A Randomized Trial of Ocular Electroacupuncture for Trochlear Nerve Palsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change from Baseline in Angle of diplopia deviation at 6 Weeks
研究概览
简要总结
The purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.
详细描述
The purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for trochlear nerve palsy (TNP), through treating TNP patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by trochlear nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with confirmed diagnosis of trochlear nerve palsy made by neurologist or ophthalmologist;
- •patient in stable condition after treatment for primary disease;
- •age between 18 to 80 years old without gender limitation;
- •haven't received acupuncture intervention for TNP before;
- •patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms.
排除标准
- •those with other diagnosed medical conditions known to contribute to TNP symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery;
- •those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test;
- •those with serious medical conditions that might limit their participation;
- •those with eye or other location with serious infections;
- •women who had a positive pregnancy test or who were planning to become pregnant during the study period;
- •those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs;
- •who had participate in other clinical trials, which may affect the results.
结局指标
主要结局
Change from Baseline in Angle of diplopia deviation at 6 Weeks
时间窗: 6 week
Patients will receive computerized diplopia test with the guidance from an investigator. The data will be generated by the software automatically. The changes from baseline will be recorded.
次要结局
- The quality of life questionnaire for ocular motor nerve palsy(6 week)