NCT07852611

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Sep 2027

First Submitted

Initial submission to the registry

September 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

8 months

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

HIVolder adultschronic musculoskeletal painauricular point acupressurenonpharmacological pain managementcomplementary and alternative medicinesleeprandomized controlled trialfeasibilityacceptability

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity Assessed by the Numeric Pain Rating Scale (NRS)

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NRS), on which participants rate their pain from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity. Change in pain intensity from baseline to the end of the 4-week intervention will be compared between the true APA and sham APA groups.

    Baseline and 4 weeks

Secondary Outcomes (2)

  • Change in Health-Related Quality of Life Assessed by the EQ-5D

    Baseline and 4 weeks

  • Change in Sleep Quality Assessed by the Withings Sleep Analyzer

    Baseline through 4 weeks

Study Arms (2)

True APA group

EXPERIMENTAL

Participants randomized to the true APA arm will receive a 4-week auricular point acupressure intervention targeting designated ear acupoints for chronic musculoskeletal pain.

Other: Auricular Point Acupressure

Sham APA group

SHAM COMPARATOR

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

Other: Sham Auricular Point Acupressure

Interventions

Participants will receive auricular point acupressure (APA) using Vaccaria seeds secured with adhesive tape to designated ear acupoints for chronic musculoskeletal pain. Both ears will be treated. Participants will be instructed to press the seeds for 3 minutes, 3 times daily. Treatment will continue for 4 weeks, with each weekly cycle consisting of 5 days of wearing the seeds followed by 2 days without the seeds. Seeds will be replaced weekly by trained study personnel.

True APA group

Participants will receive sham auricular point acupressure using the same materials, treatment schedule, and procedures as the APA group. However, Vaccaria seeds will be placed on non-specific ear points unrelated to chronic musculoskeletal pain. Participants will press the seeds for 3 minutes, 3 times daily for 4 weeks, following the same weekly treatment cycle as the APA group.

Sham APA group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University-Corpus Christi

Corpus Christi, Texas, 78414, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromePain

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Dan Song, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be masked to treatment assignment. Participants in both groups will receive taped ear seeds using the same treatment schedule and procedures; however, the true APA group will receive seeds placed on designated acupoints for chronic musculoskeletal pain, whereas the sham APA group will receive seeds placed on non-specific ear points unrelated to chronic musculoskeletal pain.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to either the true auricular point acupressure (APA) group or the sham APA control group. Both groups will receive a 4-week intervention using taped ear seeds. The true APA group will receive seeds placed on designated ear acupoints for chronic musculoskeletal pain, while the sham APA group will receive seeds placed on non-specific ear points unrelated to chronic musculoskeletal pain. Both groups will follow the same intervention duration, treatment schedule, and study assessments.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 23, 2026

First Posted

October 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

No. Individual participant data are not planned to be shared with researchers outside the study team. Study findings will be disseminated in aggregate form.

Locations