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NCT Number: NCT07049029

Physical Activity Pain Resilience

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

Location contact

William Black, PhD

CONTACT

[email protected]

6147222650

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREP-Y

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

Primary outcomes

  1. Feasibility of Intervention

    Time frame: From enrollment to the post-treatment visit, for a total of 6 weeks

    Fidelity checklists detailing content areas of the intervention adequately conveyed during the study visit will be used to measure intervention feasibility.

  2. Acceptability of Intervention

    Time frame: From enrollment to the post-treatment visit, for a total of 6 weeks

    Number of intervention visits completed by participants will be used to determine how acceptable the intervention is to the target population.

Secondary outcomes

  1. Accelerometry Data

    Time frame: From baseline to 3-month follow-up, for a total of 18 weeks

    Activity from the Actigraphs will assist in understanding and identifying changes in participant physical activity.

  2. Functional Disability Inventory

    Time frame: From baseline to 3-month follow-up, for a total of 18 weeks

    The Functional Disability Inventory is a 15-item questionnaire that measures an individual's perception of how their illness limits their ability to complete regular activities. A higher score indicates a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

William Black, PhD

CONTACT

[email protected]

614-472-0717

Sponsors and collaborators

Lead sponsor

William Black

Other

Collaborators

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

Registry information

Acronym: PAPR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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