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NCT Number: NCT07179016

Evaluating the Auricular Point Acupressure-Self Management Program for Chronic Musculoskeletal Pain Among Rural Populations

The investigators will test an Auricular Point Acupressure Self-Management (APA-SM) program integrated into rural primary and specialty care and rural communities for chronic musculoskeletal pain (CMP). To maximize self-management of pain, the investigators developed a smartphone app which will allow the participants to learn to self-administer APA. The investigators will have 3 arms (APA-SM self-guided with remote training, APA-SM with in-person training, and Education Control) with 231 participants per arm (total=693 for 3 arms). The investigators will evaluate the clinical effectiveness of our 4-week APA-SM intervention compared to control in primary outcomes (pain intensity, pain interference, activity), secondary outcomes (HEAL Clinical Pain Core common data elements), and analgesic use up to 6 months follow-up.

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Key information

Conditions

Chronic Pain (Back / Neck) Arthralgia Chronic Knee Pain Chronic Pain Chronic Pain Management Joint Diseases Joint Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina, Columbia, South Carolina, United States

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About this study

The investigators integrated ecological momentary assessment into our app to measure real-world outcomes resulting in participants being able to self-monitor their progress, using this as an innovative behavior change strategy based on Bandura's self-efficacy, successfully initiating and maintaining behavior change. The primary endpoint will be immediate post-intervention with secondary endpoints at 1-month, 3-month, and 6-month follow-ups after the intervention. The investigators will also evaluate implementation outcomes and cost-effectiveness. Our long-term goal is to increase the access and scalability of evidence-based interventions while addressing pain care disparities for rural individuals with limited resources and/or endure long distances to specialty pain care. Study recruitment will be 3 1/2 to 4 years followed by data analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receive any pain management for CMP (neck, back, shoulder, hands, hips, knees, feet)
  • Have CMP ≥ 4 on a scale of 0-10 that has persisted for at least 3 months or has resulted in pain on at least half the days in the past 6 months

Exclusion criteria

  • Severe ear skin disorder (Diagnosed with conditions e.g., eczema, lupus with skin involvement) which often require medical intervention and severe allergy to tape
  • Inability or unwillingness to provide informed consent
  • Use of some type of hearing aid where size may obstruct seed placement
  • Not living in rural area

Treatment and study plan

Auricular Point Acupressure (APA) - Self Management (SM)

Behavioral

APA is a noninvasive and needle-free pain management therapy based on the principles of acupuncture. The APA-SM intervention program is aimed to manage chronic musculoskeletal pain leveraging a mobile app containing APA videos and remote vs in-person guidance or coaching to practice APA based on APA study assignment.

Education Control

Behavioral

Education Control group receive an app but the content will be specific to pain and self-management (no APA content) and they practice pain self-management skills (no APA practice).

Primary outcomes

  1. Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey

    Time frame: Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months

    This is a three-item questionnaire and each is scored from 0 (no pain) to 10(worst pain) for a maximum score of 30. Higher score indicating worse outcome

Secondary outcomes

  1. Change in pain as assessed by the Pain Catastrophizing Scale (PCS6)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a six-item questionnaire and each is scored from 0 (not at all) to 4 (all the time) for a maximum score of 24. Higher score indicating greater pain catastrophizing.

  2. Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a 16-item questionnaire. Each item is scored from 0 (completely disagree) to 6 (completely agree) for a maximum score of 96. Higher score indicating greater fear-avoidance beliefs.

  3. Change in depression as assessed by the Patient Health Questionnaire (PHQ2 )

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a two-item questionnaire and each is scored from 0 (not at all) to 3(nearly every day) for a maximum score of 6. Higher score indicating greater depression.

  4. Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a two-item questionnaire and each is scored from 0 (not at all) to 3 (nearly every day) for a maximum score of 6. Higher score indicating more anxiety.

  5. Change in severity of pain and its impact on functioning as assessed by the Brief Pain Inventory (BPI) Short From

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This consist of six-item questionnaire regarding pain severity and nine-item questionnaire regarding pain interference. Higher score indicates greater pain severity and interference.

  6. Change in physical function as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 6b (SF6b)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a six-item questionnaire and each is scored from 1 (unable to do) to 5 (without any difficulty) for a maximum score of 30. Higher score indicates better physical function.

  7. Change in disability as assessed by the Roland Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a 24-item questionnaire and each is scored 0 (no) or 1 (yes) for a maximum score of 24. Higher score indicates greater disability.

  8. Change in sleep duration as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) for Sleep 6a (+Sleep Duration)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a six-item questionnaire and each is scored from 1 (very good) to 5 (very poor) for a maximum score of 30. Higher scores indicate worse sleep disturbance. It also includes an additional single item (+Sleep Duration) assessing hours and minutes of sleep per night. Higher values indicates longer sleep duration.

  9. Change in pain self-efficacy influenced by pain as assessed by the Pain Self-Efficacy Questionnaire 2 item Short Form (PSEQ2)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a two-item questionnaire and each is scored from 0 (not at all confident) to 6 (completely confident) for a maximum score of 12. Higher score indicating greater pain self-efficacy.

  10. Change in substance use as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance (TAPS1) Substance Use Screener

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a five-item questionnaire and each is scored from 0 (daily or almost daily) to 4 (never) for a maximum score of 20. Higher score indicates lower substance use.

  11. Change in quality of life as assessed by the World Health Organization Quality of Life 2 item (WHOQOL-2)

    Time frame: Baseline, post intervention(4 weeks after baseline)

    This is a two-item questionnaire and each is scored from 1 (very poor/dissatisfied) to 5 (very good/satisfied) for a maximum score of 10. Higher score indicating better quality of life.

  12. Change in positive outlook as assessed by the Healing Encounters and Attitudes Lists (HEAL)

    Time frame: Baseline, post intervention(4 weeks after baseline)

    This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates greater positive outlook.

  13. Change in treatment expectancy as assessed by the Healing Encounters and Attitudes Lists (HEAL)

    Time frame: Baseline, post intervention(4 weeks after baseline)

    This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates greater treatment expectancy.

  14. Change in attitude towards complement alternative medicine (CAM) as assessed by the Healing Encounters and Attitudes Lists (HEAL)

    Time frame: Baseline, post intervention (4 weeks after baseline)

    This is a six-item questionnaire and each is scored from 1 (not at all) to 5 (very much) for a maximum score of 30. Higher score indicates more positive attitude toward CAM.

  15. Change in analgesics and opioid use as assessed by the Ecological Momentary Assessment (EMA) diary

    Time frame: Baseline, post intervention (4 weeks after baseline)

    Daily self-reported analgesic and opioid use (type, dose, frequency) recorded via EMA diary

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN

CONTACT

[email protected]

713-500-2293

Jungkyung Min, PhD, MS, RN

CONTACT

[email protected]

979-450-2091

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

A Pragmatic, Randomized Controlled Trial of a Auricular Point Acupressure - Self-Management (APA-SM) Program for Chronic Musculoskeletal Pain Among Rural Populations.

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 17, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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