Evaluating the Auricular Point Acupressure-Self Management Program for Chronic Musculoskeletal Pain Among Rural Populations
A Pragmatic, Randomized Controlled Trial of a Auricular Point Acupressure - Self-Management (APA-SM) Program for Chronic Musculoskeletal Pain Among Rural Populations.
1 other identifier
interventional
693
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Longer than P75 for not_applicable
3 active sites
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
First Submitted
Initial submission to the registry
September 10, 2025
CompletedStudy Start
First participant enrolled
September 11, 2025
CompletedFirst Posted
Study publicly available on registry
September 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
October 1, 2025
September 1, 2025
3.8 years
September 10, 2025
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in pain as assessed by the pain, enjoyment of life, general activity (PEG) survey
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
Baseline, post intervention (4 weeks after baseline), 1 month, 3 months, 6 months
Secondary Outcomes (15)
Change in pain as assessed by the Pain Catastrophizing Scale (PCS6)
Baseline, post intervention (4 weeks after baseline)
Change in fear-avoidance beliefs as assessed by the Fear-Avoidance Beliefs Questionnaire (FABQ)
Baseline, post intervention (4 weeks after baseline)
Change in depression as assessed by the Patient Health Questionnaire (PHQ2 )
Baseline, post intervention (4 weeks after baseline)
Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD2)
Baseline, post intervention (4 weeks after baseline)
Change in severity of pain and its impact on functioning as assessed by the Brief Pain Inventory (BPI) Short From
Baseline, post intervention (4 weeks after baseline)
- +10 more secondary outcomes
Study Arms (3)
Remote APA-SM Training
EXPERIMENTALAPA-SM self-guided with remote training
In-person APA-SM Training
EXPERIMENTALAPA-SM with in-person training
Pain Education
ACTIVE COMPARATOREducation Control
Interventions
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 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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of South Carolina
Columbia, South Carolina, 29208, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, 76107, United States
The University of Texas Health science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
September 10, 2025
First Posted
September 17, 2025
Study Start
September 11, 2025
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
October 1, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
We have a Data Management and Sharing Plan and will comply with the policy set forth by NIH.