- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127694
Treatment In Acute Benign Paroxysmal Positional Vertigo
November 19, 2021 updated by: gorkem ata, Istanbul Medipol University Hospital
Comparison of the Efficacy of Medical Treatment and Vestibular Rehabilitation In Patients With 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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey
- Safa Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Vestibular Rehabilitation Group
Investigators applied vestibular rehabilitation in this group.
This group was consist of 15 participants.
After the evaluation investigators gave the patients repetitive vestibular exercises for 4 weeks and in the first week investigators performed canalith repositioning procedure depending on the affected canal.
If affected posterior semicircular canal investigators applied Epley maneuver.
If affected horizontal semicircular canal also applied barbeque roll maneuver.
|
Vestibular Rehabilitation which is consist of repetitive exercises and canalit repositioning maneuvers
|
|
NO_INTERVENTION: Pharmacological Control Group
Investigators did not apply any treatment in this group.
Participant in this group just used medications doctor-prescribed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Four weeks
|
|
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.
|
Four weeks
|
|
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.
|
Four weeks
|
|
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.
|
Four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2019
Primary Completion (ACTUAL)
December 8, 2019
Study Completion (ACTUAL)
April 16, 2020
Study Registration Dates
First Submitted
October 6, 2021
First Submitted That Met QC Criteria
November 8, 2021
First Posted (ACTUAL)
November 19, 2021
Study Record Updates
Last Update Posted (ACTUAL)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 19, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.19383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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