Paroxysmal Positional Vertigo & Repositioning Maneuvers

April 1, 2022 updated by: Neuro Counsel Hospital, Pakistan

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

: 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Fedral
      • Islamabad, Fedral, Pakistan, 44010
        • The Neurocouncil Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
Control group
Other: Modified eply & Semont maneuver
repositioning maneauvers
EXPERIMENTAL: group B
experimental group
Other: betahistine & Modified eply & Semont maneuver
antihistamine plus repositioning maneuvers
Other Names:
  • Modified eply & Semont maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DHI
Time Frame: 1 month
dizziness handicap inventery
1 month
EQ-5D-5L
Time Frame: 1 month
quality of life
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuro Counsel Hospital, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2021

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

January 1, 2022

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (ACTUAL)

April 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

we would share with other researcher so that they might be able to find study gaps

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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