Clinical Evaluation for Digital Acupuncture Manipulation Therapeutic Instrument
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Visual Analogue scale（VAS）
研究概览
简要总结
The investigators design a randomized, control study to evaluate the therapeutic effect of digital acupuncture instrument in cervical spondylotic radiculopathy patients using the following outcomes: the Visual analogue scale(VAS), neck disability index scale (NDI) and short form 36-item questionnaire (SF-36).
详细描述
Based on the digital acupuncture manipulation therapeutic instrument developed in the previous stage, the acupuncture manipulation acquisition system is used to compare and analyze the analog waves output by the experts' acupuncture manipulation and the manipulative therapeutic apparatus in the system data analysis module, in order to verify the consistency of bioelectric signals of different reinforcing and reducing manipulation of acupuncture and experts' manipulation. The biocompatibility of shock wave was detected by Massachusetts General Hospital Needle sensation scale ((Massachusetts General Hospital Acupuncture Sensation Scale, MASS)). The visual analogue pain score ((Visual analogue scale, VAS)), neck disability index scale ((Neck Disability Index,NDI) and short form 36-item questionnaire (SF-36) were used to evaluate the clinical efficacy and safety of the instrument in the treatment of cervical pain in cervical Spondylotic radiculopathy, and the appropriate syndrome type of the scheme was studied.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neck pain with the diagnosis of cervical spondylotic radiculopathy;
- •Aged between 18-70 years;
- •Have not participated in any drug clinical trials within the last month;
- •Voluntarily joining this study with informed consents
排除标准
- •A history of cervical spine trauma or have received cervical spine surgery;
- •Accompanied by obvious dizziness and spinal cord compression symptoms or imaging findings of spinal cord compression;
- •Cervical spondylosis in urgent need of surgery;
- •Pregnant women and lactating women;
- •A serious heart condition, hepatic disease, renal system disease, hematopoietic system disease, or whole-body malnutrition
- •Anticoagulant treatments such as warfarin or heparin use of pacemakers or receiving acupuncture in the past 2 weeks
结局指标
主要结局
Visual Analogue scale（VAS）
时间窗: Change from baseline VAS at 8weeks
A graphic scale that helps a patient to quantify pain, depression, and other subjective and otherwise unmeasurable states or conditions.
次要结局
- Neck Disability Index（NDI）(Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8))
- short form 36-item questionnaire, SF-36(Baseline(Week 0), After treatment(Week 4), Follow-up(Week 8))