juvenile arthritis, systemic lupus erythematosus)
• Presence of an untreated major psychiatric diagnosis (e.g., major depression, bi-polar disorder, psychoses)
• History or diagnosis of developmental delay.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

William Black

OTHER

Sponsor Role: lead

Responsible Party

William Black

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

William Black, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

William Black, PhD

Role: CONTACT

william.black@nationwidechildrens.org

614-472-0717

Facility Contacts

William Black, PhD

Role: primary

william.black@nationwidechildrens.org

6147222650

Other Identifiers

K23AR078337

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004982

Identifier Type: -

Identifier Source: org_study_id