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Electroacupuncture for Acute Pancreatitis

NCT ID: NCT03173222

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-08-29

Brief Summary

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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

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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.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EA1

Group Type ACTIVE_COMPARATOR

Electroacupuncture

Intervention Type PROCEDURE

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.

EA2

Group Type ACTIVE_COMPARATOR

Electroacupuncture

Intervention Type PROCEDURE

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DongGuk University

OTHER

Sponsor Role lead

Responsible Party

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Dong Kee Jang

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dongguk University Ilsan Medical Center

Goyang-si, , South Korea

Site Status

Countries

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South Korea

References

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Ng SSM, Leung WW, Mak TWC, Hon SSF, Li JCM, Wong CYN, Tsoi KKF, Lee JFY. 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. Epub 2012 Nov 6.

Reference Type RESULT
PMID: 23142625 (View on PubMed)

Kee Jang D, Kyu Lee J, Yung Jung C, Ho Kim K, Ra Kang H, Sun Lee Y, Hwa Yoon J, Ro Joo K, Kyu Chae M, Hyeon Baek Y, Seo BK, Hyub Lee S, Lim C. Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: A three-arm randomized controlled trial. J Integr Med. 2023 Nov;21(6):537-542. doi: 10.1016/j.joim.2023.10.004. Epub 2023 Nov 2.

Reference Type DERIVED
PMID: 37973472 (View on PubMed)

Jang DK, Jung CY, Kim KH, Lee JK. Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial. Trials. 2018 May 16;19(1):279. doi: 10.1186/s13063-018-2644-1.

Reference Type DERIVED
PMID: 29769133 (View on PubMed)

Other Identifiers

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HI16C0887

Identifier Type: -

Identifier Source: org_study_id