Using electrical stimulation to treat chronic constipation
Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
This study is testing whether a new type of electrical stimulation can help people with chronic constipation have more regular bowel movements and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03243955 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) as a non-invasive treatment for chronic constipation. Participants will be randomly assigned to either a verum group, receiving true acupoint stimulation, or a sham group, receiving stimulation at non-acupuncture points. Over a four-week period, subjects will use a TENS unit daily while tracking their bowel movements and completing weekly surveys. The study aims to assess the impact of TEAS on bowel movement frequency and quality of life for individuals suffering from functional constipation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the modified ROME-IV criteria for functional constipation.
Not a fit: Patients with recurrent abdominal pain indicative of irritable bowel syndrome (IBS) or those who do not meet the criteria for functional constipation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a convenient self-care option for patients with chronic constipation, improving their quality of life.
How similar studies have performed: Previous studies have shown positive outcomes with acupuncture-based interventions for similar conditions, suggesting potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Shubov, MD — University of California, Los Angeles
- Study coordinator: Andrew Shubov, MD
- Email: ashubov@mednet.ucla.edu
- Phone: 310-998-9118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.