The Effectiveness of Battlefield Acupuncture in Addition to Standard Physical Therapy Treatment after Shoulder Surgery: A Protocol for a Randomized Clinical Trial

Abstract

Introduction: There is a large incidence of shoulder instability among active young athletes and military personnel. Shoulder stabilization surgery is the commonly employed intervention for treating individuals with instability. Following surgery, a substantial proportion of individuals experience acute post-operative pain, which is usually managed with opioid pain medications. Unfortunately, the extended use of opioid medications can have adverse effects that impair function and reduce military operational readiness, but there are currently few alternatives. However, Battlefield Acupuncture (BFA) is a minimally invasive therapy demonstrating promise as a non-pharmaceutical intervention for managing acute post-operative pain.Methods: This is a single-blind randomized clinical trial featuring a 2x5 mixed-model factorial design. The two independent variables are intervention (2 levels; standard physical therapy and standard physical therapy plus Battlefield Acupuncture) and time (5 levels; 24-hours, 48-hours, 72-hours, 1-week, and 4-weeks post shoulder stabilization surgery). The primary dependent variable is worst and average pain as measured on the Visual Analog Scale. Secondary outcomes include medication usage, Profile of Mood States, and Global Rating of Change.Discussion: The magnitude of the effect of BFA is uncertain; current studies report confidence intervals of between group differences that include MCIDs between intervention and control groups. The results of this study may help determine if BFA is an effective adjunct to physical therapy in reducing pain and opioid usage in acute pain conditions. Trial registration: ClinicalTrials.gov, NCT04094246. Registered 16 September 2019, http://clinicaltrials.gov/NCT04094246.