Effectiveness of Treatment with RedCord in Neurogenic Bowel Dysfunction in People with Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Neurogenic Bowel Dysfunction score (NBDS)
研究概览
简要总结
The study aims to evaluate the effectiveness of Redcord treatment for neurogenic bowel dysfunction in patients with multiple sclerosis. The main objectives are:
- Assess the impact of Redcord on bowel function and quality of life in multiple sclerosis patients.
- Compare the outcomes of Redcord treatment with standard care practices.
Participants will undergo Redcord therapy sessions and their bowel function will be monitored and compared to a control group receiving standard care. The study will measure improvements in bowel control, frequency, and overall patient satisfaction.
详细描述
Study Objectives
- Primary Objective: Assess the effectiveness of Redcord therapy in improving bowel function in MS patients.
- Secondary Objectives:
- To evaluate the difference in the score of the SF-36 health questionnaire and the specific quality of life questionnaire for patients with constipation CVE-20 before and after treatment, comparing these scores between the control and intervention groups.
- To test the improvement in electrical muscle activity by electromyography of the rectus abdominis, external oblique, internal oblique, erector spinae and pelvic floor muscles and the possible relationship between the contraction of the muscles that make up the abdominal girdle (transverse abdominis, internal oblique, external oblique and rectus abdominis) and the pelvic floor muscles, comparing the control and intervention groups.
Study Design
- Type: Interventional (Clinical Trial)
- Estimated Enrollment: 76 participants
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Evaluator)
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
- Single (Outcomes Assessor)
盲法说明
This is a single-blind study. It is not possible to blind the participants or the physiotherapist who will carry out the interventions; however, the researcher in charge of conducting the pre-treatment, post-treatment and follow-up assessments, and the data analyst will be blinded.
To preserve the blindness of the evaluators and analyst, a data coding table will be used to which only the principal investigator will have access.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People diagnosed with Multiple Sclerosis according to McDonald's criteria.
- •EDSS less than 6 points.
- •Willingness to participate.
排除标准
- •People with cognitive impairment, which makes it difficult to understand the questionnaires properly.
- •Pregnant women.
- •Severe psychological or psychiatric pathology diagnosed.
结局指标
主要结局
Neurogenic Bowel Dysfunction score (NBDS)
时间窗: baseline, 6, 12 and 24 weeks
Improvement in bowel control, measured by the Neurogenic Bowel Dysfunction Score (NBD Score) over a period of 24 weeks. Neurogenic Bowel Dysfunction score (NBDS) validated in Spanish is a questionnaire used for the clinical evaluation of colorectal and anal dysfunction. It is used to assess bowel dysfunction in neurological pathologies. It quantifies the severity of bowel dysfunction in 4 categories: very mild (score 0 to 6), mild (score 7 to 9), moderate (score 10 to 13) and severe (score greater than or equal to 14). It consists of 10 items relating to frequency of bowel movements, presence of headache and/or sweating during defecation, use of medication for constipation, time used for each defecation, frequency of bowel movements by digital extraction, frequency of faecal incontinence, medication used for faecal incontinence, presence of anal incontinence, skin problems in the peri-anal area.
次要结局
- Electromyography: Root mean square(baseline, 6, 12 and 24 weeks)
研究者
Cristina Lirio
PhD
University of Castilla-La Mancha