FES_Bowel: The Effect of NMES on Bowel Management in People With Chronic SCI

Sponsor

Swiss Paraplegic Centre Nottwil (Other)

Overall Status

Recruiting

CT.gov ID

NCT04914975

Collaborator

(none)

Enrollment

Location

Arm

29.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It has been reported that 62% of all people with Spinal Cord Injury (SCI) have experienced faecal incontinence and that neurogenic bowel dysfunction (NBD) is a major sequela. As an alternative to abdominal massage or the use of suppositories, the electrical stimulation (ES) of the abdominal wall has been shown to be effective in decreasing the bowel transit time as well as decreasing constipation in children with slow-transit constipation. Due to the intrinsic nature of the guts' innervation, we expect to reproduce these positive effects in people with SCI through administration of neuromuscular electrical stimulation (NMES).

Condition or Disease	Intervention/Treatment	Phase
Electric Stimulation Therapy Bowel Dysfunction Spinal Cord Injuries Defecation Disorder	Other: Neuromuscular electrical stimulation	N/A

Detailed Description

A SCI entails devastating changes to a person's life. The extent of these changes depends on the level and degree of the lesion. NBD is one of the most important sequelae occurring in the majority of people with a SCI. It has been reported that 62% of people with SCI had experienced faecal incontinence . In fact, NBD is caused by a disruption of the autonomic nervous system leading to a disturbed colonic peristalsis. The enteric nervous system of the intestines is an intrinsic system that can function independently, but it is widely influenced by the autonomic nervous system. As such, its regulation is perturbed because the parasympathetic and the sympathetic nervous systems do modulate it but do not directly control the smooth muscle cells of the bowel . Depending on the level of the lesion, the bowel function can be affected in various ways ranging from constipation to overflow incontinence.

Hence, NBD has a major impact on the quality of life of paraplegics and tetraplegics. Not only is there a physical component to it consisting of constipation, haemorrhoids or abdominal distension but these gastrointestinal impairments also have a social aspect. People with SCI often end up avoiding social events and tend to isolate because of the fear of incontinence.

The immense expenditure of time for bowel evacuation is a consequence of the dyscoordination of faecal elimination. According to a survey study, 22% of all participants with SCI spend 31 to 60 minutes and 14% more than 60 minutes on bowel care per defecation. For example, people with an upper motor neuron lesion to their bowel are mainly confronted with faecal retention and constipation. Among the methods for bowel evacuation, the application of digital stimulation of the rectum and/or the insertion of a suppository are mostly used. Some people also use abdominal massage just before bowel evacuation . Only a few studies have investigated the effect of ES to the abdominal wall on the defaecation time in people with SCI and an upper motor neuron lesion but none investigated the defecation time in people with SCI with a lesion below the level of Th12. Nevertheless, the results of this therapeutic modality are very promising for different populations such as multiple sclerosis and children with slow-transit constipation by decreasing constipation and increasing transit times respectively.

By means of providing a more efficient and reliable method to support people with SCI in their bowel management strategy.A pilot study with a convenience sample of 20 out- and inpatients of the Swiss Paraplegic Centre will be conducted. Patients who have found a good bowel management method for themselves but claim to invest too much time in this routine are eligible for the study. During their participation, they should follow their usual routine after applying ES for 30 minutes before defaecation.

Based on the recent findings and clinical experience, it is hypothesized that NMES has the potential to reduce defaecation times as well as the bowel transit time in people with SCI experiencing NBD.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

repeated measures interventional single subject designrepeated measures interventional single subject design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of Neuromuscular Electrical Stimulation on Bowel Management in People With Chronic Spinal Cord Injury - a Pilot Study

Actual Study Start Date :

Jul 4, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NMES Group Participants will receive neuromuscular electrical stimulation of the abdominal wall before defaecation for 30 minutes over the course of 16 weeks.	Other: Neuromuscular electrical stimulation The stimulation will be conducted at home or at the SPC for half an hour about 30 minutes before the usual bowel emptying time. Four adhesive electrodes are attached to the abdominal wall for the neuromuscular electrical stimulation. The abdominal muscles are stimulated in such a way that activation occurs, i.e. the muscle alternately contracts and relaxes again. The stimulation sessions will be documented with a defined protocol. In addition, the stool consistency is rated according to the Bristol Stool Form Scale.

Arm

Intervention/Treatment

Experimental: NMES Group

Participants will receive neuromuscular electrical stimulation of the abdominal wall before defaecation for 30 minutes over the course of 16 weeks.

Other: Neuromuscular electrical stimulation

The stimulation will be conducted at home or at the SPC for half an hour about 30 minutes before the usual bowel emptying time. Four adhesive electrodes are attached to the abdominal wall for the neuromuscular electrical stimulation. The abdominal muscles are stimulated in such a way that activation occurs, i.e. the muscle alternately contracts and relaxes again. The stimulation sessions will be documented with a defined protocol. In addition, the stool consistency is rated according to the Bristol Stool Form Scale.

Outcome Measures

Primary Outcome Measures

Neurogenic Bowel Dysfunction Score (NBDS) and the defaecation time from the stimulation protocol [24 weeks]
Investigation of the effect of NMES on the change in defaecation time (minutes) and its relation to the change in NBDS between the follow-up visits and baseline

Secondary Outcome Measures

Corn Test [24 weeks; 5 time points]
"Corn Test" assessing bowel transit time
Bristol Stool Form Scale (BSFS) [24 weeks; at each defaecation]
BSFS for stool consistency

Other Outcome Measures

Qualiveen Short Form (SF) [24 weeks; 5 times]
Qualiveen SF to assess bladder function
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) [24 weeks; 5 times]
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)
Questionnaire of treatment effectiveness [24 weeks; 2 times]
Questionnaire of treatment effectiveness containing 3 questions about the application of the stimulation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Traumatic and non-traumatic SCI; > 1 year
Level of lesion: C2 - L5
AIS score A/B/C/D
Age: ≥ 18 years
Urge to reduce defaecation time

Exclusion Criteria:

Patients during primary rehabilitation
Bladder stimulator
Autonomic dysreflexia by application of ES of the abdominal wall
Pregnancy: test in women of childbearing age (15 - 49 years)
Opioid use
Inflammatory bowel disease
Cancerous tissue in abdominal region
Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc.