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

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ClinicalTrials.gov Identifier: NCT01369238
Recruitment Status : Unknown
Verified June 2011 by Korean Pharmacoacupuncture Institute.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2011
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Korean Pharmacoacupuncture Institute

Brief Summary:
  1. Purpose of study

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

    1. group 1: Bee-Venom Acupuncture Therapy
    2. group 2: zaltoprofen
    3. group 3: Bee-Venom Acupuncture Therapy & zaltoprofen

Condition or disease Intervention/treatment Phase
Whiplash Injuries Device: Bee Venom Acupuncture Therapy Drug: zaltoprofen Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

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 Name: pharmacoacupuncture
Drug: zaltoprofen
80mg/Tab, per os 1Tab tid, for 2 months
Other Name: soleton
Active Comparator: zaltoprofen Drug: zaltoprofen
80mg/Tab, per os 1Tab tid, for 2 months
Other Name: soleton
Active Comparator: Bee Venom Acupuncture Device: Bee Venom Acupuncture Therapy
1:4000, SC 1cc/day, 2~3days/wk, for 1 month
Other Name: pharmacoacupuncture



Primary Outcome Measures :
  1. pain scores on Visual Analogue Scale [ Time Frame: changes from baseline in VAS at 1 month ]

Secondary Outcome Measures :
  1. neck disability scores on Neck Disability Index [ Time Frame: changes from baseline in NDI at 1 month ]
  2. depression scores on Beck Depression Inventory [ Time Frame: changes from baseline in BDI at 1 month ]
  3. quality of life scores on short form SF-36 [ Time Frame: changes from baseline in short form SF-36 at 1 month ]
  4. quality of life scores on EQ-5D [ Time Frame: changes from baseline in EQ-5D at 1 month ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369238


Contacts
Contact: Koh-Woon Kim 82-10-5101-1075 garson83@hanmail.net

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

Responsible Party: Chung, Su-Yeon/Academic Team, Korean Pharmacoacupuncture Institute
ClinicalTrials.gov Identifier: NCT01369238     History of Changes
Other Study ID Numbers: KOMC 2010-04
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by Korean Pharmacoacupuncture Institute:
bee venom acupuncture
east west collaborative medicine
whiplash associated disorder

Additional relevant MeSH terms:
Whiplash Injuries
Neck Injuries
Wounds and Injuries
Pyranoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants