Functional Constipation
Conditions
Keywords
spinal magnetic stimulation, constipation
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.
Interventions
* 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 Menstruating women will be temporarily withdrawn from BF sessions till end of the menses.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.
Sponsors
University of Alexandria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
interventional prospective trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pressure manometry | After 15 days | Assessment of pelvic floor power of contraction |
| Number of weekly bowel movement | after 15 days | Mean weekly complete spontaneous bowel movements. |
| The Bristol Stool Scale (from 1 to 5) | After 15 days | Stool consistency |
| Numerical rating scale (from 0 to 10) | After 15 days | pain assessment, zero indicates no pain, 10 indicates maximum pain degree |
| Patient Assessment of Constipation Quality of Life questionnaire | After 15 days | Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of weekly bowel movement | after one month | Mean weekly complete spontaneous bowel movements. |
| The Bristol Stool Scale (from 1 to 5) | After one month | Stool consistency |
| Numerical rating scale (from 0 to 10) | After one month | pain assessment, zero indicates no pain, 10 indicates maximum pain degree |
| Patient Assessment of Constipation Quality of Life questionnaire | After one month | Assessment of quality of life (from 9 to 127) lower scores indicating fewer problems |
| Pressure manometry | After one month | Assessment of pelvic floor power of contraction |
Countries
Egypt
Outcome results
None listed