Status:
RECRUITING
Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
Lead Sponsor:
University of California, Los Angeles
Conditions:
Constipation - Functional
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Transcutaneous electrical acupoint stimulation (TEAS) is an emerging technology for non-invasive neuromodulation that has broad potential implications and warrants further study. The investigators' cl...
Detailed Description
This study will be a double blinded randomized controlled trial. Respondents will be screened by phone and qualified subjects will be sent home for 2 weeks to complete a bowel movement logbook, then r...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Satisfy a modified ROME-IV criteria for functional constipation including:
- Fewer than three spontaneous bowel movements per week
- and meet one of the following symptoms for at least 12 weeks in the preceding 12 months:
- straining during \>25% of the bowel movements (BMs)
- lumpy or hard stools during \>25% of BMs
- sensation of incomplete evacuation during \>25% of BMs
- sensation of anorectal obstruction or blockage for \>25% of BMs
- manual maneuvers to facilitate \>25% of BMs
- loose stools are rarely present without the use of laxatives
- insufficient criteria for IBS (does not have recurrent abdominal pain at least 1 day per week in the past 3 months)
- able to understand and provide written consent
- If over age 50, have undergone routine colon cancer screening (colonoscopy, sigmoidoscopy, colonography or fecal occult blood testing)
- subjects must have normal serum chemistry and normal thyroid stimulating hormone (TSH) within the past year
- subjects must have normal sensation over the areas where the pads will be placed (lumbar region and lower extremities surrounding the knees anteriorly)
Exclusion
- Pregnancy
- 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.
- Any changes to constipation related medications over the past 1 month
- Use of rescue medication (polyethylene glycol, bisacodyl, enema, etc) greater than once per week
- Pacemaker, implanted cardiac defibrillator or other implanted electrical device
- 10% weight loss in past 6 months
- New onset Hematochezia since last medical evaluation
Key Trial Info
Start Date :
February 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03243955
Start Date
February 28 2017
End Date
March 1 2026
Last Update
October 3 2023
Active Locations (1)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095