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

NCT ID: NCT07179016

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

693 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2029-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain (Back / Neck) Chronic Pain Management Chronic Knee Pain Joint Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remote APA-SM Training

APA-SM self-guided with remote training

Group Type EXPERIMENTAL

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

Intervention Type 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.

In-person APA-SM Training

APA-SM with in-person training

Group Type EXPERIMENTAL

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

Intervention Type 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.

Pain Education

Education Control

Group Type ACTIVE_COMPARATOR

Education Control

Intervention Type 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).

Interventions

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

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.

Intervention Type BEHAVIORAL

Education Control

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Kawi

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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University of South Carolina

Columbia, South Carolina, United States

Site Status RECRUITING

University of North Texas Health Science Center at Fort Worth

Fort Worth, Texas, United States

Site Status NOT_YET_RECRUITING

The University of Texas Health science Center at Houston

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

713-500-2293

Jungkyung Min, PhD, MS, RN

Role: CONTACT

979-450-2091

Facility Contacts

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

Role: primary

713-500-2293

Sarah Pace, PhD

Role: backup

803-220-5294

Jane Bolin, PhD, JD, BSN

Role: primary

979-571-6536

Tonychris Nnaka, PhD, MPH, RN, CPH

Role: backup

817-735-5877

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

Role: primary

702-544-8426

Jungkyung Min, PhD, MS, RN

Role: backup

9794502091

Other Identifiers

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HSC-SN-25-0443

Identifier Type: -

Identifier Source: org_study_id

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