Adjuvant Acupuncture Therapy in Patients With Severe Head Injury: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Glasgow Coma Scale (GCS)
研究概览
简要总结
The purpose of this study is to determine the therapeutic effect of acupuncture on severe head injury under conventional treatment. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' Glasgow coma scale (GCS) and muscle power is measured.
详细描述
Objective
To investigate the therapeutic effect of acupuncture on severe head injury under conventional treatment.
Methods: 90 subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less) are randomly divided into acupuncture, laser acupuncture and control group. We use restoring consciousness acupuncture (GV26 and 12 Well points) to treat the subjects 3 sessions per week under conventional treatment at Department of Neurosurgery. A double-blind clinical trial is conducted up to 6 weeks and the change of subjects' GCS and muscle power is measured.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects aged 12 to 70 years with severe head injury (Glasgow coma scale score 8 or less)
- •with informed consent
排除标准
- •dilated pupils without light reflex
- •serious complications during therapeutic course
- •interruption of therapeutic course
- •unfavored condition assessed by physician in charge
- •without informed consent
结局指标
主要结局
Glasgow Coma Scale (GCS)
时间窗: 6 weeks
Eye response (E) There are four grades starting with the most severe: 1. No eye opening 2. Eye opening in response to pain stimulus. 3. Eye opening to speech. 4. Eyes opening spontaneously Verbal response (V) There are five grades starting with the most severe: 1. No verbal response 2. Incomprehensible sounds. 3. Inappropriate words. 4. Confused. 5. Oriented. Motor response (M) There are six grades: 1. No motor response 2. Decerebrate posturing accentuated by pain 3. Decorticate posturing accentuated by pain 4. Withdrawal from pain 5. Localizes to pain 6. Obeys commands The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome.
次要结局
- Muscle Power (MP)(6 weeks)