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Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation

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ClinicalTrials.gov Identifier: NCT03243955
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Andrew Shubov, MD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Constipation - Functional Device: Verum TEAS Device: Sham TEAS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: TEAS
True acupoint locations for placement of TENS unit pads
Device: Verum TEAS
TENS unit with electrodes applied to acupuncture point locations

Sham Comparator: Placebo
non-acupoint locations for placement of TENS unit pads
Device: Sham TEAS
TENS unit with electrodes applied to non-acupuncture point locations




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. PAC-QOL [ Time Frame: 4 weeks ]
    Paired t-test will be used to compare the average PAC-QOL scores between baseline and final measurements

  3. 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. 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

  5. Bristol Stool Scale [ Time Frame: 4 weeks ]
    Comparison of the differences in the average Bristol Stool Scale between the baseline and study conclusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243955


Contacts
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Contact: Andrew Shubov, MD 310-998-9118 ashubov@mednet.ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Andrew Shubov, MD    310-998-9118    ashubov@mednet.ucla.edu   
Principal Investigator: Andrew Shubov, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Andrew Shubov, MD University of California, Los Angeles
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Responsible Party: Andrew Shubov, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03243955    
Other Study ID Numbers: 441356-KH-50890
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Andrew Shubov, MD, University of California, Los Angeles:
acupuncture
TENS
TEAS
constipation
transcutaneous
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive