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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Korean Pharmacoacupuncture Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Korean Pharmacoacupuncture Institute
ClinicalTrials.gov Identifier:
NCT01369238
First received: May 12, 2011
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

  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 Intervention
Whiplash Injuries
 Device: Bee Venom Acupuncture Therapy
Drug: zaltoprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korean Pharmacoacupuncture Institute:

Primary Outcome Measures:
  • pain scores on Visual Analogue Scale [ Time Frame: changes from baseline in VAS at 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neck disability scores on Neck Disability Index [ Time Frame: changes from baseline in NDI at 1 month ] [ Designated as safety issue: No ]
  • depression scores on Beck Depression Inventory [ Time Frame: changes from baseline in BDI at 1 month ] [ Designated as safety issue: No ]
  • quality of life scores on short form SF-36 [ Time Frame: changes from baseline in short form SF-36 at 1 month ] [ Designated as safety issue: No ]
  • quality of life scores on EQ-5D [ Time Frame: changes from baseline in EQ-5D at 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Chung, Su-Yeon/Academic Team, Korean Pharmacoacupuncture Institute
ClinicalTrials.gov Identifier: NCT01369238     History of Changes
Other Study ID Numbers: KOMC 2010-04
Study First Received: May 12, 2011
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

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
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013