Constipation - FunctionalNCT03243955
Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
A study testing Verum TEAS in people with Constipation - Functional, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Transcutaneous electrical acupoint stimulation (TEAS) is an emerging technology for non-invasive neuromodulation that has broad potential implications and warrants further study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Verum TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
Andrew Shubov, MD, 310-998-9118, ashubov@mednet.ucla.edu
Andrew Shubov, MD
About this study
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.
Read the 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.
- Conditions
- Constipation - Functional
- Being tested
- Verum TEAS, Sham TEAS
- Keywords
- acupuncture, TENS, TEAS, constipation, transcutaneous
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum TEASDevice
TENS unit with electrodes applied to acupuncture point locations
Sham TEASDevice
TENS unit with electrodes applied to non-acupuncture point locations
| Study group | Role | What they receive |
|---|---|---|
| TEAS | Active comparator | True acupoint locations for placement of TENS unit pads Receives: Device: Verum TEAS |
| Placebo | Sham comparator | non-acupoint locations for placement of TENS unit pads Receives: Device: Sham TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
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
Measured: 4 weeks
PAC-QOL
Paired t-test will be used to compare the average PAC-QOL scores between baseline and final measurements
Measured: 4 weeks
PAC-SYM
Paired t-test will be used to compare the average PAC-SYM scores between baseline and final measurements
Measured: 4 weeks
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
Measured: 4 weeks
Bristol Stool Scale
Comparison of the differences in the average Bristol Stool Scale between the baseline and study conclusion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start28 Feb 2017
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Shubov, MD, University of California, Los Angeles
- Investigators
- Andrew Shubov, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243955
- Sponsor's protocol ID
- 441356-KH-50890
- Status last verified
- Oct 2023
- First submitted
- 2 May 2017
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation (TEAS) for Chronic Constipation
- ClinicalTrials.gov ID
- NCT03243955
- Acronym / sponsor ID
- 441356-KH-50890
- Conditions
- Constipation - Functional
- Keywords
- acupuncture, TENS, TEAS, constipation, transcutaneous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS | Active comparator | Device: Verum TEASTrue acupoint locations for placement of TENS unit pads |
| Placebo | Sham comparator | Device: Sham TEASnon-acupoint locations for placement of TENS unit pads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18 years of age or older
- Satisfy a modified ROME-IV criteria for functional constipation including:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum TEASTENS unit with electrodes applied to acupuncture point locations | Device | TEAS |
| Sham TEASTENS unit with electrodes applied to non-acupuncture point locations | Device | Placebo |
Primary outcome
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.
5 secondary outcomes
Responder rate
Time frame: 4 weeks
PAC-QOL
Time frame: 4 weeks
PAC-SYM
Time frame: 4 weeks
HRV Changes
Time frame: 4 weeks
Bristol Stool Scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Shubov, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum TEAS in people with Constipation - Functional, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Shubov, MD (310-998-9118, ashubov@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spontaneous bowel movement (SBMs) per week (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.