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临床试验/NCT01369238
NCT01369238Unknown不适用

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

Korean Pharmacoacupuncture Institute0 个研究点目标入组 90 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
pain scores on Visual Analogue Scale

研究概览

简要总结

  1. Purpose of study

  2. To evaluate the efficacy of East-West collaborative medicine using Bee-Venom Acupuncture Therapy on Whiplash-Associated Disorders using VAS scale

  3. 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.

  4. Interventions & Groups

  5. group 1: Bee-Venom Acupuncture Therapy

  6. group 2: zaltoprofen

  7. group 3: Bee-Venom Acupuncture Therapy & zaltoprofen

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
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of Whiplash injuries
  • Must have cervicalgia of more than VAS 5

排除标准

  • cancer, osteoporosis, ankylosing spodylitis, cauda equina syndrome, infection
  • spinal operation
  • other musculoskeletal pain
  • physicological or mental disorders

研究组 & 干预措施

Bee Venom Acupuncture & zaltoprofen

Experimental

干预措施: Bee Venom Acupuncture Therapy (Device)

Bee Venom Acupuncture & zaltoprofen

Experimental

干预措施: zaltoprofen (Drug)

zaltoprofen

Active Comparator

干预措施: zaltoprofen (Drug)

Bee Venom Acupuncture

Active Comparator

干预措施: Bee Venom Acupuncture Therapy (Device)

结局指标

主要结局

pain scores on Visual Analogue Scale

时间窗: changes from baseline in VAS at 1 month

次要结局

  • 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)

研究者

发起方
Korean Pharmacoacupuncture Institute
申办方类型
Other

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