- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05944159
Temporomandibular Joint and Soft Tissue Mobilisation Techniques on Bening Paroxymal Vertigo
July 24, 2023 updated by: Ayça Araci, Alanya Alaaddin Keykubat University
Is the Temporamandibular Joint and Soft Tissue Mobilization Technique Effective in Individuals Diagnosed With Bening Paroxysmal Positional Vertigo?
The purpose of this study was to investigated effectiveness of temporamandibular joint and soft tissue mobilization on patients with Benign Paroxysmal Positional Vertigo (BPPV).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Aim: In this study was aimed to investigated effectiveness of temporamandibular joint and soft tissue mobilization on patients with Benign Paroxysmal Positional Vertigo (BPPV).
Material and Methods; Dix Hallpike maneuver was administered to all patients to confirm the diagnosis at the initial evaluation.
If the Dix Hallpike test was positive, Epley maneuver was applied The patients were randomly divided into 2 groups as study group (n=) and control groups (n= ).
Temporomandibular joint ve soft tissue techniques were applied 30 minutes once a week for 4 weeks by physiotherapist.
Routin medication therapy was applied to control group.
Both groups were asked to do the home exercise program twice a day consisting of vestibular exercise videos sent over whatss app.
It was questioned with a phone call once a week whether the exercises were done or not.
Patients were evaluated by Dizziness Disability Inventory (DHI) , Dizziness Assessment- Visual Analogue Scale (VAS), Vertigo Symptom Scale-Short Form (VSS) , Beck Anxiety Inventory (BAI) , Vertigo Dizziness Imbalance Questionnaire (VDI) , Tinnitus Disability Scale (TDS), Romberg Posture Test , Tandem Posture Test, Semitandem Tandem Balance Test, Fonseca's Anamnestic Index (FAI) and amount of mouth opening was measured with goniometer before and after treatment.
Study Type
Interventional
Enrollment (Actual)
41
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
-
-
Alanya
-
Antalya, Alanya, Turkey
- Alanyaaku
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being diagnosed with positional vertigo,
- Being between the ages of 18-65
- Dix Halpike maneuver test (+),
- Those who volunteered to participate in the study
- Able to read and write.
Exclusion Criteria:
- Findings of acute or chronic infection at the end of ENT examination,
- Considered to have a neurological pathology that causes dizziness,
- Head trauma, history of surgical operation,
- Having lower extremity pain that prevents standing and weight bearing,
- Having a history or symptoms of vestibular system diseases other than BPPV,
- Presence of sudden sensory hearing loss and chronic otitis media,
- Pregnancy,
- The presence of serious cognitive impairment detected by the physician at a level that prevents the tests from being performed,
- Not having the mental level to understand and answer the survey questions,
- Cervical pathologies that may cause dizziness.
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Study Group (n= 20) was recieved Temporomandibular joint ve soft tissue techniques.
The techniques were applied 30 minutes once a week for 4 weeks by physiotherapist to the study group.
|
Study Group (n= 20) was recieved Temporomandibular joint ve soft tissue techniques.
The techniques were applied 30 minutes once a week for 4 weeks by physiotherapist to the study group.
|
|
Other: Control Group
Control group (n=20) was received routin medication therapy was applied.
Both groups were asked to do the home exercise program twice a day consisting of vestibular exercise videos sent over whatss app.
It was questioned with a phone call once a week whether the exercises were done or not.
|
Routin medication therapy was applied to the control group.
Both groups were asked to do the home exercise program twice a day consisting of vestibular exercise videos sent over whatss app.
It was questioned with a phone call once a week whether the exercises were done or not.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dizzness Severity
Time Frame: Baseline - end of the treatment after 4 weeks session
|
dizziness severity was determined by Visual Analog Scale (VAS).
The patient is asked to evaluate between 0 and 10 points.
A score of "0" means no dizziness, a score of "1-4" means mild dizziness, a score of "4-8" means moderate dizziness, and a score of "10" means unbearable dizziness
|
Baseline - end of the treatment after 4 weeks session
|
|
Vertigo Symptom Scale- Shor Form
Time Frame: Baseline - end of the treatment after 4 weeks session
|
It is a 15-item scale that evaluates dizziness, feeling of imbalance, accompanying autonomic disorders and anxiety symptoms in the last 1 month.Each question has values between 0-4 points.
The scores of all items will be added together and the total score will be between 0-60 points.
High scores indicate serious problems.
A total score of 12 points or more indicates a symptom of vertigo.
It has 8 items related to vertigo and has a score between 0-32 points, it has 7 items that includes autonomic complaints and has a score of 0-28.
|
Baseline - end of the treatment after 4 weeks session
|
|
Beck Anxiety Inventory
Time Frame: Baseline - end of the treatment after 4 weeks session
|
It were used for to evaluate of anxiety level because of the vertigo. It consists of 21 questions in total. 0 points: none,
|
Baseline - end of the treatment after 4 weeks session
|
|
Vertigo Dizziness Imbalance Questionnaire (VDI)
Time Frame: Baseline - end of the treatment after 4 weeks session
|
The Vertigo-Dizziness-Imbalance Questionnaire is a scale that evaluates the quality of the daily living activities of the problems that patients experience with vertigo and dizzines.Each question has a point value of "4" points if yes, "0" points if no, and sometimes "2" points.
In the scoring, 28 points are the limit points for determining physical disability, 36 points for functional and sensory disability.
|
Baseline - end of the treatment after 4 weeks session
|
|
Tinnitus Disability Scale
Time Frame: Baseline - end of the treatment after 4 weeks session
|
The Tinnitus Disability Scale (TDS) was used for the presence and level of balance tinnitus due to vertigo.TDS has 25 questions.
The scoring of the answers is "4", "0" and "2" respectively.
The lowest score that can be obtained from the scale is 0 and the highest score is 100.
|
Baseline - end of the treatment after 4 weeks session
|
|
Balance Asssesment
Time Frame: Baseline - end of the treatment after 4 weeks session
|
Balance problems due to vertigo were determined by romberg test, tandem and semitandem tests.
Romberg Test:In peripheral vestibular pathologies, the direction of the fall is in that direction.
For the Tandem and Semitandem tests,It is asked to try to hold the position for 30 seconds with your open eyes closed.
The time it can stand is recorded in seconds
|
Baseline - end of the treatment after 4 weeks session
|
|
The presence of Temporomandibular Joint Disorders
Time Frame: Baseline - end of the treatment after 4 weeks session
|
The presence and level of temporomandibular dysfunction was determined by Fonseca's Anamnestic Index (FAI).
FAI is a questionnaire consisting of 10 questions and 3 choices.
The answers are "yes" (10 points), "sometimes" (5 points), and "no" (0 points).
Scoring TMD No signs or symptoms (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points)
|
Baseline - end of the treatment after 4 weeks session
|
|
Mouth opening
Time Frame: Baseline - end of the treatment after 4 weeks session
|
amount of mouth opening was measured with goniometer before and after treatment.
|
Baseline - end of the treatment after 4 weeks session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ayça ARACI, PhD, Physiotherapy and Rehabilitation
- Principal Investigator: Dilara GÜLER, Master, Physiotherapy and rehabilittaion
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)
July 7, 2022
Primary Completion (Actual)
December 7, 2022
Study Completion (Actual)
February 20, 2023
Study Registration Dates
First Submitted
April 15, 2023
First Submitted That Met QC Criteria
July 5, 2023
First Posted (Actual)
July 13, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 24, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Vestibular Diseases
- Sensation Disorders
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Joint Diseases
- Vertigo
- Dizziness
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
Other Study ID Numbers
- 10354421-2022/06-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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