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

June 7, 2011 updated by: Korean Pharmacoacupuncture Institute

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. 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bee Venom Acupuncture & zaltoprofen
Device: Bee Venom Acupuncture Therapy
1:4000, SC 1cc/day, 2~3days/wk, for 1 month
Other Names:
  • pharmacoacupuncture
Drug: zaltoprofen
80mg/Tab, per os 1Tab tid, for 2 months
Other Names:
  • soleton
ACTIVE_COMPARATOR: zaltoprofen
Drug: zaltoprofen
80mg/Tab, per os 1Tab tid, for 2 months
Other Names:
  • soleton
ACTIVE_COMPARATOR: Bee Venom Acupuncture
Device: Bee Venom Acupuncture Therapy
1:4000, SC 1cc/day, 2~3days/wk, for 1 month
Other Names:
  • pharmacoacupuncture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
neck disability scores on Neck Disability Index
Time Frame: changes from baseline in NDI at 1 month
changes from baseline in NDI at 1 month
depression scores on Beck Depression Inventory
Time Frame: changes from baseline in BDI at 1 month
changes from baseline in BDI at 1 month
quality of life scores on short form SF-36
Time Frame: changes from baseline in short form SF-36 at 1 month
changes from baseline in short form SF-36 at 1 month
quality of life scores on EQ-5D
Time Frame: changes from baseline in EQ-5D at 1 month
changes from baseline in EQ-5D at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2012

Study Completion (ANTICIPATED)

March 1, 2012

Study Registration Dates

First Submitted

May 12, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (ESTIMATE)

June 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOMC 2010-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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