Effect of Functional Magnetic Therapy on Constipation Predominant- Irritable Bowel Syndrome (IBS-C)

NCT07256262 | Not Yet Recruiting

• 1 other identifier: FPTBSUREC/0204/2225
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the potential benefits of functional magnetic therapy on constipation improvement and related symptoms in patients with IBS-C, including abdominal pain, bloating, bowel habits, and quality of life, as well as to assess patient satisfaction and experience with the therapy.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (3)

• IBS Severity Scoring System (IBS-SSS)

  It is a tool used to assess the severity of symptoms in patients with irritable bowel syndrome (IBS). It consists of five key questions that measure the intensity and impact of symptoms such as abdominal pain, bloating, bowel movement frequency, and the overall effect of IBS on QOL. Each symptom is rated on a scale from 0 to 100, and the total score ranges from 0 to 500. The total score helps categorize the severity of IBS as mild (75-175), moderate (175-300), or severe (300-500). The IBS-SSS is valuable for clinicians to monitor symptom progression, evaluate treatment effectiveness, and track the impact of IBS on a patient's daily life.

  8 weeks

• Complete Spontaneous Bowel Movements (CSBMs)

  A complete spontaneous bowel movement (CSBM) is defined as a natural, voluntary bowel movement without the need for medical intervention, medications, or external aids. It involves the elimination of waste with a feeling of complete evacuation, occurring regularly (from three times a week to three times a day). CSBM typically is accompanied by the sensation of complete emptying and occurs without laxative use in the previous 24 hours, indicating normal gastrointestinal health and function. It is used as a clinical marker to evaluate digestive health, particularly in assessing conditions like irritable bowel syndrome.

  8 weeks

• Bristol Stool Scale Assessment (BSS)

  It is a medical tool used to classify stool consistency and type, helping in assessing bowel health. The scale consists of seven types of stool, ranging from Type 1 (hard and lumpy) to Type 7 (liquid and watery). Types 3 and 4 are generally considered normal, with Type 3 resembling a sausage shape with cracks and Type 4 being smooth and soft, similar to a sausage or snake. It helps in monitoring bowel function, determining the effectiveness of treatments, and providing insight into gastrointestinal health.

  8 weeks

Secondary Outcomes (3)

• The Visual Analog Scale (VAS)

  8 weeks

• Pain Interference with Activities

  8 weeks

• Patient Assessment of Constipation Quality of Life (PAC-QOL )

  8 weeks

Study Arms (2)

Functional magnetic stimulation (FMS) + Conventional pharmacological therapy

EXPERIMENTAL

It will receive Trans-abdominal FMS plus the conventional pharmacological therapy for 8 weeks.

Device: Functional magnetic stimulation (FMS); Drug: Conventional pharmacological therapy

Conventional pharmacological therapy

OTHER

It will receive the conventional pharmacological therapy for 8 weeks.

Drug: Conventional pharmacological therapy

Interventions

Functional magnetic stimulation (FMS) DEVICE

Every patient will receive 20-minute FMS sessions on the TESLA FORMER device. Each treatment session will consist of one cycle (20 minutes each) based on the treatment area's size and the investigator's discretion. Treatment will be administered by a single applicator secured directly over the abdominal muscles. The device's output intensity will be escalated to a tolerable level depending on patient feedback, with average maximum intensities ranging from 98% to 100% across treatment sessions. The treatment will be 20 minutes long, with several steps including different frequency modulations to achieve stimulation of different muscle fibres.

Functional magnetic stimulation (FMS) + Conventional pharmacological therapy

Conventional pharmacological therapy DRUG

Every patient in both groups will receive conventional pharmacological therapy for 8 weeks.

Conventional pharmacological therapy; Functional magnetic stimulation (FMS) + Conventional pharmacological therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of IBS-C based on Rome IV criteria.
• Age: Adults aged 18-65 years.
• Symptom Duration: Symptoms present for at least 6 months before diagnosis.
• Ability to Consent: Patients must be able to provide informed consent and comply with study requirements.

You may not qualify if:

• Presence of Alarm Features or Red Flags:
• Unexplained weight loss.
• Blood in stool or rectal bleeding.
• Anaemia (iron deficiency anaemia).
• Persistent vomiting.
• Underlying Organic Diseases:
• \- Conditions such as inflammatory bowel disease (IBD), celiac disease, colorectal cancer, or other structural gastrointestinal abnormalities.
• Pregnancy or Lactation.
• Surgery or Anatomic Alterations: History of major gastrointestinal surgeries (e.g., bowel resection) that could affect bowel function.
• Contraindications to the Procedure:
• Patients with pacemaker
• Condition that can compromise increased abdominal pressure, such as hernia.
• Condition that can prevent adequate performance of abdominal muscle tension.
• Recent thoracic or abdominal surgery precluding the use of functional magnetic therapy.
• Rib fractures

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Tamer I Abo Elyazed, PhD

  Assistant Professor, Beni-Suef University

  STUDY CHAIR

• Ragaey Ahmad Eid, PhD

  Assistant Professor, Beni-Suef University

  STUDY DIRECTOR

• Marwa Mohamed Eleawa

  Lecturer, Beni-Suef University

  STUDY DIRECTOR

Central Study Contacts

Amira Ali Gaber Ali, B.Sc

CONTACT

+20 102 366 0326; Amira.ali_2160218@student.deraya.edu.eg

Tamer I Abo Elyazed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 28, 2025
• Primary Completion: January 28, 2026
• Study Completion: February 14, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

EG (1)