Paroxysmal Positional Vertigo & Repositioning Maneuvers

NCT ID: NCT05309538

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2022-01-01

Brief Summary

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: Benign Paroxysmal Positional Vertigo is a condition related to vestibular system accompanied by dizziness, tinnitus and balance problems leading to increased fall risk and potential disability. Various treatment options are available including pharmacotherapy and vestibular rehabilitation with varied results

Detailed Description

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Objective: The objective of this study was to compare the efficacy of Modified Epley \& Semont's maneuver with and without Betahistine for BPPV Material \& Methods: The study was a single blind randomized control trail. Total number of patients were 97 as calculated by Epitool calculator. Duration of the study was of one year from 2 January 2021 to 1st January 2022. Out of a total 97 patients, 90 met the inclusion criteria. These participants were randomized by lottery method into two equal groups. Group A (control group) was receiving both maneuvers only while group B (experimental group) included participants receiving betahistine along with both maneuvers. The impact of dizziness and quality of life was measured through EQ-5D-5L questionnaire and dizziness handicap inventory (DHI) in order to analyze the effectiveness of treatments. Pre and Post treatment results were compared within group by Wilcoxon rank test and for between groups, Mann Whitney U test was performed

Conditions

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Benign Paroxysmal Positional Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups , group A contro group and group B experimental group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Control group

Group Type ACTIVE_COMPARATOR

Modified eply & Semont maneuver

Intervention Type OTHER

repositioning maneauvers

group B

experimental group

Group Type EXPERIMENTAL

betahistine & Modified eply & Semont maneuver

Intervention Type OTHER

antihistamine plus repositioning maneuvers

Interventions

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Modified eply & Semont maneuver

repositioning maneauvers

Intervention Type OTHER

betahistine & Modified eply & Semont maneuver

antihistamine plus repositioning maneuvers

Intervention Type OTHER

Other Intervention Names

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Modified eply & Semont maneuver

Eligibility Criteria

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Inclusion Criteria

* age between 18-60
* positive modified Dix Hil pike test
* repetitive vertigo spells affecting activities of daily livings (ADLs)

Exclusion Criteria

* any cervical spine problem
* vertigo due to central disease
* tumors
* systemic disease
* cardiac disease
* Parkinson disease
* bed bound patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neuro Counsel Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MUHAMMAD SALMAN, M.Phil*

Role: PRINCIPAL_INVESTIGATOR

the neurocouncil hospital

Locations

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the Neurocouncil Clinic

Islamabad, Fedral, Pakistan

Site Status

Countries

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Pakistan

References

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You P, Instrum R, Parnes L. Benign paroxysmal positional vertigo. Laryngoscope Investig Otolaryngol. 2018 Dec 14;4(1):116-123. doi: 10.1002/lio2.230. eCollection 2019 Feb.

Reference Type BACKGROUND
PMID: 30828628 (View on PubMed)

Kerber KA, Burke JF, Skolarus LE, Meurer WJ, Callaghan BC, Brown DL, Lisabeth LD, McLaughlin TJ, Fendrick AM, Morgenstern LB. Use of BPPV processes in emergency department dizziness presentations: a population-based study. Otolaryngol Head Neck Surg. 2013 Mar;148(3):425-30. doi: 10.1177/0194599812471633. Epub 2012 Dec 21.

Reference Type BACKGROUND
PMID: 23264119 (View on PubMed)

Kitanaka J, Kitanaka N, Hall FS, Amatsu Y, Hashimoto K, Hisatomi E, Kitao E, Mimura M, Nakamura M, Ozawa R, Sato M, Tagami K, Uhl GR, Takemura M. In vivo evaluation of effects of histamine H3 receptor antagonists on methamphetamine-induced hyperlocomotion in mice. Brain Res. 2020 Aug 1;1740:146873. doi: 10.1016/j.brainres.2020.146873. Epub 2020 May 5.

Reference Type BACKGROUND
PMID: 32387137 (View on PubMed)

Other Identifiers

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336

Identifier Type: -

Identifier Source: org_study_id

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