Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation

NCT03243955 | Recruiting FDA Device

• 1 other identifier: 441356-KH-50890
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

acupuncture; TENS; TEAS; constipation; transcutaneous

Outcome Measures

Primary Outcomes (1)

• spontaneous bowel movement (SBMs) per week

  Comparison of weekly spontaneous bowel movement (SBMs) per week between the two groups using a paired t-test comparing the final time point to the lead-in measurement.

  4 weeks

Secondary Outcomes (5)

• Responder rate

  4 weeks

• PAC-QOL

  4 weeks

• PAC-SYM

  4 weeks

• HRV Changes

  4 weeks

• Bristol Stool Scale

  4 weeks

Study Arms (2)

TEAS

ACTIVE COMPARATOR

True acupoint locations for placement of TENS unit pads

Device: Verum TEAS

Placebo

SHAM COMPARATOR

non-acupoint locations for placement of TENS unit pads

Device: Sham TEAS

Interventions

Verum TEAS DEVICE

TENS unit with electrodes applied to acupuncture point locations

TEAS

Sham TEAS DEVICE

TENS unit with electrodes applied to non-acupuncture point locations

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• % weight loss in past 6 months
• New onset Hematochezia since last medical evaluation

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Shubov, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Shubov, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the patient is unaware which group he is assigned to the researchers discussing this with the patients are unaware of group assignment the investigator is unaware of group assignment the outcomes assessor is unaware of group assignment until data analysis is complete
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: August 9, 2017
• Study Start: February 28, 2017
• Primary Completion: July 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)