To determine the comparative effects of semont liberatory maneuver and Cawthorne Cooksey exercises in patients with posterior semicircular canal BPPV
To estimate the effectiveness of both the treatments
To evaluate the improvement in patient's symptoms
Design
Pragmatic, parallel group, single blinded, randomised controlled trial
Settings and conduct
Allied Hospital Faisalabad
National Hospital Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1. Gender female
2. Willing participants
3. Age 25-45 years
4. Acute cases of BPPV
5. Participants physically capable of undergoing the Semont maneuver.
6. Positive Dix-Hallpike test
7. Absence of other vestibular disorders
Exclusion Criteria
1. Patients with progressive vascular pathology
2. Patients with active vertigo complaints were excluded
3. Patients having neck fragility or neck instability
4. Patients who had some brainstem or cerebellar signs.
5. Mentally unstable patients
6. patients with cognitive and perceptual problems
Intervention groups
Intervention
Group A
Group A will receive Semont liberatory maneuver.
Group B
Group B will receive Cawthorne Cooksey Exercises.
Both groups will receive intervention 3 times per week for 3 weeks. Pre readings will be calculated before the start of intervention. 1st reading post treatment will be taken after 2 weeks, 2nd reading post treatment will be taken after 3rd week.
Comparative effects of Semont Liberatory Maneuver Versus Cawthorne Cooksey Exercise in posterior canal benign paroxysmal positional vertigo (BPPV)
Public title
Effects of Semont Liberatory Maneuver Versus Cawthorne Cooksey Exercise in posterior canal benign paroxysmal positional vertigo (BPPV)
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Gender female
Willing participants
Age 25-45 years
Acute cases of BPPV
Participants physically capable of undergoing the Semont maneuver
Positive Dix-Hallpike test
Absence of other vestibular disorders
Exclusion criteria:
Patients with progressive vascular pathology
Patients with active vertigo complaints
Patients having neck fragility or neck instability
Patients who had some brainstem or cerebellar signs
Mentally unstable patients
Patients with cognitive and perceptual problems
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
method of randomization is simple random sampling.
1- population was selected i.e. females of age 25-45
2- sample size of 28 was taken
3- two groups were made
4-each group was assigned to have 14 patients
5- We used "Drawing Lots" as a method to select and allocate population into groups.
6- we gave group A semont liberatory maneuver
7-and group B the Cawthorne cooksey exercises
8- then collected data for 3 weeks from both the groups
9- we then analyzed the data using SPSS
Blinding (investigator's opinion)
Single blinded
Blinding description
The primary aim of a single-blinded study is to reduce or eliminate the placebo effect and other forms of bias that might affect the participants' behavior or self-reported outcomes. By blinding the participants, researchers can obtain more accurate and objective data regarding the efficacy and safety of the intervention being tested.
Develop a Protocol: Created a detailed study plan, including the hypothesis, inclusion/exclusion criteria, intervention details, and outcome measures.
Recruit Participants: Selected a sample that meets the study criteria.
Randomize Participants: Randomly assigned participants to be in any of the group.
Implement Blinding: Ensured participants do not know which group they are in. This may involve using identical-looking placebos for the control group.
Administer the Intervention: Provide the treatment or placebo to the respective groups according to the study protocol.
Collect Data: Gathered data on the outcomes of interest while maintaining blinding.
Analyze Results: Compared the outcomes between the treatment and control groups using appropriate statistical methods.
Report Findings: Present the results, discussing the implications, limitations, and potential biases.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics Committee of the University of Faisalabad
Street address
university avenue faisal town canal road faisalabad
City
Faisalabad
Postal code
38000
Approval date
2024-01-05, 1402/10/15
Ethics committee reference number
TUF/addl Reg/SB /761
Health conditions studied
1
Description of health condition studied
Benign paroxysmal positional vertigo (BPPV) is one of the most common causes of vertigo — the sudden sensation that you're spinning or that the inside of your head is spinning. BPPV causes brief episodes of mild to intense dizziness. It is usually triggered by specific changes in your head's position.
ICD-10 code
H81.1
ICD-10 code description
Benign paroxysmal vertigo
Primary outcomes
1
Description
This study will help to improve the different aspects of patients' problems with posterior canal benign paroxysmal positional vertigo (BPPV) as this is one of the most common problems now a days. It will improve the understanding of clinicians about two major techniques of treating BPPV. It will improve the quality of life of patients and their attendants.
Timepoint
Before intervension and 1,2,3 weeks after intervention
Method of measurement
VAS for vertigo and Dizziness questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receives semont liberatory maneuver The Semont Liberatory Maneuver is a physical therapy technique used to treat Benign Paroxysmal Positional Vertigo (BPPV), particularly when it affects the posterior semicircular canal of the inner ear. Here is a summary of how to perform the maneuver The Semont Maneuver aims to move the dislodged otoliths (calcium carbonate crystals) in the inner ear back to their correct position, alleviating the vertigo symptoms associated with BPPV.Starting Position: The patient sits on an examination table with their legs hanging off the side and head turned 45 degrees toward the unaffected side.First Movement: Quickly move the patient to a lying position on their affected side (the side experiencing vertigo), with the head still turned 45 degrees. The patient’s head should now be facing upward.Maintain this position for about 30 seconds or until the vertigo stops. Second Movement: Without changing the head position, rapidly move the patient to the opposite side. The patient’s head will now be turned 45 degrees downward, lying on the unaffected side.Hold this position for about 30 seconds or until the vertigo subsides.Returning to Sitting Position:Slowly bring the patient back to a sitting position, keeping the head turned toward the unaffected side.
Category
Treatment - Other
2
Description
Intervention group 2: receives cawthorne cooksey exercise The primary goal of Cawthorne-Cooksey exercises is to facilitate vestibular compensation, which involves retraining the brain to adapt to changes in balance and spatial orientation signals caused by inner ear problems.The exercises are typically performed in progressive stages, starting with simple movements and gradually advancing to more complex tasks. Here’s a summary of the typical exercises included:Early Stage Exercises (Performed while sitting or lying down)Eye Movements:Look up and down, then left and right, keeping the head still. Gradually increase speed.Head Movements:Turn the head from side to side, then up and down, initially with eyes open and then with eyes closed.Shrugging and Circling Shoulders:Perform shoulder shrugging and shoulder circling exercises to enhance coordination and reduce neck tension.Intermediate Stage Exercises (Performed while sitting)Sitting and Standing Movements:Sit down and stand up repeatedly, first with eyes open and then with eyes closed.Throwing and Catching:Throw a small ball from hand to hand above eye level.Advanced Stage Exercises (Performed while standing and walking)Standing Balance:Stand with feet together, then progress to standing on one foot. Repeat with eyes open and then closed.Walking Exercises:Walk across the room with eyes open, then closed.Walk up and down a slope or stairs.Walk in a circle or figure-eight pattern.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
National Hospital Faisalabad and Allied hospital faisalabad
Full name of responsible person
Dr. Anbreena Rasool
Street address
university avenue faisal town canal road faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://tuf.edu.pk/n/contact
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
the university of Faisalabad
Full name of responsible person
Dr. Anbreena Rasool
Street address
university avenue faisal town canal road faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Physthetic Clinic
Full name of responsible person
Dr. Ruhma Tariq
Position
Consultant physiotherapist
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
P 881 shadab colony jhang road faisalabad
City
Faisalabad
Province
punjab
Postal code
38000
Phone
+92 323 6617619
Email
ruhma19@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physthetic Clinic Faisalabad
Full name of responsible person
Dr. Ruhma Tariq
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
p 881 street #6 shadab colony jhang road Faisalabad
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 323 6617619
Email
ruhma19@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
physthatic clinic faisalabad
Full name of responsible person
Dr. Ruhma Tariq
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
p 881 steet#6 shadab colony jhang road faisalabad
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 323 6617619
Email
ruhma19@yahoo.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
No - There is not 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
comparative effects of semont liberatory maneuver and cawthorne cooksey exercises in posterior canal bppv
When the data will become available and for how long
starting 6 months after publication . and it will remain available for everyone
To whom data/document is available
this will be available for everyone
Under which criteria data/document could be used
drruhmatariq@gmail.com
contact # 03236617619
From where data/document is obtainable
ruhma19@yahoo.com
contact #: 03236617619
What processes are involved for a request to access data/document
for any problem contact for data/file at ruhma19@gmail.com or contact at 03236617619