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Acupuncture for Prophylaxis of Vestibular Migraine

Sponsor
First Affiliated Hospital of Jiaxing University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04664088
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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)

  3. 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

  1. 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.

  2. 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.

  3. 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

  4. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Jiaxing University Jiaxing Zhejiang China 314000

Sponsors and Collaborators

  • First Affiliated Hospital of Jiaxing University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tianye Hu, doctor, First Affiliated Hospital of Jiaxing University
ClinicalTrials.gov Identifier:
NCT04664088
Other Study ID Numbers:
  • 2021ZQ084
First Posted:
Dec 11, 2020
Last Update Posted:
Dec 11, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tianye Hu, doctor, First Affiliated Hospital of Jiaxing University
vestibular migraine
randomized controlled trial
acupuncture
Additional relevant MeSH terms:
Migraine Disorders
Venlafaxine Hydrochloride

Study Results

No Results Posted as of Dec 11, 2020