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Trial registered on ANZCTR


Registration number
ACTRN12621000386831
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
7/04/2021
Date last updated
22/10/2021
Date data sharing statement initially provided
7/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Abdominal Functional Electrical Stimulation On Bowel Function In Spinal Cord Injury
Scientific title
The Effect of Abdominal Functional Electrical Stimulation On Bowel Function In Adults with a Spinal Cord Injury: A randomised controlled trial
Secondary ID [1] 302986 0
None
Universal Trial Number (UTN)
U1111-1262-5380
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 320037 0
Tetraplegia 320038 0
Paralysis 320039 0
Condition category
Condition code
Neurological 317962 317962 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 317963 317963 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 317964 317964 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Eighty people will be recruited to this randomised, placebo controlled trial. Participants will be recruited who are greater than 1 year post SCI. 40 participants will be randomly allocated to receive Abdominal FES and 40 will receive a placebo. In the Abdominal FES group, Abdominal FES will be applied for 45 minutes per day, 3 days per week, for 6 weeks, by a member of the research team.

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 compliance with the intervention.
Intervention code [1] 319273 0
Treatment: Devices
Intervention code [2] 319274 0
Rehabilitation
Comparator / control treatment
Participants in the placebo group will receive sham Abdominal FES for 45 minutes per day, three days per week, for 6 weeks. Placebo Abdominal FES will be similar to active FES in all respects except for the simulation intensity, which will be kept to a level which does not cause a muscle contraction. The device used to apply the sham FES is identical to the one used for the intervention arm.

Specifically, stimulation pulses will be delivered at a low current amplitude (<10 mA) that does not cause abdominal muscle contraction. These settings were chosen so that participants experience the sensation of Abdominal FES without an abdominal muscle contraction. The placebo will be applied by a member of the research team. A patient diary will also be used to monitor compliance with the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 325979 0
Whole gut transit time, measured using both the SmartPill motility system and a can of sweetcorn.
Timepoint [1] 325979 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention (primary timepoint), and 6 weeks post the intervention
Secondary outcome [1] 389753 0
Quality of Life measured using the EQ-5D-5L Health Questionnaire
Timepoint [1] 389753 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [2] 389755 0
bowel function measured using the International SCI bowel function basic data set questionnaire
Timepoint [2] 389755 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [3] 389756 0
Composite measure of bowel management strategy measured via analysis of daily diary entries regarding bowel movements (time taken and frequency), Bristol stool scale, use of laxatives and manual procedures
Timepoint [3] 389756 0
Daily from enrolment until 14 weeks post-randomisation
Secondary outcome [4] 389757 0
Forced Vital Capacity (FVC) measured using a spirometer
Timepoint [4] 389757 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [5] 389758 0
Forced Expiratory Volume in one Second (FEV1) measured using a spirometer
Timepoint [5] 389758 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [6] 389759 0
Peak Expiratory Flow (PEF) measured using a spirometer
Timepoint [6] 389759 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [7] 389760 0
Maximum Inspiratory Pressure (MIP) measured using a mouth pressure meter
Timepoint [7] 389760 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [8] 389761 0
Maximum Expiratory Pressure (MEP) measured using a mouth pressure meter
Timepoint [8] 389761 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [9] 389762 0
bladder function measured using the Neurogenic Bladder Symptom Score
Timepoint [9] 389762 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention
Secondary outcome [10] 391672 0
Colonic transit time measured using the SmartPill motility system
Timepoint [10] 391672 0
First day of enrolment (pre-intervention), the day following the last day of the 6 week intervention, and 6 weeks post the intervention

Eligibility
Key inclusion criteria
- Chronic SCI (> 12 months since injury) above the level ofT8
- >= 18 years of age
- Able to eat and drink normally
- Able to breathe independently
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- American Spinal Injuries Association Impairment Scale D or E
- History of other bowel conditions such as irritable bowel syndrome, gastro-oesophagheal reflux, organic bowel obstruction
- 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)
- Any additional contraindications for use of the SmartPill
o A history of gastric bezoars
o Suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
o History of gastrointestinal surgery within the past 3 months
o Crohn’s disease or diverticulitis
- Severely obese patients (>40 BMI)
- Lack of understanding of English
- Scheduled MRI within 14 weeks of start of the study
- Previous history of recurrent episodes of AD

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be randomly assigned to active or placebo Abdominal FES in a 1:1 ratio using a random, secure, web-based program (REDCap) by an independent investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant variables will be presented using means and standard deviations for continuous normally distributed variables, medians and interquartile ranges for continuous non-normally distributed variables, and proportions and absolute numbers for categorical variables.
A generalised linear model will be used to compare the primary outcome of whole gut transit time between the intervention and sham groups, when controlling for injury level, severity of injury (AIS score) and age. Generalised linear models will also be used to compare respiratory function (as % predicted) and bladder function between groups, when controlling for injury level, severity of injury (AIS score) and age. An exploratory analysis will be used to investigate the effect of Abdominal FES on quality of life and relations between bowel management (and medications) on colonic transit time.
An incremental cost-effectiveness ratio (ICER) of abdominal FES will be calculated to determine the cost per reduction in health care utilisation and the additional cost per Quality-adjusted Life Year (QALY) gained. A detailed sensitivity analysis, including non-parametric bootstrapping methods, will be undertaken to identify the areas of uncertainty.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
1/05/2024
Actual
Date of last data collection
Anticipated
9/08/2024
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18179 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment postcode(s) [1] 32226 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307396 0
Government body
Name [1] 307396 0
NSW Health
Country [1] 307396 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 308060 0
None
Name [1] 308060 0
Address [1] 308060 0
Country [1] 308060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307483 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 307483 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 307483 0
Australia
Date submitted for ethics approval [1] 307483 0
11/02/2021
Approval date [1] 307483 0
19/03/2021
Ethics approval number [1] 307483 0
HC210106

Summary
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 colonic transit 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107390 0
Dr Euan McCaughey
Address 107390 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 107390 0
Australia
Phone 107390 0
+61 293991064
Fax 107390 0
Email 107390 0
[email protected]
Contact person for public queries
Name 107391 0
Dr Euan McCaughey
Address 107391 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 107391 0
Australia
Phone 107391 0
+61 293991064
Fax 107391 0
Email 107391 0
[email protected]
Contact person for scientific queries
Name 107392 0
Dr Euan McCaughey
Address 107392 0
Neuroscience Research Australia
139 Barker Street
Randwick
NSW 2031
Country 107392 0
Australia
Phone 107392 0
+61 293991064
Fax 107392 0
Email 107392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All study data
When will data be available (start and end dates)?
Upon publication, no end date post publication
Available to whom?
All
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
unrestricted access via publication


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness 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.2022https://dx.doi.org/10.46292/sci22-00008
N.B. These documents automatically identified may not have been verified by the study sponsor.