Soft Tissue MobilisationNCT05944159
Temporomandibular Joint and Soft Tissue Mobilisation Techniques on Bening Paroxymal Vertigo
A study testing Study Group in people with Soft Tissue Mobilisation and Vestibular Exercises, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Soft Tissue Mobilisation, Vestibular Exercises, Physiotherapy
- What is being tested?
- Study Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2022to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Soft Tissue Mobilisation, Vestibular Exercises, Physiotherapy, Vertigo, Paroxysmal, Temporomandibular Joint Disorders
- Being tested
- Study Group, Control Group
- Keywords
- Bening Paroxymal Positional Vertigo, Temporomandibular Joint Mobilization, Soft Tissue Mobilisation, Vestibular Exrecises, Physiotherapy, Otorhynology
- Medical subject headings
- Vertigo, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study GroupBehavioural
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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. Receives: Behavioral: Study Group |
| Control Group | Other | 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline - end of the treatment after 4 weeks session
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.
Measured: Baseline - end of the treatment after 4 weeks session
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.
Measured: Baseline - end of the treatment after 4 weeks session
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.
Measured: Baseline - end of the treatment after 4 weeks session
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.
Measured: Baseline - end of the treatment after 4 weeks session
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
Measured: Baseline - end of the treatment after 4 weeks session
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)
Measured: Baseline - end of the treatment after 4 weeks session
Mouth opening
amount of mouth opening was measured with goniometer before and after treatment.
Measured: Baseline - end of the treatment after 4 weeks session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start7 Jul 2022
- Primary completion7 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue MobilisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
- Investigators
- Ayça ARACI, PhD, Study director, Physiotherapy and RehabilitationDilara GÜLER, Master, Principal investigator, Physiotherapy and rehabilittaion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944159
- Sponsor's protocol ID
- 10354421-2022/06-02
- Status last verified
- Jul 2023
- First submitted
- 15 Apr 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guler D, Araci A, Gunizi H, Kar M. The role of temporomandibular joint mobilization in the management of benign paroxysmal positional vertigo: randomized controlled trial. Sci Rep. 2026 May 21;16(1):19172. doi: 10.1038/s41598-026-52637-x.
PubMed 42168393
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Temporamandibular Joint and Soft Tissue Mobilization Technique Effective in Individuals Diagnosed With Bening Paroxysmal Positional Vertigo?
- ClinicalTrials.gov ID
- NCT05944159
- Acronym / sponsor ID
- 10354421-2022/06-02
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Study GroupStudy 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 | Other | Other: Control GroupControl 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study GroupStudy 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. | Behavioural | Study Group |
| Control GroupRoutin 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. | Other | Control Group |
Primary outcome
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
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.
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.
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.
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.
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
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 42168393Guler D, Araci A, Gunizi H, Kar M. The role of temporomandibular joint mobilization in the management of benign paroxysmal positional vertigo: randomized controlled trial. Sci Rep. 2026 May 21;16(1):19172. doi: 10.1038/s41598-026-52637-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça ARACI, PhD study director
Physiotherapy and Rehabilitation
Dilara GÜLER, Master principal investigator
Physiotherapy and rehabilittaion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Group in people with Soft Tissue Mobilisation and Vestibular Exercises, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizzness Severity (time frame: Baseline - end of the treatment after 4 weeks session). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.