Acupuncture for Prophylaxis of Vestibular Migraine

Vestibular Migraine Clinical Trial

Official title:

The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04664088
• Other study ID #: 2021ZQ084
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2020
• Source: First Affiliated Hospital of Jiaxing University
• Contact: Tianye Hu, MM
• Phone: 86-18357046386
• Email: tianye_hty[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders
• Vestibular Migraine

Intervention

Procedure:
• Acupuncture
Patients in this group will receive acupuncture once every other day (3 days per week) over an 8-week period (a total of 24 sessions). In each session, needles will be retained for 30 minutes. The acupoints will include Baihui (DU20), Qianding (DU21), Houding (DU19), Yintang (DU29), Fengchi (GB20), Shuaigu (GB8), Tongli (HT5), Hegu (LI4), Taichong (LR3), Fenglong (ST40), Xuanzhong (GB39) and Zulinqi (GB41). The selection of acupoints is on the basis of meridian theory and patients' clinical symptoms. Patients are not allowed to take prophylactic medications. But in case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented in the patient diary.

Drug:
• Venlafaxine
Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks. In case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Jiaxing University	Jiaxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Jiaxing University

Country where clinical trial is conducted

China, 

References & Publications (5)

Bednarczuk NF, Bonsu A, Ortega MC, Fluri AS, Chan J, Rust H, de Melo F, Sharif M, Seemungal BM, Golding JF, Kaski D, Bronstein AM, Arshad Q. Abnormal visuo-vestibular interactions in vestibular migraine: a cross sectional study. Brain. 2019 Mar 1;142(3):606-616. doi: 10.1093/brain/awy355. — View Citation

Beh SC. Vestibular Migraine: How to Sort it Out and What to Do About it. J Neuroophthalmol. 2019 Jun;39(2):208-219. doi: 10.1097/WNO.0000000000000791. Review. — View Citation

Morganti LO, Salmito MC, Duarte JA, Bezerra KC, Simões JC, Ganança 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of vertigo/migraine days and vertigo/migraine attacks	The number of vertigo/migraine days and vertigo/migraine attacks will be assessed by a patient diary.	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Primary	Change in vertigo severity	Vertigo severity will be measured by dizziness handicap inventory (DHI)	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Primary	Change in migraine intensity	Migraine intensity will be measured by visual analogue scale (VAS)	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Secondary	Change in doses of rescue medication	Doses of rescue medication (triptans) will be documented by patients in the patient diary.	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Secondary	Change in anxiety level	Anxiety level will be measured by Generalized Anxiety Disorder-7 (GAD-7) scale.	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Secondary	Change in depression level	Depression level will be measured by Patient Health Questionnaire (PHQ-9) scale	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Secondary	Change in quality of life	Quality of life will be measure by 36-item short form health survey (SF-36).	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up