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

Technology
Bowel health
Online since 5 November 2021, updated 837 days ago

About this trial

This is a clinical trial enrolling individuals with spinal cord injuries to study the effect on bowel function of electrical stimulation (FES) to the abdomen (belly). FES) applies electrical current through the skin to nerves; this can cause contractions of weakened or paralyzed muscles. Earlier studies suggest abdominal FES may decrease constipation, overall bowel management time, and discomfort. If selected for the trial, participants will receive either FES or sham FES (low-level inactive stimulation) to abdominal muscles over a period of 12 weeks. No one (participant, doctor, or assessor) will know which stimulation (FES or sham FES) the participant is receiving. The FES group will be compared to the sham group (controls) to measure changes in bowel speed and function. Participants will also be asked to keep a bowel diary and to complete questionnaires about quality of life and bowel management.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T11
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    Yes
    C1-T11
    Additionally, participants must
    NOT have a history of organic bowel obstruction or inflammatory bowel disease
    NOT have implanted device, e.g. pacemaker

    What’s involved

    Type

    Technology

    Details

    Electrical stimulation to the belly over a study period of 12 weeks

    Potential benefits

    Main benefits

    Bowel health

    Additional benefits

    General health

    Mental health

    Sexual health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 May 2020
    • Organisation
    • Salisbury NHS Foundation Trust
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 May 2020
    • Organisation
    • Salisbury NHS Foundation Trust

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more