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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Whiplash Injuries

Intervention / Treatment
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* Device: Bee Venom Acupuncture Therapy
* Drug: zaltoprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bee Venom Acupuncture & zaltoprofen<br> | Device: Bee Venom Acupuncture Therapy<br>* 1:4000, SC 1cc/day, 2 3days/wk, for 1 month<br>* Other names: pharmacoacupuncture;Drug: zaltoprofen<br>* 80mg/Tab, per os 1Tab tid, for 2 months<br>* Other names: soleton;|
| Active Comparator: zaltoprofen<br> | Drug: zaltoprofen<br>* 80mg/Tab, per os 1Tab tid, for 2 months<br>* Other names: soleton;|
| Active Comparator: Bee Venom Acupuncture<br> | Device: Bee Venom Acupuncture Therapy<br>* 1:4000, SC 1cc/day, 2 3days/wk, for 1 month<br>* Other names: pharmacoacupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores on Visual Analogue Scale |  | changes from baseline in VAS at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bee venom acupuncture, east west collaborative medicine, whiplash associated disorder