Clinical trial NCT04349891: Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
Official title: Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Gastroparesis Cardinal Symptom Index (GCSI) Score
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Change in Number of Spontaneous Complete Bowel Movements
timeFrame: Up to 10 weeks
measure: Change in the Patient Assessment of Constipation (PAC-SYN) Score
timeFrame: Up to 10 weeks
measure: Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale
timeFrame: Up to 10 weeks
measure: Change in Dimensions of Health as Assessed by the Short Form (SF-36v2) Health Survey
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Pankaj Pasricha, MD
role: PRINCIPAL_INVESTIGATOR
References: