NCT01966250已完成不适用
Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery: a Study Protocol for a Pilot Randomized Controlled Trial
Korean Medicine Hospital of Pusan National University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2013年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The purpose of this study is to find out the effectiveness of integrative medicine model for pain relief and improvement of function and quality of life on the patients with pain after back surgery.
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 (Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose low back pain persisted or recurred after back surgery with or without leg pain.
- •Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy).
- •Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm.
- •Patients who are 19 - 70 years of age.
- •Patients who agreed to voluntarily participate in this study and signed informed consent.
排除标准
- •Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions).
- •Patients with progressive neurological deficit or severe neurological symptoms.
- •Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout).
- •Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions).
- •Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions)
- •Patients who are currently pregnant or planning the pregnancy.
- •Patients with psychiatric diseases.
- •Patients who are participating in other clinical trial.
- •Patients who are unable to sign informed consent.
- •Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.
研究组 & 干预措施
Electroacupuncture and Usual care
Experimental
15 minutes of electroacupuncture and usual care. Usual care contains 15 minutes ICT(Interferential Current Therapy), 10 minutes hot pack or ice pack and education of patients.
干预措施: electroacupuncture and usual care (Device)
usual care
Active Comparator
15 minutes ICT, 10 minutes hot pack or ice pack and education of patients
干预措施: Usual care (Device)
结局指标
主要结局
Visual Analogue Scale
时间窗: up to 4 months
次要结局
- Oswestry Disability Index(up to 4 months)
- EuroQoL 5-Dimension Questionnaire(up to 4 months)
研究者
Byung-Cheul Shin
associate professor
Korean Medicine Hospital of Pusan National University
研究点 (2)
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