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

This study is not yet open for participant recruitment.
Verified June 2011 by Korean Pharmacoacupuncture Institute
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 May 23, 2013