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Treatment In Acute Benign Paroxysmal Positional Vertigo

Primary Purpose

Benign Paroxysmal Positional Vertigo, Balance; Distorted, Vestibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vestibular Rehabilitation
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Benign Paroxsymal Positional Vertigo, Balance, Pysiotherapy and Rehabilitation, Canalith Repositioning Procedure, Pharmacological Therapy, Dynamic Visual Acuity, Dizziness

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Safa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vestibular Rehabilitation Group

Pharmacological Control Group

Arm Description

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.

Investigators did not apply any treatment in this group. Participant in this group just used medications doctor-prescribed.

Outcomes

Primary Outcome Measures

Perceptual Dizziness
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).
Balance
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.
Vestibular Dysfunction
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.
Dynamic Visual Acuity
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.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2021
Last Updated
November 19, 2021
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05127694
Brief Title
Treatment In Acute Benign Paroxysmal Positional Vertigo
Official Title
Comparison of the Efficacy of Medical Treatment and Vestibular Rehabilitation In Patients With Acute Benign Paroxysmal Positional Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 8, 2019 (Actual)
Study Completion Date
April 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo, Balance; Distorted, Vestibular Disorder, Dizziness
Keywords
Benign Paroxsymal Positional Vertigo, Balance, Pysiotherapy and Rehabilitation, Canalith Repositioning Procedure, Pharmacological Therapy, Dynamic Visual Acuity, Dizziness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Rehabilitation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pharmacological Control Group
Arm Type
No Intervention
Arm Description
Investigators did not apply any treatment in this group. Participant in this group just used medications doctor-prescribed.
Intervention Type
Other
Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
Vestibular Rehabilitation which is consist of repetitive exercises and canalit repositioning maneuvers
Primary Outcome Measure Information:
Title
Perceptual Dizziness
Description
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).
Time Frame
Four weeks
Title
Balance
Description
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.
Time Frame
Four weeks
Title
Vestibular Dysfunction
Description
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.
Time Frame
Four weeks
Title
Dynamic Visual Acuity
Description
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.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Safa Hospital
City
Istanbul
State/Province
Bagcilar
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment In Acute Benign Paroxysmal Positional Vertigo

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