Faculty, Staff and Student Publications

Language

English

Publication Date

6-8-2026

Journal

BMJ Open

DOI

10.1136/bmjopen-2026-117632

PMID

42259555

PMCID

PMC13264852

PubMedCentral® Posted Date

6-8-2026

PubMedCentral® Full Text Version

Post-print

Abstract

Introduction: Chronic musculoskeletal pain (CMP) is a leading cause of incurred personal healthcare costs and disability in the USA. It disproportionately affects rural populations, who are more likely to be uninsured, lack access to a regular healthcare provider and experience a higher prevalence of CMP. As a result of reduced access to non-pharmacological care, there is greater reliance on opioids. The Auricular Point Acupressure - Self-Management (APA-SM) program is a simple, needleless, evidence-based therapy that empowers individuals to self-manage their pain. Preliminary studies, including a recent UG3 pilot testing, demonstrated feasibility, safety and significant improvements in pain and function. Guided by Bandura's self-efficacy model and informed by stakeholder input, APA-SM integrates a smartphone application, ecological momentary assessment and personalized motivational messaging to enhance adherence and behavior change. This study protocol describes the design of a real-world, hybrid effectiveness-implementation, randomized controlled trial to evaluate the clinical impact and sustainability of APA-SM in rural settings.

Methods and analysis: We will conduct a pragmatic, three-arm randomized controlled trial in Texas and South Carolina, enrolling 693 adults with CMP (231 per group). Participants will be randomized to: (1) APA-SM with remote training, (2) APA-SM with in-person training or (3) education control. The primary outcome is pain impact measured by the PEG (composite score of pain intensity, interference on enjoyment of life, and general activity) scale at immediate post-intervention (4 weeks), with follow-up at 1, 3 and 6 months. Secondary outcomes include National Institutes of Health Helping to End Addiction Long-Term Clinical Pain Core common data elements (eg, psychological functioning, disability, sleep, quality of life), opioid use and patient-reported adherence and satisfaction. Implementation outcomes will be assessed at both the patient and provider levels, guided by the RE-AIM framework. Cost-effectiveness will be estimated using implementation costs and incremental cost-effectiveness ratios, and predictive factors for APA-SM treatment response will be identified using statistical machine learning approaches and historical electronic health record data. The target sample size (231 per group) provides 90% power to detect a moderate effect size (Cohen's d=0.35), accounting for 25% attrition. Randomization occurs at the participant level to reflect real-world delivery and minimize contamination.

Ethics and dissemination: This study, sponsored under grant number 4UH3AT012728, has single Institutional Review Board (IRB) approval at UTHealth Houston, Texas, USA (HSC-SN-25-0443). A Data Safety Monitoring Board will oversee adverse event reporting and trial conduct. Dissemination will occur through peer-reviewed publications, conference presentations, stakeholder workshops and community-based reports tailored for rural health systems and policymakers.

Discussion: This trial will provide the first large-scale evaluation of APA-SM in rural U.S. populations, integrating digital health tools and implementation science methods to help address disparities in pain management. By assessing clinical effectiveness, implementation outcomes, cost-effectiveness and predictive response factors, study results will inform scalable strategies for integrating APA-SM further into rural communities and healthcare systems. If successful, APA-SM has the potential to improve pain care access, reduce opioid reliance and provide a sustainable, patient-centered model for chronic pain management.

Keywords

Adult, Female, Humans, Acupressure, Acupuncture, Ear, Chronic Pain, Multicenter Studies as Topic, Musculoskeletal Pain, Pain Management, Pragmatic Clinical Trials as Topic, Randomized Controlled Trials as Topic, Rural Population, Self-Management, Texas, Male

Comments

Trial registration number: NCT07179016.

Published Open-Access

yes

Download

Included in

Public Health Commons

Share

COinS
 
 

To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.