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

NCT ID: NCT04307303

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2025-06-11

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.

Conditions

Neurogenic Bowel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Abdominal functional electrical stimulation

Group Type: EXPERIMENTAL

abdominal functional electrical stimulation

Intervention Type: DEVICE

functional electrical stimulation of the abdominal muscles

Low dose abdominal functional electrical stimulation arm

Group Type: SHAM_COMPARATOR

abdominal functional electrical stimulation

Intervention Type: DEVICE

functional electrical stimulation of the abdominal muscles

Interventions

abdominal functional electrical stimulation

functional electrical stimulation of the abdominal muscles

Intervention Type: DEVICE

Other Intervention Names

ABFES

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inspire Foundation

UNKNOWN

Sponsor Role: collaborator

Salisbury NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamsyn Street

Role: PRINCIPAL_INVESTIGATOR

Salisbury NHS Foundation Trust

Locations

Salisbury NHS Foundation Trust

Salisbury, , United Kingdom

Countries

United Kingdom

Other Identifiers

BOWMAN

Identifier Type: -

Identifier Source: org_study_id