NCT07179016

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 693 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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).

Timeline

• Start date: 2025-09-11
• Primary completion: 2029-06-30
• Completion: 2029-08-31
• First posted: 2025-09-17
• Last updated: 2025-10-01

Locations

3 sites across 1 country: United States