NCT01922466已完成2 期
Clinical Research on the Efficacy and Safety of East-West Collaborative Treatment Using NSAIDs and BV on Chronic Cervical Pain; A Randomized, Controlled, Parallel, Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for bothersomeness
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of east-west collaborative treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and quality of life of patients with chronic cervicalgia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years
- •nonspecific, uncomplicated, chronic neck pain over 3 months
- •volunteer can read and write in Korean, providing written informed consent
排除标准
- •exhibited abnormalities on neurological examination
- •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.
研究组 & 干预措施
Bee Venom Acupuncture
Experimental
干预措施: Bee Venom Acupuncture (Procedure)
Loxoprofen
Experimental
干预措施: Loxoprofen (Drug)
EWCT : Bee Venom Acupucture and Loxoprofen
Experimental
干预措施: Bee Venom Acupuncture (Procedure)
EWCT : Bee Venom Acupucture and Loxoprofen
Experimental
干预措施: Loxoprofen (Drug)
结局指标
主要结局
Visual Analogue Scale for bothersomeness
时间窗: Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up
次要结局
- Neck Disability Index(Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up)
- Credibility test(Changes from baseline in credibility test at 4th week follow-up)
- Visual Analogue Scale for pain intensity(Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up)
- Depression scores on Beck's Depression Inventory(Changes from baseline in BDI at 4th and 8th week follow-up)
- Safety profile(At every visit, up to 2 months)
- Quality of Life scores on EQ-5D(Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up)
- Quality of Life scores on SF-36(Changes from baseline in SF-36 at 4th and 8th week follow-up)
研究者
Byung-Kwan Seo
Assistant Professor
Kyunghee University Medical Center
研究点 (1)
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