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

U

University of Alexandria

Status

Completed

Conditions

Functional Constipation

Treatments

Other: spinal magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05221255
0305398

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Sham Therapy
Sham Comparator group
Description:
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation.
Treatment:
Other: spinal magnetic stimulation
Spinal magnetic stimulation
Experimental group
Description:
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation.
Treatment:
Other: spinal magnetic stimulation

Trial contacts and locations

1

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Central trial contact

Nehad ElShatby, MD,PhD

Data sourced from clinicaltrials.gov

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