None listed
Conditions
Brief summary
Bowel and bladder problems, mainly in the form of constipation and urinary incontinence, affect more than half of people with Multiple Sclerosis (MS). These problems have traditionally been managed using a combination of manual and pharmacological interventions. However, such solutions are usually only partially effective. Therefore, a non-invasive method of improving bowel and bladder function for people with MS is urgently needed. The abdominal muscles play a major role during defecation and urination. Surface electrical stimulation of the abdominal muscles, termed Abdominal Functional Electrical Stimulation (Abdominal FES), has been shown to improve bowel function after spinal cord injury, with a case study suggesting this technique may also improve bowel function in MS. There is also limited evidence that Abdominal FES can improve bladder control. Therefore, we propose the first significant study to investigate the effectiveness of Abdominal FES to improve the bowel and bladder function of people with MS. Hypothesis: Abdominal FES can improve bowel and bladder function for people with MS. Individual aims of this project are to assess the effect of Abdominal FES on: 1) whole gut and colonic transit time 2) constipation and laxative use 3) incontinence related quality of life 4) frequency of defecation and nocturia
Interventions
Abdominal functional electrical stimulation (Abdominal FES) is the application of a train of electrical pulses to the abdominal muscles, causing them to contract. Abdominal FES will be applied to the rectus abdominis and external oblique muscles for one hour per day (2 x 30 minutes, once in am and once in pm), five days per week, for six weeks. Researchers from Neuroscience Research Australia will visit the participant’s home and demonstrate how to apply this risk and complication free intervent
Abdominal functional electrical stimulation (Abdominal FES) is the application of a train of electrical pulses to the abdominal muscles, causing them to contract. Abdominal FES will be applied to the rectus abdominis and external oblique muscles for one hour per day (2 x 30 minutes, once in am and once in pm), five days per week, for six weeks. Researchers from Neuroscience Research Australia will visit the participant’s home and demonstrate how to apply this risk and complication free intervention, with participants applying the intervention at home for the remainder of their participation (compliance monitored via daily training diary). Stimulation will be applied bilaterally using four pairs of surface electrodes (33 mm x 53 mm, Axelgaard, USA). Current will be adjusted to achieve a visible contraction of the abdominal muscles without discomfort (likely to be 40-50 mA) at 40 Hz and a pulsewidth of 300 µs. Stimulation will be applied using a commercially available FES device (Empi Continuum, EMPI Inc, USA), with devices supplied to all participants.
Sponsors
Neuroscience Research Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with diagnosed MS and an Expanded Disability Status Scale score of 3 to 8, who are able to eat and drink normally, fulfil the Rome III criteria for functional constipation, and constipated for at least three months.
Exclusion criteria
Current urinary tract infection, pregnancy, history of irritable bowel syndrome, organic bowel obstruction or other bowel disease, physical obstacles that prevent Abdominal FES (e.g. abdominal trauma, pacemaker), no response to Abdominal FES (e.g. lower motor neuron impairment), taking medication designed to alter bowel or bladder function.
Outcome results
None listed