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The Effect of Abdominal Functional Electrical Stimulation On Bowel Function In Spinal Cord Injury

The Effect of Abdominal Functional Electrical Stimulation On Bowel Function In Adults with a Spinal Cord Injury: A prospective cohort trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000386831
Enrollment
2
Registered
2021-04-07
Start date
2022-11-01
Completion date
2025-06-30
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with a spinal cord injury (SCI) have high rates of bowel related morbidity, even compared with those with other neurological disorders. This includes high rates of abdominal pain, constipation, faecal incontinence and bloating. These problems lower the quality of life of people with a SCI and place a financial burden on the health system. The abdominal muscles are one of the major muscle groups used during expiratory and expulsive manoeuvres such as defecation and coughing. Surface electrical stimulation of the abdominal muscles, termed Abdominal Functional Electrical Stimulation (FES), can make the abdominal muscles contract, even when ‘paralysed’. There is some limited evidence that abdominal FES may improve bowel function in people with SCI via increased intra-abdominal pressure. The primary objective of this study is to investigate the effectiveness of Abdominal FES to improve bowel management time for people with chronic Spinal Cord Injury (SCI). Secondary objectives will evaluate whether Abdominal FES can improve: 1) bowel related quality of life, 2) bowel function , 3) bowel management strategy 4) respiratory function and 5) bladder function . In addition, a cost-utility analysis will determine if there is a financial benefit resulting from improved bowel function associated with Abdominal FES.

Interventions

Colorectal, anal and pelvic floor complications are common in people with spinal cord injury (SCI). The abdominal muscles are one of the major muscle groups used during expiratory and expulsive manoeuvres such as defecation and coughing. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function. Furthermore, there is evidence that abdominal FES may also improve bowel function in people with SCI via increas

Colorectal, anal and pelvic floor complications are common in people with spinal cord injury (SCI). The abdominal muscles are one of the major muscle groups used during expiratory and expulsive manoeuvres such as defecation and coughing. We have shown that surface Functional Electrical Stimulation (FES) of the abdominal muscles, termed Abdominal FES, can improve respiratory function. Furthermore, there is evidence that abdominal FES may also improve bowel function in people with SCI via increased intra-abdominal pressure. However, there is a lack of data from randomised, controlled trials to substantiate this evidence and there is no standard Abdominal FES protocol for improving bowel function. 34 people will be recruited to this prospective cohort trial. Participants will be recruited who are greater than 1 year post SCI. Abdominal FES will be applied to the abdominal muscles for eight week day bowel management (BM) sessions (which will last for the duration of the bowel routine for an estimated 30-60 minutes) over an estimated period of three to four weeks. This will be delivered by the participant pressing a button (where able) to trigger the FES when required, and by a carer or researcher when this is not possible Specifically, Abdominal FES will be delivered, via electrodes placed over the posterolateral surface of the abdomen. The stimulation amplitude will initially be set to cause a strong visible muscle contraction (typically 60 - 80 mA). In addition, the stimulation amplitude will be evaluated every five minutes to ensure that stimulation is still tolerable and causing a suitable muscle contraction. A patient diary will also be used to monitor bowel management time for six sessions, prior to and also after the intervention period.

Sponsors

Neuroscience Research Australia
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Chronic SCI (> 12 months since injury) above the level ofT8 - >= 18 years of age - A measurable and consistent start and end bowel routine event

Exclusion criteria

- American Spinal Injuries Association Impairment Scale E - Current bowel conditions such as irritable bowel syndrome, gastro-oesophagheal reflux, bowel obstruction, Crohn’s disease or diverticulitis - Physical obstacles that prevent Abdominal FES (e.g. pregnancy, abdominal trauma, cardiac pacemaker or other implanted electromedical devices) - No response to Abdominal FES (e.g. lower motor neuron impairment) - Self-reported Bowel management time of <30 minutes - Severely obese patients (>40 BMI) - Lack of understanding of English - Unable to give informed consent - Previous history of recurrent episodes of AD - Resting systolic blood pressure reported as > 140mmHg

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026