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

Last updated: April 25, 2024
Sponsor: Salisbury NHS Foundation Trust
Overall Status: Active - Recruiting

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

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: abdominal functional electrical stimulation
Phase:
Study Start date:
July 07, 2021
Estimated Completion Date:
May 30, 2024

Connect with a study center

  • Salisbury NHS Foundation Trust

    Salisbury, SP2 9BJ
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.