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Comparison of the Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Consipation

Primary Purpose

Constipation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Auricular vagus stimulation
Tibial Nerve Stimulation
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Constipation focused on measuring Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 18-65 ages Female Rome III diagnostic criteria Exclusion Criteria: Severe heart or kidney diseaseprevious 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 altered constipation and diarrhea pattern.

Sites / Locations

  • HAZAL genç

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Auricular vagus stimulation:

Tibial Nerve Stimulation

Arm Description

This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear (auricle). Somatosensory innervation is provided by the auricular branch. The name of this device is vagustim device, which consists of a TENS device placed in the outer ear; headphones that can be selected to the size of the individual's ear and a TENS device in which stimulation current is given superficially. In our study, we will perform the application non-invasively by stimulating the branch of the vagus nerve in the auricle. The application time will take 20 minutes.

The nervus tibialis approaches the surface when it approaches the medial malleolus. In this study, transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus at the point where the nervus tibialis contacts the surface and approximately bilaterally.

Outcomes

Primary Outcome Measures

Bristol Stool Scale (BGS)
n the scale developed by Lewis and Heaton in 1990, the type of stool is classified in 7 different groups. In the Bristol Stool Scale, the transit time of stool through the intestine is evaluated over seven different stool types. According to BGS, 1-2 points are shown as "hard stool", 3-4-5 points as "normal stool" and 6-7 points as "soft-watery stool
Pelvic Pain Impact Questionnaire
The questionnaire for clinical assessment of the impact of pelvic pain on women consists of 10 questions. However, the first 8 questions are scored. The range of scores to be obtained from the questionnaire varies between 1- 32. As the score value to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person increases.
Constipation Severity Scale
Constipation Severity Scale (CSS): The CSS is a scale for determining the frequency, intensity and difficulty/difficulty during defecation. This scale can also be used to measure symptoms of constipation. The scale includes 16 questions.The minimum total score that can be obtained from the KCS is 0 and the maximum score is 73. A high score on 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. As the scores obtained from the scale increase, it is thought that the quality of life is negatively affected
Superficial Electromyography Biofeedback
For the assessment, the display scale was used as visual feedback and the signal sound, which increases or decreases with changing muscle activity, was used as sensory feedback. Before starting the treatment, the desired goal for the patient is determined. 10 seconds of contraction and relaxation is practiced with the "set target" feature on the device and the average target is determined.
Autonomic nervous system device
The Polar H10 device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can connect to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that contacts the chest to capture heart rate in real time. The study will evaluate the autonomic nervous system with the Polar H10 device. The data will be recorded by connecting the device to a smart phone via bluetooth and the software supported by the device will be used to analyze the data. The participant will be in a sitting position and a measurement will be made for 1 minute. In order for the device to make an accurate measurement, the electrode surface must be wetted before each measurement.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2023
Last Updated
October 7, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06073249
Brief Title
Comparison of the Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Consipation
Official Title
Comparison of the Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Consipation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
June 10, 2024 (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
Consipation is the most common digestive complaint in the general population. The normal frequency of defecation ranges from a minimum of three times a week to a maximum of two times a day.
Detailed Description
Constipation is one of the most common health problems in the geriatric population, negatively affecting the physical and emotional status of individuals. Constipation can be classified into three main groups: normal transit time constipation, slow transit time constipation and dyssynergic defecation disorders . Treatment in chronic constipation should be directed towards the underlying cause. In the treatment of chronic constipation, lifestyle modifications and physiotherapy are the first, pharmacologic treatment is the second, and surgical treatment is the third. 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
Constipation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auricular vagus stimulation:
Arm Type
Experimental
Arm Description
This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear (auricle). Somatosensory innervation is provided by the auricular branch. The name of this device is vagustim device, which consists of a TENS device placed in the outer ear; headphones that can be selected to the size of the individual's ear and a TENS device in which stimulation current is given superficially. In our study, we will perform the application non-invasively by stimulating the branch of the vagus nerve in the auricle. The application time will take 20 minutes.
Arm Title
Tibial Nerve Stimulation
Arm Type
Active Comparator
Arm Description
The nervus tibialis approaches the surface when it approaches the medial malleolus. In this study, transcutaneous electrical nerve stimulation (TENS) electrodes will be placed under the medial malleolus at the point where the nervus tibialis contacts the surface and approximately bilaterally.
Intervention Type
Other
Intervention Name(s)
Auricular vagus stimulation
Intervention Description
Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular or carotid artery. It is also used to treat various disorders such as epilepsy, pain and headache. This device stimulates the auricular branch of the vagus nerve non-invasively without any procedure. As a result, it has been found that the pain threshold increases and mechanical pain sensitivity decreases.
Intervention Type
Other
Intervention Name(s)
Tibial Nerve Stimulation
Intervention Description
The sacral plexus provides innervation of the perineal muscle. Its branches (lumbar 4-5 and sacral 1-3) merge to form the nervus ischiadicus, which then divides into two branches. The thick branch of the nervus ischiadicus is the nervus tibialis (lumbar 4-5 and sacral 1-3) and the thin branch is the nervus peroneus communis (lumbar 4-5 and sacral 1-2).
Primary Outcome Measure Information:
Title
Bristol Stool Scale (BGS)
Description
n the scale developed by Lewis and Heaton in 1990, the type of stool is classified in 7 different groups. In the Bristol Stool Scale, the transit time of stool through the intestine is evaluated over seven different stool types. According to BGS, 1-2 points are shown as "hard stool", 3-4-5 points as "normal stool" and 6-7 points as "soft-watery stool
Time Frame
4 weeks
Title
Pelvic Pain Impact Questionnaire
Description
The questionnaire for clinical assessment of the impact of pelvic pain on women consists of 10 questions. However, the first 8 questions are scored. The range of scores to be obtained from the questionnaire varies between 1- 32. As the score value to be obtained from the questionnaire increases, the degree of functional limitation of pelvic pain on the person increases.
Time Frame
4 weeks
Title
Constipation Severity Scale
Description
Constipation Severity Scale (CSS): The CSS is a scale for determining the frequency, intensity and difficulty/difficulty during defecation. This scale can also be used to measure symptoms of constipation. The scale includes 16 questions.The minimum total score that can be obtained from the KCS is 0 and the maximum score is 73. A high score on 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. As the scores obtained from the scale increase, it is thought that the quality of life is negatively affected
Time Frame
4 weeks
Title
Superficial Electromyography Biofeedback
Description
For the assessment, the display scale was used as visual feedback and the signal sound, which increases or decreases with changing muscle activity, was used as sensory feedback. Before starting the treatment, the desired goal for the patient is determined. 10 seconds of contraction and relaxation is practiced with the "set target" feature on the device and the average target is determined.
Time Frame
4 weeks
Title
Autonomic nervous system device
Description
The Polar H10 device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can connect to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that contacts the chest to capture heart rate in real time. The study will evaluate the autonomic nervous system with the Polar H10 device. The data will be recorded by connecting the device to a smart phone via bluetooth and the software supported by the device will be used to analyze the data. The participant will be in a sitting position and a measurement will be made for 1 minute. In order for the device to make an accurate measurement, the electrode surface must be wetted before each measurement.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
woman
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 ages Female Rome III diagnostic criteria Exclusion Criteria: Severe heart or kidney diseaseprevious 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 altered constipation and diarrhea pattern.
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
HAZAL genç
City
Istanbul
State/Province
None Selected
ZIP/Postal Code
34353
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of the Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Consipation

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