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East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders

Sponsor
Korean Pharmacoacupuncture Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT01369238
Collaborator
(none)
90
Enrollment
3
Arms
9
Duration (Months)

Study Details

Study Description

Brief Summary

  1. Purpose of study

  2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale

  3. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using NDI, BDI, SF-36, and EQ-5D.

  4. Interventions & Groups

  5. group 1: Bee-Venom Acupuncture Therapy

  6. group 2: zaltoprofen

  7. group 3: Bee-Venom Acupuncture Therapy & zaltoprofen

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Research on the Efficacy of East-West Collaborative Medicine Using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders After Traffic Collisions; A Randomized, Controlled, Parallel Trial
Study Start Date :
Jun 1, 2011
Anticipated Primary Completion Date :
Jan 1, 2012
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bee Venom Acupuncture & zaltoprofen

Device: Bee Venom Acupuncture Therapy
1:4000, SC 1cc/day, 2~3days/wk, for 1 month
Other Names:
  • pharmacoacupuncture

    • Drug: zaltoprofen
    80mg/Tab, per os 1Tab tid, for 2 months
    Other Names:
  • soleton

    		•
    Active Comparator: zaltoprofen

    Drug: zaltoprofen
    80mg/Tab, per os 1Tab tid, for 2 months
    Other Names:
  • soleton

    		•
    Active Comparator: Bee Venom Acupuncture

    Device: Bee Venom Acupuncture Therapy
    1:4000, SC 1cc/day, 2~3days/wk, for 1 month
    Other Names:
  • pharmacoacupuncture

    		•

    Outcome Measures

    Primary Outcome Measures

    1. pain scores on Visual Analogue Scale [changes from baseline in VAS at 1 month]

    Secondary Outcome Measures

    1. neck disability scores on Neck Disability Index [changes from baseline in NDI at 1 month]

    2. depression scores on Beck Depression Inventory [changes from baseline in BDI at 1 month]

    3. quality of life scores on short form SF-36 [changes from baseline in short form SF-36 at 1 month]

    4. quality of life scores on EQ-5D [changes from baseline in EQ-5D at 1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • clinical diagnosis of Whiplash injuries

    • Must have cervicalgia of more than VAS 5

    Exclusion Criteria:

    • cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection

    • spinal operation

    • other musculoskeletal pain

    • physicological or mental disorders

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Korean Pharmacoacupuncture Institute

    Investigators

    • Study Chair: Seok-Hee Chung, Kyung Hee Oriental Medical Center
    • Study Director: Jun-Hwan Lee, Kyung Hee University Hospital at Gangdong
    • Principal Investigator: Koh-Woon Kim, Kyung Hee Oriental Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01369238
    Other Study ID Numbers:
    • KOMC 2010-04
    First Posted:
    Jun 8, 2011
    Last Update Posted:
    Jun 8, 2011
    Last Verified:
    Jun 1, 2011
    Keywords provided by , ,
    bee venom acupuncture
    east west collaborative medicine
    whiplash associated disorder
    Additional relevant MeSH terms:
    Whiplash Injuries
    Pyranoprofen

    Study Results

    No Results Posted as of Jun 8, 2011