Sinew Acupuncture for Chronic Mechanical Neck Pain: a Randomized Assessor-blind Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The study aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).
详细描述
Objectives:
Sinew acupuncture is a superficial needling technique with the advantage of minimal pain, feasible manipulation, and no apparent adverse effects. The proposal aims to examine the efficacy and safety of sinew acupuncture for chronic mechanical neck pain (CMNP).
Hypothesis to be tested:
Sinew acupuncture can reduce pain intensity, and improve neck pain disability and health-related quality of life without significant side effects for CMNP subjects compared to a sham acupuncture treatment.
Design:
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 18 years or above; (2) able to read and write Chinese; (3) the pain is located between the neck and shoulder regions and movement or palpation of the cervical region provokes the symptoms (18); (4) the pain has persisted for more than 3 months; (5) VAS (0 to 100 mm) pain score is ≥30 mm at baseline assessment; (6) no treatments (Chinese medicine, acupuncture, moxibustion, physiotherapies, medications, etc) intended for pain management have been received within the preceding two weeks.
排除标准
- •(1) a history of fracture or surgery to the neck; (2) malignant tumor; (3) cervical congenital abnormality; (4) a severe psychiatric illness; (5) needle phobia; (6) acupuncture treatment in the preceding 3 months, and (7) other acupuncture contraindications as indicated in Hospital Authority Guideline on Safety in Acupuncture for Chinese Medicine Practitioners (Quality and Risk Sub-Committee, Hospital Authority, 2010).
研究组 & 干预措施
Sinew acupuncture
Sinew acupuncture
干预措施: Sinew acupuncture (Device)
Sham acupuncture
Sham acupuncture
干预措施: Sham acupuncture (Device)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: week 3
VAS at week 3
次要结局
- Northwick Park Neck Pain Questionnaire (NPQ)(week 1, 2, 3 & 6)
- Short Form-36 (SF-36)(week 1, 2, 3 & 6)
- VAS(week 1, 2 & 6)