Effect of Functional Magnetic Therapy on Constipation Predominant- Irritable Bowel Syndrome (IBS-C)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional magnetic stimulation (FMS), Conventional pharmacological therapy.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. T - Drug Conventional pharmacological therapy
Every patient in both groups will receive conventional pharmacological therapy for 8 weeks.
Primary outcome measures
- IBS Severity Scoring System (IBS-SSS) [Time frame: 8 weeks]
- Complete Spontaneous Bowel Movements (CSBMs) [Time frame: 8 weeks]
- Bristol Stool Scale Assessment (BSS) [Time frame: 8 weeks]
Secondary outcome measures (3)
- The Visual Analog Scale (VAS) [Time frame: 8 weeks]
- Pain Interference with Activities [Time frame: 8 weeks]
- Patient Assessment of Constipation Quality of Life (PAC-QOL ) [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Beni-Suef University — Banī Suwayf
Identifiers
NCT: NCT07256262 · FPTBSUREC/0204/2225