A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Time required for defecation
研究概览
简要总结
A well-managed bowel program is an essential part of daily life for many people with a SCI. Nevertheless, constipation is frequently reported (42-95%). Constipation embraces a spectrum of harms including both physical & psychological distress. Initial exploratory studies suggest abdominal FES may be useful for decreasing overall bowel management time, decreasing colonic transit time and reducing discomfort. The current study will seek to reproduce previous findings in a 12 week study, using overall bowel management time as a benchmark for establishing proof of principle. The study will include 36 people with a spinal cord injury aged 18 and over with an above T12 injury, a complete or incomplete lesion in a medically stable condition, one year or more after injury. Participants will be randomised into two groups. One group will receive abdominal electrical stimulation and the other group low dose abdominal electrical stimulation. Participants will be asked to keep a bowel diary and complete questionnaires examining quality of life and bowel management.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People with a diagnosis of spinal cord injury
- •Age =>18 years of age
- •Injury level at or above T12
- •complete or incomplete spinal cord lesion
- •Medically stable condition
- •Reflex bowel
- •=>1 year post spinal cord injury
排除标准
- •A history of organic bowel obstruction
- •Frequent opioid use,
- •Intrathecal baclofen or percutaneous endoscopic gastrostomy
- •Inflammatory bowel disease
- •Recent abdominal hernia
- •Recent gastrointestinal or abdominal surgery
- •Lower motor neuron lesions,
- •Suspected strictures or fistulae along the gastrointestinal tract
- •Physiologic gastrointestinal obstruction.
- •Other causes of constipation such as hypothyroidism, hypercalcaemia
- •Constipation predominant irritable bowel syndrome prior to diagnosis of SCI
- •Involvement in other research trial interventions likely to impact current trial
- •Poorly controlled epilepsy,
- •Cardiac pacemaker in situ
- •Other implanted electrical devices
- •Pregnancy or pregnancy planned
- •Cancerous tissue in the abdominal region
- •Any major skin disorders affecting the abdominal area)
- •Severe autonomic dysreflexia (tested at initial assessment).
结局指标
主要结局
Time required for defecation
时间窗: 8 weeks
Time taken to have a bowel movement
次要结局
- Neurogenic bowel dysfunction score(8 weeks)