Electroacupuncture for Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

A Clinical Study of Electroacupuncture for Abdominal Pain Relief in Patients With Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173222
• Other study ID #: HI16C0887
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 29, 2020

Study information

• Verified date: November 2020
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 29, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Procedure:
• Electroacupuncture
A combined procedure with acupuncture and electric current stimulation. Local electroacupuncture will be given in group EA 1, while local with distal electroacupuncture will be given in group EA 2.

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Medical Center	Goyang-si

Sponsors (1)

Lead Sponsor	Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Ng SS, Leung WW, Mak TW, Hon SS, Li JC, Wong CY, Tsoi KK, Lee JF. Electroacupuncture reduces duration of postoperative ileus after laparoscopic surgery for colorectal cancer. Gastroenterology. 2013 Feb;144(2):307-313.e1. doi: 10.1053/j.gastro.2012.10.050. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale of pain	0-100	Day 5 (after planned interventions)