East-West Collaboration Treatment Using Bee Venom Acupuncture and NSAIDs for Chronic Cervicalgia
NCT ID: NCT01922466
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2013-07-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bee Venom Acupuncture
Bee Venom Acupuncture
Bee Venom 1:20,000 under BVA Increment Protocol
\- Increment Protocol as
* 1st week - SC 0.2cc/day, 2 days/week
* 2nd week - SC 0.4cc/day, 2 days/week
* 3nd week - SC 0.8cc/day, 2 days/week
Loxoprofen
Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
EWCT : Bee Venom Acupucture and Loxoprofen
Bee Venom Acupuncture
Bee Venom 1:20,000 under BVA Increment Protocol
\- Increment Protocol as
* 1st week - SC 0.2cc/day, 2 days/week
* 2nd week - SC 0.4cc/day, 2 days/week
* 3nd week - SC 0.8cc/day, 2 days/week
Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Interventions
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Bee Venom Acupuncture
Bee Venom 1:20,000 under BVA Increment Protocol
\- Increment Protocol as
* 1st week - SC 0.2cc/day, 2 days/week
* 2nd week - SC 0.4cc/day, 2 days/week
* 3nd week - SC 0.8cc/day, 2 days/week
Loxoprofen
60 mg/Tab, pers os 1Tab tid, for 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* nonspecific, uncomplicated, chronic neck pain over 3 months
* volunteer can read and write in Korean, providing written informed consent
Exclusion Criteria
* radicular pain
* serious spinal disorders including malignancy, vertebral fracture, spinal infection or inflammatory spondylitis
* other chronic diseases that could affect or interfere with the therapeutic outcomes including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia or epilepsy
* previous spinal surgery or scheduled procedures during the study
* painful conditions induced by traffic accidents
* a substantial musculoskeletal problem generating pain from an area other than the neck
* conditions for which administration of BVA might not be safe including clotting disorders, administration of an anticoagulant agent, pregnancy and seizure disorders
* a documented hypersensitive reaction to previous BVA treatments, bee stings or insect bites
* positive reaction observed during a skin hypersensitivity test
* severe psychiatric or psychological disorders
* current use of corticosteroids, narcotics, muscle relaxants or herbal medicines to treat neck pain or any medication considered inappropriate by the investigator
* pending lawsuits or receipt of compensation due to neck pain.
18 Years
65 Years
ALL
No
Sponsors
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Kyung Hee University Hospital at Gangdong
OTHER
Kyunghee University
OTHER
Korea Institute of Oriental Medicine
OTHER_GOV
Kyunghee University Medical Center
OTHER
Responsible Party
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Byung-Kwan Seo
Assistant Professor
Principal Investigators
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Byung-Kwan Seo, PhD., KMD
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University
Locations
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Spine Center, Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Countries
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References
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Seo BK, Lee JH, Kim PK, Baek YH, Jo DJ, Lee S. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial. Trials. 2014 Apr 21;15:132. doi: 10.1186/1745-6215-15-132.
Other Identifiers
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KHNMC-OH-IRB 2012-019
Identifier Type: -
Identifier Source: org_study_id