Back to resultsEfficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation
Primary Purpose
Constipation
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Auricular vagus stimulation
Tibial Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring vagus, tibial nerve stimülation
Eligibility Criteria
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.
Sites / Locations
- Medipol hospitalRecruiting
- Medipol hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Auricular vagus stimulation
Tibial Nerve Stimulation
Arm Description
Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid.
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.
Outcomes
Primary Outcome Measures
Bristol Stool Scale
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)".
Pelvic Pain Impact Questionnaire
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.
Superficial Electromyography Biofeedback
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.
Constipation Severity Scale
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.
Autonomic nervous system device
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05833191
First Posted
April 17, 2023
Last Updated
April 27, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05833191
Brief Title
Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation
Official Title
Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
vagus, tibial nerve stimülation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be included in a 12-session treatment program over four weeks.
Masking
Investigator
Masking Description
In our study, which is planned as a single-blind evaluation, different physiotherapists will perform the evaluation and application.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Auricular vagus stimulation
Arm Type
Experimental
Arm Description
Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid.
Arm Title
Tibial Nerve Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Auricular vagus stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Tibial Nerve Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bristol Stool Scale
Description
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)".
Time Frame
4 weeks
Title
Pelvic Pain Impact Questionnaire
Description
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.
Time Frame
4 weeks
Title
Superficial Electromyography Biofeedback
Description
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.
Time Frame
4 weeks
Title
Constipation Severity Scale
Description
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.
Time Frame
4 weeks
Title
Autonomic nervous system device
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAZAL genç, PhD
Phone
05413204291
Email
hazaloksuz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
gamze demircioğlu, PhD
Facility Information:
Facility Name
Medipol hospital
City
Istanbul
State/Province
Istanbul Avrupa Kitasi
ZIP/Postal Code
34353
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze kantar, phd(c)
Phone
05413204291
Email
hazaloksuz@gmail.com
Facility Name
Medipol hospital
City
Istanbul
ZIP/Postal Code
34070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HAZAL genç, phd
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31889364
Citation
Tan K, Wells CI, Dinning P, Bissett IP, O'Grady G. Placebo Response Rates in Electrical Nerve Stimulation Trials for Fecal Incontinence and Constipation: A Systematic Review and Meta-Analysis. Neuromodulation. 2020 Dec;23(8):1108-1116. doi: 10.1111/ner.13092. Epub 2019 Dec 30.
Results Reference
background
Learn more about this trial
Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation
We'll reach out to this number within 24 hrs