HIV (Human Immunodeficiency Virus)NCT07852611
Auricular Point Acupressure for Pain
A study testing Auricular Point Acupressure in people with HIV (Human Immunodeficiency Virus) and Pain, run by Dan Song at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV (Human Immunodeficiency Virus), Pain
- What is being tested?
- Auricular Point Acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Texas A&M University-Corpus Christi
Corpus Christi, Texas, 78414
Dan Song, PhD, RN, 800-555-5555, dan.song@tamucc.edu
About this study
Official title: Effects of Auricular Point Acupressure for Chronic Musculoskeletal Pain in Older People With HIV: a Pilot Randomized Controlled Trial
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?
Read more
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
Read the detailed description
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.
- Conditions
- HIV (Human Immunodeficiency Virus), Pain
- Being tested
- Auricular Point Acupressure, Sham Auricular Point Acupressure
- Keywords
- HIV, older adults, chronic musculoskeletal pain, auricular point acupressure, nonpharmacological pain management, complementary and alternative medicine, sleep, randomized controlled trial, feasibility, acceptability
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Point AcupressureOther
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.
Sham Auricular Point AcupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Sham Auricular Point Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Change in Health-Related Quality of Life Assessed by the EQ-5D
Health-related quality of life will be assessed using the EuroQol 5-Dimension (EQ-5D) questionnaire. The EQ-5D assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ Visual Analogue Scale (EQ-VAS) records participants' self-rated overall health on a scale from 0 to 100, with higher scores indicating better perceived health. Change from baseline to the end of the 4-week intervention will be compared between the true APA and sham APA groups.
Measured: Baseline and 4 weeks
Change in Sleep Quality Assessed by the Withings Sleep Analyzer
Sleep will be objectively assessed using the Withings Sleep Analyzer, an under-mattress sleep sensor. The device will continuously track night-to-night sleep measures during the study, including sleep timing, sleep efficiency, and wake after sleep onset. Changes in sleep measures during the 4-week intervention will be evaluated between the true APA and sham APA groups.
Measured: Baseline through 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dan Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dan Song, Texas A&M University - Corpus Christi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852611
- Sponsor's protocol ID
- TAMU-CC-IRB-2025-1443
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Individual participant data are not planned to be shared with researchers outside the study team. Study findings will be disseminated in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auricular Point Acupressure for Chronic Musculoskeletal Pain in Older People With HIV: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07852611
- Acronym / sponsor ID
- TAMU-CC-IRB-2025-1443
- Conditions
- HIV (Human Immunodeficiency Virus), Pain
- Keywords
- HIV, older adults, chronic musculoskeletal pain, auricular point acupressure, nonpharmacological pain management, complementary and alternative medicine, sleep, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dan SongUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| True APA group | Experimental | Other: Auricular Point AcupressureParticipants 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 AcupressureParticipants 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Point AcupressureParticipants 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. | Other | True APA group |
| Sham Auricular Point AcupressureParticipants 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. | Other | Sham APA group |
Primary outcome
Change in Pain Intensity Assessed by the Numeric Pain Rating Scale (NRS)
Time frame: Baseline and 4 weeks
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.
2 secondary outcomes
Change in Health-Related Quality of Life Assessed by the EQ-5D
Time frame: Baseline and 4 weeks
Change in Sleep Quality Assessed by the Withings Sleep Analyzer
Time frame: Baseline through 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. No. Individual participant data are not planned to be shared with researchers outside the study team. Study findings will be disseminated in aggregate form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Point Acupressure in people with HIV (Human Immunodeficiency Virus) and Pain, run by Dan Song at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Song, PhD, RN (800-555-5555, dan.song@tamucc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Assessed by the Numeric Pain Rating Scale (NRS) (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.