Neurogenic Bowel Dysfunction: Evaluation of the Effects of Osteopathic Manipulative Treatment in People With Central Nervous System Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Neurogenic bowel dysfunction score (NBDS)
研究概览
简要总结
People affected central nervous system (CNS) diseases often suffer from neurogenic bowel dysfunction (NBD) that causes a reduction in the quality of life and participation in social life. Although some conservative approaches exist to treat NBD, none has shown to be effective in managing this complex condition. Osteopathic manipulative treatment (OMT) has shown to be efficient in CNS diseases such as epilepsy and migraine.
This randomised trial aims at evaluating the efficacy of osteopathic manipulative treatment (OMT) in supporting the management of NBD. The research will be conducted at the outpatient service of Neuro-Urology / Spinal Unit of the Città della Salute e della Scienza Hospital of Torino.
A sample of 62 participants will be divided into two groups: standard (nursing intervention) and experimental (nursing intervention and OMT). A neuro-urologist will determine the eligibility for the study. The outcomes will include self-reported and instrumental measures that will be evaluated in 3 times (before, at the end of the intervention and the follow- up three months).
The protocol has been approved by the Ethics Committee of the Città della Salute e della Scienza Hospital of Torino on 15.04.2019, protocol number 0040534. The standard intervention has been scheduled for 28.10.2019.
详细描述
Aim of the study The present randomised trial aims to evaluate the efficacy of osteopathic manipulative treatment in supporting the management of neurogenic bowel dysfunction in CNS diseases.
Study design Randomised controlled trial. Participants recruited will be divided into two groups. The treatment group will receive five osteopathic manipulative treatment sessions in addition to the standard treatment.
The control group will only receive standard treatment.
Sample A neuro-urologist will determine eligibility for the study during an interview. Participants will be conducted during outpatient visits to the Neuro Urology department. This study does not include any diagnostic assessment or treatment, which are different from the normal patient's evaluation and management process.
Informed consent will be obtained before any evaluation or treatment. Principal Investigator will explain in detail the study purpose and procedures, risks and potential benefits. Participants will be provided with contact information and have adequate time to consider their participation in the study and encouraged to ask questions, both during the initial interview and throughout the study.
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
- •neurogenic bowel dysfunction secondary to acquired disease of the central nervous system
- •Neurogenic Bowel Dysfunction Score (NBDS) between 6 and 30
排除标准
- •previous dysfunctional conditions or organic diseases affecting the bowel tract that are pre-existing at neurological diagnosis
- •patients with an NBDS score lower than 6 (very mild bowel dysfunction) and above 30 (very severe neurogenic bowel dysfunction)
- •ostomy condition (ileus and colon)
- •psychiatric patients
- •presence of cognitive disorders
- •female patients with proven, or even doubtful, pregnancy status.
结局指标
主要结局
Neurogenic bowel dysfunction score (NBDS)
时间窗: - Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment
self-reported questionnaire. The Neurogenic Bowel Dysfunction Score is a 10-item questionnaire covering frequency of bowel movements, headache, perspiration or discomfort during defaecation; medication for constipation or faecal incontinence; time spent on defaecation; frequency of digital stimulation or evacuation; frequency of faecal incontinence; flatus; and perianal skin problems. It ranges between 0 and 47; lower scores indicate a better bowel function, while a score over 14 is considered to be an index of severe bowel dysfunction. Score 0-6 Very low 7-9 Low 10-13 Moderate 14 or more Severe The hypothesis of treatment efficacy is supported by the observation of a difference between the groups in the NBDS score.
次要结局
- Bowel transit time(- Pre-treatment - Follow-up at three months after the end of the treatment)
- Quality of Life Short Form-36 (SF-36) Questionnaire(- Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment)
研究者
Alessio Conti
RN, PhD - Postoctoral Fellow in Nursing
University of Turin, Italy