KCT0002734招募中未知
A multicenter, randomized, double-blinded, parallel comparison, investigator-initiated, confirmatory clinical trial to evaluate the curative effect and safety of high-frequency (HIPER-500) stimulation in patients with subacute low back pain
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 69(Year)（—）
- 性别
- All
入选标准
- •1. Person who is aged 19 or more to less than 70, and complains subacute low back pain (1-6 months after developed).
- •2. Person who complains pain between 12th ribs and hips in terms of the range of low back pain.
- •3. Person who does not having radiating pain in infrapatellar areas within 3 days.
- •4. Person who does not take a spinal surgery within last 6 months.
- •5. Person who is not treated with steroid injection for the purpose of lumbar pain treatment within last 2 months.
- •6. Person who scores more than 30% in Oswestry Disability Index (ODI)(%).
- •7. Person who shows more than 4 in Numeric Rating Scale (NRS).
- •8. Person who any fracture or tumor is not observed after simple radiography
排除标准
- •1. Person who has neurological deficits of the lower extremity.
- •2. Based on pregnancy and urine test, person who tests positive, or is supposed to be pregnant during the study.
- •3. Person who has suffered from a heart disease before, or carries a pacemaker.
- •4. Person who inserts metallic aids into each body site (heart, bone, leg, foot, and waist, etc.).
- •5. Person who participates in other clinical trials or is supposed to do so during the study period.
- •6. Person who has a high fever (more than 38?) or turns out to be normal as a result of a blood test (leukocyte count 12,000 or more, and platelet count 50,000 or less).
- •7. Person who is not capable of taking part in the study because he cannot properly express the area of pain and the severity owing to cognitive hypofunction or impossibility of normal communication.
- •8. Person who is confirmed as an inadequate subject in participating in the study by other testers.
- •9. Person who is hard to apply physiotherapy devices or gel to his skin due to contact dermatitis.
研究者
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