Skip to main content
OpenTrials
Completed

NCT Number: NCT05221255

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nehad ElShatby

Alexandria, 25700, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Menstruating women will be temporarily withdrawn from BF sessions till end of the menses.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

Primary outcomes

  1. Number of weekly bowel movement

    Time frame: after 15 days

    Mean weekly complete spontaneous bowel movements.

  2. The Bristol Stool Scale (from 1 to 5)

    Time frame: After 15 days

    Stool consistency

  3. Numerical rating scale (from 0 to 10)

    Time frame: After 15 days

    pain assessment, zero indicates no pain, 10 indicates maximum pain degree

  4. 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

  5. pressure manometry

    Time frame: After 15 days

    Assessment of pelvic floor power of contraction

Secondary outcomes

  1. Number of weekly bowel movement

    Time frame: after one month

    Mean weekly complete spontaneous bowel movements.

  2. The Bristol Stool Scale (from 1 to 5)

    Time frame: After one month

    Stool consistency

  3. Numerical rating scale (from 0 to 10)

    Time frame: After one month

    pain assessment, zero indicates no pain, 10 indicates maximum pain degree

  4. Patient Assessment of Constipation Quality of Life questionnaire

    Time frame: After one month

    Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems

  5. Pressure manometry

    Time frame: After one month

    Assessment of pelvic floor power of contraction

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.