Acupuncture for Whiplash Associated Disorder: a Randomised, Waiting-list Controlled, Open-label, Parallel-group Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain Scores on the Visual Analog Scale
研究概览
简要总结
The purpose of this study is to determine whether acupuncture is effective and safe therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and discomfort due to Whiplash associated disorder. (Traumatic car accidents)
We recruit 40 participants who had cervical, shoulder and upper extremity pain and had discomfort due to Whiplash associated disorder. And then we check initial data of 40 participants (Pain;VAS, Cervical ROM, SF-36, SDS, CMI)
40 participants were randomly allocated to two groups ; acupuncture group or waiting-list group.
Acupuncture group: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes at each session. After 6 times acupuncture treatments, we check information of participants again after 2 weeks(VAS, ROM, SF-36, SDS, CMI)
Waiting-list group : The waiting-list group did not receive acupuncture treatment. After 2 weeks we check information of participants again (VAS, ROM, SF-36, SDS, CMI)
The waiting-Patients in both groups were permitted to receive usual care including physical therapy and exercise and were not permitted to take analgesics and antiphlogistics during the trial periods.
详细描述
We recruited participants through advertisements in local newspapers or on the homepage of a Kyung-hee Medical Centre during December 8, 2009 to October 14, 2010.
Patients who met eligibility criteria were randomly allocated into either acupuncture treatment group or waiting-list group. Random sequences were generated by computerized number table. Allocation was concealed using sealed envelopes. According to priority, sealed envelope was matched when the patients had given informed consent.
The method of acupuncture: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes (Needle retention time) at each session. (Total 6 times)
We select about ten acupuncture points
- Local Acupoints : SI14, SI15, BL10, BL12, BL13, BL14, TE15, GB20, SI9
- Distal Acupoints :
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who suffer cervical pain, limitation of cervical ROM, discomfort sensation due to traffic accidents (Whiplash associated disorder)
- •The patients who had no effect with 3 months orthopedical treatment.
- •willing to give their permission approval.
- •patients of at least 20 years of age (Both men, women)
排除标准
- •Cervical fracture
- •Cervical spondylosis
- •suspect malignant disease(ex. tumor, stroke, etc)
- •suspect hemorrhagic disease infection disease, inflammatory disease
- •unable to communicate with Korean
- •The patients who had conscious disorder
- •Any other conditions deemed unsuitable for trial as evaluated by Physician-in-charge.
结局指标
主要结局
Pain Scores on the Visual Analog Scale
时间窗: Change from Baseline in VAS at 2 weeks (post treatment)
VAS which assessed the cervical and back pain intensity used a 0 to 10 point line, which zero corresponded to no pain and 10 to the extreme pain
次要结局
- Cervical mobility on the Cervical ROM(Change from Baseline in cervical ROM at 2 weeks (post treatment))
- Quality of life on the SF-36(36-Item Short-Form Health Survey)(Change from Baseline in SF-36 at 2 weeks (post treatment))
- SDS (Zung Self Rating Depression Scale)(Change from Baseline in SDS at 2 weeks (post treatment))
- CMI (Cornell Medical Index)(Change from Baseline in CMI at 2 weeks (post treatment))