Acupuncture for Prophylaxis of Vestibular Migraine

Not Applicable

• Conditions: Vestibular Migraine
• Interventions: Procedure: Acupuncture; Drug: Venlafaxine

• Registration Number: NCT04664088
• Lead Sponsor: Affiliated Hospital of Jiaxing University

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-06
• Last Update Submitted: 2020-12-06
• Study First Posted: 2020-12-11
• Last Update Posted: 2020-12-11
• Study Start: 2021-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	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).
Medication group	Venlafaxine	Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the number of vertigo/migraine days and vertigo/migraine attacks	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up	The number of vertigo/migraine days and vertigo/migraine attacks will be assessed by a patient diary.
Change in vertigo severity	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up	Vertigo severity will be measured by dizziness handicap inventory (DHI)
Change in migraine intensity	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up	Migraine intensity will be measured by visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Change in anxiety level	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up	Anxiety level will be measured by Generalized Anxiety Disorder-7 (GAD-7) scale.
Change in depression level	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up	Depression level will be measured by Patient Health Questionnaire (PHQ-9) scale
Change in quality of life	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up	Quality of life will be measure by 36-item short form health survey (SF-36).
Change in doses of rescue medication	4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up	Doses of rescue medication (triptans) will be documented by patients in the patient diary.

Trial Locations

Locations (1)

The First Affiliated Hospital of Jiaxing University; 🇨🇳 Jiaxing, Zhejiang, China