- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03243955
Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
October 2, 2023 updated by: Andrew Shubov, MD, University of California, Los Angeles
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will be a double blinded randomized controlled trial.
Respondents will be screened by phone and qualified subjects will be sent home for 2 weeks to complete a bowel movement logbook, then return into the CEWM office where they will submit validated surveys (specifically, the PAC-SYM and PAC-QOL) and have a photo taken of their tongue.
A baseline non-invasive heart rate variability (HRV) measurement will be taken at this time as well.
Study personnel will instruct each subject on TEAS pad placement and how to use the device, but not tell the subjects where to place the pads.
The subjects will been assigned to one of two experimental groups (verum and sham) based on a 1:1 random allocation, with the study personnel blinded to the allocation.
Both groups will be given transcutaneous electrical nerve stimulator (TENS) units with pre-set parameters and access to the adjustable amplitude dial for self-adjustment of amplitude, with the verum group given pre-printed information on proper application on true acupoints, and sham group will be given information on non-acupuncture points.
The subjects will be instructed on daily use for 30 minutes per day for at least 5 days per week, and asked to track device use as well as bowel movement frequency and quality using a logbook.
They will also submit to an online survey every week during the 4-week trial period.
At the conclusion of the study, they will return the units and repeat the survey and HRV measurements.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrew Shubov, MD
- Phone Number: 310-998-9118
- Email: ashubov@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Contact:
- Andrew Shubov, MD
- Phone Number: 310-998-9118
- Email: ashubov@mednet.ucla.edu
-
Principal Investigator:
- Andrew Shubov, MD
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TEAS
True acupoint locations for placement of TENS unit pads
|
TENS unit with electrodes applied to acupuncture point locations
|
Sham Comparator: Placebo
non-acupoint locations for placement of TENS unit pads
|
TENS unit with electrodes applied to non-acupuncture point locations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
spontaneous bowel movement (SBMs) per week
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Responder rate
Time Frame: 4 weeks
|
Comparison of the responder rate (responder defined as having >1 SBM per week for 2 out of the 4 treatment weeks) at the end of the study in each group
|
4 weeks
|
PAC-QOL
Time Frame: 4 weeks
|
Paired t-test will be used to compare the average PAC-QOL scores between baseline and final measurements
|
4 weeks
|
PAC-SYM
Time Frame: 4 weeks
|
Paired t-test will be used to compare the average PAC-SYM scores between baseline and final measurements
|
4 weeks
|
HRV Changes
Time Frame: 4 weeks
|
Comparison of the differences between the high frequency (HF), low frequency (LF), and LF/HF measures of the spectral analysis of HRV (heart rate variability) between the baseline and study conclusion
|
4 weeks
|
Bristol Stool Scale
Time Frame: 4 weeks
|
Comparison of the differences in the average Bristol Stool Scale between the baseline and study conclusion
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Shubov, MD, 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 Major Dates
Study Start (Actual)
February 28, 2017
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
May 2, 2017
First Submitted That Met QC Criteria
August 4, 2017
First Posted (Actual)
August 9, 2017
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 441356-KH-50890
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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