Recruiting

TEAS

Sponsor:

UCLA

Code:

NCT03243955

Conditions

Constipation - Functional

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Verum TEAS

Sham TEAS

Study Details

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' 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.

Conditions

Constipation - Functional

Study ID

NCT03243955

Start date

Feb 28, 2017

Status verified date

Oct, 2023

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: TEAS

True acupoint locations for placement of TENS unit pads

sham comparator: Placebo

non-acupoint locations for placement of TENS unit pads

Interventions

Verum TEAS

TENS unit with electrodes applied to acupuncture point locations

Sham TEAS

TENS unit with electrodes applied to non-acupuncture point locations

Primary outcome measure

  • spontaneous bowel movement (SBMs) per week [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Andrew Shubov, MD

310-998-9118ashubov@mednet.ucla.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Andrew Shubov, MD

310-998-9118ashubov@mednet.ucla.edu

Principal Investigator:

Andrew Shubov, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Oct 3, 2023

Last verified

Oct, 2023

Keywords

  • acupuncture
  • TENS
  • TEAS
  • constipation
  • transcutaneous

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2023-10-03.