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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Препарат Conventional pharmacological therapy
  Every patient in both groups will receive conventional pharmacological therapy for 8 weeks.

Первичные конечные точки

• IBS Severity Scoring System (IBS-SSS) [Срок оценки: 8 weeks]
• Complete Spontaneous Bowel Movements (CSBMs) [Срок оценки: 8 weeks]
• Bristol Stool Scale Assessment (BSS) [Срок оценки: 8 weeks]

Вторичные конечные точки (3)

• The Visual Analog Scale (VAS) [Срок оценки: 8 weeks]
• Pain Interference with Activities [Срок оценки: 8 weeks]
• Patient Assessment of Constipation Quality of Life (PAC-QOL ) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Beni-Suef University — Banī Suwayf

Идентификаторы

NCT: NCT07256262 · FPTBSUREC/0204/2225

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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