Effect of Spinal Magnetic Stimulation on Management of Functional Constipation in Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alexandria
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Numerical rating scale (from 0 to 10)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sham Therapy
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation plus non-real magnetic stimulation.
Intervention: spinal magnetic stimulation (Other)
Spinal magnetic stimulation
Patients will receive 12 sessions of biofeedback-assisted pelvic floor muscle relaxation followed by real spinal magnetic stimulation.
Intervention: spinal magnetic stimulation (Other)
Outcomes
Primary Outcomes
Numerical rating scale (from 0 to 10)
Time Frame: After 15 days
pain assessment, zero indicates no pain, 10 indicates maximum pain degree
Patient Assessment of Constipation Quality of Life questionnaire
Time Frame: After 15 days
Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems
pressure manometry
Time Frame: After 15 days
Assessment of pelvic floor power of contraction
Number of weekly bowel movement
Time Frame: after 15 days
Mean weekly complete spontaneous bowel movements.
The Bristol Stool Scale (from 1 to 5)
Time Frame: After 15 days
Stool consistency
Secondary Outcomes
- Number of weekly bowel movement(after one month)
- The Bristol Stool Scale (from 1 to 5)(After one month)
- Numerical rating scale (from 0 to 10)(After one month)
- Pressure manometry(After one month)
- Patient Assessment of Constipation Quality of Life questionnaire(After one month)
Investigators
Nehad Mohamed Elshatby Mahmoud
Physician
University of Alexandria