Acupuncture for Prophylaxis of Vestibular Migraine

The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vestibular Migraine
• Intervention / Treatment: Procedure: Acupuncture; Drug: Venlafaxine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianye Hu, MM; Phone Number: 86-18357046386; Email: tianye_hty@gmail.com

Study Locations

• China
  • Zhejiang
    • Jiaxing, Zhejiang, China, 314000
      • The First Affiliated Hospital of Jiaxing University
      • Contact: Tianye Hu, MM; Phone Number: 86-18357048386; Email: tianye_hty@gmail.com
      • Contact: Jin Hu, MM; Phone Number: 86-13819347974; Email: leihendieyu@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; 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).	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.
Active Comparator: Medication group; Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Jiaxing University
• Investigators: Principal Investigator: Tianye Hu, MM, First Affiliated Hospital of Jiaxing University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; acupuncture; vestibular migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: 2021ZQ084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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