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Search / Trial NCT04307303

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

Launched by SALISBURY NHS FOUNDATION TRUST · Mar 11, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of electrical stimulation on the abdominal muscles to help manage bowel issues in people with spinal cord injuries (SCI). Many individuals with SCI experience constipation, which can cause both physical pain and emotional stress. Researchers want to see if using electrical stimulation for 12 weeks can reduce the time it takes to manage bowel movements and improve overall comfort. The trial will include 36 participants aged 18 and older who have had a spinal cord injury at or above the T12 level for at least a year.

To participate, individuals must be medically stable and have certain types of bowel function. Participants will be divided into two groups: one will receive regular electrical stimulation, while the other will receive a lower dose. Throughout the study, participants will keep a bowel diary and complete questionnaires to help researchers understand how this treatment affects their quality of life and bowel management. It's important to note that certain health conditions and treatments may exclude some people from joining this study.

Gender

ALL

Eligibility 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).

About Salisbury Nhs Foundation Trust

Salisbury NHS Foundation Trust is a leading healthcare provider in the UK, dedicated to delivering high-quality patient care and advancing medical research through innovative clinical trials. As a trusted sponsor, the Trust emphasizes collaboration with academic institutions and industry partners to foster groundbreaking studies that improve clinical outcomes and enhance patient safety. With a robust infrastructure and a commitment to ethical standards, Salisbury NHS Foundation Trust strives to contribute significantly to the advancement of medical knowledge and the development of new therapies.

Locations

Salisbury, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Tamsyn Street

Principal Investigator

Salisbury NHS Foundation Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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