Chronic Spinal Cord Injury
Conditions
Keywords
spinal cord injury, functional electrical stimulation, transcutaneous electrical stimulation, neurogenic bowel dysfunction, bowel dysfunction, abdominal electrical stimulation, sensory stimulation, defecation time, bowel transit time, stool consistency, bowel routine
Brief summary
Many people with spinal cord injury (SCI) have bowel problems resulting in constipation and need a long time to empty the bowel. Some people spend an hour or more to empty their bowel. The investigators want test if using a small device to deliver electrical pulses to the belly (abdomen), would improve bowel function. The investigators hope that electrical stimulation will shorten the time needed to evacuate the bowel (defecation), improve stool consistency, and speed up food passing through the bowel. A pilot study found that electrical stimulation of the belly can speed up defecation if stimulation is making the abdominal muscles contract and squeeze the belly, which is what the investigators expected. However, some results suggested that people may benefit from low stimulation levels without making the muscles contract. Therefore, the investigators will do small study at the University of Alberta on 12 people who lived with SCI for more than 1 year, to find out the best way to apply the electrical stimulation, and to better understand how it works. The participants will use an electrical stimulator at home, to stimulate the skin with 4 sticky pads attached over the abdomen, without causing the muscles to contract. During a 2-month period, they will use the stimulator for 30 minutes before every bowel routine. The investigators will compare how long it takes to empty the bowel, stool consistency, and how long it takes for food to pass through the bowel, with and without using the electrical stimulator.
Interventions
DEVICEAbdominal transcutaneous electrical stimulation (TES)
Low-intensity sensory abdominal transcutaneous electrical stimulation (TES)
Sponsors
University of Alberta
Praxis Spinal Cord Institute
Glenrose Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study uses an interrupted time-series design with 4 phases of observation and 3 changes in condition in a single group of participants. The conditions per phase and phase durations are as follows: Phase 1 (duration 2 weeks): Participants apply their usual bowel routine for baseline observation. Phase 2 (duration 4 weeks): In case that the initial assessment resulted in recommendations for improvement to the participant's usual bowel routine (See 2. Interventions), participants apply their optimized bowel routine in Phase 2 for 4 weeks. If no bowel routine adjustment was recommended, Phase 2 is omitted. Phase 3 (duration 8 weeks): Participants apply abdominal TES for 30 minutes prior to every bowel routine. In case the bowel routine was optimized, they keep applying the optimized bowel routine. Phase 4 (duration 4 weeks): Participants go back to their optimized bowel routine only, without using abdominal TES.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Traumatic or non-traumatic SCI 2. \>1 year post injury 3. Injury level C2 - S5 (NLI, neurological level of injury) 4. AIS A, B, C, D (American Spinal Injury Association Impairment Scale) 5. Feels defecation takes too long and wants to do something about it 6. Defecation takes \> 30 minutes
Exclusion criteria
1. Bladder stimulator 2. Inflammatory bowel disease 3. Pregnancy 4. Unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean defecation time at 2 weeks | 2 weeks after enrollment (after 2 weeks of usual bowel routine) | Mean defecation time for all bowel routines from 0 to 2 weeks (2 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation. |
| Mean defecation time at 6 weeks | 6 weeks after enrollment (after 4 weeks of optimized bowel routine) | Mean defecation time for all bowel routines from 2 to 6 weeks (4 weeks of optimized bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation. |
| Mean defecation time at 14 weeks | 14 weeks after enrollment (after 8 weeks of abdominal TES) | Mean defecation time for all bowel routines from 6 to 14 weeks (8 weeks of abdominal TES). Defecation time = time from initiation of bowel movement to the end of stool evacuation. |
| Mean defecation time at 18 weeks | 18 weeks after enrollment (after 4 weeks of usual bowel routine) | Mean defecation time for all bowel routines from 14 to 18 weeks (4 weeks of usual bowel routine). Defecation time = time from initiation of bowel movement to the end of stool evacuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bristol Stool Form | Every bowel routine | The Bristol Stool Form Scale will be used to score stool form or consistency. The scale from 1-7 is scored using a 1-page document with a graphic and description of 7 different types of stool |
| Bowel Transit Time at 2 weeks | 2 weeks after enrollment (after 2 weeks of usual bowel routine) | Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool |
| Bowel Transit Time at 6 weeks | 6 weeks after enrollment (after 4 weeks of optimized bowel routine) | Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool |
| Bowel Transit Time at 14 weeks | 14 weeks after enrollment (after 8 weeks of abdominal TES) | Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool |
| Bowel Transit Time at 18 weeks | 18 weeks after enrollment (after 4 weeks of usual bowel routine) | Bowel transit time is defined as the time from ingestion of food to time of evacuation, and will be measured using the "corn test". The participants will eat a full can of corn, on its own or with a meal, and write down the date and time of ingestion on a log sheet. They will then inspect stool after every defecation for the presence of corn kernels, and write down the date and time of the first appearance of corn in the stool |
| Neurogenic Bowel Dysfunction Score (NBDS) at 2 weeks | 2 weeks after enrollment (after 2 weeks of usual bowel routine) | The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems |
| Neurogenic Bowel Dysfunction Score (NBDS) at 6 weeks | 6 weeks after enrollment (after 4 weeks of optimized bowel routine) | The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems |
| Neurogenic Bowel Dysfunction Score (NBDS) at 14 weeks | 14 weeks after enrollment (after 8 weeks of abdominal TES) | The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems |
| Neurogenic Bowel Dysfunction Score (NBDS) at 18 weeks | 18 weeks after enrollment (after 4 weeks of usual bowel routine) | The Neurogenic Bowel Dysfunction Score is a score from 0 to 47 documenting severity of bowel dysfunction, and is based on a 1-page form with 10 questions about frequency and time used for defecation, medication use for constipation and incontinence, use of digital stimulation, fecal incontinence and flatus, peri-anal skin problems |
| Participant Feedback | 18 weeks after enrollment (end of study) | At the end of the study, the participants participate in a semi-structured interview (in person or over the phone) to evaluate their level of satisfaction and acceptability of abdominal TES, problems that were encountered, potential benefits they perceived |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORChester Ho, MD
University of Alberta, Faculty of Medicine and Dentistry
Outcome results
None listed