{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T12:11:17Z","timestamp":1780920677792,"version":"3.54.1"},"reference-count":34,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T00:00:00Z","timestamp":1780876800000},"content-version":"unspecified","delay-in-days":7,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008460","name":"National Center for Complementary and Integrative Health","doi-asserted-by":"publisher","award":["4UH3AT012728-02"],"award-info":[{"award-number":["4UH3AT012728-02"]}],"id":[{"id":"10.13039\/100008460","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,5,13]]},"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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 \u2013 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\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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\u2019s\n                      <jats:italic>d<\/jats:italic>\n                      =0.35), accounting for 25% attrition. Randomization occurs at the participant level to reflect real-world delivery and minimize contamination.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT07179016\">NCT07179016<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-117632","type":"journal-article","created":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T11:46:15Z","timestamp":1780919175000},"page":"e117632","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Auricular Point Acupressure Self-Management (APA-SM) program for chronic musculoskeletal pain among rural populations: a protocol for a pragmatic, randomized controlled trial"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct07179016","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct07179016","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Jennifer","family":"Kawi","sequence":"first","affiliation":[{"name":"Cizik School of Nursing, The University of Texas Health Science Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Bolin","sequence":"additional","affiliation":[{"name":"College of Nursing, University of North Texas Health Science Center, Fort Worth, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hulin","family":"Wu","sequence":"additional","affiliation":[{"name":"School of Public Health, The University of Texas Health Science Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2450-0336","authenticated-orcid":false,"given":"Jungkyung","family":"Min","sequence":"additional","affiliation":[{"name":"Cizik School of Nursing, The University of Texas Health Science Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupsikha","family":"Bora","sequence":"additional","affiliation":[{"name":"Cizik School of Nursing, The University of Texas Health Science Center, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Pace","sequence":"additional","affiliation":[{"name":"College of Social Work, University of South Carolina, Columbia, South Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Idara N","family":"Akpan","sequence":"additional","affiliation":[{"name":"Texas College of Osteopathic Medicine, Department of Public Health, University of North Texas Health Science Center, Fort Worth, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alee","family":"Lockman","sequence":"additional","affiliation":[{"name":"School of Public Health, Texas A&M University System, College Station, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7306-4759","authenticated-orcid":false,"given":"Tonychris","family":"Nnaka","sequence":"additional","affiliation":[{"name":"College of Nursing, University of North Texas Health Science Center, Fort Worth, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,6,8]]},"reference":[{"key":"2026060804451885000_16.6.e117632.1","article-title":"Chronic Pain and High-impact Chronic Pain in U.S. Adults, 2023","volume":"518","author":"Lucas","year":"2024","journal-title":"NCHS Data 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Decision memo for acupuncture for chronic low back pain (CAG-00452N). 2020. Available: https:\/\/www.cms.gov\/medicare-coverage-database\/details\/nca-decision-memo.aspx?NCAId=295 [Accessed 25 Sep 2025]."},{"key":"2026060804451885000_16.6.e117632.7","doi-asserted-by":"publisher","DOI":"10.1136\/acupmed-2016-011106"},{"key":"2026060804451885000_16.6.e117632.8","doi-asserted-by":"publisher","DOI":"10.3122\/jabfm.2018.02.170381"},{"key":"2026060804451885000_16.6.e117632.9","doi-asserted-by":"crossref","first-page":"e486","DOI":"10.1093\/milmed\/usy028","article-title":"Building Capacity for Complementary and Integrative Medicine Through a Large, Cross-Agency, Acupuncture Training Program: Lessons Learned from a Military Health System and Veterans Health Administration Joint Initiative Project","volume":"183","author":"Niemtzow","year":"2018","journal-title":"Mil Med"},{"key":"2026060804451885000_16.6.e117632.10","doi-asserted-by":"crossref","DOI":"10.3390\/healthcare12100969","article-title":"Adapting and Evaluating a Theory-Driven, Non-Pharmacological Intervention to Self-Manage Pain","volume":"12","author":"Kawi","year":"2024","journal-title":"Healthcare (Basel)"},{"key":"2026060804451885000_16.6.e117632.11","doi-asserted-by":"crossref","first-page":"515","DOI":"10.1093\/pm\/pnaf035","article-title":"Auricular point acupressure for older adults with chronic low back pain: a randomized controlled trial","volume":"26","author":"Kawi","year":"2025","journal-title":"Pain Med"},{"key":"2026060804451885000_16.6.e117632.12","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1089\/jicm.2023.0630","article-title":"The Effectiveness of Auricular Acupressure on Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"31","author":"Lee","year":"2025","journal-title":"J Integr Complement Med"},{"key":"2026060804451885000_16.6.e117632.13","doi-asserted-by":"crossref","first-page":"1276","DOI":"10.1093\/pm\/pnz379","article-title":"Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events","volume":"21","author":"Nielsen","year":"2020","journal-title":"Pain Med"},{"key":"2026060804451885000_16.6.e117632.14","doi-asserted-by":"crossref","DOI":"10.1155\/2017\/6383649","article-title":"Efficacy of Auricular Acupressure for Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"2017","author":"Yang","year":"2017","journal-title":"Evid Based Complement Alternat Med"},{"key":"2026060804451885000_16.6.e117632.15","doi-asserted-by":"crossref","first-page":"1857","DOI":"10.1111\/pme.12789","article-title":"Day-to-day changes of auricular point acupressure to manage chronic low back pain: A 29-day randomized control study","volume":"16","author":"Yeh","year":"2015","journal-title":"Pain Med"},{"key":"2026060804451885000_16.6.e117632.16","doi-asserted-by":"crossref","DOI":"10.1155\/2022\/8079691","article-title":"Exploring the Feasibility of Virtually Delivered Auricular Point Acupressure in Self-Managing Chronic Pain: Qualitative Study","volume":"2022","author":"Kawi","year":"2022","journal-title":"Evid Based Complement Alternat Med"},{"key":"2026060804451885000_16.6.e117632.17","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1093\/pm\/pnw215","article-title":"Ear Acupuncture for Immediate Pain Relief-A Systematic Review and Meta-Analysis of Randomized Controlled Trials","volume":"18","author":"Murakami","year":"2017","journal-title":"Pain Med"},{"key":"2026060804451885000_16.6.e117632.18","doi-asserted-by":"crossref","unstructured":"Kawi J , Yeh CH , Li M , et al . 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