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OpenTrials
Completed

NCT Number: NCT05309538

Paroxysmal Positional Vertigo & Repositioning Maneuvers

: 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

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Key information

Conditions

Benign Paroxysmal Positional Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Neurocouncil Clinic

Islamabad, Fedral, 44010, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified eply & Semont maneuver

Other

repositioning maneauvers

betahistine & Modified eply & Semont maneuver

Other

antihistamine plus repositioning maneuvers

Other names: Modified eply & Semont maneuver

Primary outcomes

  1. DHI

    Time frame: 1 month

    dizziness handicap inventery

  2. EQ-5D-5L

    Time frame: 1 month

    quality of life

Sponsors and collaborators

Lead sponsor

Neuro Counsel Hospital, Pakistan

Other

Registry information

Official study title

Effect of Modified Epley's & Semont's Maneuvers With or Without Beta-histine on Benign Paroxysmal Positional Vertigo: A Randomized Control Trail

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2022
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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