Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders - Trial NCT04349891
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Study Focus
Sponsor & Location
Johns Hopkins University
Timeline & Enrollment
N/A
Oct 01, 2020
Oct 01, 2024
Primary Outcome
Change in the Gastroparesis Cardinal Symptom Index (GCSI) score,Change in number of Spontaneous Complete Bowel Movements,Change in the Patient Assessment of Constipation (PAC-SYN) score
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT04349891
Device Trial