Acupuncture-like Transcutaneous Electrical Nerve Stimulation on Bowel Symptom and Quality of Life in Patients With Irritable Bowel Syndrome

NCT05042661 | Terminated

• 1 other identifier: TFang
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acupuncture-like Transcutaneous Electrical Nerve Stimulation; Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; acupuncture-like transcutaneous electrical nervestimulation; quality of life

Outcome Measures

Primary Outcomes (16)

• 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.

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  8 weeks after the pretest

Other Outcomes (17)

• Part 1: Basic personal information:Basic and disease information list 1

  pretest

• Part 1: Basic personal information:Basic and disease information list 2

  pretest

• Part 1: Basic personal information:Basic and disease information list 3

  pretest

Study Arms (2)

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

Device: acupuncture-like transcutaneous electrical nerve stimulation

Control group:conventional therapy

NO INTERVENTION

The control group will receive routine care.

Interventions

acupuncture-like transcutaneous electrical nerve stimulation DEVICE

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.

acupuncture-like transcutaneous electrical nerve stimulation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Tsu Ying Fang

New Taipei City, 237, Taiwan

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 13, 2021
• Study Start: February 1, 2021
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: January 6, 2026

Record last verified: 2023-02

Locations

TW (1)