Multi-Site Feasibility Study in Preparation for a Definitive Clinical Trial Randomizing Patients with Acute Pain to Battlefield Acupuncture, Battlefield Acupressure, or Sham - Project Summary / Abstract Acute postoperative pain is highly prevalent in the United States, with over 40-million annual surgical procedures and many evolving into persistent pain. Pain is often treated with opioids that have undesirable and sometimes dangerous side effects, and yet over 80% of patients still experience inadequate pain relief. Moreover, opioids have a significant potential for misuse, dependence, overdose, and diversion. Acupuncture, an alternative non-opioid analgesic involving needle insertion at specific points on the body, is typically administered by licensed practitioners with extensive training, limiting its accessibility and scalability. A more accessible and easily-expandable alternative, “battlefield acupuncture , requires no formal acupuncture training and only a 4-hour certification course. This method involves inserting 1-10 small needles into the ear(s) which remain in place for multiple days. The treatment has no systemic side effects or serious medical risks and is appropriate for nearly all individuals—in other words, it offers the possibility of a low-cost analgesic that may be applied by individuals without extensive medical training, with negligible risks, and applicable to nearly all patients. For these reasons, battlefield acupuncture was widely adopted in US military and Veterans Affairs healthcare facilities over the past decade, with imminent implementation throughout NATO’s 31-nation membership. Recently, a needleless variant, battlefield acupressure , is under consideration. While tens-of- thousands of patients are treated with these techniques annually, remarkably the efficacy of both remains unclear due to limited, methodologically flawed trials. This lack of high-quality evidence doubtlessly limits its adoption by non-VA civilian healthcare providers. Consequently, we propose a multi-site feasibility study with quantitative benchmarks to test and refine logistical components for a future definitive trial that will assess the efficacy/effectiveness and benefits duration of battlefield acupuncture and acupressure in managing acute postoperative pain. This project fits within the mission of the National Center for Complementary and Integrative Health: to conduct rigorous scientific research on complementary health practices (e.g., acupuncture). The proposed feasibility study will (1) assess recruitment viability across multiple enrolling centers; (2) assess study protocol feasibility and intervention fidelity across sites and over time; (3) assess intervention acceptability, tolerability, and duration of use; (4) assess blinding effectiveness among participants and outcome assessors; (5) assess the reliability of the data collection processes and outcome measures; (6) identify and mitigate sources of bias; (7) estimate variability to help inform the sample size calculation for the definitive trial; and (8) help prepare the study team. If successful, a subsequent definitive trial could provide data on battlefield acupuncture and/or acupressure that could revolutionize analgesia for acute postoperative pain as it has been practiced for the past century.
