ClinicalTrials.gov
ClinicalTrials.gov Menu

Electroacupuncture for Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03173222
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dong Kee Jang, 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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Procedure: Electroacupuncture Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of Electroacupuncture for Abdominal Pain Relief in Patients With Acute Pancreatitis
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: EA1 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.

Active Comparator: EA2 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.

No Intervention: Control



Primary Outcome Measures :
  1. Visual analogue scale of pain [ Time Frame: Day 5 (after planned interventions) ]
    0-100



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173222


Contacts
Contact: Dong Kee Jang, M.D. 82319617129 mapmotive@hanmail.net

Locations
Korea, Republic of
Dongguk University Ilsan Medical Center Recruiting
Goyang-si, Korea, Republic of
Contact: Dong Kee Jang, Dr.         
Sponsors and Collaborators
DongGuk University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dong Kee Jang, Assistant professor, DongGuk University
ClinicalTrials.gov Identifier: NCT03173222     History of Changes
Other Study ID Numbers: HI16C0887
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases