Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Device: Auricular vagus stimulation
* Device: Tibial Nerve Stimulation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be included in a 12-session treatment program over four weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular vagus stimulation<br>Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. | Device: Auricular vagus stimulation<br>* 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.<br>|
| Experimental: Tibial Nerve Stimulation<br>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. | Device: Tibial Nerve Stimulation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4 weeks | 
| 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. | 4 weeks | 
| 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. | 4 weeks | 
| 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. | 4 weeks | 
| 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. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vagus, tibial nerve stimülation