Status:
TERMINATED
Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
Lead Sponsor:
Johns Hopkins University
Conditions:
Gastroparesis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 discomf...
Eligibility Criteria
Inclusion
- Inclusion criteria for FD patients
- 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.
- Inclusion criteria for chronic constipation patients
- 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.
- Inclusion criteria for gastroparesis patients
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04349891
Start Date
October 1 2020
End Date
July 29 2022
Last Update
September 19 2024
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224