Clinical trial NCT05309538: Paroxysmal Positional Vertigo & Repositioning Maneuvers
Official title: Effect of Modified Epley's & Semont's Maneuvers With or Without Beta-histine on Benign Paroxysmal Positional Vertigo: A Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: BPPV
Lead sponsor: Neuro Counsel Hospital, Pakistan
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups , group A contro group and group B experimental group
Primary purpose: TREATMENT

Brief summary: : 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: DHI
timeFrame: 1 month
measure: EQ-5D-5L
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: the Neurocouncil Clinic
state: Fedral
Study officials:
affiliation: the neurocouncil hospital
name: MUHAMMAD SALMAN, M.Phil*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.