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

A

Abant Izzet Baysal University

Status

Enrolling

Conditions

Meniere Disease

Treatments

Other: Vestibular Rehabilitation + Cervical Mobilization
Other: vestibular rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT07272473
AIBU-FTR-OOP-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

33 participants in 3 patient groups

Vestibular Rehabilitation + Cervical Mobilization
Experimental group
Description:
Participants receive both vestibular rehabilitation and cervical mobilization interventions.
Treatment:
Other: Vestibular Rehabilitation + Cervical Mobilization
Vestibular Rehabilitation Alone
Active Comparator group
Description:
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.
Treatment:
Other: vestibular rehabilitation
Control Group
No Intervention group
Description:
Participants receive standard therapy only and do not receive vestibular rehabilitation or cervical mobilisation.

Trial contacts and locations

1

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Central trial contact

omer pala, associate professor; nurgul sarı, Master's Degree

Data sourced from clinicaltrials.gov

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