Comprehensive Evaluation in Patients With Meniere's Disease

Quality of Life Clinical Trial

Official title:

Investigation of the Physical and Psychosocial Status and Quality of Life of People With Meniere's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05844657
• Other study ID #: Hacettepe Universitey
• Status: Completed
• Start date: May 15, 2023
• Est. completion date: October 4, 2023

Study information

• Verified date: October 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 4, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Meniere Disease
• Physical Disability
• Psychosocial Problem
• Quality of Life

Intervention

Other:
• Case report form
Sociodemographic information (age, gender, height, body mass index, marital status, occupation, education level, contact information), frequency of smoking and alcohol use, frequency of caffeine consumption, frequency of salt consumption, dominant side, background, family history, medical and audiological information were recorded.
• Tinnitus disability scale
Tinnitus disability scale was used to evaluate the tinnitus severity of Meniere's patients. It consists of 25 items in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Tinnitus level or severity is determined by calculating the total score of the answers given.
• A feeling of fullness and/or pressure in the ear
The feeling of fullness or pressure in the ear was evaluated verbally by receiving yes/no responses from the participants.
• Dizziness intensity and frequency
In order to determine the frequency and severity of dizziness, the participants were asked to mark the appropriate score between 1-10 points.
• Dizziness disability inventory
The dizziness disability inventory was used to determine the disability level of the individuals participating in our study. It consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'.
• Vertigo symptom scale-short form
The short form of the vertigo symptom scale was used to determine the frequency and duration of vertigo in the individuals participating in our study. The vertigo symptom scale consisting of 8 questions consists of vertigo (VSS-V), and the vertigo symptom scale consisting of 7 questions consists of two subsections consisting of a total of 15 questions: anxiety (VSS-A). Each item; Never (0), Very rarely (1 point), Often (2 points), Often - every week (3 points), Very often - On average, at least twice a week (4 points). The total score ranges from 0 to 60.
• Hearing Impairment Scale
The Adult Hearing Impairment Scale was used to determine the effect of the current hearing impairment levels of the individuals participating in our study on their daily living activities. The scale consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Participants mark the most appropriate expression for them.
• Cervical Range of Motion (CROM 3) device
"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception and range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.
• Temporomandibular joint range of motion assessment
In our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation.
• Posture evaluation with New York posture analysis
The New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65.
• Evaluation of the anterior tilt angle of the head
Anterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7.
• Evaluation of postural balance with the Freemed pressure platform
Postural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable.
• Static balance assessment with tandem stance test
In our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed.
• Dynamic balance assessment with tandem gait test
In our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open.
• Headache, Temporomandibular pain and Craniocervical pain presence and severity assessment
Headache, temporomandibular pain and craniocervical pain were asked to mark the person from the photographs taken from the front, back and side in the form of a human figure. Pain severity was evaluated with the numerical rating scale (NRS).
• Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region
In our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides.
• International physical activity questionnaire-measurement of physical activity level with short
The short form of the international physical activity questionnaire was used to determine the physical activity level of the individuals participating in our study. The short form of the international physical activity questionnaire evaluates the last week and consists of a total of 4 sections and 7 questions. Duration of physical activity that requires intense physical effort, such as heavy lifting, soccer, or fast cycling; times of doing moderate physical activities that cause breathing slightly more often than usual; The total duration of walks at work, home, for sports, exercise and hobby, and the total sitting time spent in a day at work, at home or while resting are calculated.
• Evaluation of sleep quality with the Pittsburgh sleep quality index
The Pittsburgh Sleep Quality Index (PUKI) was used to evaluate the sleep quality and disturbance of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant responds to each item according to the frequency between 0-3 points. The total score (0-21 points) from these components indicates whether the sleep quality is good or not.
• Evaluation of fatigue with the fatigue severity scale
The Fatigue severity scale was used to evaluate the fatigue status of the individuals participating in our study. The scale uses a scoring system ranging from 1-7, which starts as I do not agree (1 point) and increases gradually towards I agree (7 point). It consists of 9 items in total and people mark the option that suits them.
• Evaluation of anxiety-depression status with hospital anxiety and depression scale
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the anxiety and depression status of the individuals participating in our study. For each item, the participant answers with a four-point (0-3 points) response option. Therefore, the possible score probabilities in line with the answers given are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, while the cut-off point for the depression subscale is 7 points.
• Evaluation of quality of life with short form-12 (SF-12)
The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life.
• the International Fall Efficiency Scale
The International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 (no worries) to 64 (extremely worried).
• assessment of muscle performance
In our study, the strength of cervical flexors, anterior and oblique trunk flexors, cervical extensor muscles, back extensor muscles, trapezius muscle, and rhomboid major-minor muscles were evaluated. In addition, the endurance of the deep cervical flexor muscles, cervical flexors and cervical extensor muscles were also evaluated.

Locations

Country	Name	City	State
Turkey	Hacettepe Saglik Bilimleri Enatitüsü	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Bjorne A, Agerberg G. Craniomandibular disorders in patients with Meniere's disease: a controlled study. J Orofac Pain. 1996 Winter;10(1):28-37. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the sense of proprioception with the "Cervical Range of Motion" (CROM) device	"Cervical Range of Motion" (CROM) device was used to evaluate the sense of proprioception. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.	March 2023- May 2023
Primary	Evaluation of the range of motion (ROM) in the cervical region muscles with the "Cervical Range of Motion" (CROM) device	"Cervical Range of Motion" (CROM) device was used to evaluate the range of motion (ROM) in the cervical region muscles. A total of six positions were performed: right cervical rotation, left cervical rotation, right cervical lateral flexion, left cervical lateral flexion, cervical extension and cervical flexion.	March 2023-May 2023
Primary	Temporomandibular joint range of motion assessment	In our study, the temporamandibular joint range of motion (ROM) was evaluated with a ruler specific to each participant in four positions, including mandibular depression, protraction, and right and left lateral deviation.	March 2023- May 2023
Primary	Posture evaluation with New York posture analysis	The New York Posture Evaluation method was used to obtain information about the general posture correctness of the participants. Posture changes that may occur in 13 different parts of the body, 7 from the side and 6 from the back, including the head, neck, shoulder, back, waist, hip and ankle, were examined in the anatomical position of the individuals. As a result of the observation, the posture of the individual was scored according to whether it was severely bad (1 point), moderately bad (3 points), and straight (5 points). The total score obtained varies between 13-65.	March 2023- May 2023
Primary	Evaluation of the anterior tilt angle of the head	Anterior tilt angles of the head of the participants were evaluated with photographs taken from the lateral (lateral) side. The anterior tilt angle was calculated as the angle between the line drawn between the C7 cervical spinous process and the tragus and the straight line drawn vertically from C7.	March 2023- May 2023
Primary	Evaluation of postural balance with the Freemed pressure platform	Postural sway and lower extremity weight transfer were evaluated with the Freemed baropodometric pressure platform (Rome, Italy) system, which has been shown to be valid and reliable.	March 2023- May 2023
Primary	Static balance assessment with tandem stance test	In our study, the tandem stance test was used for static evaluation. A total of four assessments were made on the participants, first with their right foot in front, eyes open and eyes closed, then left foot in front with eyes open and eyes closed.	March 2023- May 2023
Primary	Dynamic balance assessment with tandem gait test	In our study, the tandem gait test was used for dynamic evaluation. A straight line was created with a white tape attached to the floor, almost 2 feet away from the 10-foot-long wall. The participant was asked to walk along the line created by taping the heel of the forward foot to touch the toe of the back foot, at a comfortable pace in daily life and with eyes open.	March 2023- May 2023
Primary	Headache presence and severity assessment	The participant was asked to mark the places where the headache occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.	March 2023- May 2023
Primary	Craniocervical pain presence and severity assessment	The participant was asked to mark the areas of craniocervical pain from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.	March 2023-May 2023
Primary	Temporomandibular pain presence and severity assessment	The participant was asked to mark the places where temporomandibular pain occurred from the photographs taken in the form of a human figure from the front, back and side. Pain severity was evaluated with the Numerical Rating Scale. The lowest score 0 indicates 'I have no pain' and the highest score 10 indicates 'I have unbearable pain'. As the score increases, the severity of pain increases.	March 2023-May 2023
Primary	Pain sensitivity assessment in the head, neck, shoulder girdle and upper back region	In our study, muscle tenderness was evaluated by manual pressure algometry and palpation. Muscle tenderness was assessed in the upper and lower regions of the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles on both right and left sides.	March 2023- May 2023
Primary	Evaluation of sleep quality with the Pittsburgh sleep quality index	The Pittsburgh Sleep Quality Index was used to evaluate the sleep quality and discomfort of the individuals participating in our study in the last month. It consists of a total of 24 questions. The participant answers each item between 0-3 points according to the frequency. The total score (0-21 points) from these components indicates whether the sleep quality is good or not. As the total score increases, sleep quality decreases and sleep disorder status increases. A total score of 5 or more indicates poor sleep quality.	March 2023- May 2023
Primary	Evaluation of fatigue with the fatigue severity scale	The Fatigue Severity Scale was used to evaluate the fatigue status of the individuals participating in our study. The Fatigue Severity Scale uses a scoring system ranging from 1-7, starting with disagree (1 point) and gradually increasing to agree (7 points). It consists of 9 items in total and people mark the option that suits them. Possibilities of total points that can be taken vary between 9-63 points. A score of 36 and above indicates that the level of fatigue is severe. The higher the score, the higher the level of fatigue.	March 2023- May 2023
Primary	Evaluation of anxiety-depression status with hospital anxiety and depression scale	The Hospital Anxiety and Depression Scale was used to evaluate the anxiety and depression status of the individuals participating in our study. The participant answers with a four-point (0-3 point) response option for each item. Therefore, according to the answers given, the possible score probabilities are minimum '0' and maximum '21'. The cut-off point for the anxiety subscale is 10 points, and the cut-off point for the depression subscale is 7 points. The higher the total score, the higher the level of depression and anxiety.	March 2023- May 2023
Primary	Evaluation of quality of life with short form-12 (SF-12)	The Short form SF-12 Questionnaire was used to evaluate the quality of life of the individuals participating in our study. The summary score of the physical and mental components varies between 0-100, and the higher the score in the components, the better the quality of life.	March 2023- May 2023
Primary	the International Fall Efficiency Scale	The International Fall Activity Scale (UDES) was used to evaluate both the attack and the general fear of falling of the individuals participating in our study. It consists of 16 questions in total. The answer to each question is marked on a scale between 1 and 4 points. Expressions such as I never worry (1 point), I worry a little (2 point), I am very worried (3 point), I am very worried (4 point) are used as the level of anxiety increases as the score increases. The total score obtained ranges from 16 to 64.	March 2023- May 2023
Secondary	Tinnitus disability scale	Tinnitus disability scale was used to evaluate the tinnitus severity of Meniere's patients. It consists of 25 items in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Tinnitus level or severity is determined by calculating the total score of the answers given.	March 2023- May 2023
Secondary	A feeling of fullness and/or pressure in the ear	The feeling of fullness or pressure in the ear was evaluated verbally by receiving yes/no responses from the participants.	March 2023- May 2023
Secondary	Dizziness intensity and frequency	In order to determine the frequency and severity of dizziness, the participants were asked to mark the appropriate score between 1-10 points. 1 point indicates no dizziness, 10 points indicates continuous and extremely severe dizziness. As the score increases, the frequency and severity of dizziness also increase.	March 2023- May 2023
Secondary	Dizziness disability inventory	The dizziness disability inventory was used to determine the disability level of the individuals participating in our study. It consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'.	March 2023- May 2023
Secondary	Vertigo symptom scale-short form	The short form of the vertigo symptom scale was used to determine the frequency and duration of vertigo in the individuals participating in our study. The vertigo symptom scale consisting of 8 questions consists of vertigo (VSS-V), and the vertigo symptom scale consisting of 7 questions consists of two subsections consisting of a total of 15 questions: anxiety (VSS-A). Each item; Never (0), Very rarely (1 point), Often (2 points), Often - every week (3 points), Very often - On average, at least twice a week (4 points). The total score ranges from 0 to 60.	March 2023- May 2023
Secondary	Hearing Impairment Scale	The Adult Hearing Impairment Scale was used to determine the effect of the current hearing impairment levels of the individuals participating in our study on their daily living activities. The scale consists of 25 questions in total. The questions are scored between 0-2-4. It is calculated as 'Yes (4 points)', 'Sometimes (2 points)', 'No (0 points)'. Participants mark the most appropriate expression for them.	March 2023- May 2023
Secondary	International physical activity questionnaire-measurement of physical activity level with short	The short form of the international physical activity questionnaire was used to determine the physical activity levels of the individuals participating in our study. The short form of the international physical activity questionnaire evaluates the last week and consists of a total of 4 sections and 7 questions. The duration of physical activity that requires intense physical exertion, such as heavy lifting, soccer, or fast cycling; times of doing moderate physical activities that cause breathing slightly more often than usual; The total duration of walks at work, home, sports, exercise and hobby, and the total sitting time spent in a day at work, at home or while resting are calculated. The physical activity score is calculated by converting the Metabolic Equivalent of Task, which corresponds to the basal metabolic rate. Total Metabolic Equivalent of Task value varies between 0-3000. The higher the total score, the higher the level of physical activity.	March 2023- May 2023
Secondary	Assessment of muscle strength	In our study, the strength of cervical flexors, anterior and oblique trunk flexors, cervical extensor muscles, back extensor muscles, trapezius muscle and rhomboid major-minor muscles were evaluated.	March 2023- May 2023
Secondary	Evaluation of muscle endurance	In our study, the endurance of deep cervical flexor muscles, neck cervical flexors and neck cervical extensor muscles were evaluated.	March 2023- May 2023

External Links

•   Craniomandibular disorders in patients with Menière's disease: a controlled study
•   Factors associated with quality of life in Menière's disease
•   Symptom relief after treatment of temporomandibular and cervical spine disorders in patients with Meniere's disease: a three-year follow-up