IBSTEANCT04953728

Optimization of Transcutaneous Electrical Acustimulation (TEA) Modalities for Treatment of IBS-C

A study testing Transcutaneous Electrical Acustimulation (TEA) in people with IBS and Constipation, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: IBS, Constipation
What is being tested?: Transcutaneous Electrical Acustimulation (TEA)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2021to 5 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing to comply with all study procedures and be available for the duration of the study
Diagnosed with IBS-C satisfying Rome IV criteria
Have symptoms present for at least the last 3 months
Have abdominal pain that is not adequately relieved at the time of screening and the time of randomization
Has a Visual Analog Scale (VAS) pain score of >3 (on 0-10 score)

Who cannot join

Have an unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes, unstable thyroid disease
Have history of abdominal surgery (other than cholecystectomy or appendectomy)
Are taking anticoagulants or antispasmodic, antidiarrheal, or opioids or other pain relief medications and cannot stop these medications for three consecutive days before each study visit
Are pregnant or lactating; women of child bearing potential complete a pregnancy test at each visit
Have known allergic reactions to components of the ECG electrodes
Received treatment with an investigational drug or other intervention within 6 months of the date of consent
Anything that, in the opinion of the investigator, would place the study participant at increased risk or preclude the study participant's full compliance with or completion of the study
Are unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: TEA for Study Participants With IBS-C Optimization of TEA Modalities for Treatment of IBS-C: A Phase 1 25 Study Participant Clinical Trial of Transcutaneous Electrical Acustimulation (TEA) in Study Participants With IBS-C

This study aims to determine the most effective treatment with Transcutaneous Electrical Acustimulation (TEA) for Irritable Bowel Syndrome with Constipation (IBS-C) by comparing efficacy between 5 separate sessions. The rectum pressure as measured by a device called a barostat will be compared between visits. Each session will be testing a different combination of frequency and body position of the electrodes. Electrodes placed at either the wrist or knee will be stimulated at either 25 Hz or 100 Hz.

Read the detailed description

This study aims to discern whether acute, single-session Transcutaneous Electrical Acustimulation (TEA) at acupuncture points ST36 or PC6 will relieve abdominal pain induced by rectal distension in patients with IBS-C. Each study participant will have 5 research visits at the Michigan Medicine GI physiology lab. During these visits, participants will undergo a procedure similar to Anal Rectal Manometry (ARM) performed by the GI physiology lab staff. TEA is similar to this procedure as it uses the barostat device and is performed by the GI physiology lab staff. This device has a rubber catheter that will be inserted 5-15 cm into the rectum of the study participant. Then the GI physiology staff will inflate the catheter. Study participants will then be asked when they can sense the catheter. Then the GI physiology staff will continue to inflate the catheter and the study participants feel discomfort (described as the 'urge to defecate'). Then the study participant will be asked to pass the balloon (like they would pass a bowel movement).

The difference between ARM procedure and the study procedure is that there will be stimulation of acupuncture point ST36 which is below the knee cap or stimulation of acupuncture point PC6 which is just above the wrist. For this study, this mild electrical stimulation will occur simultaneously with the barostat procedure.

At each visit there will be stimulation of only one of the points at either 100Hz or 25Hz. These are the potential combinations: ST36 100Hz, ST36-25Hz, PC6-100Hz, PC6-25Hz, Sham-TEA.

The frequency and position combination (or sham visit) is randomly assigned. The randomization determines the order in which the study participant moves through the study. Every study participant will, in the end, complete one visit at each frequency and a sham visit. The study participant will also complete surveys at the appointment.

The TEA device is classified by the FDA as a non-significant risk device.

Conditions: IBS, Constipation
Being tested: Transcutaneous Electrical Acustimulation (TEA)
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Electrical Acustimulation (TEA)Device
Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.

Study groups in NCT04953728
Study group	Role	What they receive
Subjects with IBS-C	Experimental	All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart. Receives: Device: Transcutaneous Electrical Acustimulation (TEA)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.
The barostat device will measure the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham. Higher numbers represent a higher degree of tolerance.
Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's tolerance with stimulation and that participant's baseline for that day.
Measured: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities.
The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention was compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham for that person. Higher numbers represent a higher degree of tolerance. Scores were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham.
Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average maximums under 1 treatment or another for the group as a whole.
Measured: After 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks.

Secondary outcomes (4)

Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration.
VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score was 0 and the maximum possible score was 80, if a participant experienced 10/10 pain. These scores were collected at 15 through 50 mmHg of distension at 5-mmHg intervals during baseline and compared to the scores collected at the same intervals during treatment on the same day. Data below show values post stimulation minus pre stimulation.
Each participant came in for 1 treatment in 1 session on each of 5 separate days. Sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pain compared only to their own pain.
Measured: Up to 8 mins between 15 and 50 mmHg during baseline. After deflating balloon, 15 mins of treatment and resumption of distention (up to 30 mins later), more surveys were taken during treatment increasing distensions up to 8 mins between 15 and 50 mmHg.
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment.
VAS surveys, a pain scale from 0 (lowest) to 10 (highest), were taken to assess efficacy of treatment on a 10-point scale. The minimum possible score is 0 and the maximum possible score is 80, if a participant experienced 10/10 pain. These scores, collected at maximum distension during treatment, were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham for each individual.
Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average pain scores under 1 treatment or another for the group as a whole.
Measured: Surveys taking less than 1 minute were taken at maximum-tolerated distension during treatment. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 survey and another was 12 weeks.
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.
The barostat device will measure the volume changes in the rectum during controlled distension, as measured in milliliters. The study participant's maximum volume will be compared to tolerance pre and post TEA. A higher number corresponds to a higher maximum volume.
Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' maximum volume may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's maximum volume with stimulation and that participant's baseline for that day. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's maximum volume compared only to their own maximum volume.
Measured: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.
Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.
The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. Values below show the pressure at which each participant experienced first sensation of the rectum during stimulation minus the pressure at which each participant experienced first sensation at baseline.
Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pressure may have changed over time between sessions. Analysis is shown as a single arm rather than a cross-over because the averages below are calculated from the change in each participant's pressure compared only to their own pressure.
Measured: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20215 Dec 2022

First posted8 Jul 2021
Study start1 Jul 2021
Primary completion5 Dec 2022
Study completion5 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for IBSStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04953728
Sponsor's protocol ID: HUM00189911
Other IDs: 1UG3NS115108-01A1
Acronym: TEA
Status last verified: Jan 2024
First submitted: 28 Jun 2021
Last updated: 16 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared

Publications

Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738.
PubMed 25989154
Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20.
PubMed 24657460
Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30.
PubMed 28915981
Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26.
PubMed 31347247
Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21.
PubMed 29925916

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All IBS trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: TEA for Study Participants With IBS-C Optimization of TEA Modalities for Treatment of IBS-C: A Phase 1 25 Study Participant Clinical Trial of Transcutaneous Electrical Acustimulation (TEA) in Study Participants With IBS-C
ClinicalTrials.gov ID: NCT04953728
Acronym / sponsor ID: TEA / HUM00189911
Conditions: IBS, Constipation
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Transtimulation Research, Inc, National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 1 Jul 2021 (actual)
Primary completion: 5 Dec 2022 (actual)
Study completion: 5 Dec 2022 (actual)
First posted: 8 Jul 2021 (actual)
Results: Posted 16 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

At each visit there will be stimulation of only one of the points at either 100Hz or 25Hz. These are the potential combinations: ST36 100Hz, ST36-25Hz, PC6-100Hz, PC6-25Hz, Sham-TEA.

The TEA device is classified by the FDA as a non-significant risk device.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subjects with IBS-C	Experimental	Device: Transcutaneous Electrical Acustimulation (TEA)All participants will receive all treatment options. Each participant will receive all of the following treatments; 100 Hz ST36, 100 Hz PC6, 25 Hz ST36, 25 Hz PC6, as well as the sham comparator. Each administration will be performed on different dates, between 1 and 3 weeks apart.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Willing to comply with all study procedures and be available for the duration of the study
Diagnosed with IBS-C satisfying Rome IV criteria
Have symptoms present for at least the last 3 months
Have abdominal pain that is not adequately relieved at the time of screening and the time of randomization
Has a Visual Analog Scale (VAS) pain score of >3 (on 0-10 score)

Key exclusion criteria (8 listed)

Have an unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes, unstable thyroid disease
Have history of abdominal surgery (other than cholecystectomy or appendectomy)
Are taking anticoagulants or antispasmodic, antidiarrheal, or opioids or other pain relief medications and cannot stop these medications for three consecutive days before each study visit
Are pregnant or lactating; women of child bearing potential complete a pregnancy test at each visit
Have known allergic reactions to components of the ECG electrodes

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
Transcutaneous Electrical Acustimulation (TEA)Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.	Device	Subjects with IBS-C

Primary outcome

Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.
Time frame: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.
The barostat device will measure the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham. Higher numbers represent a higher degree of tolerance. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. In each session, a new baseline was established, because individuals' pain/discomfort may have changed over time between sessions. Each change value listed below represents the mean of the differences between each participant's tolerance with stimulation and that participant's baseline for that day.
Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities.
Time frame: After 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks.
The barostat device measured the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention was compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham for that person. Higher numbers represent a higher degree of tolerance. Scores were compared between modalities of body position (ST36 or PC6), frequency (100 Hz or 25 Hz), and sham. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over the course of their sessions was randomized per participant. Analysis is shown as a difference in treatment-induced change between different treatment modalities rather than a comparison between the average maximums under 1 treatment or another for the group as a whole.

4 secondary outcomes

Change in Pain as Measured by Visual Analog Scale (VAS) Surveys When Compared to Pre-TEA Administration.
Time frame: Up to 8 mins between 15 and 50 mmHg during baseline. After deflating balloon, 15 mins of treatment and resumption of distention (up to 30 mins later), more surveys were taken during treatment increasing distensions up to 8 mins between 15 and 50 mmHg.
Change in Individual's Pain as Measured by Visual Analog Scale (VAS) Surveys at Max Distension During 1 Treatment Compared to Their Own Pain During a Different Treatment.
Time frame: Surveys taking less than 1 minute were taken at maximum-tolerated distension during treatment. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 survey and another was 12 weeks.
Change in Maximum Volume in mL of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.
Time frame: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.
Change in Pressure of First Sensation of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.
Time frame: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.

Results and safety

Results posted to the registry on 16 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With IBS-C	23	19

Primary outcome: Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration.

Time frame: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.. Mean (Standard Error). Unit: mmHg

Measure	Subjects With IBS-C n = 19
Change in avg max tolerance per person: value at ST36 100Hz minus value at that day's baseline	0.79 (1.80)
Change in avg max tolerance per person: value at ST36 25Hz minus value at that day's baseline	1.32 (2.26)
Change in avg max tolerance per person: value at PC6 100Hz minus value at that day's baseline	-4.44 (2.45)
Change in avg max tolerance per person: value at PC6 25Hz minus value at that day's baseline	-4.21 (3.40)
Change in avg max tolerance per person: value at sham minus value at that day's baseline	1.84 (1.03)

Subjects With IBS-C: p = 0.77306724, t-test, 2 sided
Subjects With IBS-C: p = 0.24, t-test, 2 sided
Subjects With IBS-C: p = 0.45, t-test, 2 sided

Population analysed: Data was analyzed only for participants who received all 5 treatments to avoid the compounding impact of day-to-day variations. In the case of PC6 100 HZ, post-treatment value is missing for 1 participant.

Primary outcome: Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Other Modalities.

Time frame: After 15 minutes of treatment, rectum was distended incrementally with treatment for up to 12 minutes. Because between sessions, participants had 1-3 weeks off, the maximum time between 1 maximum-tolerated distension and another was 12 weeks.. Mean (Standard Error). Unit: mmHg

Measure	Subjects With IBS-C n = 19
Change in avg max tolerance per person: value at ST36 100Hz minus value at ST36 25Hz	-0.53 (2.03)
Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 100Hz	-1.66 (1.04)
Change in avg max tolerance per person: value at ST36 100Hz minus value at PC6 25Hz	5.00 (2.60)
Change in avg max tolerance per person: value at ST36 100Hz minus value at sham	-1.05 (1.42)
Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 100Hz	-1.13 (1.26)
Change in avg max tolerance per person: value at ST36 25Hz minus value at PC6 25Hz	5.53 (2.83)
Change in avg max tolerance per person: value at ST36 25Hz minus value at sham	-0.53 (1.64)
Change in avg max tolerance per person: value at PC6 100Hz minus value at PC6 25Hz	6.66 (1.84)

Subjects With IBS-C: p = 0.81019363, t-test, 2 sided
Subjects With IBS-C: p = 0.18, t-test, 2 sided
Subjects With IBS-C: p = 0.21, t-test, 2 sided

Population analysed: For each of the rows of data below, data from 19 participants at one treatment are compared with data from either 19 or 18 participants in the other treatment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from first visit of the study to one month after the last visit of the study, a maximum of 16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ST36 100 HZ	0 of 20 (0%)	0 of 20 (0%)	0 of 20
ST36 25 HZ	0 of 20 (0%)	0 of 20 (0%)	0 of 20
PC6 100 HZ	0 of 20 (0%)	1 of 20 (5%)	0 of 20
PC6 25 HZ	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Sham 25 HZ	0 of 22 (0%)	2 of 22 (9.1%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25989154Ma D, Han JS, Diao QH, Deng GF, Ping XJ, Jin WJ, Wu LZ, Cui CL, Li XD. Transcutaneous electrical acupoint stimulation for the treatment of withdrawal syndrome in heroin addicts. Pain Med. 2015 May;16(5):839-48. doi: 10.1111/pme.12738.
Background: PubMed 24657460Jiang Y, Liu J, Liu J, Han J, Wang X, Cui C. Cerebral blood flow-based evidence for mechanisms of low- versus high-frequency transcutaneous electric acupoint stimulation analgesia: a perfusion fMRI study in humans. Neuroscience. 2014 May 30;268:180-93. doi: 10.1016/j.neuroscience.2014.03.019. Epub 2014 Mar 20.
Background: PubMed 28915981Qu F, Wang FF, Wu Y, Zhou J, Robinson N, Hardiman PJ, Pan JX, He YJ, Zhu YH, Wang HZ, Ye XQ, He KL, Cui L, Zhao HL, Ye YH. Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study. Explore (NY). 2017 Sep-Oct;13(5):306-312. doi: 10.1016/j.explore.2017.06.004. Epub 2017 Jun 30.
Background: PubMed 31347247Yu Y, Wei R, Liu Z, Xu J, Xu C, Chen JDZ. Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway. Neuromodulation. 2019 Aug;22(6):751-757. doi: 10.1111/ner.13021. Epub 2019 Jul 26.
Background: PubMed 29925916Zhang B, Xu F, Hu P, Zhang M, Tong K, Ma G, Xu Y, Zhu L, Chen JDZ. Needleless Transcutaneous Electrical Acustimulation: A Pilot Study Evaluating Improvement in Post-Operative Recovery. Am J Gastroenterol. 2018 Jul;113(7):1026-1035. doi: 10.1038/s41395-018-0156-y. Epub 2018 Jun 21.
Individual participant dataSharing planned: No. De-identified individual participant data will not be shared. However, the study protocol and the study results will be shared

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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.

Jiande Chen, Ph.D. principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Electrical Acustimulation (TEA) in people with IBS and Constipation, run by University of Michigan 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 16 Feb 2024. 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. 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?

Yes. Results are posted in the registry (first posted 16 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pressure of Maximum Tolerance in mmHg of the Rectum as Measured by a Barostat Device When Compared to Pre-TEA Administration. (time frame: Baseline data collected up to 12 minutes; participants rested for 15 minutes; 15 minutes of treatment was administered, then rectum was distended again with treatment for up to 12 minutes. Between each of 5 sessions, participants had 1-3 weeks off.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04953728, which also lists 5 linked publications.

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 16 Feb 2024.