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Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation

Primary Purpose

Constipation - Functional

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verum TEAS
Sham TEAS
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional focused on measuring acupuncture, TENS, TEAS, constipation, transcutaneous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TEAS

Placebo

Arm Description

True acupoint locations for placement of TENS unit pads

non-acupoint locations for placement of TENS unit pads

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Responder rate
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
PAC-QOL
Paired t-test will be used to compare the average PAC-QOL scores between baseline and final measurements
PAC-SYM
Paired t-test will be used to compare the average PAC-SYM scores between baseline and final measurements
HRV Changes
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
Bristol Stool Scale
Comparison of the differences in the average Bristol Stool Scale between the baseline and study conclusion

Full Information

First Posted
May 2, 2017
Last Updated
October 2, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03243955
Brief Title
Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
Official Title
Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional
Keywords
acupuncture, TENS, TEAS, constipation, transcutaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAS
Arm Type
Active Comparator
Arm Description
True acupoint locations for placement of TENS unit pads
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
non-acupoint locations for placement of TENS unit pads
Intervention Type
Device
Intervention Name(s)
Verum TEAS
Intervention Description
TENS unit with electrodes applied to acupuncture point locations
Intervention Type
Device
Intervention Name(s)
Sham TEAS
Intervention Description
TENS unit with electrodes applied to non-acupuncture point locations
Primary Outcome Measure Information:
Title
spontaneous bowel movement (SBMs) per week
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Responder rate
Description
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
Time Frame
4 weeks
Title
PAC-QOL
Description
Paired t-test will be used to compare the average PAC-QOL scores between baseline and final measurements
Time Frame
4 weeks
Title
PAC-SYM
Description
Paired t-test will be used to compare the average PAC-SYM scores between baseline and final measurements
Time Frame
4 weeks
Title
HRV Changes
Description
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
Time Frame
4 weeks
Title
Bristol Stool Scale
Description
Comparison of the differences in the average Bristol Stool Scale between the baseline and study conclusion
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Shubov, MD
Phone
310-998-9118
Email
ashubov@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Shubov, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Shubov, MD
Phone
310-998-9118
Email
ashubov@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Andrew Shubov, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation

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