Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Numerical rating scale (from 0 to 10)
研究概览
简要总结
conservative management of functional constipation is a preferable method including biofeedback and spinal magnetic stimulation sessions
详细描述
Constipation varies in presentation and severity among patients and affects patients' quality of life of varied degrees depending on how it manifests and how severe it is. The prevalence of constipation in the general population is estimated to affect about 20% of the population
Spinal Magnetic Stimulation (SMS) is a non-invasive, painless neurophysiological treatment that uses extracorporeal magnetic stimulation to direct extracorporeal magnetic stimulation to the spinal nerves and deep muscles to aid bowl evacuation without the use of surgery. This noninvasive approach was created to help with micturition, expiration, and bowel function
The aim of this work is to study the efficacy of SMS and biofeedback versus biofeedback in the management of functional constipation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults patients diagnosed by Rome IV criteria as having functional constipation
排除标准
- •Patients younger than 18 years old.
- •Patients with irritable bowel syndrome.
- •Anal hemorrhoids or bleeding.
- •Any condition that may complicate bowel problems, such as Parkinson's disease, stroke, or traumatic brain injury.
研究组 & 干预措施
Sham Therapy
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation.
干预措施: spinal magnetic stimulation (Other)
Spinal magnetic stimulation
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation.
干预措施: spinal magnetic stimulation (Other)
结局指标
主要结局
Numerical rating scale (from 0 to 10)
时间窗: After 15 days
pain assessment, zero indicates no pain, 10 indicates maximum pain degree
Patient Assessment of Constipation Quality of Life questionnaire
时间窗: After 15 days
Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems
pressure manometry
时间窗: After 15 days
Assessment of pelvic floor power of contraction
Number of weekly bowel movement
时间窗: after 15 days
Mean weekly complete spontaneous bowel movements.
The Bristol Stool Scale (from 1 to 5)
时间窗: After 15 days
Stool consistency
次要结局
- Number of weekly bowel movement(after one month)
- The Bristol Stool Scale (from 1 to 5)(After one month)
- Numerical rating scale (from 0 to 10)(After one month)
- Pressure manometry(After one month)
- Patient Assessment of Constipation Quality of Life questionnaire(After one month)
研究者
Nehad Mohamed Elshatby Mahmoud
Physician
University of Alexandria