Mesotherapy Treatment of Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS)
研究概览
简要总结
Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.
Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.
Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from Irritable Bowel Syndrome according to the Rome IV criteria, whose diagnosis was made by a specialist in Hepato-Gastro-Enterology,
- •Francis score >75/500, i.e. minimal, moderate or severe severity,
- •Patient who has failed conventional treatment (treatment followed for at least 1 year and not showing an improvement in symptoms)
- •Absence of risk of ongoing pregnancy in women of childbearing age, validated by a urine test during the first consultation and before treatment and each month during treatment and until 1 month after the end of treatment
排除标准
- •Patient with the following medical history or current pathologies: organic gastrointestinal pathology, disabling neurological pathology, disabling psychiatric pathology
- •Recent Post Traumatic Stress Syndrome (<1 year),
- •Fibromyalgia syndrome,
- •Known allergy to medications used in mesotherapy treatment,
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Experimental group
干预措施: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate (Drug)
结局指标
主要结局
Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS)
时间窗: day 8, day 15, day 30, day 45
Includes 5 items regarding pain (intensity and number of days), abdominal distention, satisfaction of bowel habit, and interference of daily life of the last 10 d on a 10-point scale. Gives a score between 0 and 500, and groups of severity can be made: mild (≤175), moderate (175-300), and severe (≥300) IBS.
次要结局
- Pain evaluation(day 8, day 15, day 30, day 45)
- Global satisfaction(day 45)
- Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale"(day 30, day 45)
- Functional Digestive Disorders Quality of Life questionnaire (FDDQL)(day 30, day 45)