Effect of Functional Magnetic Therapy on Constipation Predominant- Irritable Bowel Syndrome (IBS-C)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- IBS Severity Scoring System (IBS-SSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Conventional pharmacological therapy
It will receive the conventional pharmacological therapy for 8 weeks.
干预措施: Conventional pharmacological therapy (Drug)
Functional magnetic stimulation (FMS) + Conventional pharmacological therapy
It will receive Trans-abdominal FMS plus the conventional pharmacological therapy for 8 weeks.
干预措施: Functional magnetic stimulation (FMS) (Device)
Functional magnetic stimulation (FMS) + Conventional pharmacological therapy
It will receive Trans-abdominal FMS plus the conventional pharmacological therapy for 8 weeks.
干预措施: Conventional pharmacological therapy (Drug)
结局指标
主要结局
IBS Severity Scoring System (IBS-SSS)
时间窗: 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.
Complete Spontaneous Bowel Movements (CSBMs)
时间窗: 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.
Bristol Stool Scale Assessment (BSS)
时间窗: 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.
次要结局
- The Visual Analog Scale (VAS)(8 weeks)
- Pain Interference with Activities(8 weeks)
- Patient Assessment of Constipation Quality of Life (PAC-QOL )(8 weeks)
研究者
Amira Ali Gaber Ali
Principal Investigator
Beni-Suef University