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

Not Applicable

Completed

• Conditions: Functional Constipation
• Interventions: Other: spinal magnetic stimulation

• Registration Number: NCT05221255
• Lead Sponsor: University of Alexandria

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-22
• Study First Posted: 2022-02-02
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Therapy	spinal magnetic stimulation	Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation.
Spinal magnetic stimulation	spinal magnetic stimulation	Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nehad ElShatby; 🇪🇬 Alexandria, Egypt