Acupuncture-like Transcutaneous Electrical Nerve StimulationNCT05042661
Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome
A study testing acupuncture-like transcutaneous electrical nerve stimulation in people with Acupuncture-like Transcutaneous Electrical Nerve Stimulation and Irritable Bowel Syndrome, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
To discuss the effects of improving the irritable bowel syndrome patients' quality of life and defecation after implementing acupuncture-like Transcutaneous Electrical nerve stimulation. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acupuncture-like Transcutaneous Electrical Nerve Stimulation, Irritable Bowel Syndrome
- What is being tested?
- acupuncture-like transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2021to 13 Feb 2023
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are at least 20 years old (inclusive) and are willing to sign a written informed consent after explaining the purpose of the research.
- A patient with irritable bowel syndrome diagnosed by a doctor for at least 6 months (inclusive).
- Communicate in Mandarin or Hokkien.
Who cannot join
- Those who cannot take care of themselves in daily life.
- Those who have had severe abdominal and colorectal surgery.
- Those who have been diagnosed with inflammatory bowel disease or colorectal cancer.
- Those with a history of mental illness, such as schizophrenia and obsessive- compulsive disorder.
- Women who are pregnant, breastfeeding, and less than 12 months after delivery.
- Other serious diseases, such as acute myocardial infarction, endocrine disease, decompensated cirrhosis, stroke, and end-stage renal disease, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Taipei University of Nursing and Health Sciences
To discuss the effects of improving the irritable bowel syndrome patients' quality of life and defecation after implementing acupuncture-like Transcutaneous Electrical nerve stimulation.
Read the detailed description
This experiment will use a clinical design that will collect cases in a local teaching hospital. The way of convenience sampling will gather from the irritable bowel syndrome patients. After a questionnaire, randomly to make invention and control groups. Invention and control groups are 4 weeks and 3 weeks respectively. Each time will be for 20 minutes acupuncture-like transcutaneous electrical nerve stimulation treatment. The Control group will still have normal nursing. There will be 72 patients in two groups. The measured timing will be in the second, fourth, and eighth weeks after the prediction and invention.
- Being tested
- acupuncture-like transcutaneous electrical nerve stimulation
- Keywords
- irritable bowel syndrome, acupuncture-like transcutaneous electrical nervestimulation, quality of life
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture-like transcutaneous electrical nerve stimulationDevice
The intervention group performed Al-TENS therapy 3 times a week for at least 20 minutes each time for 4 consecutive weeks. The second, fourth, and eighth week after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture-like transcutaneous electrical nerve stimulation | Experimental | 1. The experimental group received acupuncture-like transcutaneous electrical nerve stimulation three times a week for 4 weeks.
2. Invention and control groups are 4 weeks and 3 weeks respectively. Each time will be for 20 minutes acupuncture-like transcutaneous electrical nerve stimulation treatment Receives: Device: acupuncture-like transcutaneous electrical nerve stimulation |
| Control group:conventional therapy | No intervention | The control group will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHOQOL-BREF,Taiwan version
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life.
Measured: pretest
WHOQOL-BREF,Taiwan version
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life
Measured: 2 weeks after the pretest
WHOQOL-BREF,Taiwan version
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life
Measured: 4 weeks after the pretest
WHOQOL-BREF,Taiwan version
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life
Measured: 8 weeks after the pretest
irritable bowel syndrome Severity Score
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
Measured: pretest
irritable bowel syndrome Severity Score
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
Measured: 2 weeks after the pretest
irritable bowel syndrome Severity Score
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
Measured: 4 weeks after the pretest
irritable bowel syndrome Severity Score
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
Measured: 8 weeks after the pretest
Irritable Bowel Syndrome Quality of Life
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Measured: pretest
Irritable Bowel Syndrome Quality of Life
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Measured: 2 weeks after the pretest
Irritable Bowel Syndrome Quality of Life
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Measured: 4 weeks after the pretest
Irritable Bowel Syndrome Quality of Life
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Measured: 8 weeks after the pretest
Bristol Stool Form Scale
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Measured: pretest
Bristol Stool Form Scale
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Measured: 2 weeks after the pretest
Bristol Stool Form Scale
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Measured: 4 weeks after the pretest
Bristol Stool Form Scale
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Measured: 8 weeks after the pretest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Feb 2021
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Why it stopped: The number of cases accepted has reached expectations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture-like Transcutaneous Electrical Nerve StimulationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsu Ying Fang, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042661
- Sponsor's protocol ID
- TFang
- Status last verified
- Feb 2023
- First submitted
- 4 Sep 2021
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taipei University of Nursing and Health Sciences
- ClinicalTrials.gov ID
- NCT05042661
- Acronym / sponsor ID
- TFang
- Keywords
- irritable bowel syndrome, acupuncture-like transcutaneous electrical nervestimulation, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of cases accepted has reached expectations.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 13 Sep 2021 (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.
To discuss the effects of improving the irritable bowel syndrome patients' quality of life and defecation after implementing acupuncture-like Transcutaneous Electrical nerve stimulation.
Detailed description
This experiment will use a clinical design that will collect cases in a local teaching hospital. The way of convenience sampling will gather from the irritable bowel syndrome patients. After a questionnaire, randomly to make invention and control groups. Invention and control groups are 4 weeks and 3 weeks respectively. Each time will be for 20 minutes acupuncture-like transcutaneous electrical nerve stimulation treatment. The Control group will still have normal nursing. There will be 72 patients in two groups. The measured timing will be in the second, fourth, and eighth weeks after the prediction and invention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture-like transcutaneous electrical nerve stimulation | Experimental | Device: acupuncture-like transcutaneous electrical nerve stimulation1. The experimental group received acupuncture-like transcutaneous electrical nerve stimulation three times a week for 4 weeks. 2. Invention and control groups are 4 weeks and 3 weeks respectively. Each time will be for 20 minutes acupuncture-like transcutaneous electrical nerve stimulation treatment |
| Control group:conventional therapy | No intervention | –The control group will receive routine care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those who are at least 20 years old (inclusive) and are willing to sign a written informed consent after explaining the purpose of the research.
- A patient with irritable bowel syndrome diagnosed by a doctor for at least 6 months (inclusive).
- Communicate in Mandarin or Hokkien.
Key exclusion criteria (6 listed)
- Those who cannot take care of themselves in daily life.
- Those who have had severe abdominal and colorectal surgery.
- Those who have been diagnosed with inflammatory bowel disease or colorectal cancer.
- Those with a history of mental illness, such as schizophrenia and obsessive- compulsive disorder.
- Women who are pregnant, breastfeeding, and less than 12 months after delivery.
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 |
|---|---|---|
| acupuncture-like transcutaneous electrical nerve stimulationThe intervention group performed Al-TENS therapy 3 times a week for at least 20 minutes each time for 4 consecutive weeks. The second, fourth, and eighth week after the intervention. | Device | acupuncture-like transcutaneous electrical nerve stimulation |
Primary outcome
WHOQOL-BREF,Taiwan version
Time frame: pretest
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life.
WHOQOL-BREF,Taiwan version
Time frame: 2 weeks after the pretest
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life
WHOQOL-BREF,Taiwan version
Time frame: 4 weeks after the pretest
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life
WHOQOL-BREF,Taiwan version
Time frame: 8 weeks after the pretest
There are a total of 28 questions on this scale, of which 26 are common questions around the world, and the other 2 are local questions. This questionnaire is a positive question and a five-point scoring system. The higher the score, the better the quality of life
irritable bowel syndrome Severity Score
Time frame: pretest
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
irritable bowel syndrome Severity Score
Time frame: 2 weeks after the pretest
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
irritable bowel syndrome Severity Score
Time frame: 4 weeks after the pretest
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
irritable bowel syndrome Severity Score
Time frame: 8 weeks after the pretest
There are a total of 5 questions on this scale. This questionnaire is a positive question type. The score of each item can be from 0 to 100. Therefore, the overall severity of IBS ranges from 0 to 500. The severity of symptoms can be divided into mild; moderate; severe, the higher the score, the more severe the IBS symptoms
Irritable Bowel Syndrome Quality of Life
Time frame: pretest
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Irritable Bowel Syndrome Quality of Life
Time frame: 2 weeks after the pretest
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Irritable Bowel Syndrome Quality of Life
Time frame: 4 weeks after the pretest
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Irritable Bowel Syndrome Quality of Life
Time frame: 8 weeks after the pretest
This questionnaire has a total of 34 questions, all of which are positive questions, and are scored with five points, divided into 1 point = completely no, 2 points = a little bit, 3 points = medium, 4 points = equivalent, 5 points = extreme. The score range is 34~170 points, the higher the score, the worse the quality of life
Bristol Stool Form Scale
Time frame: pretest
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Bristol Stool Form Scale
Time frame: 2 weeks after the pretest
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Bristol Stool Form Scale
Time frame: 4 weeks after the pretest
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Bristol Stool Form Scale
Time frame: 8 weeks after the pretest
The first and second types of stool show that the patient has constipation, the first type is more serious than the second type; the normal stool types are the third and fourth types, and the fifth to seventh types are suspected Diarrhea (Lewis, \& Heaton, 1997), the above description indicates that the lower the score, the more severe the constipation symptoms, and vice versa, the more severe the diarrhea symptoms
Results and safety
The study was stopped early (reason given: The number of cases accepted has reached expectations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture-like transcutaneous electrical nerve stimulation in people with Acupuncture-like Transcutaneous Electrical Nerve Stimulation and Irritable Bowel Syndrome, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Jan 2026. 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 Taiwan. 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?
The study was stopped early (reason given: The number of cases accepted has reached expectations.). Results are not available in the source record.
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?
WHOQOL-BREF,Taiwan version (time frame: pretest). The study lists 16 primary outcomes in all. 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 6 Jan 2026.