Assessing the Epley’s maneuver effects on reducing craniovertebral angle (less than 50-53 degrees) in patients having posterior canalithiasis due to forward head posture, vertigo after positive Dix-Hallpike maneuver
Design
Randomized clinical trial
Settings and conduct
The settings are The University of Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion criteria: Both male and female genders; reduced craniovertebral angle that is less than 50-53 degrees; computer/ laptop users; individuals with forward head posture; IT students of final year (The University of Faisalabad)
Individuals with neck pain; positive Dix-Hallpike maneuver. Exclusion criteria: CVA (cerebrovascular accident); vestibular migraine; cervical spondylosis; history of fracture; upper cross syndrome; already diagnosed with Benign paroxysmal positional vertigo; other musculoskeletal conditions; other neurological conditions; mentally or emotionally unstable; brain tumor, hypertension.
Intervention groups
interventional group: Epley’s maneuver
control group: gaze stabilization exercises
The effect of vestibular rehabilitation using Epley’s Maneuver in patients with canalithiasis due to forward head posture; a randomized clinical trial
Public title
The effect of vestibular rehabilitation using Epley’s Maneuver in patients with canalithiasis due to forward head posture; a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Craniovertebral Angle that is less than 50-53 degrees
Gender: Both male and female
Computer/ laptop users
IT students of final year
Positive Dix-Hallpike maneuver
age 20-24
Exclusion criteria:
CVA (cerebrovascular accident)
Vestibular migraine
Cervical spondylosis
History of skull fracture
Upper cross syndrome
Already diagnosed with BPPV
Other musculoskeletal conditions
Other neurological conditions
Mentally or emotionally unstable
Carcinoma of brain
ear infections
hypertension
Age
From 20 years old to 24 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling via lottery method. The IDs of all the participants were written on the slips of paper having same color and size and mix it up. Then blindfold selection were made.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Faisalabad
Street address
Canal road, Faisalabad
City
Faisalabad
Postal code
38610
Approval date
2023-03-25, 1402/01/05
Ethics committee reference number
TUF/Addl Reg/SB/379
Health conditions studied
1
Description of health condition studied
Vertigo; dizziness
ICD-10 code
H81.10
ICD-10 code description
Benign paroxysmal vertigo, unspecified ear
Primary outcomes
1
Description
Dizziness
Timepoint
Dizziness handicap inventory
Method of measurement
The DHI have 25 items, and a total score of 0-100 points , The patient is asked to answer each question as it pertains to dizziness, specifically considering their condition during the last month. Questions are designed to incorporate functional (F), physical (P), and emotional (E) impacts on disability. Positional (F3) sub-scale shows maximum scoring in BPPV cases.
2
Description
Vertigo
Timepoint
Visual Vertigo Analogue scale
Method of measurement
The VVAS is a visual analog scale that rates the intensity of visual vertigo in 9 challenging situations of visual motions that particularly provoke dizziness.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Epley’s maneuver contains a sequence of 4 consecutive movements. 45° head rotation towards the affected side in reference to the body is made in sitting, 45° head rotation towards the affected side and slight extension of head below the level of the plinth in supine (the first step), now 45° head rotation towards the healthy side and slight extension of head below the level of the plinth in supine (the second step), 135° head rotation towards the healthy side in position of lateral decubitus also known as 135° sound-ear down position (the third step), the last step is then sitting in the upright position(the fourth step)
Category
Rehabilitation
2
Description
Control group: received Vestibular rehabilitation therapy in which participants receive gaze and head stability exercises. Gaze stabilization exercises were performed while participants were seated and the individuals have to follow the card through gaze by moving their eyes and head.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Faisalabad
Full name of responsible person
Maryam Asif
Street address
Canal Road, Faisal Town, Faisalabad.
City
Faisalabad
Postal code
38800
Phone
+92 41 8750971
Email
drmaryamasifpt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Maryam Asif
Street address
Canal Road, Faisal Town, Faisalabad.
City
Faisalabad
Postal code
38800
Phone
+92 333 1448119
Email
drmaryamasifpt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Maryam Asif
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Neuromuscular Physical Therapy
Street address
Canal Road, Faisal Town, Faisalabad.
City
Faisalabad
Province
Punjab
Postal code
38800
Phone
+92 41 8750971
Email
drmaryamasifpt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Tayyaba Falak
Position
doctor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canal Road
City
Faisalabad
Province
Punjab
Postal code
38800
Phone
+92 41 8750971
Email
tayyabafalak14@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Madinah teaching hospital
Full name of responsible person
Kishwar Batool
Position
Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Muslim town Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38090
Phone
+92 41 8750971
Email
kishwarbatool922@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of vestibular rehabilitation using EPLEY's maneuver in patients with canalithiasis due to forward head posture; A randomized clinical trial
When the data will become available and for how long
Data will be available after the completion of the study and will remain available till 6 months
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator Maryam Asif
From where data/document is obtainable
Maryam Asif
drmaryamasifpt@gmail.com
What processes are involved for a request to access data/document
The data/document could be used by communicating with the principle investigator Maryam Asif