Whiplash InjuriesNCT01369238
East-West Collaborative Medicine Using Bee-Venom Acupuncture on Whiplash-Associated Disorders
A study testing Bee Venom Acupuncture Therapy and zaltoprofen in people with Whiplash Injuries, run by Korean Pharmacoacupuncture Institute.
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… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Whiplash Injuries
- What is being tested?
- Bee Venom Acupuncture Therapy and zaltoprofen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of Whiplash injuries
- Must have cervicalgia of more than VAS 5
Who cannot join
- cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection
- spinal operation
- other musculoskeletal pain
- physicological or mental disorders
Trial locations and contacts
No sites are listed yet.
About this study
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
- 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
- Conditions
- Whiplash Injuries
- Being tested
- Bee Venom Acupuncture Therapy, zaltoprofen
- Keywords
- bee venom acupuncture, east west collaborative medicine, whiplash associated disorder
- Medical subject headings
- Whiplash Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Venom Acupuncture TherapyDevice
Also called pharmacoacupuncture
1:4000, SC 1cc/day, 2~3days/wk, for 1 month
zaltoprofenDrug
Also called soleton
80mg/Tab, per os 1Tab tid, for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Bee Venom Acupuncture & zaltoprofen | Experimental | Not described Receives: Device: Bee Venom Acupuncture Therapy; Drug: zaltoprofen |
| zaltoprofen | Active comparator | Not described Receives: Drug: zaltoprofen |
| Bee Venom Acupuncture | Active comparator | Not described Receives: Device: Bee Venom Acupuncture Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores on Visual Analogue Scale
Measured: changes from baseline in VAS at 1 month
Secondary outcomes (4)
neck disability scores on Neck Disability Index
Measured: changes from baseline in NDI at 1 month
depression scores on Beck Depression Inventory
Measured: changes from baseline in BDI at 1 month
quality of life scores on short form SF-36
Measured: changes from baseline in short form SF-36 at 1 month
quality of life scores on EQ-5D
Measured: changes from baseline in EQ-5D at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Pharmacoacupuncture Institute
- Sponsor type
- University, hospital or other
- Investigators
- Seok-Hee Chung, Study chair, Kyung Hee Oriental Medical CenterJun-Hwan Lee, Study director, Kyung Hee University Hospital at GangdongKoh-Woon Kim, Principal investigator, Kyung Hee Oriental Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369238
- Sponsor's protocol ID
- KOMC 2010-04
- Status last verified
- Jun 2011
- First submitted
- 12 May 2011
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01369238
- Acronym / sponsor ID
- KOMC 2010-04
- Conditions
- Whiplash Injuries
- Keywords
- bee venom acupuncture, east west collaborative medicine, whiplash associated disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Korean Pharmacoacupuncture InstituteUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bee Venom Acupuncture & zaltoprofen | Experimental | Device: Bee Venom Acupuncture Therapy, Drug: zaltoprofen |
| zaltoprofen | Active comparator | Drug: zaltoprofen |
| Bee Venom Acupuncture | Active comparator | Device: Bee Venom Acupuncture Therapy |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of Whiplash injuries
- Must have cervicalgia of more than VAS 5
Key exclusion criteria (4 listed)
- cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection
- spinal operation
- other musculoskeletal pain
- physicological or mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bee Venom Acupuncture TherapyAlso: pharmacoacupuncture1:4000, SC 1cc/day, 2~3days/wk, for 1 month | Device | Bee Venom Acupuncture, Bee Venom Acupuncture & zaltoprofen |
| zaltoprofenAlso: soleton80mg/Tab, per os 1Tab tid, for 2 months | Drug | Bee Venom Acupuncture & zaltoprofen, zaltoprofen |
Primary outcome
pain scores on Visual Analogue Scale
Time frame: changes from baseline in VAS at 1 month
4 secondary outcomes
neck disability scores on Neck Disability Index
Time frame: changes from baseline in NDI at 1 month
depression scores on Beck Depression Inventory
Time frame: 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
quality of life scores on EQ-5D
Time frame: changes from baseline in EQ-5D at 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok-Hee Chung study chair
Kyung Hee Oriental Medical Center
Jun-Hwan Lee study director
Kyung Hee University Hospital at Gangdong
Koh-Woon Kim principal investigator
Kyung Hee Oriental Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Bee Venom Acupuncture Therapy and zaltoprofen in people with Whiplash Injuries, run by Korean Pharmacoacupuncture Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Koh-Woon Kim (82-10-5101-1075, garson83@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain scores on Visual Analogue Scale (time frame: changes from baseline in VAS at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.