Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Medication group | Active Comparator | Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianye Hu, MM | Contact | 86-18357046386 | tianye_hty@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tianye Hu, MM | Affiliated Hospital of Jiaxing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jiaxing University | Jiaxing | Zhejiang | 314000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094996 | Background | 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. | |
| 30759189 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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 |
| 26017509 | 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. |
| 26614042 | 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. |
| 32285435 | 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. |
| D005233 |
| Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |