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

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

Study Overview

• Status: Completed
• Conditions: Functional Constipation
• Intervention / Treatment: Other: spinal magnetic stimulation

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 25700
    • Nehad ElShatby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Therapy; Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation.	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 Menstruating women will be temporarily withdrawn from BF sessions till end of the menses.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.
Experimental: Spinal magnetic stimulation; Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Nehad ElShatby, MD,PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 22, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: spinal magnetic stimulation, constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 0305398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD will be available with the corresponding author for three years after publishing the study, and ready to be shared with other researchers
• IPD Sharing Time Frame: from date of publication and 3 years after
• IPD Sharing Access Criteria: Contact the corresponding author via dr.nehad@yahoo.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No