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Temporomandibular Joint and Soft Tissue Mobilisation Techniques on Bening Paroxymal Vertigo

Primary Purpose

Soft Tissue Mobilisation, Vestibular Exercises, Physiotherapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Study Group
Control Group
Sponsored by
Alanya Alaaddin Keykubat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Mobilisation focused on measuring Bening Paroxymal Positional Vertigo, Temporomandibular Joint Mobilization, Soft Tissue Mobilisation, Vestibular Exrecises, Physiotherapy, Otorhynology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alanyaaku

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Study Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dizzness Severity
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
Vertigo Symptom Scale- Shor Form
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.
Beck Anxiety Inventory
It were used for to evaluate of anxiety level because of the vertigo. It consists of 21 questions in total. 0 points: none, point: mild points: intermediate, points: seriously scored. It was classified as mild anxiety symptoms between 8-15 points, moderate anxiety symptoms between 16-25 points, and severe anxiety symptoms between 26-63 points.
Vertigo Dizziness Imbalance Questionnaire (VDI)
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.
Tinnitus Disability Scale
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.
Balance Asssesment
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
The presence of Temporomandibular Joint Disorders
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)
Mouth opening
amount of mouth opening was measured with goniometer before and after treatment.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2023
Last Updated
July 24, 2023
Sponsor
Alanya Alaaddin Keykubat University
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1. Study Identification

Unique Protocol Identification Number
NCT05944159
Brief Title
Temporomandibular Joint and Soft Tissue Mobilisation Techniques on Bening Paroxymal Vertigo
Official Title
Is the Temporamandibular Joint and Soft Tissue Mobilization Technique Effective in Individuals Diagnosed With Bening Paroxysmal Positional Vertigo?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
December 7, 2022 (Actual)
Study Completion Date
February 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alanya Alaaddin Keykubat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to investigated effectiveness of temporamandibular joint and soft tissue mobilization on patients with Benign Paroxysmal Positional Vertigo (BPPV).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Mobilisation, Vestibular Exercises, Physiotherapy, Vertigo, Paroxysmal, Temporomandibular Joint Disorders
Keywords
Bening Paroxymal Positional Vertigo, Temporomandibular Joint Mobilization, Soft Tissue Mobilisation, Vestibular Exrecises, Physiotherapy, Otorhynology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Study Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dizzness Severity
Description
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
Time Frame
Baseline - end of the treatment after 4 weeks session
Title
Vertigo Symptom Scale- Shor Form
Description
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.
Time Frame
Baseline - end of the treatment after 4 weeks session
Title
Beck Anxiety Inventory
Description
It were used for to evaluate of anxiety level because of the vertigo. It consists of 21 questions in total. 0 points: none, point: mild points: intermediate, points: seriously scored. It was classified as mild anxiety symptoms between 8-15 points, moderate anxiety symptoms between 16-25 points, and severe anxiety symptoms between 26-63 points.
Time Frame
Baseline - end of the treatment after 4 weeks session
Title
Vertigo Dizziness Imbalance Questionnaire (VDI)
Description
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.
Time Frame
Baseline - end of the treatment after 4 weeks session
Title
Tinnitus Disability Scale
Description
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.
Time Frame
Baseline - end of the treatment after 4 weeks session
Title
Balance Asssesment
Description
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
Time Frame
Baseline - end of the treatment after 4 weeks session
Title
The presence of Temporomandibular Joint Disorders
Description
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)
Time Frame
Baseline - end of the treatment after 4 weeks session
Title
Mouth opening
Description
amount of mouth opening was measured with goniometer before and after treatment.
Time Frame
Baseline - end of the treatment after 4 weeks session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayça ARACI, PhD
Organizational Affiliation
Physiotherapy and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dilara GÜLER, Master
Organizational Affiliation
Physiotherapy and rehabilittaion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alanyaaku
City
Antalya
State/Province
Alanya
Country
Turkey

12. IPD Sharing Statement

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Temporomandibular Joint and Soft Tissue Mobilisation Techniques on Bening Paroxymal Vertigo

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