Electroacupuncture for Acute Pancreatitis

Not Applicable

Completed

• Conditions: Acute Pancreatitis
• Interventions: Procedure: Electroacupuncture

• Registration Number: NCT03173222
• Lead Sponsor: DongGuk University

Brief Summary

This study aims to prove the efficacy of electroacupuncture (EA) for pain relief in patients with acute pancreatitis compared with conventional treatment. Patients diagnosed with acute pancreatitis will be enrolled after obtaining informed consents. They will be randomly assigned to EA 1, EA 2, or control group in a 1:1:1 ratio. All the enrolled patients will basically receive the conventional standard-of-care therapy for acute pancreatitis. Local electroacupuncture will be given in group EA 1, while local with distal electroacupuncture will be given in group EA 2, additionally. For the conventional therapy, first non-steroidal anti-inflammatory drugs will be administered; afterwards, if inadequately controlled, low-potency narcotic analgesics such as codeine and then high-potency narcotic analgesics such as morphine or meperidine will be given sequentially as required. The patients randomized to the EA 1 and 2 groups will undergo 1 session of electroacupuncture daily from day 1 until day 4, or until pain is resolved. The primary endpoint is the visual analogue scale (VAS) for pain on day 5. Secondary endpoints include daily VAS, requirement of analgesics, changes of inflammatory markers, and hospital days.

Detailed Description

Acute pancreatitis (AP) causes significant abdominal pain, which can destroy patients'quality of life. Most patients have associated nausea and vomiting. Pain control for such patients is the mainstay of AP management. Opioids are safe and effective for pain control in patients with AP. Compared with other analgesic options, opioids may decrease the need for supplementary analgesia. However, frequent administration of opioid analgesics may result in opioid dependency. Unfortunately, any innovative treatment for the pain better than opioids has not been developed in the medical science so far. Therefore, the development of novel treatment for pain relief without triggering dependency is urgent. Acupuncture originated in China approximately 2000 years ago and is one of the oldest medical procedures in the world. Acupuncture continued to be developed and codified in texts over the subsequent centuries and gradually became one of the standard therapies used in China. Later, acupuncture was introduced to other countries including Asia, Europe, and Unites States. The most thoroughly studied application of acupuncture is for pain relief. In this sense, acupuncture in the oriental medicine could be an appropriate alternative for opioid analgesics, since it has been known as an effective treatment for pain relief without dependency. Electroacupuncture (EA) is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. Previous studies suggested that EA blocks pain by activating a variety of bioactive chemicals through peripheral, spinal, and supraspinal mechanisms. Therefore, we plan to prove the efficacy of EA for pain relief in patients with AP compared with conventional treatment.

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Study Start: 2017-08-01
• Primary Completion: 2020-04-10
• Study Completion: 2020-08-29
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-24
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Patients diagnosed with acute pancreatitis
• The definition of acute pancreatitis is based on the fulfillment of 2 out of 3 of the following criteria: clinical (upper abdominal pain), laboratory (serum amylase or lipase > 3 x upper limit of normal) and/or imaging (computed tomography, magnetic resonance imaging, ultrasonography) criteria.

Exclusion Criteria

• Those whose informed consent could not be obtained
• Patients with severe pancreatitis accompanying multiple organ failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EA1	Electroacupuncture	-
EA2	Electroacupuncture	-

Primary Outcome Measures

Name	Time	Method
Visual analogue scale of pain	Day 5 (after planned interventions)	0-100

Trial Locations

Locations (1)

Dongguk University Ilsan Medical Center; 🇰🇷 Goyang-si, Korea, Republic of