Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults

Study Overview
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Brief Summary
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conservative management of functional constipation is a preferable method including biofeedback and spinal magnetic stimulation sessions

Detailed Description
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Constipation varies in presentation and severity among patients and affects patients' quality of life of varied degrees depending on how it manifests and how severe it is. The prevalence of constipation in the general population is estimated to affect about 20% of the population Spinal Magnetic Stimulation (SMS) is a non-invasive, painless neurophysiological treatment that uses extracorporeal magnetic stimulation to direct extracorporeal magnetic stimulation to the spinal nerves and deep muscles to aid bowl evacuation without the use of surgery. This noninvasive approach was created to help with micturition, expiration, and bowel function The aim of this work is to study the efficacy of SMS and biofeedback versus biofeedback in the management of functional constipation.

Official Title
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Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults

Conditions
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Functional Constipation

Intervention / Treatment
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* Other: spinal magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults patients diagnosed by Rome IV criteria as having functional constipation Exclusion Criteria: Patients younger than 18 years old. Patients with irritable bowel syndrome. Anal hemorrhoids or bleeding. Any condition that may complicate bowel problems, such as Parkinson's disease, stroke, or traumatic brain injury.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: interventional prospective trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Therapy<br>Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation. | Other: spinal magnetic stimulation<br>* Biofeedback pelvic floor muscle training sessions will be performed for both groups for a total of 12 sessions. Menstruating women will be temporarily withdrawn from BF sessions till end of the menses. The session will last for 30 minutes of transrectal pressure biofeedback relaxation technique. Auditory and visual feedback will be provided in addition to positive verbal reinforcement. Sham SMS will be used in the Sham group using the placebo program in the magnetic stimulation machine. Spinal magnetic stimulation using the Neuro-MS/D machine. It will be used in spinal magnetic stimulation group, circular coil will be used to stimulate S2,3 and 4 sacral roots. Intensities will be adjusted to 50-70 % of maximal output (2.2 Tesla), stimulation frequency will be fixed at 20 Hz, burst length = 5 seconds, inter-burst interval = 25 seconds.<br>|
| Experimental: Spinal magnetic stimulation<br>Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation. | Other: spinal magnetic stimulation<br>* Biofeedback pelvic floor muscle training sessions will be performed for both groups for a total of 12 sessions. Menstruating women will be temporarily withdrawn from BF sessions till end of the menses. The session will last for 30 minutes of transrectal pressure biofeedback relaxation technique. Auditory and visual feedback will be provided in addition to positive verbal reinforcement. Sham SMS will be used in the Sham group using the placebo program in the magnetic stimulation machine. Spinal magnetic stimulation using the Neuro-MS/D machine. It will be used in spinal magnetic stimulation group, circular coil will be used to stimulate S2,3 and 4 sacral roots. Intensities will be adjusted to 50-70 % of maximal output (2.2 Tesla), stimulation frequency will be fixed at 20 Hz, burst length = 5 seconds, inter-burst interval = 25 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of weekly bowel movement | Mean weekly complete spontaneous bowel movements. | after 15 days | 
| The Bristol Stool Scale (from 1 to 5) | Stool consistency | After 15 days | 
| Numerical rating scale (from 0 to 10) | pain assessment, zero indicates no pain, 10 indicates maximum pain degree | After 15 days | 
| Patient Assessment of Constipation Quality of Life questionnaire | Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems | After 15 days | 
| pressure manometry | Assessment of pelvic floor power of contraction | After 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of weekly bowel movement | Mean weekly complete spontaneous bowel movements. | after one month | 
| The Bristol Stool Scale (from 1 to 5) | Stool consistency | After one month | 
| Numerical rating scale (from 0 to 10) | pain assessment, zero indicates no pain, 10 indicates maximum pain degree | After one month | 
| Patient Assessment of Constipation Quality of Life questionnaire | Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems | After one month | 
| Pressure manometry | Assessment of pelvic floor power of contraction | After one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal magnetic stimulation, constipation