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

NCT ID: NCT05221255

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-10-01

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.

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sham Therapy

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

Group Type: SHAM_COMPARATOR

spinal magnetic stimulation

Intervention Type: OTHER

• 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 Menstruating women will be temporarily withdrawn from BF sessions till end of the menses.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.

Spinal magnetic stimulation

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

Group Type: EXPERIMENTAL

spinal magnetic stimulation

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alexandria

OTHER

Sponsor Role: lead

Responsible Party

Nehad Mohamed Elshatby Mahmoud

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nehad ElShatby, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Nehad ElShatby

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0305398

Identifier Type: -

Identifier Source: org_study_id