RECRUITING

Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Transcutaneous electrical acupoint stimulation (TEAS) is an emerging technology for non-invasive neuromodulation that has broad potential implications and warrants further study. The investigators' clinical experience from the University of California, Los Angeles (UCLA) Center for East-West Medicine (CEWM) has also demonstrated that TEAS can be used as an effective self-care tool for patients with chronic illness who do not have the time or resources for frequent acupuncture treatments. Chronic constipation is the chosen area of study because of the large population with a substantial impairment in health-related quality of life and work productivity. The investigators have recently completed a randomized controlled trial (RCT) demonstrating the benefit of perineal self-acupressure on quality of life measurements in this population, which supports investigation into other acupuncture-based self-care interventions. Given these findings, the investigators hypothesize that home patient-administered TEAS can provide measurable improvements in both symptom severity and health related quality of life.

Official Title

Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation

Quick Facts

Study Start:2017-02-28
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03243955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Satisfy a modified ROME-IV criteria for functional constipation including:
  3. * Fewer than three spontaneous bowel movements per week
  4. * and meet one of the following symptoms for at least 12 weeks in the preceding 12 months:
  5. * straining during \>25% of the bowel movements (BMs)
  6. * lumpy or hard stools during \>25% of BMs
  7. * sensation of incomplete evacuation during \>25% of BMs
  8. * sensation of anorectal obstruction or blockage for \>25% of BMs
  9. * manual maneuvers to facilitate \>25% of BMs
  10. * loose stools are rarely present without the use of laxatives
  11. * insufficient criteria for IBS (does not have recurrent abdominal pain at least 1 day per week in the past 3 months)
  12. * able to understand and provide written consent
  13. * If over age 50, have undergone routine colon cancer screening (colonoscopy, sigmoidoscopy, colonography or fecal occult blood testing)
  14. * subjects must have normal serum chemistry and normal thyroid stimulating hormone (TSH) within the past year
  15. * subjects must have normal sensation over the areas where the pads will be placed (lumbar region and lower extremities surrounding the knees anteriorly)
  1. * Pregnancy
  2. * 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.
  3. * Any changes to constipation related medications over the past 1 month
  4. * Use of rescue medication (polyethylene glycol, bisacodyl, enema, etc) greater than once per week
  5. * Pacemaker, implanted cardiac defibrillator or other implanted electrical device
  6. * 10% weight loss in past 6 months
  7. * New onset Hematochezia since last medical evaluation

Contacts and Locations

Study Contact

Andrew Shubov, MD
CONTACT
310-998-9118
ashubov@mednet.ucla.edu

Principal Investigator

Andrew Shubov, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Andrew Shubov, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-28
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2017-02-28
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • acupuncture
  • TENS
  • TEAS
  • constipation
  • transcutaneous

Additional Relevant MeSH Terms

  • Constipation - Functional