Acupuncture for Prophylaxis of Vestibular Migraine

NCT04664088 | Unknown DMC

• 1 other identifier: 2021ZQ084
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Migraine

Keywords

vestibular migraine; randomized controlled trial; acupuncture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• Change in anxiety level

  4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

• Change in depression level

  4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

• Change in quality of life

  4 weeks before intervention, at 4, 8 weeks after intervention and at 4, 8, 16 weeks of follow-up

Study Arms (2)

Acupuncture group

EXPERIMENTAL

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

Medication group

ACTIVE COMPARATOR

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

Drug: Venlafaxine

Interventions

Acupuncture PROCEDURE

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.

Acupuncture group

Venlafaxine DRUG

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.

Medication group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

The First Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

Location

Related Publications (5)

• 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.

  PMID: 31094996 BACKGROUND

• 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.

  PMID: 30759189 BACKGROUND

• 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.

  PMID: 26017509 BACKGROUND

• 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.

  PMID: 26614042 BACKGROUND

• 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.

  PMID: 32285435 BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy; Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Tianye Hu, MM

  Affiliated Hospital of Jiaxing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianye Hu, MM

CONTACT

86-18357046386; tianye_hty@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)