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

Whiplash Injuries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01369238
• Other study ID #: KOMC 2010-04
• Status: Not yet recruiting
• Phase: N/A
• First received: May 12, 2011
• Last updated: June 7, 2011
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2011
• Source: Korean Pharmacoacupuncture Institute
• Contact: Koh-Woon Kim
• Phone: 82-10-5101-1075
• Email: garson83[@]hanmail.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Whiplash Injuries

Intervention

Device:
• Bee Venom Acupuncture Therapy
1:4000, SC 1cc/day, 2~3days/wk, for 1 month

Drug:
• zaltoprofen
80mg/Tab, per os 1Tab tid, for 2 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korean Pharmacoacupuncture Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores on Visual Analogue Scale		changes from baseline in VAS at 1 month	No
Secondary	neck disability scores on Neck Disability Index		changes from baseline in NDI at 1 month	No
Secondary	depression scores on Beck Depression Inventory		changes from baseline in BDI at 1 month	No
Secondary	quality of life scores on short form SF-36		changes from baseline in short form SF-36 at 1 month	No
Secondary	quality of life scores on EQ-5D		changes from baseline in EQ-5D at 1 month	No