NCT03173222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2020

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

May 30, 2017

Last Update Submit

November 24, 2020

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale of pain

    0-100

    Day 5 (after planned interventions)

Study Arms (3)

EA1

ACTIVE COMPARATOR
Procedure: Electroacupuncture

EA2

ACTIVE COMPARATOR
Procedure: Electroacupuncture

Control

NO INTERVENTION

Interventions

ElectroacupuncturePROCEDURE

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.

EA1EA2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk University Ilsan Medical Center

Goyang-si, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 23142625RESULT

  • 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.

    PMID: 37973472DERIVED

  • 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.

    PMID: 29769133DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

August 1, 2017

Primary Completion

April 10, 2020

Study Completion

August 29, 2020

Last Updated

November 25, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)