Clinical trial NCT04307303: Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury
Official title: A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurogenic Bowel
Lead sponsor: Salisbury NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Inspire Foundation
First posted: 2020-03-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: Time required for defecation
timeFrame: 8 weeks
Secondary outcomes:
measure: Neurogenic bowel dysfunction score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust
Study officials:
affiliation: Salisbury NHS Foundation Trust
name: Tamsyn Street
role: PRINCIPAL_INVESTIGATOR
References: