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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05309538
Other study ID # 336
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2021
Est. completion date January 1, 2022

Study information

Verified date April 2022
Source Neuro Counsel Hospital, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Modified eply & Semont maneuver
repositioning maneauvers
betahistine & Modified eply & Semont maneuver
antihistamine plus repositioning maneuvers

Locations

Country Name City State
Pakistan the Neurocouncil Clinic Islamabad Fedral

Sponsors (1)

Lead Sponsor Collaborator
Neuro Counsel Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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 H(3) 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary DHI dizziness handicap inventery 1 month
Primary EQ-5D-5L quality of life 1 month
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