Vestibular Rehabilitation in Patients With Vestibular Migraine

Efficacy of Vestibular Rehabilitation in Patients With Vestibular Migraine

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Migraine; Vestibular Disorder; Migraine Variant
• Intervention / Treatment: Behavioral: Vestibular Rehabilitation; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Vestibular Rehabilitation; Adaptation Exercises The exercises were performed in horizontal and vertical planes, for a period of one minute each, three times a day. Substitution Exercises Standing dynamic balance exercises: The patient stands and moves without walking. The patient might march in place, step forward or backward, step to the side, step up or down, or turn around. Habituation exercises: These exercises that cause mild to moderate difficulty in daily life was given as an exercise to the patient. These exercises involved movements and positions sufficient to cause mild-to-moderate symptoms during the patient's daily activities Ambulation exercises: Exercises that include walking with head moving towards different sides. The exercise program consisted of one session per week for a period of eight weeks. Each session lasted approximately 30-45 minutes and was conducted in the rehabilitation unit.	Behavioral: Vestibular Rehabilitation; Exercise and rehabilitation programme was individualized
EXPERIMENTAL: Vestibular Rehabilitation+Pharmacological Therapy; Same exercises that were applied in first group were also applied to this group. For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.	Behavioral: Vestibular Rehabilitation; Exercise and rehabilitation programme was individualized; Other: Control; Routine treatment
OTHER: Pharmacological Therapy only; Patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.	Other: Control; Routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dizziness Handicap Inventory	A standardized inventory to assess the impact of dizziness in patients' life.	6 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertigo attack severity	Self reported outcome in which patients give insight about their vertigo attack severity	6 months

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2015
• Primary Completion (ACTUAL): April 10, 2016
• Study Completion (ACTUAL): April 15, 2016

Study Registration Dates

• First Submitted: January 14, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Vestibular Diseases
• Other Study ID Numbers: VM-Rehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No