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Clinical Trials/NCT05221255
NCT05221255
Completed
Not Applicable

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

University of Alexandria1 site in 1 country40 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Functional Constipation
Sponsor
University of Alexandria
Enrollment
40
Locations
1
Primary Endpoint
Numerical rating scale (from 0 to 10)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
October 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nehad Mohamed Elshatby Mahmoud

Physician

University of Alexandria

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Numerical rating scale (from 0 to 10)

Time Frame: After 15 days

pain assessment, zero indicates no pain, 10 indicates maximum pain degree

Patient Assessment of Constipation Quality of Life questionnaire

Time Frame: After 15 days

Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems

pressure manometry

Time Frame: After 15 days

Assessment of pelvic floor power of contraction

Number of weekly bowel movement

Time Frame: after 15 days

Mean weekly complete spontaneous bowel movements.

The Bristol Stool Scale (from 1 to 5)

Time Frame: After 15 days

Stool consistency

Secondary Outcomes

  • Number of weekly bowel movement(after one month)
  • The Bristol Stool Scale (from 1 to 5)(After one month)
  • Numerical rating scale (from 0 to 10)(After one month)
  • Pressure manometry(After one month)
  • Patient Assessment of Constipation Quality of Life questionnaire(After one month)

Study Sites (1)

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