Abstract
BACKGROUND: Previous studies have shown that electroacupuncture (EA) reduces the severity of acute pancreatitis. However, the effect of EA for pain relief in patients with acute pancreatitis has not been evaluated yet. The purpose of this study was to prove the efficacy of EA for pain relief in patients with acute pancreatitis compared with conventional treatment. METHODS: This study is a randomized, controlled, three-arm, parallel-group, multi-center trial. Patients diagnosed with acute pancreatitis are enrolled and randomly assigned to EA 1, EA 2, or a control group in a 1:1:1 ratio. All the enrolled patients basically receive the conventional standard-of-care therapy for acute pancreatitis. Local EA is given in group EA 1, while local with additional distal EA is given in group EA 2. Local EA includes two acupoints, Zhong Wan (CV12) and Shang Wan (CV13), located in the abdomen, while distal EA includes 12 peripheral acupoints, Zhong Wan (CV12), Shang Wan (CV13), He Gu (LI4), Nei Guan (PC6), San Yin Jiao (SP6), Xuan Zhong (GB39), Zu San Li (ST36), and Shang Ju Xu (ST37). The patients randomized to the EA 1 and EA 2 groups undergo one session of EA daily from day 1 until day 4, or until pain resolves. The primary endpoint is the Visual Analog Scale (VAS) change for pain on day 5. Secondary endpoints include daily VAS, requirement of analgesics, changes of inflammatory markers, time to pain disappearance, and hospital days. DISCUSSION: The results of this trial are expected to prove the efficacy of EA for pain relief in patients with acute pancreatitis. Based upon the results, EA would be applied to a variety of clinical practices for reducing pain. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov, ID: NCT03173222 . Registered on 1 August 2017.