Laser Acupuncture on Irritable Bowel Syndrome in Females

Constipation-predominant Irritable Bowel Syndrome Clinical Trial

Official title:

Laser Acupuncture for Treatment of Female Patients With Irritable Bowel Syndrome:RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757037
• Other study ID #: P.T/WH/2/2023/31
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: sara Magdy Ahmed, lecturer
• Phone: 01063998331
• Email: saramagdy87[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study to investigate effect of laser acupuncture on constipation predominant irritable bowel syndrome in female patients

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Constipation-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Device:
• laser acupuncture
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].

Locations

Country	Name	City	State
Egypt	Egypt , Giza	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022)		6 weeks
Primary	Irritable Bowel Syndrome Severity Score (IBS-SSS)		6 weeks
Secondary	IBS Quality of Life (IBS-QOL) (Andrae et al., 2013)		6 weeks
Secondary	Visceral Sensitivity Index (VSI)		6 weeks