STOMP for Chronic Pain

(STOMP Trial)

No longer recruiting at 1 trial location

Overseen By Michael Mugavero, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speakers, Surgery plans, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve chronic pain treatment, particularly for people living with HIV, by testing a new program called STOMP (Skills TO Manage Pain). Participants will either engage in 12 sessions of the STOMP program or continue their usual treatment while receiving a manual on pain management. The goal is to determine if learning specific skills can better manage chronic pain, which significantly impacts daily life. Ideal candidates are those who have experienced moderate or severe chronic pain for at least three months and can attend scheduled group sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management strategies and potentially enhance quality of life.

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's best to discuss this with the trial coordinators.

What prior data suggests that the STOMP intervention is safe for managing chronic pain in people living with HIV?

Research has shown that the Skills TO Manage Pain (STOMP) treatment is safe. STOMP is a program designed to help individuals, particularly those with HIV, manage long-term pain through specialized sessions. Previous studies found that participants tolerated STOMP well, with no reports of serious negative side effects. The program's emphasis on skill-building and knowledge-sharing makes it a promising option for managing chronic pain without significant risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STOMP (Skills TO Manage Pain) method for chronic pain because it offers a unique, comprehensive approach that blends group and individual sessions focused on behavioral intervention. Unlike many standard treatments that may rely heavily on medication, STOMP emphasizes skill-building through structured sessions and a study manual, promoting self-management techniques. This approach empowers patients to actively engage in their pain management, potentially reducing reliance on medications and improving quality of life through personalized strategies.

What evidence suggests that the STOMP intervention could be effective for chronic pain in people living with HIV?

Research shows that the Skills TO Manage Pain (STOMP) program, which participants in this trial may receive, works well for people with chronic pain, especially those with HIV. Studies have found that STOMP can lower pain levels and improve daily activities. Specifically, research using the Brief Pain Inventory (BPI) confirmed STOMP's positive effects on pain management. This program includes sessions that teach pain management skills and has the potential for wider use. Overall, STOMP is a promising option for those dealing with chronic pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Jessica Merlin, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with chronic pain, specifically those living with HIV who experience moderate to severe pain lasting at least 3 months. Participants must be able to attend group sessions and not have major surgery planned that could interfere with the study.

Inclusion Criteria

I experience chronic pain that significantly affects my daily life.

I can and will attend all group sessions as scheduled.

Enrolled in CNICS

Exclusion Criteria

I cannot speak or understand English.

I am planning to undergo surgery for pain management.

Unwilling to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the STOMP behavioral intervention consisting of 12 sessions over 12-16 weeks

12-16 weeks

6 group sessions, 6 individual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• comparison group
• Skills TO Manage Pain (STOMP)

Trial Overview The STOMP intervention, a program designed to help manage chronic pain tailored for people living with HIV, is being tested against a comparison group. The goal is to see if STOMP can improve quality of life and health outcomes in this vulnerable population.

How Is the Trial Designed?

Group I: Skills to Manage Pain (STOMP) Experimental Treatment 1 Intervention

The intervention group will receive treatment as usual plus the STOMP behavioral intervention. The STOMP behavioral intervention consists of 12 intervention sessions (6 group and 6 individual sessions). The sessions will be completed over a period of 12-16 weeks from enrollment. The first intervention session will be a group session for all participants followed by individual and then alternating group and individual sessions for the rest of the intervention. The intervention group will utilize a study manual on pain management in which they will use with each session.

Group II: comparison group Active Control 1 Intervention

The comparison group will receive treatment as usual.The comparison group will also be provided with the intervention manual, however, no additional treatment will be provided to participants allocated to the control group. The group will not receive the PSM intervention.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39008317/

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

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2821262

Efficacy of a Pain Self-Management Intervention Tailored to ... The results demonstrated STOMP as an efficacious chronic pain intervention for people with HIV with potential for widespread implementation.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40748350/

Trajectories of Pain Impact and Pain Self-Efficacy in People ... Skills TO Manage Pain (STOMP), a novel pain self-management intervention tailored for PWH and chronic pain, has demonstrated efficacy in ...

4. pharmacist.com pharmacist.com/Blogs/CEO-Blog/does-the-stomp-intervention-help-hiv-patients-manage-pain

Does the STOMP intervention help HIV patients manage ... The study's findings underscore the need for peer support and pain self-management education as essential for patients coping with chronic pain.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423000861

Evaluation of the efficacy and mechanisms of a novel ... This manuscript outlines the protocol for a randomized control trial of a novel theory-based pain self-management intervention, “Skills TO Manage Pain” (STOMP), ...

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

Efficacy of a Pain Self-Management Intervention Tailored to ... The results demonstrated STOMP as an efficacious chronic pain intervention for people with HIV with potential for widespread implementation.

7. aahivm.org aahivm.org/clinical-research-update-082625/

Clinical Research Update 8.26.25 STOMP is a 12-week pain self-management intervention designed specifically for people with HIV, incorporating 1-on-1 knowledge- and skill- ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36958702/

The STOMP protocol - PubMed - NIH STOMP is a 12-week intervention developed from prior work on pain self-management in PWH and rigorous intervention mapping.

9. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/novel-behavioral-intervention-for-chronic-pain-in-patients-with-hiv/

Novel Behavioral Intervention Efficacious Against Chronic ... Skills to Manage Pain (STOMP) is an efficacious novel behavioral intervention for chronic pain in patients with HIV infection, according to ...