Effects of Auricular Point Acupressure for Chronic Musculoskeletal Pain in Older People With HIV: a Pilot Randomized Controlled Trial
| Registry | NCT07852611 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 30 (Estimated) |
| Sponsor | Dan Song (Other) |
| Conditions | HIV (Human Immunodeficiency Virus), Pain |
| Interventions | Auricular Point Acupressure, Sham Auricular Point Acupressure (Other) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-06-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-10-01, last updated 2026-10-01 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for HIV (Human Immunodeficiency Virus) All trials for Pain All trials of Auricular Point Acupressure All trials of Sham Auricular Point Acupressure
The goal of this pilot clinical trial is to learn whether auricular point acupressure (APA) can help reduce chronic musculoskeletal pain in adults age 50 and older who are living with HIV. The study will also examine whether APA is feasible, acceptable, and safe for this population. The main questions it aims to answer are:
Does APA reduce chronic musculoskeletal pain and improve sleep and quality of life? Is APA feasible, acceptable, and safe for older people living with HIV?
Researchers will compare true APA, in which small seeds are taped to specific ear points related to pain, with sham APA, in which seeds are taped to ear points not related to pain. The intervention will last 4 weeks.
Participants will:
Receive true APA or sham APA for 4 weeks Visit the study site weekly for placement of the ear seeds Press the ear seeds for 3 minutes, 3 times each day Complete daily surveys about pain and pain medication use Use a sleep monitor to track sleep Complete study assessments at the beginning and end of the intervention Complete an exit interview about their experience with APA
hronic musculoskeletal pain is common among older people living with HIV and can negatively affect mobility, independence, sleep, and quality of life. Although medications are commonly used to manage chronic pain, older adults living with HIV may already take multiple medications for HIV and other health conditions, increasing concerns about medication burden, side effects, and drug interactions. Accessible, low-cost, non-drug approaches to pain management are therefore needed for this population.
This pilot randomized controlled trial will evaluate auricular point acupressure (APA) as a non-invasive approach for managing chronic musculoskeletal pain among adults age 50 years and older who are living with HIV. APA involves placing small seeds on specific points of the outer ear using adhesive tape. Participants apply pressure to these seeds themselves. Unlike acupuncture, APA does not involve needles and can be largely self-administered.
The study will enroll 30 participants with chronic musculoskeletal pain and randomly assign them to one of two groups. One group will receive true APA, with seeds placed on ear points designated for chronic musculoskeletal pain. The other group will receive sham APA, with seeds placed on ear points not associated with the painful areas. Both groups will follow the same treatment schedule for four weeks.
During the four-week intervention, participants will attend weekly visits for placement of the ear seeds. They will be instructed to press the seeds for three minutes, three times each day. The seeds will remain on the ears for five days, followed by two days without the seeds before the next weekly placement. Participants will also complete daily electronic surveys about their pain and pain medication use and use an under-mattress sleep sensor to measure sleep. Study assessments will be conducted at baseline and at the end of the four-week intervention.
The study will examine whether APA shows preliminary benefits for reducing pain and improving sleep and health-related quality of life. It will also evaluate whether APA is feasible, acceptable, and safe for older people living with HIV. Feasibility will be assessed through measures such as recruitment, adherence to the study protocol, and adverse events. At the end of the intervention, participants will complete an individual interview to share their experiences and perceptions of APA.
Because this is a small pilot study, its purpose is to provide preliminary information rather than definitive evidence about the effectiveness of APA. The findings will help determine the feasibility of conducting a larger clinical trial and provide preliminary information about APA's potential as an accessible, non-drug approach to chronic pain management for older people living with HIV.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| True APA group | Experimental | Other: Auricular Point Acupressure | Participants randomized to the true APA arm will receive a 4-week auricular point acupressure intervention targeting designated ear acupoints for chronic musculoskeletal pain. |
| Sham APA group | Sham comparator | Other: Sham Auricular Point Acupressure | Participants randomized to the sham APA arm will receive a 4-week sham auricular point acupressure intervention using ear points not associated with chronic musculoskeletal pain |
Sex: All, ages: 50 Years to any
Inclusion Criteria: * Age 50 years or older * Living with HIV * Chronic musculoskeletal pain affecting the muscles, joints, or bones for at least 3 months * Average chronic musculoskeletal pain intensity of ≥4 on a 0-10 Numeric Pain Rating Scale during the past week Exclusion Criteria: * Recent trauma as the primary cause of pain * Concurrent use of other adjunctive pain therapies, including physical therapy, chiropractic treatment, or acupuncture * Allergy to latex due to the use of latex-containing tape on the ear points Presence of acute pain
| Facility | City | Country | Status |
|---|---|---|---|
| Texas A&M University-Corpus Christi | Corpus Christi, Texas | United States |