Battlefield Acupuncture Does Not Provide Additional Improvement in Pain When Combined With Standard Physical Therapy After Shoulder Surgery: A Randomized Clinical Trial.

Abstract

Introduction: Shoulder stabilization surgery is common among military personnel, causing severe acute postoperative pain that may contribute to the development of chronic pain, thereby reducing military readiness. Battlefield Acupuncture (BFA) has shown promise as a non-pharmaceutical intervention for acute postoperative pain. The purpose of this study was to determine the effectiveness of BFA combined with standard physical therapy on pain, self-reported mood, self-reported improvement, and medication use in patients after shoulder stabilization surgery.

Materials and methods: The study design was a single-blind, randomized clinical trial, approved by the Naval Medical Center Portsmouth Institutional Review Board and registered with ClinicalTrials.gov (NCT04094246). Ninety-five participants were recruited after shoulder stabilization surgery. Participants were randomized via concealed allocation into a standard physical therapy (PT) group or a group receiving standard PT and BFA. Both groups received standard postoperative pain medication. The BFA intervention followed a standard protocol with the insertion of gold aiguille d'acupuncture emiermanente needles at 5 specific points in the ear. At 4 time points (baseline [24-48 hours], 72 hours, 1 week, and 4 weeks post-surgery), participants reported worst and average pain using a Visual Analog Scale (VAS), self-reported mood using the Profile of Mood States (POMS), self-recorded medication intake between study visits, and self-reported improvement in symptoms using a Global Rating of Change (GROC) Scale. Outcome assessors were blinded to treatment allocation. An alpha level of 0.05 was set a priori. For pain, a mixed-model analysis of variance was used to analyze the interaction effect between group and time. Differences in baseline data, total opioid usage, and pain change scores between groups were analyzed using independent t-tests.

Results: Of the 95 participants enrolled, 7 failed to provide complete study visits after the baseline, leaving 88 patients (43 BFA, 45 control, mean age 21.8 (2.1) years, 23% female). There were no significant group-by-time interactions for VAS worst pain (F = 0.70, P = .54), VAS average pain (F = 0.99, P = .39), the POMS (F = 1.04, P = .37), or GROC (F = 0.43, P = 0.63). There was a significant main effect of time for VAS worst pain (F = 159.7, P < .001), VAS average pain (F = 122.4, P < .001), the POMS (F = 11.4, P < .001), and the GROC (F = 78.5, P < .001). While both groups demonstrated statistically significant and clinically meaningful improvements in pain and self-reported mood over time, BFA did not provide any additional benefit compared to standard physical therapy alone. There was no significant difference in opioid usage between groups at 4 weeks (t = 0.49, P = .63). Finally, both groups also demonstrated statistically significant and clinically meaningful self-reported improvements in function, but again, there was no additional benefit when adding BFA to standard physical therapy.

Conclusion: The results of this study do not support the effectiveness of BFA for postsurgical pain management as there were no significant differences in pain, self-reported mood, self-reported improvement, and medication use between participants who received BFA and those who did not. As this is the only known study of BFA in postsurgical participants, continued research is needed to determine if BFA is effective for pain reduction in that setting.

Clinical trial registration: ClinicalTrials.gov, NCT04094246. Registered September 16, 2019, http://clinicaltrials.gov/NCT04094246.