The effects of electroacupuncture and laser acupuncture therapy for patients with major trauma: A study protocol

BACKGROUND: Major trauma is the leading cause of death in the young population. The inflammatory and anti-inflammatory responses are associated with posttraumatic morbidity and mortality; however, it is not fully clear how to reestablish the homeostasis in patients with major trauma. METHODS: This study will be a prospective, randomized, placebo-controlled, partially double-blinded, three-armed trial. One hundred eighty participants diagnosed with major trauma will be randomly assigned to an electroacupuncture (EA), a laser acupuncture (LA), or a sham laser acupuncture group in a 1:1:1 ratio. All participants will undergo EA, LA, or sham laser acupuncture intervention once a day on 5 acupoints (LI4, PC6, ST36, SP6, and EX-HN1) for 14 consecutive days after enrollment. The primary outcome measure will be the length of hospital stay. Secondary outcomes will be inflammatory mediators, including serum C-reactive protein, interleukin (IL)-6, tumor necrosis factor-α, IL-1β, and IL-10. Clinical outcomes will be numeric rating scale scores for pain, sequential organ failure assessment, ICU length of stay, 30-day mortality, and WHO Disability Assessment Schedule. Data will be analyzed by chi-square test or t test for pairwise comparisons, as well as one-way ANOVA followed by post hoc Tukey method between groups. OBJECTIVES: The aim of this protocol is to investigate the clinical effects of EA and LA on major trauma. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04970433. Registered on July 21, 2021.