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

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

abdominal functional electrical stimulation

Clinical Study ID

NCT04307303

BOWMAN

Ages 18-100
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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).

Study Design