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

NCT05221255 | Completed DMC

• 1 other identifier: 0305398
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Constipation

Keywords

spinal magnetic stimulation, constipation

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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

• Patient Assessment of Constipation Quality of Life questionnaire

  After one month

• Pressure manometry

  After one month

Study Arms (2)

Sham Therapy

SHAM COMPARATOR

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

Other: spinal magnetic stimulation

Spinal magnetic stimulation

EXPERIMENTAL

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

Other: spinal magnetic stimulation

Interventions

spinal magnetic stimulation 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 Menstruating women will be temporarily withdrawn from BF sessions till end of the menses.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.

Sham Therapy; Spinal magnetic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults patients diagnosed by Rome IV criteria as having functional constipation

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Nehad ElShatby

Alexandria, 25700, Egypt

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nehad ElShatby, MD,PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: interventional prospective trial

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: February 2, 2022
• Study Start: January 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from date of publication and 3 years after
• Access Criteria: Contact the corresponding author via dr.nehad@yahoo.com

Locations

EG (1)