- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173222
Electroacupuncture for Acute Pancreatitis
November 24, 2020 updated by: Dong Kee Jang, DongGuk University
A Clinical Study of Electroacupuncture for Abdominal Pain Relief in Patients With Acute Pancreatitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Goyang-si, Korea, Republic of
- Dongguk University Ilsan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
|
|
ACTIVE_COMPARATOR: EA1
|
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.
|
ACTIVE_COMPARATOR: EA2
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale of pain
Time Frame: Day 5 (after planned interventions)
|
0-100
|
Day 5 (after planned interventions)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2017
Primary Completion (ACTUAL)
April 10, 2020
Study Completion (ACTUAL)
August 29, 2020
Study Registration Dates
First Submitted
May 30, 2017
First Submitted That Met QC Criteria
May 30, 2017
First Posted (ACTUAL)
June 1, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 25, 2020
Last Update Submitted That Met QC Criteria
November 24, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HI16C0887
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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