NCT07256262

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
DRUG	Conventional pharmacological therapy	Every patient in both groups will receive conventional pharmacological therapy for 8 weeks.

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-01-28
• Completion: 2026-02-14
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: Egypt