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Laser Acupuncture on Irritable Bowel Syndrome in Females

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05757037
Enrollment
50
Registered
2023-03-07
Start date
2023-03-01
Completion date
2024-09-01
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation-predominant Irritable Bowel Syndrome

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.

Interventions

DEVICElaser 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 \[B1: 599.5Hz, B2: 1199Hz, B3: 2398Hz, B4: 4776Hz, B5: 9552 Hz, B6: 19,104Hz, and B7: 38,208Hz\].

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 40 Years
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

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.

Design outcomes

Primary

MeasureTime frame
The number of complete spontaneous bowel movement (CSBMs) per week (Zhihui et al., 2022)6 weeks
Irritable Bowel Syndrome Severity Score (IBS-SSS)6 weeks

Secondary

MeasureTime frame
IBS Quality of Life (IBS-QOL) (Andrae et al., 2013)6 weeks
Visceral Sensitivity Index (VSI)6 weeks

Countries

Egypt

Contacts

Primary Contactsara Magdy Ahmed, lecturer
saramagdy87@cu.edu.eg01063998331
Backup ContactMarwa Shafik Mustafa Saleh, Ass.Prof
Marwa_shafiek2000@cu.edu.eg01008342466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026