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Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders (TEA)

Primary Purpose

Gastroparesis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electroacupuncture
Sham TEA
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TEA at ST36 and PC6 first and then sham TEA

Sham-TEA and then TEA ST36 and PC6

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the Gastroparesis Cardinal Symptom Index (GCSI) score
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of the Gastroparesis Cardinal Symptom Index (GCSI) including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe).
Change in number of Spontaneous Complete Bowel Movements
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the number of Spontaneous Complete Bowel Movements.
Change in the Patient Assessment of Constipation (PAC-SYN) score
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of Patient Assessment of Constipation (PAC-SYN). This questionnaire asks about constipation in the past 2 weeks. Symptoms include: abdominal discomfort, abdominal pain, bloating, stomach cramps, painful bowel movements, rectal burning, rectal bleeding, incomplete bowel movement, hardness of stool, size of bowel movements, straining and feeling to pass a bowel without success. Each symptom will be scored between 1 to 4 being 1 for mild symptoms; 2 for moderate; 3 for severe and 4 for very severe.

Secondary Outcome Measures

Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
The effect of TEA on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QoL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL).
Change in Quality of Life as assessed by the Short Form (SF-36v2) Health Survey
The effect of TEA on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change in electrogastrogram gastric slow waves
The effect of TEA on gastric rhythm by changes in electrogastrogram gastric slow waves in cycles/minute. The normal frequency of the gastric rhythm is around 3 cycles/minute.
Change in the R - R interval (seconds)
The effect of TEA on the electrical activity of the heart by changes in the R - R interval. The normal range of the R - R interval is: 0.6-1.2 seconds.

Full Information

First Posted
April 14, 2020
Last Updated
March 16, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04349891
Brief Title
Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
Acronym
TEA
Official Title
Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEA at ST36 and PC6 first and then sham TEA
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-TEA and then TEA ST36 and PC6
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electroacupuncture
Intervention Description
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
Intervention Name(s)
Sham TEA
Intervention Description
Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
Primary Outcome Measure Information:
Title
Change in the Gastroparesis Cardinal Symptom Index (GCSI) score
Description
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of the Gastroparesis Cardinal Symptom Index (GCSI) including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibly larger. Each symptom will be graded from 0 to 5 (none, very mild, mild, moderate, severe and very severe).
Time Frame
Weekly, up to 10 weeks
Title
Change in number of Spontaneous Complete Bowel Movements
Description
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the number of Spontaneous Complete Bowel Movements.
Time Frame
Weekly, up to 10 weeks
Title
Change in the Patient Assessment of Constipation (PAC-SYN) score
Description
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of Patient Assessment of Constipation (PAC-SYN). This questionnaire asks about constipation in the past 2 weeks. Symptoms include: abdominal discomfort, abdominal pain, bloating, stomach cramps, painful bowel movements, rectal burning, rectal bleeding, incomplete bowel movement, hardness of stool, size of bowel movements, straining and feeling to pass a bowel without success. Each symptom will be scored between 1 to 4 being 1 for mild symptoms; 2 for moderate; 3 for severe and 4 for very severe.
Time Frame
Every 2 weeks, up to 10 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life as assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life scale
Description
The effect of TEA on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QoL instrument consists of 30 items, each with response options based on a 6-point scale and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. A score per dimension as well as a total score can be calculated. The PAGI-QOL scores range from 0 (lowest QoL) to 5 (highest QoL).
Time Frame
Every 2 weeks, up to 10 weeks
Title
Change in Quality of Life as assessed by the Short Form (SF-36v2) Health Survey
Description
The effect of TEA on quality of life assessed by the SF-36v2 Health Survey. The SF-36v2 is a 36-item, self-report measure designed to assess quality of life in patients. This measure also provides two summary scores (physical and mental health) and eight scale scores. The eight sections are: vitality, physical functioning, bodily pain and general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Baseline, week 4, week 6 and week 10
Title
Change in electrogastrogram gastric slow waves
Description
The effect of TEA on gastric rhythm by changes in electrogastrogram gastric slow waves in cycles/minute. The normal frequency of the gastric rhythm is around 3 cycles/minute.
Time Frame
Baseline, week 4, week 6 and week 10
Title
Change in the R - R interval (seconds)
Description
The effect of TEA on the electrical activity of the heart by changes in the R - R interval. The normal range of the R - R interval is: 0.6-1.2 seconds.
Time Frame
Baseline, week 4, week 6 and week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pankaj Pasricha, MD
Phone
4105501793
Email
pasricha@jhu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Barahona, MD
Phone
4105508871
Email
gbaraho1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pankaj Pasricha, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pankaj J Pasricha, MD
Phone
410-550-1793
Email
pasricha@jhu.edu
First Name & Middle Initial & Last Name & Degree
Guillermo Barahona
Phone
4105508871
Email
gbaraho1@jhmi.edu

12. IPD Sharing Statement

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Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders

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