East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders
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
1 other identifier
interventional
90
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 8, 2011
June 1, 2011
7 months
May 12, 2011
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain scores on Visual Analogue Scale
changes from baseline in VAS at 1 month
Secondary Outcomes (4)
neck disability scores on Neck Disability Index
changes from baseline in NDI at 1 month
depression scores on Beck Depression Inventory
changes from baseline in BDI at 1 month
quality of life scores on short form SF-36
changes from baseline in short form SF-36 at 1 month
quality of life scores on EQ-5D
changes from baseline in EQ-5D at 1 month
Study Arms (3)
Bee Venom Acupuncture & zaltoprofen
EXPERIMENTALzaltoprofen
ACTIVE COMPARATORBee Venom Acupuncture
ACTIVE COMPARATORInterventions
1:4000, SC 1cc/day, 2\~3days/wk, for 1 month
80mg/Tab, per os 1Tab tid, for 2 months
Eligibility Criteria
You may qualify if:
- clinical diagnosis of Whiplash injuries
- Must have cervicalgia of more than VAS 5
You may not qualify if:
- cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection
- spinal operation
- other musculoskeletal pain
- physicological or mental disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 12, 2011
First Posted
June 8, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2012
Study Completion
March 1, 2012
Last Updated
June 8, 2011
Record last verified: 2011-06