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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
Other: Control Group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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,

  1. point: mild
  2. points: intermediate,
  3. 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.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alanya Alaaddin Keykubat University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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