KCT0007145进行中(未招募)未知
Effectiveness and safety of pharmacopuncture therapy for patients with lumbar spinal stenosis: Multicentered, pragmatic randomized controlled, parallel grouped study
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 入组人数
- 98
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. Diagnosed with lumbar spinal stenosis based on radiology including computed tomography or magnetic resonance imaging.
- •2. Clear neurogenic claudication symptoms existed (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position).
- •3. reported radiating leg pain or low back pain (LBP) with intensity of NRS =5
- •4. Between the age of 19 and 69 years old.
- •5. Participants who agreed to participate the study and voluntarily signed the informed consent form.
排除标准
- •1. Patients with vascular claudication
- •2. Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, fracture)
- •3. Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g. tumor, fibromyalgia, rheumatoid arthritis, gout)
- •4. Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- •5. Patients who administrate those prescribed medicine that may interfere with interpretation of the result (e.g. corticosteroids, immunosuppressants, physchotropic drugs)
- •6. Patients for whom pharmacopuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection)
- •7. Patients who were treated with one of the following intervention within the past week; medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs), pharmacopuncture, or physical therapies.
- •8. Pregnant patients or patients planning pregnancy
- •9. Patients with medical history of spinal surgery within the past 3 months
- •10. Previous participation in other clinical studies within 1 month of current study enrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment
- •11. Patients unable to fill out study participation consent form
- •12. Patients deemed unsuitable for study participation as assessed by the researchers
研究者
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