Vestibular Rehabilitation in Patients With Vestibular Migraine

Vestibular Disorder Clinical Trial

Official title:

Efficacy of Vestibular Rehabilitation in Patients With Vestibular Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417596
• Other study ID #: VM-Rehab
• Status: Completed
• Phase: N/A
• First received: January 14, 2018
• Last updated: January 24, 2018
• Start date: January 10, 2015
• Est. completion date: April 15, 2016

Study information

• Verified date: January 2018
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abstract: Introduction:

Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. VM can make a huge impact on quality of life, therefore advances in its diagnosis and management are valuable. While pharmacotherapy that is being used in migraine can be beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most important types of treatment in management of VM. This study compares the results of pharmacological management options and vestibular rehabilitation programmes in the context of dizziness, balance problems and headache.

Material and methods:

77 patients with VM were included in study, and 60 of them completed it. While one group took only VR programme, and another took only pharmacological prophylaxis. The third group took a combined therapy, and the groups were consisted of 20 patients. Patients were assessed with caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI), and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3 times throughout the study, and the results were compared with relevant statistical tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 15, 2016
• Est. primary completion date: April 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1-Vestibular Migraine diagnosis according to International Classification of Headache Disorders (3 rd edition-Beta version) 2- No history of vestibular rehabilitation or exercises

Exclusion Criteria:

• History of psychiatric disorder which might interfere with compliance to study

• Other diagnosis that might possibly cause vestibular disorder(cerebellar disorders, Meniere disease etc)

• Anatomical defects of the inner ear or vestibular system

• Patients who are unable to stand up straight or walk

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine Variant
• Vestibular Diseases
• Vestibular Disorder
• Vestibular Migraine

Intervention

Other:
• Control
Routine treatment

Behavioral:
• Vestibular Rehabilitation
Exercise and rehabilitation programme was individualized

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dizziness Handicap Inventory	A standardized inventory to assess the impact of dizziness in patients' life.	6 months
Primary	Activities-specific balance confidence scale	A scale which is used to evaluate balance confidence of patients in some specific activities. Confidence in daily activities requiring balance is rated by subject as percentage(from %0 to %100). Higher percentage relates to better confidence in balance.	6 months
Primary	Static Posturography	Static posturography was performed using the NeuroCom System Version 8.0.3 (NeuroCom International Inc., Clackamas, OR, USA). Mean center of gravity (COG) sway velocity (°/s) was recorded on a static platform with eyes open (ST-EO) and closed (ST-EC) and on foam with eyes open (FO-EO) and closed (FO-EC)	6 months
Secondary	Vertigo attack severity	Self reported outcome in which patients give insight about their vertigo attack severity	6 months