Laser Acupuncture on Irritable Bowel Syndrome in Females

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05757037
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Constipation-predominant Irritable Bowel Syndrome	Device: laser acupuncture	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Laser Acupuncture for Treatment of Female Patients With Irritable Bowel Syndrome:RCT
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Apr 15, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laser acupuncture group The participants in this group will receive 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 in the supine position.	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].
Sham Comparator: Sham laser acupuncture The participants in the control group will receive sham laser acupuncture treatment, without any laser output	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].

Outcome Measures

Primary Outcome Measures

1. The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022) [6 weeks]

2. Irritable Bowel Syndrome Severity Score (IBS-SSS) [6 weeks]

Secondary Outcome Measures

1. IBS Quality of Life (IBS-QOL) (Andrae et al., 2013) [6 weeks]

2. Visceral Sensitivity Index (VSI) [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

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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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sara Magdy Ahmed, PRINCIPAL INVESTIGATOR, Cairo University
• ClinicalTrials.gov Identifier: NCT05757037
• Other Study ID Numbers: P.T/WH/2/2023/31
• First Posted: Mar 7, 2023
• Last Update Posted: Mar 7, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation

Study Results

No Results Posted as of Mar 7, 2023