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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAbant Izzet Baysal University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vestibular Rehabilitation + Cervical Mobilization

    Other intervention

    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

    Other intervention

    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.

Treatment groups

33 Participants
are divided into 3 treatment groups
Group A: Vestibular Rehabilitation + Cervical MobilizationExperimental treatment 1 intervention
Group B: Vestibular Rehabilitation AloneActive comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
From enrollment to the end of treatment at 6 weeks

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 6 weeks
2

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.

Time frame
From enrollment to the end of treatment at 6 weeks
3

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."

Time frame
From enrollment to the end of treatment at 6 weeks
4

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.

Time frame
From enrollment to the end of treatment at 6 weeks

Other outcomes

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