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Auricular Point Acupressure for Pain

ConditionsHIV (Human Immunodeficiency Virus)Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorDan Song

About this 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?

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Auricular Point Acupressure

    Other intervention

    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 Acupressure

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: True APA groupExperimental treatment 1 intervention
Group B: Sham APA groupSham comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and 4 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 4 weeks
2

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.

Time frame
Baseline through 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dan Song

Lead sponsor

Texas A&M University - Corpus Christi

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: