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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Other: Auricular vagus stimulation; Other: Tibial Nerve Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazal GENÇ, PhD; Phone Number: 05413204291; Email: hazaloksuz@gmail.com
• Study Contact Backup: Name: Gamze Demircioğlu, PhD

Study Locations

• Turkey
  • None Selected
    • Istanbul, None Selected, Turkey, 34353
      • Hazal GENÇ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular vagus stimulation: 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.	Other: Auricular vagus stimulation; 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.
Active Comparator: Tibial Nerve Stimulation; 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.	Other: Tibial Nerve Stimulation; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks
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.	4 weeks
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	4 weeks
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2023
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: E-10840098-772.02-6150

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