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

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.

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome; Acupuncture-like Transcutaneous Electrical Nerve Stimulation
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 237
    • Tsu Ying Fang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. A patient with irritable bowel syndrome diagnosed by a doctor for at least 6 months (inclusive).
3. Communicate in Mandarin or Hokkien.

Exclusion Criteria:

1. Those who cannot take care of themselves in daily life.
2. Those who have had severe abdominal and colorectal surgery.
3. Those who have been diagnosed with inflammatory bowel disease or colorectal cancer.
4. Those with a history of mental illness, such as schizophrenia and obsessive- compulsive disorder.
5. Women who are pregnant, breastfeeding, and less than 12 months after delivery.
6. Other serious diseases, such as acute myocardial infarction, endocrine disease, decompensated cirrhosis, stroke, and end-stage renal disease, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture-like transcutaneous electrical nerve stimulation; The experimental group received acupuncture-like transcutaneous electrical nerve stimulation three times a week for 4 weeks.; 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; 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.
No Intervention: Control group:conventional therapy; The control group will receive routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Basic personal information:Basic and disease information list 1	gender	pretest
Part 1: Basic personal information:Basic and disease information list 2	Date of birth	pretest
Part 1: Basic personal information:Basic and disease information list 3	marital status	pretest
Part 1: Basic personal information:Basic and disease information list 4	education level	pretest
Part 1: Basic personal information:Basic and disease information list 5	Work	pretest
Part 1: Basic personal information:Basic and disease information list 6	religion	pretest
Part 1: Basic personal information:Basic and disease information list 7	family history	pretest
Part 1: Basic personal information:Basic and disease information list 8	History of chronic disease	pretest
Basic and disease information list 9	smokes	pretest
Part 1: Basic personal information:Basic and disease information list 10	drink wine	pretest
Part 1: Basic personal information:Basic and disease information list 11	Betel nut	pretest
Part 1: Basic personal information:Basic and disease information list 12	Sleep status	pretest
Part 1: Basic personal information:Basic and disease information list 13	Special eating habits	pretest
Part 1: Basic personal information:Basic and disease information list 14	Exercise habits	pretest
Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 1	Irritable bowel disease onset time	pretest
Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 2	Bowel movement	pretest
Part 2: Symptoms of Irritable Bowel Syndrome:Basic and disease information list 3	treatment	pretest

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: September 4, 2021
• First Submitted That Met QC Criteria: September 4, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; irritable bowel syndrome; acupuncture-like transcutaneous electrical nervestimulation
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: TFang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No