Meniere DiseaseNCT07272473
Effects of Cervical Mobilization on Dizziness, Balance, and Joint Position Sense in Patients With Meniere's Disease
A study testing Vestibular Rehabilitation + Cervical Mobilization and vestibular rehabilitation in people with Meniere Disease, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The study will employ a stratified randomization method. Patients presenting to the Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose, and Throat Outpatient Clinic, with a definitive diagnosis of Meniere's disease, unilateral or bilateral involvement, and who consent to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Meniere Disease
- What is being tested?
- Vestibular Rehabilitation + Cervical Mobilization and vestibular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2025to 23 Jul 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definitive clinical diagnosis of unilateral or bilateral Meniere's disease
- Age between 18 and 60 years
- Presence of fluctuating symptoms or chronic imbalance for at least 3 months
- Cognitive ability to participate in balance rehabilitation tasks (Mini Mental State Examination score ≥ 24)
- Willingness to participate in the study and provide informed consent
Who cannot join
- Diagnosis of vertigo not associated with Meniere's disease
- Presence of another acute medical condition
- Neurological, psychological, or cognitive dysfunction
- History of orthopedic surgery within the last 3 months
- Planned surgical intervention during the rehabilitation program
- Cervical spine instability
- Acute cervical trauma
- Vertebral artery insufficiency
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose and Throat Polyclinic
Afyonkarahisar, Afyonkarahisar, 03030
About this study
The study will employ a stratified randomization method. Patients presenting to the Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose, and Throat Outpatient Clinic, with a definitive diagnosis of Meniere's disease, unilateral or bilateral involvement, and who consent to participate in the study will be divided into three groups. The control group will receive only their routine Betahistine. Their usual treatment will remain unchanged. The first study group will receive 20 minutes of Vestibular Rehabilitation (VR) and 10 minutes of cervical mobilization in addition to their routine Betahistine. The second study group will receive 30 minutes of VR in addition to Betahistine. The study will last 6 weeks. Participants will be assessed using a sociodemographic information questionnaire, the Dizziness Handicap Inventory (DHI), the Vertigo Symptom Scale (VSS), the Neck Disability Index (NDI), the International Tinnitus Inventory (ITI), balance assessment with the K-Force Plates, and joint position sense and proprioception assessment with the Kinvent Physio K-Move. All assessments will be conducted twice, before and after treatment.
Read the detailed description
Patients who have been diagnosed with Meniere's disease and who have applied to the Afyonkarahisar Health Sciences University Health Practice and Research Center, Ear, Nose, and Throat Outpatient Clinic will be included in the study.
The study will employ a stratified randomization method. Patients who have been diagnosed with Meniere's disease and have unilateral or bilateral involvement and who agree to participate in the study will be divided into three groups. The control group will only receive their routine Betahistine. Their usual treatments will remain unchanged. The first study group will receive 20 minutes of Vestibular Rehabilitation (VR) and 10 minutes of cervical mobilization in addition to their routine Betahistine. The second study group will receive 30 minutes of VR in addition to Betahistine. The study will last 6 weeks. During the VR sessions:
- Adaptation exercises
- Habituation exercises
- Compensation exercises. A 6-week exercise protocol will be developed. The exercises will gradually increase in difficulty each week. Adaptation exercises will include visual tracking of a moving object while the head is stationary, and tracking objects in different directions while walking. Habituation exercises will include challenging exercises such as coming from lying down to sitting quickly and rising from sitting to standing. Compensation exercises will include walking on surfaces of varying hardness, standing on a balance board, and balancing on a trampoline, each with increasing difficulty each week.
For cervical mobilization, participants will first undergo 3-4 minutes of suboccipital release while lying on their backs to relax, then 2-3 minutes of cervical traction will be applied, and then, while sitting, they will mobilize the C1 and C2 vertebrae using the Mulligan concept.
Participants will be assessed using a sociodemographic questionnaire, the The Dizziness Handicap Inventory (DHI), the Vertigo Symptom Scale (VSS), the Neck Disability Index (NDI), the International Tinnitus Inventory (ITI), balance assessment with the K-Force Plates, and joint position sense and proprioception assessment with the Kinvent Physio K-Move. All assessments will be conducted twice: at baseline and after 6 weeks. This will allow for comparison of the three groups and provide a pre- and post-treatment assessment.
- Conditions
- Meniere Disease
- Being tested
- Vestibular Rehabilitation + Cervical Mobilization, vestibular rehabilitation
- Keywords
- Endolymphatic hydrops, Postural Balance, Tinnitus, Position Sense, Kinesthesis, Vestibular Sense, Neck Pains
- Medical subject headings
- Meniere Disease, Endolymphatic Hydrops, Tinnitus, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation + Cervical MobilizationOther
Treatment will be administered twice a week for 6 weeks, consisting of 20 minutes of vestibular rehabilitation and 10 minutes of cervical mobilization, each lasting 30 minutes. Vestibular rehabilitation will include adaptation exercises, habituation exercises, and compensation exercises. For cervical mobilization, participants will first undergo 3-4 minutes of suboccipital relaxation while lying supine to help them relax, then 2-3 minutes of cervical traction will be applied, and then, while sitting, they will mobilize the C1 and C2 vertebrae using the Mulligan concept.
vestibular rehabilitationOther
Vestibular rehabilitation will be applied for 30 minutes, twice a week, for 6 weeks. Adaptation exercises, habituation exercises, and compensation exercises will be applied as vestibular rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Rehabilitation + Cervical Mobilization | Experimental | Participants receive both vestibular rehabilitation and cervical mobilization interventions. Receives: Other: Vestibular Rehabilitation + Cervical Mobilization |
| Vestibular Rehabilitation Alone | Active comparator | Participants receive vestibular rehabilitation only, administered for 30 minutes per session, twice a week for 6 weeks.The program will include adaptation exercises, habituation exercises, and compensation exercises. Receives: Other: vestibular rehabilitation |
| Control Group | No intervention | Participants receive standard therapy only and do not receive vestibular rehabilitation or cervical mobilisation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance assessments
Balance assessments will be conducted statically and dynamically using K-Force Plates. Both bilateral and unilateral balance tests will be conducted for static balance assessments. In the bilateral balance test, participants will be tested on both feet, first with their eyes open and then with their eyes closed. In the unilateral test, participants will first be asked to stand on their right and left legs for 10 seconds, with their eyes open, and then three repetitions, with the average calculated. They will then be asked to stand on their right and left legs, again, with their eyes closed.
In the dynamic balance test, participants will be asked to jump and descend from a step placed 19 cm above the force plate. (Both feet will be suspended before landing.) They will then be asked to balance with their hands on their hips for 15 seconds. If the participant moves their foot or loses their balance completely, the trial will be cancelled and repeated.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (5)
Dizziness assesment
The Dizziness Handicap Inventory (DHI) will be used to assess dizziness. DHI was developed by Jacobson and Newman in 1990. The DHI consists of 25 items that identify factors that aggravate dizziness and balance disorders in patients, as well as the sensory and functional consequences of vestibular system disorders. Sub-inventories are designed to determine the physical, sensory, and functional effects of vestibular system disorders.
Each question has a yes (4 points), no (0 points), and sometimes (2) response. When scoring the sub-items of the inventory, a score of 28 is recommended as the threshold for determining physical disability, and a score of 36 is recommended as the threshold for determining functional and sensory disability. High scores are interpreted as indicating that the patient's dizziness complaint significantly impedes their life. The Turkish validity and reliability test of the inventory was conducted.
Measured: From enrollment to the end of treatment at 6 weeks
Vertigo Symptom Assesment
The Vertigo Symptom Scale (VSS) is used to assess the frequency of symptoms such as imbalance, somatic symptoms, autonomic symptoms, anxiety, and panic, which are commonly encountered in patients with vertigo and feelings of imbalance. The scale consists of two subsections: the Vertigo Symptom Scale-Vertigo Section (VSS-V), which relates to vertigo and balance disorders, and the Vertigo Symptom Scale-Anxiety Section, which relates to autonomic disorders and anxiety symptoms. The VSS-V consists of 8 questions (0-32 points), and the VSS-A consists of 7 questions (0-28 points). Symptom frequency is scored from 0= never, 1= very infrequently, 2= often, 3= often (every week), and 4= very often (more than 1 day per week on average). Patients are asked to answer these questions about their dizziness, thinking back to the past month. Higher scores (maximum 60) indicate an increased frequency of experiencing vertigo-related symptoms. A score of ≥12 is defined as severe dizziness.
Measured: From enrollment to the end of treatment at 6 weeks
Neck Disability Assessment
The Neck Disability Index (NDI) is a 10-item assessment tool covering pain severity, personal care, weightlifting, reading, headache, concentration, working, driving, sleep, and rest. It measures the level of functional limitations associated with the neck. Each item is scored from 0 (no disability) to 5 (maximum disability). The highest total score is 50. It is accepted that as an individual's score increases, the level of disability due to neck pain also increases. A total score of 0 indicates no disability, while a score of 50 indicates maximum disability. According to the assessment, scores between 0 and 4 are classified as "no disability", 5-14 as "mild disability", 15-24 as "moderate disability," 25-34 as "severe disability," and 35 and above as "complete disability."
Measured: From enrollment to the end of treatment at 6 weeks
Tinnitus Assessment
The International Tinnitus Inventory (ITI), aims to assess the multidimensional effects of tinnitus on individuals.This assessment encompasses perceptions of hearing, general health status, sleep patterns, inner peace, social relationships, daily living activities, enjoyment of life, and the level of discomfort caused by tinnitus. The inventory consists of eight items, and each item is scored from 1 to 5; the total score ranges from 8 to 40. Lower total scores indicate a greater perception of the negative effects of tinnitus on the individual.
Measured: From enrollment to the end of treatment at 6 weeks
Proprioception Assessment
The Kinvent Physio K-Move device is a wireless, portable motion sensor developed for the objective assessment of movement. This device is used specifically in physiotherapy and rehabilitation processes to precisely measure and monitor joint range of motion (ROM) and joint position sense. Validity and reliability of the device for assessing joint position sense and proprioception have been established.
The device measures head flexion, extension, lateral flexion, and rotation angles. During the measurements, participants' cervical joint range of motion will be assessed first. Participants will be seated in a comfortable sitting position with their feet flat on the floor and their heads in a neutral position, arms at their sides. Participants will be instructed and demonstrated on all movements they will perform before the assessment.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start20 Sep 2025
- Primary completion23 Jul 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Model description
- The study included three groups: two intervention groups and one control group. All groups continued their routine betahistine treatment. The control group received only this standard therapy. Intervention group 1 additionally received 20 minutes of vestibular rehabilitation and 10 minutes of cervical mobilization. Intervention group 2 additionally received 30 minutes of vestibular rehabilitation. The planned enrollment was 33 participants, with 11 participants per group. Actual enrollment was 48 participants, with 16 participants in each group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Osman Pala, Abant Izzet Baysal University
- Investigators
- omer pala, associate professor, Study director, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272473
- Sponsor's protocol ID
- AIBU-FTR-OOP-10
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Mobilization on Dizziness, Balance, and Joint Position Sense in Patients With Meniere's Disease
- ClinicalTrials.gov ID
- NCT07272473
- Acronym / sponsor ID
- AIBU-FTR-OOP-10
- Conditions
- Meniere Disease
- Keywords
- Endolymphatic hydrops, Postural Balance, Tinnitus, Position Sense, Kinesthesis, Vestibular Sense, Neck Pains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 9 Dec 2025 (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 study will employ a stratified randomization method. Patients presenting to the Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose, and Throat Outpatient Clinic, with a definitive diagnosis of Meniere's disease, unilateral or bilateral involvement, and who consent to participate in the study will be divided into three groups. The control group will receive only their routine Betahistine. Their usual treatment will remain unchanged. The first study group will receive 20 minutes of Vestibular Rehabilitation (VR) and 10 minutes of cervical mobilization in addition to their routine Betahistine. The second study group will receive 30 minutes of VR in addition to Betahistine. The study will last 6 weeks. Participants will be assessed using a sociodemographic information questionnaire, the Dizziness Handicap Inventory (DHI), the Vertigo Symptom Scale (VSS), the Neck Disability Index (NDI), the International Tinnitus Inventory (ITI), balance assessment with the K-Force Plates, and joint position sense and proprioception assessment with the Kinvent Physio K-Move. All assessments will be conducted twice, before and after treatment.
Detailed description
Patients who have been diagnosed with Meniere's disease and who have applied to the Afyonkarahisar Health Sciences University Health Practice and Research Center, Ear, Nose, and Throat Outpatient Clinic will be included in the study.
The study will employ a stratified randomization method. Patients who have been diagnosed with Meniere's disease and have unilateral or bilateral involvement and who agree to participate in the study will be divided into three groups. The control group will only receive their routine Betahistine. Their usual treatments will remain unchanged. The first study group will receive 20 minutes of Vestibular Rehabilitation (VR) and 10 minutes of cervical mobilization in addition to their routine Betahistine. The second study group will receive 30 minutes of VR in addition to Betahistine. The study will last 6 weeks. During the VR sessions:
- Adaptation exercises
- Habituation exercises
- Compensation exercises. A 6-week exercise protocol will be developed. The exercises will gradually increase in difficulty each week. Adaptation exercises will include visual tracking of a moving object while the head is stationary, and tracking objects in different directions while walking. Habituation exercises will include challenging exercises such as coming from lying down to sitting quickly and rising from sitting to standing. Compensation exercises will include walking on surfaces of varying hardness, standing on a balance board, and balancing on a trampoline, each with increasing difficulty each week.
For cervical mobilization, participants will first undergo 3-4 minutes of suboccipital release while lying on their backs to relax, then 2-3 minutes of cervical traction will be applied, and then, while sitting, they will mobilize the C1 and C2 vertebrae using the Mulligan concept.
Participants will be assessed using a sociodemographic questionnaire, the The Dizziness Handicap Inventory (DHI), the Vertigo Symptom Scale (VSS), the Neck Disability Index (NDI), the International Tinnitus Inventory (ITI), balance assessment with the K-Force Plates, and joint position sense and proprioception assessment with the Kinvent Physio K-Move. All assessments will be conducted twice: at baseline and after 6 weeks. This will allow for comparison of the three groups and provide a pre- and post-treatment assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study included three groups: two intervention groups and one control group. All groups continued their routine betahistine treatment. The control group received only this standard therapy. Intervention group 1 additionally received 20 minutes of vestibular rehabilitation and 10 minutes of cervical mobilization. Intervention group 2 additionally received 30 minutes of vestibular rehabilitation. The planned enrollment was 33 participants, with 11 participants per group. Actual enrollment was 48 participants, with 16 participants in each group.
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation + Cervical Mobilization | Experimental | Other: Vestibular Rehabilitation + Cervical MobilizationParticipants receive both vestibular rehabilitation and cervical mobilization interventions. |
| Vestibular Rehabilitation Alone | Active comparator | Other: vestibular rehabilitationParticipants receive vestibular rehabilitation only, administered for 30 minutes per session, twice a week for 6 weeks.The program will include adaptation exercises, habituation exercises, and compensation exercises. |
| Control Group | No intervention | –Participants receive standard therapy only and do not receive vestibular rehabilitation or cervical mobilisation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Definitive clinical diagnosis of unilateral or bilateral Meniere's disease
- Age between 18 and 60 years
- Presence of fluctuating symptoms or chronic imbalance for at least 3 months
- Cognitive ability to participate in balance rehabilitation tasks (Mini Mental State Examination score ≥ 24)
- Willingness to participate in the study and provide informed consent
Key exclusion criteria (8 listed)
- Diagnosis of vertigo not associated with Meniere's disease
- Presence of another acute medical condition
- Neurological, psychological, or cognitive dysfunction
- History of orthopedic surgery within the last 3 months
- Planned surgical intervention during the rehabilitation program
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 |
|---|---|---|
| Vestibular Rehabilitation + Cervical MobilizationTreatment will be administered twice a week for 6 weeks, consisting of 20 minutes of vestibular rehabilitation and 10 minutes of cervical mobilization, each lasting 30 minutes. Vestibular rehabilitation will include adaptation exercises, habituation exercises, and compensation exercises. For cervical mobilization, participants will first undergo 3-4 minutes of suboccipital relaxation while lying supine to help them relax, then 2-3 minutes of cervical traction will be applied, and then, while sitting, they will mobilize the C1 and C2 vertebrae using the Mulligan concept. | Other | Vestibular Rehabilitation + Cervical Mobilization |
| vestibular rehabilitationVestibular rehabilitation will be applied for 30 minutes, twice a week, for 6 weeks. Adaptation exercises, habituation exercises, and compensation exercises will be applied as vestibular rehabilitation. | Other | Vestibular Rehabilitation Alone |
Primary outcome
Balance assessments
Time frame: From enrollment to the end of treatment at 6 weeks
Balance assessments will be conducted statically and dynamically using K-Force Plates. Both bilateral and unilateral balance tests will be conducted for static balance assessments. In the bilateral balance test, participants will be tested on both feet, first with their eyes open and then with their eyes closed. In the unilateral test, participants will first be asked to stand on their right and left legs for 10 seconds, with their eyes open, and then three repetitions, with the average calculated. They will then be asked to stand on their right and left legs, again, with their eyes closed. In the dynamic balance test, participants will be asked to jump and descend from a step placed 19 cm above the force plate. (Both feet will be suspended before landing.) They will then be asked to balance with their hands on their hips for 15 seconds. If the participant moves their foot or loses their balance completely, the trial will be cancelled and repeated.
5 secondary outcomes
Dizziness assesment
Time frame: From enrollment to the end of treatment at 6 weeks
Vertigo Symptom Assesment
Time frame: From enrollment to the end of treatment at 6 weeks
Neck Disability Assessment
Time frame: From enrollment to the end of treatment at 6 weeks
Tinnitus Assessment
Time frame: From enrollment to the end of treatment at 6 weeks
Proprioception Assessment
Time frame: From enrollment to the end of treatment at 6 weeks
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 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
omer pala, associate professor study director
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation + Cervical Mobilization and vestibular rehabilitation in people with Meniere Disease, run by Abant Izzet Baysal 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 8 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 6 Oct 2026. 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?
Balance assessments (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.