Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation

Constipation Clinical Trial

Official title:

Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833191
• Other study ID #: Chronic Constipation
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: April 2023
• Source: Istanbul Medipol University Hospital
• Contact: HAZAL genç, PhD
• Phone: 05413204291
• Email: hazaloksuz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation

Intervention

Device:
• Auricular vagus stimulation
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
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.

Locations

Country	Name	City	State
Turkey	Medipol hospital	Istanbul	Istanbul Avrupa Kitasi
Turkey	Medipol hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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