Clinical trial NCT04664088: Acupuncture for Prophylaxis of Vestibular Migraine
Official title: The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Migraine
Keywords: vestibular migraine
randomized controlled trial
acupuncture
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With its high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect patients' quality of life. Current treatment of VM mainly contain rescue treatment and prophylaxis, both of which are often pharmacological-based therapies and bring a series of unavoidable side effects, which leads to poor compliance of patients. Moreover, frequent VM attacks can seriously affect patients' daily life and work. Therefore, prophylaxis treatment is of great significance for VM patients. As a non-pharmarceutical therapy, acupuncture is widely used for a wide range of migrainous and emotional disorders. Thus, it might be an alternative treatment for VM, but current evidence remains inconclusive. The aim of this randomized controlled trial is to investigate the prophylactic efficacy and safety of acupuncture therapy in patients with VM.

Detailed description: This randomized controlled trial will enroll patients with vestibular migraine from the First Affiliated Hospital of Jiaxing University. All participants will be randomly assigned to two groups. Participants will receive acupuncture in the treatment group, while participants in the control group will be treated by venlafaxine. All treatments will be given for 8 weeks. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in dosage of rescue medication, anxiety level，depression level，and quality of life per 4 weeks from baseline.

Eligibility criteria: Inclusion Criteria:

1. Patients with age 18 to 80 , male or female;
2. Patients meet the criteria proposed by the collaboration of Barany Society and the International Headache Society in 2012;
3. Vertigo/migraine attacks at least 3 times per month in the last 3 months; or vertigo/migraine days are at least 4 days per month;
4. Patients have unsatisfactory response to rescue treatments and seek for preventive treatments;
5. Patients can fully understand the study protocol and agree to sign written informed consent forms.

Exclusion Criteria:

1. Patients'vertigo and headache are caused by other diseases, such as vestibular neuritis, Meniere disease, tension headache, and other cerebrovascular diseases.
2. Patients have prophylactic headache treatment with drugs in the past 3 months.
3. Patients are receiving adjunctive therapy that is not widely accepted for treating VM, such as Chinese herbs.
4. Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems that are not controlled significantly;
5. Pregnant and lactating female patients;
6. Patients have mental illness that affects cognitive function.

Primary outcomes:
measure: Change in the number of vertigo/migraine days and vertigo/migraine attacks
timeFrame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
measure: Change in vertigo severity
timeFrame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
measure: Change in migraine intensity
timeFrame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Secondary outcomes:
measure: Change in doses of rescue medication
timeFrame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
measure: Change in anxiety level
timeFrame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
measure: Change in depression level
timeFrame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
measure: Change in quality of life
timeFrame: 4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: The First Affiliated Hospital of Jiaxing University
state: Zhejiang
Study officials:
affiliation: Affiliated Hospital of Jiaxing University
name: Tianye Hu, MM
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Tedeschi G, Russo A, Conte F, Laura M, Tessitore A. Vestibular migraine pathophysiology: insights from structural and functional neuroimaging. Neurol Sci. 2015 May;36 Suppl 1:37-40. doi: 10.1007/s10072-015-2161-x.
citation: Morganti LO, Salmito MC, Duarte JA, Bezerra KC, Simoes JC, Gananca FF. Vestibular migraine: clinical and epidemiological aspects. Braz J Otorhinolaryngol. 2016 Jul-Aug;82(4):397-402. doi: 10.1016/j.bjorl.2015.06.003. Epub 2015 Oct 29.
citation: Nowaczewska M. Vestibular migraine - an underdiagnosed cause of vertigo. Diagnosis and treatment. Neurol Neurochir Pol. 2020;54(2):106-115. doi: 10.5603/PJNNS.a2020.0031. Epub 2020 Apr 14.