Clinical trial NCT05472675: Local Sensory Nerve Block in the Treatment of Vestibular Migraine
Official title: Local Sensory Nerve Block in the Treatment of Vestibular Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Migraine
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is no standard approach to the treatment of vestibular migraine. Agents used in the treatment of migraine are frequently used. In treating migraine, local anesthetic agents, nerve-blocking methods, and botulinum toxin local injection is commonly applied, and successful results are obtained. Adapting the nerve-blocking method used in the treatment of migraine to the treatment of vestibular migraine is the purpose of the study.

Detailed description: Patients between 18-75 diagnosed with/without aura or chronic migraine according to IHCD-3 diagnostic criteria and who describe dizziness during or between attacks will be evaluated in the ENT clinic.

Patients included in the study will be recorded as definite vestibular migraine or probable vestibular migraine according to criteria defined in the BARANY community and IHCD-3. Differential diagnosis of vertigo will be made with pure tone audiometry, Caloric test, VHIT, Videonystagmography, and cVEMP. MIDAS (migraine disability scale), DHI (dizziness handicap inventory), VSS (vertigo symptom scale), DASÖ-21 anxiety test, and Allodynia Symptom Checklist (ASKL) forms will be filled.

Patients will be randomly divided into two groups. Patients in the control group will be given beta-blocker therapy, the standard treatment. The local anesthetic agent bupivacaine will be injected into the greater/small occipital nerves and supratrochlear/ supraorbital nerves. Patients in the study group will be asked to keep a diary of pain, dizziness, and painkiller use for one month. At the end of the 1st month, the scoring will be repeated, and the patients who show a decrease in half will be accepted to the next stage, botulinum toxin application. BoNT/A botulinum toxin A (botox; Allergan) will be injected bilaterally into the same regionns. All scoring will be repeated in the 1st, 3rd and 6th months.

Eligibility criteria: Inclusion Criteria:

* vestibuler migraine(IHCD3)
* probable vestibular migraine (IHCD3)

Exclusion Criteria:

* Systemic disorders unsuitable for injection administration
* Keloidal scarring
* Neuromuscular disorders
* Botulinum toxin allergies
* Body dysmorphic disorder
* Pregnancy
* Breastfeeding
* Amyotrophic lateralizing sclerosis myopathies

Primary outcomes:
measure: MIDAS(Migraine Disability Assessment)
timeFrame: 6 months
measure: DHI(Dizziness Handicap Inventory)
timeFrame: 6 months
measure: VSS(Vertigo symptom sclae)
timeFrame: 6 months
Secondary outcomes:
measure: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
timeFrame: 6 months
measure: Allodynia Symptom Checklist
timeFrame: 6 months
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
affiliation: Head of Department
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References: