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Laser Acupuncture on Irritable Bowel Syndrome in Females

Primary Purpose

Constipation-predominant Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser acupuncture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation-predominant Irritable Bowel Syndrome

Eligibility Criteria

35 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: All participants will meet diagnostic criteria (Rome IV) for IBS-C Their age will range from 20-35 years old Their body mass index (BMI) will range from >18.5kg/m2 and <29.9kg/m2 Exclusion Criteria: Taking medications known to cause constipation Any organic diseases that might induce constipation such as colorectal cancer, metabolic disorders, multiple sclerosis, or neurological disorders Organic diseases of the small or large intestine such as ulcerative colitis and Crohn's disease A history of gastrointestinal surgery (other than appendectomy or cholecystectomy) Mechanical obstruction Serious concomitant disease of the heart, liver, or kidney or diabetes Pregnant or lactating women Severe psychiatric disorders Knowledgeable of acupoints and meridians that might unblind the treatment.

Sites / Locations

  • Egypt , GizaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser acupuncture group

Sham laser acupuncture

Arm Description

The participants in this group will receive low level laser therapy 3 times weekly for 4 weeks. A diode laser emitter with a 650 nm wavelength, an average power of 30 mW, and a 0.15 cm2 spot size, with continuous wave, and exposure of 90 s per acupuncture point had been used in the current study at each of the following acupoints: : ST25, ST37 , LI11 , BL60 , and BL25 Also, participants will recieve received behavioral therapy advice: Sitting on the toilet for 10-15 min after breakfast and after dinner and maintaining the same bathroom schedule every day, sitting in the correct position on the toilet (leaning forward while resting forearms on thighs, raising both feet on a small block (like a step stool) with feet apart, relax and lower the shoulders, and do not suppress urges to defecate and relax stomach muscles). Dietary modifications include a high-fiber diet, fruits, vegetables, whole grain, dairy, and wheat

The participants in the control group will receive sham laser acupuncture treatment, without any laser output. The participants are unable to recognize whether they are being treated or not because laser acupuncture is a low-intensity and non-thermal laser irradiation. Also, participants will receive behavioral therapy advice.

Outcomes

Primary Outcome Measures

The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022)
Irritable Bowel Syndrome Severity Score (IBS-SSS)

Secondary Outcome Measures

IBS Quality of Life (IBS-QOL) (Andrae et al., 2013)
Visceral Sensitivity Index (VSI)

Full Information

First Posted
February 24, 2023
Last Updated
July 21, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05757037
Brief Title
Laser Acupuncture on Irritable Bowel Syndrome in Females
Official Title
Laser Acupuncture for Treatment of Female Patients With Irritable Bowel Syndrome:RCT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study to investigate effect of laser acupuncture on constipation predominant irritable bowel syndrome in female patients
Detailed Description
Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder characterized by recurrent abdominal pain and/or bloating related to defecation without reliable biological markers . IBS is associated with substantial burden, such as higher levels of anxiety, lost productivity at work, work absenteeism (Pimentel, 2018). IBS has a strong predominance in women IBS-C includes a wide range of symptoms, and its pathophysiology is complex and not fully understood. Visceral hypersensitivity and delayed gut transit are recognized as major pathophysiological mechanisms in IBS-C. Visceral hypersensitivity may account for symptoms of abdominal pain, bloating, and discomfort. Delayed gut transit causes constipation The unsatisfactory treatment responses and adverse effects associated with pharmacologic therapies have resulted in a higher demand for alternative therapies Acupoints and manipulations are the same in both the experimental and the control groups. The participants in the control group will receive sham laser acupuncture treatment, without any laser output, while the participants in the experimental group will sequentially receive 0.375J of energy at each of the following acupoints: Baihui (GV20), Yintang (GV29), Taichong (LR3), Zusanli (ST36), Sanyinjiao (SP6), Tianshu (ST25), and Shangjuxu (ST37) acupoint .Using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz]. The laser treatment will be applied to each point for 5 seconds, to deliver a total treatment dose of 4.5J/cm2 . intervention will be 3t/ week for 6 weeks in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation-predominant Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture group
Arm Type
Experimental
Arm Description
The participants in this group will receive low level laser therapy 3 times weekly for 4 weeks. A diode laser emitter with a 650 nm wavelength, an average power of 30 mW, and a 0.15 cm2 spot size, with continuous wave, and exposure of 90 s per acupuncture point had been used in the current study at each of the following acupoints: : ST25, ST37 , LI11 , BL60 , and BL25 Also, participants will recieve received behavioral therapy advice: Sitting on the toilet for 10-15 min after breakfast and after dinner and maintaining the same bathroom schedule every day, sitting in the correct position on the toilet (leaning forward while resting forearms on thighs, raising both feet on a small block (like a step stool) with feet apart, relax and lower the shoulders, and do not suppress urges to defecate and relax stomach muscles). Dietary modifications include a high-fiber diet, fruits, vegetables, whole grain, dairy, and wheat
Arm Title
Sham laser acupuncture
Arm Type
Sham Comparator
Arm Description
The participants in the control group will receive sham laser acupuncture treatment, without any laser output. The participants are unable to recognize whether they are being treated or not because laser acupuncture is a low-intensity and non-thermal laser irradiation. Also, participants will receive behavioral therapy advice.
Intervention Type
Device
Intervention Name(s)
laser acupuncture
Intervention Description
a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz].
Primary Outcome Measure Information:
Title
The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022)
Time Frame
6 weeks
Title
Irritable Bowel Syndrome Severity Score (IBS-SSS)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
IBS Quality of Life (IBS-QOL) (Andrae et al., 2013)
Time Frame
6 weeks
Title
Visceral Sensitivity Index (VSI)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All participants will meet diagnostic criteria (Rome IV) for IBS-C Their age will range from 20-35 years old Their body mass index (BMI) will range from >18.5kg/m2 and <29.9kg/m2 Exclusion Criteria: Taking medications known to cause constipation Any organic diseases that might induce constipation such as colorectal cancer, metabolic disorders, multiple sclerosis, or neurological disorders Organic diseases of the small or large intestine such as ulcerative colitis and Crohn's disease A history of gastrointestinal surgery (other than appendectomy or cholecystectomy) Mechanical obstruction Serious concomitant disease of the heart, liver, or kidney or diabetes Pregnant or lactating women Severe psychiatric disorders Knowledgeable of acupoints and meridians that might unblind the treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sara Magdy Ahmed, lecturer
Phone
01063998331
Email
saramagdy87@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Shafik Mustafa Saleh, Ass.Prof
Phone
01008342466
Email
Marwa_shafiek2000@cu.edu.eg
Facility Information:
Facility Name
Egypt , Giza
City
Giza
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Laser Acupuncture on Irritable Bowel Syndrome in Females

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