Trial Summary

Despite the availability of a range of therapeutic approaches, chronic musculoskeletal pain persists at a high rate. Prior research supports the use of auricular point acupressure to reduce pain intensity and pain interference and improve physical function. Individuals in rural communities often have limited resources or must travel long distances to access evidence-based specialty pain care. To maximize self-management of pain, the study team developed and tested the APA-SM program, which includes a smartphone app to enable patients to self-administer auricular point acupressure. The app includes short demonstration videos with English- and Spanish-language versions and ecological momentary assessments to measure real-world outcomes, with participants being able to monitor their progress as part of an innovative behavior change strategy. In the APA-SM study, the team will conduct a hybrid implementation-effectiveness trial of the APA-SM program, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, in diverse healthcare systems serving rural communities in Texas and South Carolina. In the planning phase, the study team planned and evaluated the APA-SM program’s integration into rural healthcare systems and communities. In the implementation phase, the study team will conduct a pragmatic, randomized clinical trial to evaluate the clinical effectiveness of the 4-week APA-SM program. The trial will compare 3 groups: self-guided APA-SM with remote training, APA-SM plus in-person training, and an education control. The primary outcome is a composite score of pain intensity and interference in daily life and function, and the secondary outcomes include the NIH HEAL Initiative’s pain common data elements and analgesic use, for up to 6 months of follow-up. The study team will also evaluate implementation outcomes, cost-effectiveness, and predictive factors for APA-SM treatment response. A 2-phase design in the implementation phase will include an initiation phase (providing support for buy-in) and a maintenance phase (with no support).

NIH Project Information