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

NCT06073249 | Completed

• 1 other identifier: E-10840098-772.02-6150
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Constipation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Auricular vagus stimulation:

EXPERIMENTAL

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

Tibial Nerve Stimulation

ACTIVE COMPARATOR

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

Interventions

Auricular vagus stimulation OTHER

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.

Auricular vagus stimulation:

Tibial Nerve Stimulation OTHER

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).

Tibial Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages Female
• Rome III diagnostic criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

HAZAL genç

Istanbul, None Selected, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: October 15, 2023
• Primary Completion: November 15, 2023
• Study Completion: June 10, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)