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

Primary Purpose

Functional Constipation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
spinal magnetic stimulation
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring spinal magnetic stimulation, constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nehad ElShatbyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham Therapy

Spinal magnetic stimulation

Arm Description

Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation.

Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2022
Last Updated
January 11, 2023
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT05221255
Brief Title
Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults
Official Title
Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
Keywords
spinal magnetic stimulation, constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
interventional prospective trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham Therapy
Arm Type
Sham Comparator
Arm Description
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation.
Arm Title
Spinal magnetic stimulation
Arm Type
Experimental
Arm Description
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation.
Intervention Type
Other
Intervention Name(s)
spinal magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of weekly bowel movement
Description
Mean weekly complete spontaneous bowel movements.
Time Frame
after 15 days
Title
The Bristol Stool Scale (from 1 to 5)
Description
Stool consistency
Time Frame
After 15 days
Title
Numerical rating scale (from 0 to 10)
Description
pain assessment, zero indicates no pain, 10 indicates maximum pain degree
Time Frame
After 15 days
Title
Patient Assessment of Constipation Quality of Life questionnaire
Description
Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems
Time Frame
After 15 days
Title
pressure manometry
Description
Assessment of pelvic floor power of contraction
Time Frame
After 15 days
Secondary Outcome Measure Information:
Title
Number of weekly bowel movement
Description
Mean weekly complete spontaneous bowel movements.
Time Frame
after one month
Title
The Bristol Stool Scale (from 1 to 5)
Description
Stool consistency
Time Frame
After one month
Title
Numerical rating scale (from 0 to 10)
Description
pain assessment, zero indicates no pain, 10 indicates maximum pain degree
Time Frame
After one month
Title
Patient Assessment of Constipation Quality of Life questionnaire
Description
Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems
Time Frame
After one month
Title
Pressure manometry
Description
Assessment of pelvic floor power of contraction
Time Frame
After one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nehad ElShatby, MD,PhD
Phone
01090840279
Email
dr.nehad@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nehad ElShatby, MD,PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nehad ElShatby
City
Alexandria
ZIP/Postal Code
25700
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nehad ElShatby
Phone
01090840279
Email
dr.nehad@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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