Back to resultsParoxysmal Positional Vertigo & Repositioning Maneuvers
Primary Purpose
Benign Paroxysmal Positional Vertigo
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Modified eply & Semont maneuver
betahistine & Modified eply & Semont maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring BPPV
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
Sites / Locations
- the Neurocouncil Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
group B
Arm Description
Control group
experimental group
Outcomes
Primary Outcome Measures
DHI
dizziness handicap inventery
EQ-5D-5L
quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT05309538
First Posted
March 24, 2022
Last Updated
April 1, 2022
Sponsor
Neuro Counsel Hospital, Pakistan
1. Study Identification
Unique Protocol Identification Number
NCT05309538
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuro Counsel Hospital, Pakistan
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
BPPV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups , group A contro group and group B experimental group
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Control group
Arm Title
group B
Arm Type
Experimental
Arm Description
experimental group
Intervention Type
Other
Intervention Name(s)
Modified eply & Semont maneuver
Intervention Description
repositioning maneauvers
Intervention Type
Other
Intervention Name(s)
betahistine & Modified eply & Semont maneuver
Other Intervention Name(s)
Modified eply & Semont maneuver
Intervention Description
antihistamine plus repositioning maneuvers
Primary Outcome Measure Information:
Title
DHI
Description
dizziness handicap inventery
Time Frame
1 month
Title
EQ-5D-5L
Description
quality of life
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MUHAMMAD SALMAN, M.Phil*
Organizational Affiliation
the neurocouncil hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Neurocouncil Clinic
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44010
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
we would share with other researcher so that they might be able to find study gaps
Citations:
PubMed Identifier
30828628
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.
Results Reference
background
PubMed Identifier
23264119
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.
Results Reference
background
PubMed Identifier
32387137
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.
Results Reference
background
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Paroxysmal Positional Vertigo & Repositioning Maneuvers
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