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

Beni-Suef University

Status: Not yet enrolling

Conditions: Irritable Bowel Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07256262

FPTBSUREC/0204/2225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Functional magnetic stimulation (FMS) + Conventional pharmacological therapy

Experimental group

Description:

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

Treatment:

Drug: Conventional pharmacological therapy

Device: Functional magnetic stimulation (FMS)

Conventional pharmacological therapy

Other group

Description:

It will receive the conventional pharmacological therapy for 8 weeks.

Treatment:

Drug: Conventional pharmacological therapy