Effects of Cervical Mobilization on Dizziness, Balance, and Joint Position Sense in Patients With Meniere's Disease

NCT ID: NCT07272473

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2026-05-05

Brief Summary

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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

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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:

1. Adaptation exercises
2. Habituation exercises
3. 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

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Meniere Disease

Keywords

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Endolymphatic hydrops Postural Balance Tinnitus Position Sense Kinesthesis Vestibular Sense Neck Pains

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be a total of 3 groups in the study, two intervention groups and one control group. All groups will continue their routine betahistine treatment. The control group will receive only this standard therapy. Intervention group 1 will receive an additional intervention consisting of 20 minutes of vestibular rehabilitation and 10 minutes of cervical mobilization. Intervention group 2 will receive an additional total of 30 minutes of vestibular rehabilitation. A total of 33 people, 11 in each group, will be included in the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

Participants receive standard therapy only and do not receive vestibular rehabilitation or cervical mobilisation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Vestibular Rehabilitation + Cervical Mobilization

Participants receive both vestibular rehabilitation and cervical mobilization interventions.

Group Type EXPERIMENTAL

Vestibular Rehabilitation + Cervical Mobilization

Intervention Type OTHER

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 Rehabilitation Alone

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.

Group Type ACTIVE_COMPARATOR

vestibular rehabilitation

Intervention Type OTHER

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.

Interventions

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Vestibular Rehabilitation + Cervical Mobilization

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.

Intervention Type OTHER

vestibular rehabilitation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Ömer Osman Pala

ASSOCIATE PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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omer pala, associate professor

Role: STUDY_DIRECTOR

Abant Izzet Baysal University

Locations

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Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose and Throat Polyclinic

Afyonkarahisar, Afyonkarahisar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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nurgul sarı, Master's Degree

Role: CONTACT

Phone: +905344527440

Email: [email protected]

omer pala, associate professor

Role: CONTACT

Phone: +905327975716

Facility Contacts

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pakize sarı

Role: primary

Other Identifiers

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AIBU-FTR-OOP-10

Identifier Type: -

Identifier Source: org_study_id