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Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
16-001046
Category
General Medicine & Health Services
Contact
Andrew Shubov
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03243955
For detailed technical eligibility, visit ClinicalTrials.gov.