Neurogenic Bowel
Conditions
Brief 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.
Interventions
functional electrical stimulation of the abdominal muscles
Sponsors
Inspire Foundation
Salisbury NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time required for defecation | 8 weeks | Time taken to have a bowel movement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurogenic bowel dysfunction score | 8 weeks | Participants can score between 0 and 47 (0=minimum and 47=maximum score) a higher score = greater severity of symptoms |
Countries
United Kingdom
Outcome results
None listed