- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05833191
Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation
April 27, 2023 updated by: hazal genc, Istanbul Medipol University Hospital
Constipation is the most common digestive complaint in the general population.
Normal stool frequency ranges from at least three times a week to a maximum of two times a day.
Constipation can be classified into three main groups as constipation with normal transit time, constipation with slow transit time and dyssynergic defecation disorders.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In chronic constipation, treatment should be directed towards the underlying cause.
In the treatment of chronic constipation, lifestyle changes and physiotherapy are in the first place, pharmacological treatment is in the second place, and surgical treatment is in the third place.
Physiotherapy modalities such as defecation training, classical massage, electrical stimulation, anorectal biofeedback and exercise training can be used in the treatment of chronic constipation.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HAZAL genç, phd
- Phone Number: 05413204291
- Email: hazaloksuz@gmail.com
Study Contact Backup
- Name: Gamze Demircioğlu, PhD
Study Locations
-
-
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Istanbul, Turkey, 34070
- Recruiting
- Medipol hospital
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Contact:
- HAZAL genç, phd
-
-
Istanbul Avrupa Kitasi
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Istanbul, Istanbul Avrupa Kitasi, Turkey, 34353
- Recruiting
- Medipol hospital
-
Contact:
- Gamze kantar, phd(c)
- Phone Number: 05413204291
- Email: hazaloksuz@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
•Being diagnosed with chronic constipation
Exclusion criteria:
- Metabolic diseases
- Severe heart or kidney disease, previous gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy,
- Neurological diseases such as multiple sclerosis, stroke, Parkinson's disease or spinal injury, impaired awareness
- Mini-mental score < 15
- Legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating pattern of constipation and diarrhea.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Auricular vagus stimulation
Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid.
|
When the nervus tibialis approaches the medial malleolus, it approaches the surface.
In this study, bilateral transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus approximately at the point where the tibialis nerve contacts the surface.
|
Experimental: Tibial Nerve Stimulation
Transcutaneous tibial nerve stimulation (TTNS) is reported to be beneficial for fecal and urinary incontinence.
A review of the literature showed that there are very few studies using TTNS that have been shown to be effective for constipation.
|
When the nervus tibialis approaches the medial malleolus, it approaches the surface.
In this study, bilateral transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus approximately at the point where the tibialis nerve contacts the surface.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bristol Stool Scale
Time Frame: 4 weeks
|
Bristol Stool Scale (BGS) In the scale, the type of stool is classified into 7 different groups.
In the Bristol stool scale, the intestinal transit time of stool is evaluated over seven different stool types.
According to BGS, 1-2 points are "hard stools", 3-4-5 points are "normal stools" and 6-7 points are "soft-watery stools (diarrhea)".
|
4 weeks
|
Pelvic Pain Impact Questionnaire
Time Frame: 4 weeks
|
The clinical assessment of the effect of pelvic pain on women consists of 10 questions.
However, the first 8 questions are scored.
The range of points to be taken from the questionnaire varies between 1 and 32.
As the score to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person also increases.
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4 weeks
|
Superficial Electromyography Biofeedback
Time Frame: 4 weeks
|
Before starting the treatment, the target that the patient wants to reach is determined.
With the "set target" feature on the device, tensing and relaxation are practiced for 10 seconds and the average target is determined.
Then, the target is created by taking the percentage of this determined target.
Since the goal in this study is relaxation, the patient is asked to decrease the value on the graph during the session.
|
4 weeks
|
Constipation Severity Scale
Time Frame: 4 weeks
|
The lowest possible total score is 0, and the highest is 73.
A high score from the scale indicates that the symptoms are serious.
The highest score that can be obtained from the five-point Likert-type scale is 140, and the lowest score is 28.
It is thought that as the scores obtained from the scale increase, the quality of life is negatively affected.
|
4 weeks
|
Autonomic nervous system device
Time Frame: 4 weeks
|
In the study, the autonomic nervous system will be evaluated with the Polar H10 device.
By connecting the device to a smart phone via bluetooth, the data will be recorded and the software supported by the device will be used for the analysis of the data.
A measurement will be made with the participant in a sitting position and lasting up to 3 minutes.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2023
Primary Completion (Anticipated)
May 15, 2023
Study Completion (Anticipated)
August 15, 2023
Study Registration Dates
First Submitted
April 17, 2023
First Submitted That Met QC Criteria
April 17, 2023
First Posted (Actual)
April 27, 2023
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 27, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chronic Constipation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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