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. 2022 Fall;28(4):22-31.
doi: 10.46292/sci22-00008. Epub 2022 Nov 15.

Effectiveness of Abdominal Functional Electrical Stimulation for Improving Bowel Function in People With a Spinal Cord Injury: A Study Protocol for a Double-Blinded Randomized Placebo-Controlled Clinical Trial

Gabrielle M Allen  1   2 , Anne E Palermo  1   2 , Keith M D McNaughton  1   2 , Claire L Boswell-Ruys  1   2   3 , Bonsan B Lee  1   2   3 , Jane E Butler  1   2 , Simon C Gandevia  1   2   4 , Euan J McCaughey  1   2   5
Affiliations

Effectiveness of Abdominal Functional Electrical Stimulation for Improving Bowel Function in People With a Spinal Cord Injury: A Study Protocol for a Double-Blinded Randomized Placebo-Controlled Clinical Trial

Gabrielle M Allen et al. Top Spinal Cord Inj Rehabil. 2022 Fall.

Abstract

Background: People with a spinal cord injury (SCI) have a high rate of bowel-related morbidity, even compared with people with other neurological disorders. These complications lower quality of life and place a financial burden on the health system. A noninvasive intervention that improves the bowel function of people with an SCI should reduce morbidity, improve quality of life, and lead to cost savings for health care providers.

Objectives: To investigate the effectiveness of noninvasive abdominal functional electrical stimulation (FES) for improving bowel function in people with a chronic SCI.

Methods: A prospective, double-blinded, 1:1 randomized, placebo-controlled intervention trial will be conducted with 80 adults with chronic SCI (>12 months since injury) above T8 single neurological level. The intervention will be a 45-minute abdominal FES (or placebo) session, 3 days per week, for 6 weeks.

Main study parameters/endpoints: Primary endpoint is whole gut transit time before and after 6 weeks of abdominal FES. Secondary endpoints measured before and after 6 weeks of abdominal FES are (1) colonic transit time; (2) quality of life (EQ-5D-5L); (3) participant-reported bowel function (International SCI Bowel Function Basic Data Set Questionnaire and visual analogue scale); (4) respiratory function (forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow, maximal inspiratory pressure, and maximal expiratory pressure); (5) bladder symptoms (Neurogenic Bladder Symptom Score); (6) daily bowel management diary; and (7) unplanned hospital visits.

Conclusion: Safety data will be collected, and a cost utility analysis using quality of life scores will be performed.

Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000386831.

Keywords: abdominal functional electrical stimulation; bowel function; respiratory function; spinal cord injury; whole gut transit time.

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Conflict of interest statement

Conflicts of Interest The authors declare no conflicts of interest.

Figures

Figure 1.
Figure 1.
Timeline of study assessments and outcome measurements.
None
See this image and copyright information in PMC

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