Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2024-07-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

In our study, which is planned as a single-blind evaluation, different physiotherapists will perform the evaluation and application.

Study Groups

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Auricular vagus stimulation

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

Group Type EXPERIMENTAL

Auricular vagus stimulation

Intervention Type 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

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.

Group Type EXPERIMENTAL

Tibial Nerve Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No