Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury (NCT04307303) | Clinical Trial Compass
CompletedNot Applicable
Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury
United Kingdom36 participantsStarted 2021-07-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Inclusion Criteria:
* 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
* Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.