Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation

NCT05833191 | Completed

• 1 other identifier: Chronic Constipation
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Constipation

Keywords

vagus; tibial nerve stimülation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Auricular vagus stimulation

EXPERIMENTAL

Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid.

Device: Auricular vagus stimulation

Tibial Nerve Stimulation

EXPERIMENTAL

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

Interventions

Auricular vagus stimulation DEVICE

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.

Auricular vagus stimulation

Tibial Nerve Stimulation DEVICE

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.

Tibial Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with chronic constipation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (2)

Medipol hospital

Istanbul, Istanbul Avrupa Kitasi, 34353, Turkey (Türkiye)

Location

Medipol hospital

Istanbul, 34070, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 31889364 BACKGROUND

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: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: In our study, which is planned as a single-blind evaluation, different physiotherapists will perform the evaluation and application.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist PhD

Model Details: The study will be included in a 12-session treatment program over four weeks.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: April 15, 2023
• Primary Completion: May 15, 2023
• Study Completion: July 9, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)