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

NCT07272473 | Recruiting

• 1 other identifier: AIBU-FTR-OOP-10
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Meniere Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (5)

• Dizziness assesment

  From enrollment to the end of treatment at 6 weeks

• Vertigo Symptom Assesment

  From enrollment to the end of treatment at 6 weeks

• Neck Disability Assessment

  From enrollment to the end of treatment at 6 weeks

• Tinnitus Assessment

  From enrollment to the end of treatment at 6 weeks

• Proprioception Assessment

  From enrollment to the end of treatment at 6 weeks

Study Arms (3)

Vestibular Rehabilitation + Cervical Mobilization

EXPERIMENTAL

Participants receive both vestibular rehabilitation and cervical mobilization interventions.

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.

Other: vestibular rehabilitation

Control Group

NO INTERVENTION

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

Interventions

Vestibular Rehabilitation + Cervical Mobilization 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 + Cervical Mobilization

vestibular rehabilitation 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.

Vestibular Rehabilitation Alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

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

Afyonkarahisar, Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Meniere Disease; Endolymphatic Hydrops; Tinnitus; Neck Pain

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• omer pala, associate professor

  Abant Izzet Baysal University

  STUDY DIRECTOR

Central Study Contacts

nurgul sarı, Master's Degree

CONTACT

+905344527440; nurgulsen12@gmail.com

omer pala, associate professor

CONTACT

+905327975716

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 9, 2025
• Study Start: September 20, 2025
• Primary Completion: March 30, 2026
• Study Completion: May 5, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)