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

Overview

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:

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.

Interventions

• Other 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 sit
• 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.

Primary outcome measures

• Balance assessments [Time frame: From enrollment to the end of treatment at 6 weeks]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nos — Afyonkarahisar

Identifiers

NCT: NCT07272473 · AIBU-FTR-OOP-10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗