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

Medipol Health Group

Status: Completed

Conditions: Constipation

Treatments: Other: Auricular vagus stimulation; Other: Tibial Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06073249

E-10840098-772.02-6150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Auricular vagus stimulation:

Experimental group

Description:

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.

Treatment:

Other: Auricular vagus stimulation

Tibial Nerve Stimulation

Active Comparator group

Description:

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.

Treatment:

Other: Tibial Nerve Stimulation