<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243955</url>
  </required_header>
  <id_info>
    <org_study_id>441356-KH-50890</org_study_id>
    <nct_id>NCT03243955</nct_id>
  </id_info>
  <brief_title>Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation</brief_title>
  <official_title>Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transcutaneous electrical acupoint stimulation (TEAS) is an emerging technology for&#xD;
      non-invasive neuromodulation that has broad potential implications and warrants further&#xD;
      study. The investigators' clinical experience from the University of California, Los Angeles&#xD;
      (UCLA) Center for East-West Medicine (CEWM) has also demonstrated that TEAS can be used as an&#xD;
      effective self-care tool for patients with chronic illness who do not have the time or&#xD;
      resources for frequent acupuncture treatments. Chronic constipation is the chosen area of&#xD;
      study because of the large population with a substantial impairment in health-related quality&#xD;
      of life and work productivity. The investigators have recently completed a randomized&#xD;
      controlled trial (RCT) demonstrating the benefit of perineal self-acupressure on quality of&#xD;
      life measurements in this population, which supports investigation into other&#xD;
      acupuncture-based self-care interventions. Given these findings, the investigators&#xD;
      hypothesize that home patient-administered TEAS can provide measurable improvements in both&#xD;
      symptom severity and health related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a double blinded randomized controlled trial. Respondents will be screened&#xD;
      by phone and qualified subjects will be sent home for 2 weeks to complete a bowel movement&#xD;
      logbook, then return into the CEWM office where they will submit validated surveys&#xD;
      (specifically, the PAC-SYM and PAC-QOL) and have a photo taken of their tongue. A baseline&#xD;
      non-invasive heart rate variability (HRV) measurement will be taken at this time as well.&#xD;
      Study personnel will instruct each subject on TEAS pad placement and how to use the device,&#xD;
      but not tell the subjects where to place the pads. The subjects will been assigned to one of&#xD;
      two experimental groups (verum and sham) based on a 1:1 random allocation, with the study&#xD;
      personnel blinded to the allocation. Both groups will be given transcutaneous electrical&#xD;
      nerve stimulator (TENS) units with pre-set parameters and access to the adjustable amplitude&#xD;
      dial for self-adjustment of amplitude, with the verum group given pre-printed information on&#xD;
      proper application on true acupoints, and sham group will be given information on&#xD;
      non-acupuncture points. The subjects will be instructed on daily use for 30 minutes per day&#xD;
      for at least 5 days per week, and asked to track device use as well as bowel movement&#xD;
      frequency and quality using a logbook. They will also submit to an online survey every week&#xD;
      during the 4-week trial period. At the conclusion of the study, they will return the units&#xD;
      and repeat the survey and HRV measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <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</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>spontaneous bowel movement (SBMs) per week</measure>
    <time_frame>4 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responder rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of the responder rate (responder defined as having &gt;1 SBM per week for 2 out of the 4 treatment weeks) at the end of the study in each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAC-QOL</measure>
    <time_frame>4 weeks</time_frame>
    <description>Paired t-test will be used to compare the average PAC-QOL scores between baseline and final measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PAC-SYM</measure>
    <time_frame>4 weeks</time_frame>
    <description>Paired t-test will be used to compare the average PAC-SYM scores between baseline and final measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRV Changes</measure>
    <time_frame>4 weeks</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bristol Stool Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Comparison of the differences in the average Bristol Stool Scale between the baseline and study conclusion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Constipation - Functional</condition>
  <arm_group>
    <arm_group_label>TEAS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>True acupoint locations for placement of TENS unit pads</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>non-acupoint locations for placement of TENS unit pads</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Verum TEAS</intervention_name>
    <description>TENS unit with electrodes applied to acupuncture point locations</description>
    <arm_group_label>TEAS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham TEAS</intervention_name>
    <description>TENS unit with electrodes applied to non-acupuncture point locations</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Satisfy a modified ROME-IV criteria for functional constipation including:&#xD;
&#xD;
               -  Fewer than three spontaneous bowel movements per week&#xD;
&#xD;
               -  and meet one of the following symptoms for at least 12 weeks in the preceding 12&#xD;
                  months:&#xD;
&#xD;
                    -  straining during &gt;25% of the bowel movements (BMs)&#xD;
&#xD;
                    -  lumpy or hard stools during &gt;25% of BMs&#xD;
&#xD;
                    -  sensation of incomplete evacuation during &gt;25% of BMs&#xD;
&#xD;
                    -  sensation of anorectal obstruction or blockage for &gt;25% of BMs&#xD;
&#xD;
                    -  manual maneuvers to facilitate &gt;25% of BMs&#xD;
&#xD;
               -  loose stools are rarely present without the use of laxatives&#xD;
&#xD;
               -  insufficient criteria for IBS (does not have recurrent abdominal pain at least 1&#xD;
                  day per week in the past 3 months)&#xD;
&#xD;
          -  able to understand and provide written consent&#xD;
&#xD;
          -  If over age 50, have undergone routine colon cancer screening (colonoscopy,&#xD;
             sigmoidoscopy, colonography or fecal occult blood testing)&#xD;
&#xD;
          -  subjects must have normal serum chemistry and normal thyroid stimulating hormone (TSH)&#xD;
             within the past year&#xD;
&#xD;
          -  subjects must have normal sensation over the areas where the pads will be placed&#xD;
             (lumbar region and lower extremities surrounding the knees anteriorly)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Numbness around the genitals or groin, bladder or bowel dysfunction or incontinence,&#xD;
             new sciatica type leg pain or new onset sexual dysfunction within the past year.&#xD;
&#xD;
          -  Any changes to constipation related medications over the past 1 month&#xD;
&#xD;
          -  Use of rescue medication (polyethylene glycol, bisacodyl, enema, etc) greater than&#xD;
             once per week&#xD;
&#xD;
          -  Pacemaker, implanted cardiac defibrillator or other implanted electrical device&#xD;
&#xD;
          -  10% weight loss in past 6 months&#xD;
&#xD;
          -  New onset Hematochezia since last medical evaluation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Shubov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew Shubov, MD</last_name>
    <phone>310-998-9118</phone>
    <email>ashubov@mednet.ucla.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Shubov, MD</last_name>
      <phone>310-998-9118</phone>
      <email>ashubov@mednet.ucla.edu</email>
    </contact>
    <investigator>
      <last_name>Andrew Shubov, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>May 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Andrew Shubov, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>TENS</keyword>
  <keyword>TEAS</keyword>
  <keyword>constipation</keyword>
  <keyword>transcutaneous</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243955
org study id: 441356-KH-50890
nct id: NCT03243955
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
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
measure: spontaneous bowel movement (SBMs) per week
time frame: 4 weeks
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.
measure: Responder rate
time frame: 4 weeks
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
measure: PAC-QOL
time frame: 4 weeks
description: Paired t-test will be used to compare the average PAC-QOL scores between baseline and final measurements
measure: PAC-SYM
time frame: 4 weeks
description: Paired t-test will be used to compare the average PAC-SYM scores between baseline and final measurements
measure: HRV Changes
time frame: 4 weeks
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
measure: Bristol Stool Scale
time frame: 4 weeks
description: Comparison of the differences in the average Bristol Stool Scale between the baseline and study conclusion
arm group label: TEAS
arm group type: Active Comparator
description: True acupoint locations for placement of TENS unit pads
arm group label: Placebo
arm group type: Sham Comparator
description: non-acupoint locations for placement of TENS unit pads
intervention type: Device
intervention name: Verum TEAS
description: TENS unit with electrodes applied to acupuncture point locations
arm group label: TEAS
intervention type: Device
intervention name: Sham TEAS
description: TENS unit with electrodes applied to non-acupuncture point locations
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Shubov, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Andrew Shubov, MD
phone: 310-998-9118
email: ashubov@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Andrew Shubov, MD
investigator title: Principal Investigator
mesh term: Constipation
sharing ipd: No