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

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05221255
• Other study ID #: 0305398
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2024
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Other:
• spinal magnetic stimulation
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 Menstruating women will be temporarily withdrawn from BF sessions till end of the menses.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.

Locations

Country	Name	City	State
Egypt	Nehad ElShatby	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of weekly bowel movement	Mean weekly complete spontaneous bowel movements.	after 15 days
Primary	The Bristol Stool Scale (from 1 to 5)	Stool consistency	After 15 days
Primary	Numerical rating scale (from 0 to 10)	pain assessment, zero indicates no pain, 10 indicates maximum pain degree	After 15 days
Primary	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
Primary	pressure manometry	Assessment of pelvic floor power of contraction	After 15 days
Secondary	Number of weekly bowel movement	Mean weekly complete spontaneous bowel movements.	after one month
Secondary	The Bristol Stool Scale (from 1 to 5)	Stool consistency	After one month
Secondary	Numerical rating scale (from 0 to 10)	pain assessment, zero indicates no pain, 10 indicates maximum pain degree	After one month
Secondary	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
Secondary	Pressure manometry	Assessment of pelvic floor power of contraction	After one month