Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders

NCT ID: NCT04349891

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-07-29

Brief Summary

Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments in Eastern countries. The most commonly used acupuncture points (acupoints) for focused treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points. Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human.

Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles, similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but applied to acupoints. The investigators hypothesize that TEA as a new treatment option, improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility and therefore improves quality of life of the patients.

The success of this project will lead to a noninvasive and convenient therapy for treating GI motility disorders. The proposed TEA method is expected to improve gastric and colonic functions and thus improve quality of life. In addition, the proposed TEA method and device are self-administrative after training during the first office visit. It provides a long-term treatment option for both FD, gastroparesis and chronic constipation.

Conditions

Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TEA at ST36 and PC6 first and then sham TEA

Patients in this group will be treated with TEA at ST36 and PC6 for 4 weeks, followed with a 2-week washout period and another 4-week period with sham TEA.

Group Type: EXPERIMENTAL

Transcutaneous Electroacupuncture

Intervention Type: DEVICE

Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Sham TEA

Intervention Type: DEVICE

Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Sham-TEA and then TEA ST36 and PC6

Patients in this group will be treated with sham-TEA for 4 weeks, followed with a 2-week washout period and another 4-week period with TEA at ST36 and PC6.

Group Type: EXPERIMENTAL

Transcutaneous Electroacupuncture

Intervention Type: DEVICE

Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Sham TEA

Intervention Type: DEVICE

Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Interventions

Transcutaneous Electroacupuncture

Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Intervention Type: DEVICE

Sham TEA

Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Bothersome postprandial fullness
• Symptoms of early satiation, epigastric pain, epigastric burning during the last 3 months
• No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms.
• Males and females between ages 18-80 yrs;
• Subjects with high probability for compliance and completion of the study.

• Satisfying Rome IV criteria for diagnosis of functional constipation;
• abdominal X-ray or anorectal manometry test during the past 3 months indicating delayed colonic transit (more than 20% ingested markers are retained) or abnormal colonic motility;
• ages 18-80 years;
• no constipation medication for a minimum of 1 week before enrollment except for rescue agents (stimulant laxatives, such as bisacodyl);
• willing to comply with the treatment regimen.

• At least one severe gastroparetic symptom or two moderate gastroparetic symptoms (see assessment of gastroparetic symptoms);
• Abnormal gastric emptying diagnosed during the past year;
• Males and females between ages 18-80 yrs;
• Subjects with high probability for compliance and completion of the study.
• Upper endoscopy or upper GI within last 2 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.

Exclusion Criteria

• History of gastric bezoar or diverticulitis.
• Severe daily abdominal pain requiring narcotic medications.
• Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.
• Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy;
• Surgery within the past 3 months.
• Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test).
• Those who have been treated with acupuncture or those who are familiar with acupuncture points.
• Anyone with an implantable cardiac pacemaker or defibrillator.
• unable to give informed consent;
• taking prokinetics, anticholinergic or dopaminergic agents;
• history of gastrointestinal surgery;
• pregnant or preparing to conceive a child;
• diabetes;
• allergic to skin preparation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pankaj Pasricha, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00247402

Identifier Type: -

Identifier Source: org_study_id