Back to resultsEast-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders
Primary Purpose
Whiplash Injuries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bee Venom Acupuncture Therapy
zaltoprofen
Sponsored by
About this trial
This is an interventional treatment trial for Whiplash Injuries focused on measuring bee venom acupuncture, east west collaborative medicine, whiplash associated disorder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Bee Venom Acupuncture & zaltoprofen
zaltoprofen
Bee Venom Acupuncture
Arm Description
Outcomes
Primary Outcome Measures
pain scores on Visual Analogue Scale
Secondary Outcome Measures
neck disability scores on Neck Disability Index
depression scores on Beck Depression Inventory
quality of life scores on short form SF-36
quality of life scores on EQ-5D
Full Information
NCT ID
NCT01369238
First Posted
May 12, 2011
Last Updated
June 7, 2011
Sponsor
Korean Pharmacoacupuncture Institute
1. Study Identification
Unique Protocol Identification Number
NCT01369238
Brief Title
East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders
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 Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Korean Pharmacoacupuncture Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose of study
To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale
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.
Interventions & Groups
group 1: Bee-Venom Acupuncture Therapy
group 2: zaltoprofen
group 3: Bee-Venom Acupuncture Therapy & zaltoprofen
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Whiplash Injuries
Keywords
bee venom acupuncture, east west collaborative medicine, whiplash associated disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bee Venom Acupuncture & zaltoprofen
Arm Type
Experimental
Arm Title
zaltoprofen
Arm Type
Active Comparator
Arm Title
Bee Venom Acupuncture
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Bee Venom Acupuncture Therapy
Other Intervention Name(s)
pharmacoacupuncture
Intervention Description
1:4000, SC 1cc/day, 2~3days/wk, for 1 month
Intervention Type
Drug
Intervention Name(s)
zaltoprofen
Other Intervention Name(s)
soleton
Intervention Description
80mg/Tab, per os 1Tab tid, for 2 months
Primary Outcome Measure Information:
Title
pain scores on Visual Analogue Scale
Time Frame
changes from baseline in VAS at 1 month
Secondary Outcome Measure Information:
Title
neck disability scores on Neck Disability Index
Time Frame
changes from baseline in NDI at 1 month
Title
depression scores on Beck Depression Inventory
Time Frame
changes from baseline in BDI at 1 month
Title
quality of life scores on short form SF-36
Time Frame
changes from baseline in short form SF-36 at 1 month
Title
quality of life scores on EQ-5D
Time Frame
changes from baseline in EQ-5D at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koh-Woon Kim
Phone
82-10-5101-1075
Email
garson83@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok-Hee Chung
Organizational Affiliation
Kyung Hee Oriental Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jun-Hwan Lee
Organizational Affiliation
Kyung Hee University Hospital at Gangdong
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Koh-Woon Kim
Organizational Affiliation
Kyung Hee Oriental Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders
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