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TEAS for Chronic Constipation
N/A
Recruiting
Led By Andrew Shubov, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
sensation of incomplete evacuation during >25% of BMs
sensation of anorectal obstruction or blockage for >25% of BMs
Must not have
Numbness around the genitals or groin, bladder or bowel dysfunction or incontinence, new sciatica type leg pain or new onset sexual dysfunction within the past year
Use of rescue medication (polyethylene glycol, bisacodyl, enema, etc) greater than once per week
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial is testing whether electrical stimulation can help with chronic constipation, which can cause a lot of pain and problems. They hope that this will be a helpful, self-care tool for people who can't afford or don't have time for acupuncture treatments.
Who is the study for?
This trial is for adults over 18 with chronic constipation, meeting specific criteria like straining or hard stools during bowel movements. They must not have numbness in certain areas, bladder issues, recent weight loss, or use of frequent laxatives. Participants need normal blood tests and can't have a pacemaker or similar devices.
What is being tested?
The study is testing TEAS—a non-invasive technique stimulating acupoints electrically—as a self-care treatment for chronic constipation. It compares real TEAS to sham (fake) TEAS to see if it improves symptoms and quality of life.
What are the potential side effects?
Since the trial involves electrical stimulation at acupoints, potential side effects may include discomfort at the site of application or skin irritation but are generally expected to be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I often feel like I haven't fully emptied my bowels.
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I often feel blocked or obstructed when going to the bathroom.
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I can feel normally where the treatment pads will be placed on my lower back and knees.
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I am 18 years old or older.
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I have less than three bowel movements a week.
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I often strain during more than a quarter of my bowel movements.
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I often have hard or lumpy stools.
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I use manual methods to help with over 25% of my bowel movements.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have experienced new numbness, pain, or dysfunction in my lower body this year.
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I use medication to help with bowel movements more than once a week.
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I have started experiencing blood in my stool since my last doctor's visit.
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I have lost 10% of my weight in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
spontaneous bowel movement (SBMs) per week
Secondary study objectives
Bristol Stool Scale
HRV Changes
PAC-QOL
+2 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: TEASActive Control1 Intervention
True acupoint locations for placement of TENS unit pads
Group II: PlaceboPlacebo Group1 Intervention
non-acupoint locations for placement of TENS unit pads
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,565 Previous Clinical Trials
10,263,089 Total Patients Enrolled
2 Trials studying Constipation
355 Patients Enrolled for Constipation
Andrew Shubov, MDPrincipal Investigator - University of California, Los Angeles
Providence Saint John's Health Center, Ronald Reagan UCLA Medical Center, Santa Monica-UCLA Medical Center
University of Southern California School Of Medicine (Medical School)
3 Previous Clinical Trials
204 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I often feel like I haven't fully emptied my bowels.I often feel blocked or obstructed when going to the bathroom.I can feel normally where the treatment pads will be placed on my lower back and knees.I have experienced new numbness, pain, or dysfunction in my lower body this year.I use medication to help with bowel movements more than once a week.I have had specific symptoms for at least 12 weeks in the last year.You have a pacemaker, implanted cardiac defibrillator, or any other implanted electrical device.I am 18 years old or older.You meet the criteria for functional constipation as defined by the ROME-IV guidelines.I have less than three bowel movements a week.I often strain during more than a quarter of my bowel movements.I often have hard or lumpy stools.I have started experiencing blood in my stool since my last doctor's visit.I use manual methods to help with over 25% of my bowel movements.I have lost 10% of my weight in the last 6 months.I rarely have loose stools without taking laxatives.I am over 50 and have had a colon cancer screening test.I don't have abdominal pain once a week for the last 3 months.I haven't changed my constipation medication in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: TEAS
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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