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Acupuncture for Prophylaxis of Vestibular Migraine

Primary Purpose

Vestibular Migraine

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Venlafaxine
Sponsored by
Affiliated Hospital of Jiaxing University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vestibular Migraine focused on measuring vestibular migraine, randomized controlled trial, acupuncture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Jiaxing University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture group

Medication group

Arm Description

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).

Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks.

Outcomes

Primary Outcome Measures

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.
Change in vertigo severity
Vertigo severity will be measured by dizziness handicap inventory (DHI)
Change in migraine intensity
Migraine intensity will be measured by visual analogue scale (VAS)

Secondary Outcome Measures

Change in doses of rescue medication
Doses of rescue medication (triptans) will be documented by patients in the patient diary.
Change in anxiety level
Anxiety level will be measured by Generalized Anxiety Disorder-7 (GAD-7) scale.
Change in depression level
Depression level will be measured by Patient Health Questionnaire (PHQ-9) scale
Change in quality of life
Quality of life will be measure by 36-item short form health survey (SF-36).

Full Information

First Posted
December 6, 2020
Last Updated
December 6, 2020
Sponsor
Affiliated Hospital of Jiaxing University
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1. Study Identification

Unique Protocol Identification Number
NCT04664088
Brief Title
Acupuncture for Prophylaxis of Vestibular Migraine
Official Title
The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiaxing University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Migraine
Keywords
vestibular migraine, randomized controlled trial, acupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Description
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).
Arm Title
Medication group
Arm Type
Active Comparator
Arm Description
Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of vertigo/migraine days and vertigo/migraine attacks
Description
The number of vertigo/migraine days and vertigo/migraine attacks will be assessed by a patient diary.
Time Frame
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Title
Change in vertigo severity
Description
Vertigo severity will be measured by dizziness handicap inventory (DHI)
Time Frame
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Title
Change in migraine intensity
Description
Migraine intensity will be measured by visual analogue scale (VAS)
Time Frame
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Secondary Outcome Measure Information:
Title
Change in doses of rescue medication
Description
Doses of rescue medication (triptans) will be documented by patients in the patient diary.
Time Frame
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Title
Change in anxiety level
Description
Anxiety level will be measured by Generalized Anxiety Disorder-7 (GAD-7) scale.
Time Frame
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Title
Change in depression level
Description
Depression level will be measured by Patient Health Questionnaire (PHQ-9) scale
Time Frame
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up
Title
Change in quality of life
Description
Quality of life will be measure by 36-item short form health survey (SF-36).
Time Frame
4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with age 18 to 80 , male or female; Patients meet the criteria proposed by the collaboration of Barany Society and the International Headache Society in 2012; 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; Patients have unsatisfactory response to rescue treatments and seek for preventive treatments; Patients can fully understand the study protocol and agree to sign written informed consent forms. Exclusion Criteria: Patients'vertigo and headache are caused by other diseases, such as vestibular neuritis, Meniere disease, tension headache, and other cerebrovascular diseases. Patients have prophylactic headache treatment with drugs in the past 3 months. Patients are receiving adjunctive therapy that is not widely accepted for treating VM, such as Chinese herbs. Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems that are not controlled significantly; Pregnant and lactating female patients; Patients have mental illness that affects cognitive function.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tianye Hu, MM
Phone
86-18357046386
Email
tianye_hty@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tianye Hu, MM
Organizational Affiliation
Affiliated Hospital of Jiaxing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Jiaxing University
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tianye Hu, MM
Phone
86-18357048386
Email
tianye_hty@gmail.com
First Name & Middle Initial & Last Name & Degree
Jin Hu, MM
Phone
86-13819347974
Email
leihendieyu@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31094996
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.
Results Reference
background
PubMed Identifier
30759189
Citation
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.
Results Reference
background
PubMed Identifier
26017509
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.
Results Reference
background
PubMed Identifier
26614042
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.
Results Reference
background
PubMed Identifier
32285435
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.
Results Reference
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Acupuncture for Prophylaxis of Vestibular Migraine

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