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临床试验/NCT05944159
NCT05944159已完成不适用

Is the Temporamandibular Joint and Soft Tissue Mobilization Technique Effective in Individuals Diagnosed With Bening Paroxysmal Positional Vertigo?

Alanya Alaaddin Keykubat University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Dizzness Severity

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Dizzness Severity

时间窗: 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

Tinnitus Disability Scale

时间窗: 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.

Vertigo Dizziness Imbalance Questionnaire (VDI)

时间窗: 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.

Vertigo Symptom Scale- Shor Form

时间窗: 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

时间窗: 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.

The presence of Temporomandibular Joint Disorders

时间窗: 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

时间窗: Baseline - end of the treatment after 4 weeks session

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

Balance Asssesment

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Alanya Alaaddin Keykubat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Araci

Dr, Head of Physiotherapy and Rehabilitation Department

Alanya Alaaddin Keykubat University

研究点 (1)

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