Clinical trial NCT05844657: Comprehensive Evaluation in Patients With Meniere's Disease
Official title: Investigation of the Physical and Psychosocial Status and Quality of Life of People With Meniere's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meniere Disease
Psychosocial Problem
Physical Disability
Quality of Life
Keywords: Meniere's disease
postural balance
posture
vertigo
tinnitus
proprioception
quality of life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Meniere's disease and people with without Meniere's disease

Brief summary: The aim of our study is to determine the severity of the disease in people with Meniere's Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy volunteers.

Detailed description: Meniere's disease (MD) is an inner ear disease characterized by independent attacks and lasting for at least 20 minutes, dizziness, recurrent hearing loss during seizures, tinnitus, fullness in the ear, and a feeling of headache. After the diagnosis of the disease, the most disturbing situation for the patient is the uncertainty of the progression of the disease and the deterioration of the quality of life. It is very difficult to know and predict how the disease will progress. Quality of life is impaired by current symptoms and may be further reduced by uncertainty about when another attack may occur and activity restriction due to fear of provoking symptoms with exertion or stress.

When the studies on MD are examined, it is seen that the symptoms affect not only certain physical conditions but also psychological conditions. It has been observed that psychological factors play a more important role than is commonly realized in terms of their impact on patients' quality of life. MD has a negative impact on the person's daily life, and the person avoids certain daily activities or situations because of the illness. Looking at the literature, it is not known whether the severity of disease symptoms or whether the psychological state precedes the physical state.

In light of all this information, MD appears to be a multifaceted condition that can have major and often alarming effects on the lives of affected individuals. Therefore, it is important to evaluate individuals with MD with a holistic approach.

The aim of our study is to determine the severity of the disease in people with Meniere's Disease; physical conditions such as balance, posture, pain, physical activity level, neck joint range of motion, proprioception; to examine psychosocial conditions such as depression, anxiety, sleep quality, fatigue, and quality of life and to make a comprehensive evaluation by comparing it with healthy volunteers.

Eligibility criteria: Study group Inclusion Criteria:

* Having been diagnosed with Meniere's disease as a result of clinical and audiological evaluation by an ENT specialist
* ability to read and write
* be between the ages of 18-65
* Not having an acute attack and not receiving acute attack treatment during the study period,
* Having given consent to participate in the study as a result of the information
* A minimum score of 24 on the Mini Mental Test (MMDT)

Study group Exclusion Criteria:

* Known neurological disease (head trauma, spinal trauma, multiple sclerosis, intracranial tumor, etc.) Having an anatomical problem or disease related to the outer and middle ear
* Peripheral and central vestibular pathology other than Meniere's disease
* Sensorineural hearing loss due to other causes
* Other neurological, orthopedic, circulatory system or vision problems that may cause vertigo, dizziness and balance disorder

Control group Inclusion Criteria:

* ability to read and write
* be between the ages of 18-65
* Not having an acute attack and not receiving acute attack treatment during the study period,
* Having given consent to participate in the study as a result of the information
* A minimum score of 24 on the Mini Mental Test (MMDT)
* without vertigo

Control group Exclusion Criteria:

* suffering from vertigo
* Known neurological disease (head trauma, spinal trauma, multiple sclerosis, intracranial tumor, etc.) Having an anatomical problem or disease related to the outer and middle ear
* Peripheral and central vestibular pathology other than Meniere's disease
* Sensorineural hearing loss due to other causes
* Other neurological, orthopedic, circulatory system or vision problems that may cause vertigo, dizziness and balance disorder

Primary outcomes:
measure: Evaluating the sense of proprioception with the "Cervical Range of Motion" (CROM) device
timeFrame: March 2023- May 2023
measure: Evaluation of the range of motion (ROM) in the cervical region muscles with the "Cervical Range of Motion" (CROM) device
timeFrame: March 2023-May 2023
measure: Temporomandibular joint range of motion assessment
timeFrame: March 2023- May 2023
measure: Posture evaluation with New York posture analysis
timeFrame: March 2023- May 2023
measure: Evaluation of the anterior tilt angle of the head
timeFrame: March 2023- May 2023
measure: Evaluation of postural balance with the Freemed pressure platform
timeFrame: March 2023- May 2023
measure: Static balance assessment with tandem stance test
timeFrame: March 2023- May 2023
measure: Dynamic balance assessment with tandem gait test
timeFrame: March 2023- May 2023
measure: Headache presence and severity assessment
timeFrame: March 2023- May 2023
measure: Craniocervical pain presence and severity assessment
timeFrame: March 2023-May 2023
measure: Temporomandibular pain presence and severity assessment
timeFrame: March 2023-May 2023
measure: Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
timeFrame: March 2023- May 2023
measure: Evaluation of sleep quality with the Pittsburgh sleep quality index
timeFrame: March 2023- May 2023
measure: Evaluation of fatigue with the fatigue severity scale
timeFrame: March 2023- May 2023
measure: Evaluation of anxiety-depression status with hospital anxiety and depression scale
timeFrame: March 2023- May 2023
measure: Evaluation of quality of life with short form-12 (SF-12)
timeFrame: March 2023- May 2023
measure: the International Fall Efficiency Scale
timeFrame: March 2023- May 2023
Secondary outcomes:
measure: Tinnitus disability scale
timeFrame: March 2023- May 2023
measure: A feeling of fullness and/or pressure in the ear
timeFrame: March 2023- May 2023
measure: Dizziness intensity and frequency
timeFrame: March 2023- May 2023
measure: Dizziness disability inventory
timeFrame: March 2023- May 2023
measure: Vertigo symptom scale-short form
timeFrame: March 2023- May 2023
measure: Hearing Impairment Scale
timeFrame: March 2023- May 2023
measure: International physical activity questionnaire-measurement of physical activity level with short
timeFrame: March 2023- May 2023
measure: Assessment of muscle strength
timeFrame: March 2023- May 2023
measure: Evaluation of muscle endurance
timeFrame: March 2023- May 2023
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe Sağlık Bilimleri Enatitüsü
Study officials:
affiliation: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
name: Nezire Kose
role: STUDY_DIRECTOR
References:
citation: Bjorne A, Agerberg G. Craniomandibular disorders in patients with Meniere's disease: a controlled study. J Orofac Pain. 1996 Winter;10(1):28-37.
citation: Bjorne A, Agerberg G. Symptom relief after treatment of temporomandibular and cervical spine disorders in patients with Meniere's disease: a three-year follow-up. Cranio. 2003 Jan;21(1):50-60. doi: 10.1080/08869634.2003.11746232.
citation: Yardley L, Dibb B, Osborne G. Factors associated with quality of life in Meniere's disease. Clin Otolaryngol Allied Sci. 2003 Oct;28(5):436-41. doi: 10.1046/j.1365-2273.2003.00740.x.