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

November 20, 2025 updated by: Amira Ali Gaber Ali, Beni-Suef University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Tamer I Abo Elyazed, PhD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Functional magnetic stimulation (FMS) + Conventional pharmacological therapy
It will receive Trans-abdominal FMS plus the conventional pharmacological therapy for 8 weeks.
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.
Other: Conventional pharmacological therapy
It will receive the conventional pharmacological therapy for 8 weeks.
Drug: Conventional pharmacological therapy
Every patient in both groups will receive conventional pharmacological therapy for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IBS Severity Scoring System (IBS-SSS)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Visual Analog Scale (VAS)
Time Frame: 8 weeks
The VAS consists of a straight line, typically 10 cm in length, where one end represents "no pain" and the other end represents "worst possible pain". Patients will be asked to mark a point on the line that represents the severity of their pain, with the position of the mark indicating their pain level. The scale is then measured in centimetres or millimeters, with higher values indicating more intense pain.
8 weeks
Pain Interference with Activities
Time Frame: 8 weeks
It refers to the interference of pain with different activities such as walking, sitting, working light or heavy work and It grades from (None □ Mild □ Moderate □ Severe Complete).
8 weeks
Patient Assessment of Constipation Quality of Life (PAC-QOL )
Time Frame: 8 weeks
It is a self-reported questionnaire designed to assess the impact of constipation on a patient's quality of life. It helps evaluate the psychological, social, and physical effects of constipation on daily living. The questionnaire consists of a series of statements that the patient rates based on their experiences over the past week, with responses typically ranging from "not at all" to "very much. The PAC-QOL is divided into four domains.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beni-Suef University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tamer I Abo Elyazed, PhD, Assistant Professor, Beni-Suef University
  • Study Director: Ragaey Ahmad Eid, PhD, Assistant Professor, Beni-Suef University
  • Study Director: Marwa Mohamed Eleawa, Lecturer, Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FPTBSUREC/0204/2225

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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