Physical Activity Pain Resilience
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PREP-Y.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral 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
Primary outcome measures
- Feasibility of Intervention [Time frame: From enrollment to the post-treatment visit, for a total of 6 weeks]
- Acceptability of Intervention [Time frame: From enrollment to the post-treatment visit, for a total of 6 weeks]
Secondary outcome measures (2)
- Accelerometry Data [Time frame: From baseline to 3-month follow-up, for a total of 18 weeks]
- Functional Disability Inventory [Time frame: From baseline to 3-month follow-up, for a total of 18 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Nationwide Children's Hospital — Columbus
Identifiers
NCT: NCT07049029 · STUDY00004982 · K23AR078337