Temporomandibular Joint and Soft Tissue Mobilisation Techniques on Bening Paroxymal Vertigo

NCT05944159 | Completed

• 1 other identifier: 10354421-2022/06-02
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  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, 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)

  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

  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

  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

  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

  amount of mouth opening was measured with goniometer before and after treatment.

  Baseline - end of the treatment after 4 weeks session

Study Arms (2)

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.

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.

Other: Control Group

Interventions

Study Group BEHAVIORAL

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

Control Group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead

Study Sites (1)

Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vertigo; Temporomandibular Joint Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayça ARACI, PhD

  Physiotherapy and Rehabilitation

  STUDY DIRECTOR

• Dilara GÜLER, Master

  Physiotherapy and rehabilittaion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Head of Physiotherapy and Rehabilitation Department

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: July 13, 2023
• Study Start: July 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: February 20, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

TU (1)