NCT05127694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

October 6, 2021

Last Update Submit

November 19, 2021

Conditions

Keywords

Benign Paroxsymal Positional VertigoBalancePysiotherapy and RehabilitationCanalith Repositioning ProcedurePharmacological TherapyDynamic Visual AcuityDizziness

Outcome Measures

Primary Outcomes (4)

  • 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).

    Four weeks

  • 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.

    Four weeks

  • 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.

    Four weeks

  • 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.

    Four weeks

Study Arms (2)

Vestibular Rehabilitation Group

EXPERIMENTAL

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.

Other: Vestibular Rehabilitation

Pharmacological Control Group

NO INTERVENTION

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

Interventions

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

Vestibular Rehabilitation Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Safa Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoVestibular DiseasesDizziness

Condition Hierarchy (Ancestors)

VertigoLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist MSc, Lecturer

Study Record Dates

First Submitted

October 6, 2021

First Posted

November 19, 2021

Study Start

July 1, 2019

Primary Completion

December 8, 2019

Study Completion

April 16, 2020

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations