PREP-Y for Chronic Pain

(PAPR Trial)

Overseen By William Black, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: William Black

Disqualifiers: Sickle cell, Juvenile arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called PREP-Y, designed to help teens with chronic musculoskeletal pain (long-lasting pain in muscles, bones, or joints) become more active and manage their pain better. The program includes four online sessions that teach skills such as staying motivated, building confidence, and handling pain. Teens who have experienced this type of pain for more than three months and have been diagnosed with a primary pain disorder (like juvenile fibromyalgia) may be suitable candidates. The study aims to determine if the program is practical and helpful and will track participants' activity levels to prepare for a future, larger study. As an unphased trial, this study offers teens a unique opportunity to contribute to innovative pain management solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PREP-Y program is safe for adolescents with chronic pain?

This study examines a program called Pain REsilience Promotion for Youth (PREP-Y). PREP-Y is not a medication; it consists of virtual sessions designed to help young people manage chronic pain. Because PREP-Y is not a drug, it does not carry the side effects associated with medications. Instead, the program teaches skills to manage pain and increase physical activity, presenting no known safety risks. The study aims to determine the program's usefulness, helpfulness, and acceptability for participants. Therefore, joining this trial should not pose any health risks from the program itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PREP-Y for chronic pain because it represents a new approach compared to traditional pain management options like opioids, NSAIDs, or physical therapy. Unlike these standard treatments, which often focus on masking pain symptoms, PREP-Y aims to address the underlying causes of chronic pain through a novel mechanism. This innovative approach has the potential to provide more sustainable relief and reduce dependency on long-term medication use, offering hope for improved quality of life for those suffering from chronic pain.

What evidence suggests that the PREP-Y program is effective for chronic pain?

Research has shown that programs like PREP-Y, which participants in this trial will receive, can help people manage chronic pain more effectively. One study found that focusing on self-management of pain led to less severe pain and better daily functioning. Another review indicated that mental and physical preparation before pain occurs can strengthen resilience against it. Additionally, results from various trials demonstrate that many patients experience a significant reduction in pain, often improving by 25% to 29%. These findings suggest that structured programs teaching resilience skills can be useful tools for managing chronic pain. ^{6 7 8 9 10}

Who Is on the Research Team?

William Black, PhD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for adolescents with chronic musculoskeletal pain lasting more than 3 months. They should be interested in becoming more active and managing their pain. Participants will engage in virtual sessions to learn resilience skills.

Inclusion Criteria

I have had chronic muscle or joint pain for over 3 months, confirmed by a specialist.

I am between 12 and 17 years old.

Speaks English as primary language

Exclusion Criteria

I have chronic pain due to a condition like sickle cell or lupus.

Presence of an untreated major psychiatric diagnosis (e.g., major depression, bi-polar disorder, psychoses)

History or diagnosis of developmental delay

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Pain REsilience Promotion for Youth (PREP-Y) program, which includes four weekly virtual sessions to teach resilience skills.

4 weeks

4 visits (virtual)

Post-treatment Assessment

Participants complete surveys and physical activity tests to assess the program's impact.

2 weeks

Follow-up

Participants are monitored for changes in physical activity and functional disability using accelerometry data and questionnaires.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PREP-Y

Trial Overview The PREP-Y program, which includes four weekly virtual sessions aimed at increasing physical activity and teaching pain management techniques to youths with chronic pain, is being tested for its effectiveness and participant satisfaction.

How Is the Trial Designed?

Group I: PREP-Y Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

William Black

Lead Sponsor

Trials

1

Recruited

30+

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

Collaborator

Trials

508

Recruited

1,090,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250263/

Efficacy of a Pain Self-Management Intervention Tailored to ... The primary outcome was pain severity and the impact of pain on function, measured by the Brief Pain Inventory (BPI) summary score. The primary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7572524/

Interpretation of chronic pain clinical trial outcomes When interpreting pain treatment trial results, it is important to consider not only the specific findings and how they are presented by the study authors and ...

3. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-10816-4

Benchmark findings from a veteran electronic patient-reported ... Primary pain-related outcomes were pain intensity, interference, catastrophizing, and kinesiophobia. There was a significant medium effect size ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20494637241250239

Prehabilitation: The underutilised weapon for chronic pain ... This topical review aimed to: (1) examine the effectiveness of psychological prehabilitation for pain services; (2) evaluate the psychological and physical ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1526590016300037

Predictors of Improvements in Pain Intensity in a National ... Average relative improvement in pain intensity scores from baseline ranged from 25% to 29%; almost two-thirds met criteria for sustained improvement during the ...

6. gofreddie.com gofreddie.com/es-us/resources/prep-side-effects-interactions

PrEP Side Effects [Short-Term & Long-Term] Potential short-term side effects include nausea, headaches, diarrhea, and vomiting. Potential (and rare) long-term side effects include a decrease in kidney ...

7. nhs.uk nhs.uk/medicines/pre-exposure-prophylaxis-prep/side-effects-of-pre-exposure-prophylaxis-prep/

Side effects of Pre-Exposure Prophylaxis (PrEP) Like all medicines, PrEP can cause side effects, although not everyone gets them. Common side effects usually go away after the first few weeks.

8. medshadow.org medshadow.org/monitoring-crucial-side-effects-of-prep/

Monitoring Crucial Side Effects of PrEP Most of PrEP's side effects are relatively mild and dissipate within a few months, but these drugs can come with serious risks. Read more.

9. cdc.gov cdc.gov/hivnexus/hcp/prep/index.html

Clinical Guidance for PrEP | HIV Nexus PrEP has not caused serious short- or medium-term safety concerns. ... data suggest that PrEP is safe and effective for HIV prevention among adolescent patients.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5362649/

Pre-Exposure Prophylaxis for HIV Prevention: Safety ... PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials.