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

NCT ID: NCT07256262

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-28
• Study Completion Date: 2026-02-14

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.

Detailed Description

Functional magnetic stimulation (FMS) has emerged as a promising non-invasive therapeutic approach for managing irritable bowel syndrome (IBS) with predominant constipation, operating through the application of electromagnetic fields that induce electrical currents to modulate neural activity and gastrointestinal function.

Previous research has demonstrated multiple therapeutic benefits of FMS including enhanced bowel motility, increased rectal pain thresholds leading to reduced abdominal pain, improved visceral hypersensitivity, and alleviation of associated psychological symptoms such as anxiety and depression in patients with functional bowel disorders.

The TESLA Former is a high-intensity Functional Magnetic Stimulation (FMS) device, that operates through multiple therapeutic mechanisms in treating IBS with predominant constipation: it delivers electromagnetic pulses to strengthen pelvic floor muscles and enhance defecation dynamics while modulating the brain-gut axis through stimulation of pudendal and sacral nerves (S2-S4); additionally, it influences the enteric nervous system (ENS) to normalize gut peristalsis and bowel transit, while simultaneously reducing inflammation and stress response through autonomic nervous system modulation, ultimately addressing both the physical and psychological components of IBS by improving muscle coordination, reducing visceral hypersensitivity, and promoting a balanced gut microbiota environment.

Research has demonstrated that the TESLA Former delivers significant therapeutic outcomes in treating IBS, including improved bowel function with increased frequency and ease of bowel movements, reduced abdominal discomfort manifested through diminished bloating and visceral pain, and enhanced quality of life (QOL) through reduced laxative dependency and improved symptom control; notably, this non-invasive therapy demonstrates excellent safety and tolerability profile.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Functional magnetic stimulation (FMS) + Conventional pharmacological therapy

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

Group Type: EXPERIMENTAL

Functional magnetic stimulation (FMS)

Intervention Type: 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.

Conventional pharmacological therapy

Intervention Type: DRUG

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

Conventional pharmacological therapy

It will receive the conventional pharmacological therapy for 8 weeks.

Group Type: OTHER

Conventional pharmacological therapy

Intervention Type: DRUG

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

Interventions

Functional magnetic stimulation (FMS)

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.

Intervention Type: DEVICE

Conventional pharmacological therapy

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of IBS-C based on Rome IV criteria.

2. Age: Adults aged 18-65 years.

3. Symptom Duration: Symptoms present for at least 6 months before diagnosis.

4. Ability to Consent: Patients must be able to provide informed consent and comply with study requirements.

Exclusion Criteria

1. Presence of Alarm Features or Red Flags:

• Unexplained weight loss.
• Blood in stool or rectal bleeding.
• Anaemia (iron deficiency anaemia).
• Persistent vomiting.

2. Underlying Organic Diseases:

• Conditions such as inflammatory bowel disease (IBD), celiac disease, colorectal cancer, or other structural gastrointestinal abnormalities.

3. Pregnancy or Lactation.

4. Surgery or Anatomic Alterations: History of major gastrointestinal surgeries (e.g., bowel resection) that could affect bowel function.

5. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Amira Ali Gaber Ali

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamer I Abo Elyazed, PhD

Role: STUDY_CHAIR

Assistant Professor, Beni-Suef University

Ragaey Ahmad Eid, PhD

Role: STUDY_DIRECTOR

Assistant Professor, Beni-Suef University

Marwa Mohamed Eleawa

Role: STUDY_DIRECTOR

Lecturer, Beni-Suef University

Locations

Beni-Suef University

Banī Suwayf, , Egypt

Countries

Egypt

Central Contacts

Amira Ali Gaber Ali, B.Sc

Role: CONTACT

Amira.ali_2160218@student.deraya.edu.eg

+20 102 366 0326

Tamer I Abo Elyazed, PhD

Role: CONTACT

Facility Contacts

Amira Ali Gaber Ali

Role: primary

Amira.ali_2160218@student.deraya.edu.eg

+20 102 366 0326

Other Identifiers

FPTBSUREC/0204/2225

Identifier Type: -

Identifier Source: org_study_id