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Completed

NCT Number: NCT05127694

Treatment In Acute Benign Paroxysmal Positional Vertigo

Benign paroxysmal positional vertigo (BPPV) is a vestibular disorder that manifests itself as a result of dizziness caused by the otoconia in the inner ear coming out of their places and circulating freely in the semicircular canals or by attaching to the cupula and sensitizing the cupula to head movements against gravity. The aim of the study is to compare the effectiveness of pharmacological treatment initiated by the physician and vestibular rehabilitation initiated by physiotherapist in patients with acute benign paroxysmal positional vertigo (BPPV). Thirty patients, aged 18-50 years, who applied to the Bağcılar Safa Hospital, were included in the study. The patients were divided into two groups, 15 pharmacological control group and 15 vestibular rehabilitation group. 8 patients in the pharmacological control group were given the drug containing betahistine by the physician, and 7 patients received the drug containing additional dimenhydrinate to the betahistine. In the rehabilitation group, exercises including head and eye movements and maneuvering were performed according to the direction of the canal after the exercise, and the patients were given a home exercise program. Treatment continued for 4 weeks. Visual Analogue Scale (VAS), dynamic visual acuity test, romberg, semitandem, tandem posture tests with a stopwatch, standing test on one leg with eyes open and closed, and unterberger tests were applied to patients before and after treatment.

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Key information

Conditions

Benign Paroxysmal Positional Vertigo Balance; Distorted Dizziness Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertigo Vestibular Diseases Vestibular Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Safa Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 years of age,
  • Positive Dix-Hallpike test result, and
  • No spontaneous nystagmus.

Exclusion criteria

  • Patients with Meniere's disease, vestibular neuritis, labyrinthitis, sudden sensory hearing loss, chronic otitis media, non-ambulatory patients, patients with vertigo due to central causes, and patients with cardiac complaints were excluded from the study.
  • In addition, patients with conditions contraindicated for canalith repositioning procedures (such as cervical spine stenosis, severe kyphoscoliosis, cervical radiculopathy, ankylosing spondylitis, severe lumbar dysfunction, and spinal injuries) were excluded from the vestibular rehabilitation group.

Treatment and study plan

Vestibular Rehabilitation

Other

Vestibular Rehabilitation which is consist of repetitive exercises and canalit repositioning maneuvers

Primary outcomes

  1. Perceptual Dizziness

    Time frame: Four weeks

    Perceived dizziness was assessed using the Visual Analog Scale (VAS). The patients stated the severity of their dizziness between 0-10 (0 being the mildest, 10 being unbearable).

  2. Balance

    Time frame: Four weeks

    The balance of the patients was evaluated using the tandem, romberg, and one-leg standing test with eyes open and closed using a stopwatch. Individuals were expected to maintain their balance for 30 seconds.

  3. Vestibular Dysfunction

    Time frame: Four weeks

    Vestibular Dysfunction was assessed with the Unterberger Test performed with the eyes closed. During the Unterberger test, the patient should marching where they are. If more than 45 degrees of deflection is detected, the test is positive.

  4. Dynamic Visual Acuity

    Time frame: Four weeks

    Dynamic visual acuity was evaluated using the Snellen chart. A person taking the test is seated in a chair 2 meters away from the Snellen chart and while the therapist shakes the patient's head from right to left, the patient is asked if he can see the letters of each line, starting from the top. The test is terminated on the line where the letter sequence cannot be seen clearly.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Comparison of the Efficacy of Medical Treatment and Vestibular Rehabilitation In Patients With Acute Benign Paroxysmal Positional Vertigo

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 19, 2021
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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