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Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial

Primary Purpose

Dizziness, Vertigo

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Po-Chi Hsu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dizziness focused on measuring dizziness and vertigo, emergency department (ED), clinical trial, acupuncture

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Visit emergency department and stay in observation unit.
  • Consult otolaryngologist and neurologist to rule in dizziness and giddiness, auditory vertigo, vertebrobasilar artery syndrome, and peripheral vestibular disorders - Ménière's disease, benign paroxymal peripheral vertigo, and vestibular neuritis.

Exclusion Criteria:

  1. Serious comorbid conditions (for example, life-threatening condition or progressive central disorder).
  2. Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Efficacy and safety of acupuncture for dizziness and vertigo

    Arm Description

    To evaluate the efficacy and safety of acupuncture in treating patients with dizziness and vertigo in ED.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale (VAS) of dizziness

    Secondary Outcome Measures

    Full Information

    First Posted
    January 28, 2015
    Last Updated
    February 3, 2015
    Sponsor
    Po-Chi Hsu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02358239
    Brief Title
    Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Po-Chi Hsu

    4. Oversight

    5. Study Description

    Brief Summary
    Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ED). Pharmacological therapy is often solicited for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with unavoidable side-effects. To the best of the investigators knowledge, no papers surveyed assess the feasibility of applying acupuncture as an emergent intervention means to the treatment of dizziness and vertigo. The investigators study targeted on filling in this gap by performing a clinical control trial to evaluate the efficacy and safety of traditional Chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ED.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dizziness, Vertigo
    Keywords
    dizziness and vertigo, emergency department (ED), clinical trial, acupuncture

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Efficacy and safety of acupuncture for dizziness and vertigo
    Arm Type
    Experimental
    Arm Description
    To evaluate the efficacy and safety of acupuncture in treating patients with dizziness and vertigo in ED.
    Intervention Type
    Procedure
    Intervention Name(s)
    acupuncture
    Intervention Description
    Experiment group received acupuncture at Zusanli (ST36) and Neiguan (PC6) acupuncture points
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS) of dizziness
    Time Frame
    after the first 30 minutes after acupuncture

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Visit emergency department and stay in observation unit. Consult otolaryngologist and neurologist to rule in dizziness and giddiness, auditory vertigo, vertebrobasilar artery syndrome, and peripheral vestibular disorders - Ménière's disease, benign paroxymal peripheral vertigo, and vestibular neuritis. Exclusion Criteria: Serious comorbid conditions (for example, life-threatening condition or progressive central disorder). Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26055400
    Citation
    Chiu CW, Lee TC, Hsu PC, Chen CY, Chang SC, Chiang JY, Lo LC. Efficacy and safety of acupuncture for dizziness and vertigo in emergency department: a pilot cohort study. BMC Complement Altern Med. 2015 Jun 9;15:173. doi: 10.1186/s12906-015-0704-6.
    Results Reference
    derived

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    Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial

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