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conservative management of functional constipation is a preferable method including biofeedback and spinal magnetic stimulation sessions
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Therapy | Sham Comparator | Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation. |
|
| Spinal magnetic stimulation | Experimental | Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal magnetic stimulation | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nehad ElShatby, MD,PhD | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nehad ElShatby | Alexandria | 25700 | Egypt |
All IPD will be available with the corresponding author for three years after publishing the study, and ready to be shared with other researchers
from date of publication and 3 years after
Contact the corresponding author via dr.nehad@yahoo.com
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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interventional prospective trial
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|
| 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 |