Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury

Study Overview
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Brief Summary
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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 managementitme 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.

Official Title
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A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)

Conditions
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Neurogenic Bowel

Intervention / Treatment
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* Device: abdominal functional electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with a diagnosis of SCI (age=>18) above T12 complete or incomplete lesion in a medically stable condition with a reflex bowel =>1 year post spinal injury). - Exclusion Criteria: A history of organic bowel obstruction, frequent opioid use, intrathecal baclofen or percutaneous endoscopic gastrostomy, inflammatory bowel disease, abdominal hernia, any gastrointestinal or abdominal surgery (not necessarily excluded unless recent will require further investigation), lower motor neuron lesions, suspected strictures or fistulae along the gastrointestinal tract, physiologic gastrointestinal obstruction. Other causes of constipation such as hypothyroidism, hypercalcaemia and a prior history of constipation predominant IBS prior to diagnosis of SCI. Involvement in other research trial interventions likely to have an impact on the protocol or results of the current study. Contra indications to electrical stimulation Poorly controlled epilepsy, cardiac pacemaker in situ or other implanted electrical devices (will require further investigation to examine whether there is an interaction between the device and FES) 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). -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal functional electrical stimulation<br> | Device: abdominal functional electrical stimulation<br>* functional electrical stimulation of the abdominal muscles<br>* Other names: ABFES;|
| Sham Comparator: Low dose abdominal functional electrical stimulation arm<br> | Device: abdominal functional electrical stimulation<br>* functional electrical stimulation of the abdominal muscles<br>* Other names: ABFES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for defecation |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurogenic bowel dysfunction score |  | 8 weeks | 
| Male/Female sexual function index |  | 8 weeks |