KCT0007229尚未招募未知
Add-on effect and safety of pharmacopuncture therapy in the treatment of patients with lumbar spinal stenosis: a pragmatic assessor-blinded, randomized, controlled pilot trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 40
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
- 40?(Year) 至 80?(Year)（—）
- 性别
- All
入选标准
- •1. Diagnosed with lumbar spinal stenosis by CT or MRI.
- •- If there is no existing image data or if re-examination is necessary, L-spine CT scan will be performed
- •2. Pain or discomfort in the lower extremities/buttocks = VAS 40mm
- •3. Those who have clinical features of spinal stenosis, such as neurogenic claudication or changes in symptoms due to position
- •4. Those who are finally diagnosed with lumbar spinal stenosis as a result of a comprehensive physical examination, medical history examination, and imaging examination
- •5. Those who voluntarily decide to participate after hearing the explanation of the research purpose and process and consent in writing
排除标准
- •1. Those who are diagnosed with congenital or developmental spinal stenosis
- •2. Those who have serious defects due to spinal canal problems such as spinal segment muscle atrophy, gait disorder, and Cauda equina syndrome
- •3. Those who are moderate to severe spinal malalignment and spinal instability due to spondylolisthesis, spondylolysis, thoracic and lumbar fractures, etc.
- •4. Those who are diagnosed with other spinal diseases such as vertebral body tumors, spinal infections, ankylosing spondylosis, etc.
- •5. History of spinal surgery such as spinal fusion or laminectomy
- •6. Those who have factors that may affect hemostasis, such as taking anticoagulants and antiplatelet drugs, and bleeding disorders
- •7. History of acupuncture hypersensitivity, metal allergy, severe atopic dermatitis, keloid skin, and other skin hypersensitivity
- •8. Those with moderate to severe chronic kidney disease (Chronic Kidney Disease stage = 4), uncontrolled diabetes mellitus, or severe cardiovascular disease
- •9. Those who have a significant neuropsychiatric history or who are currently mentally or cognitively unstable
- •10. History of alcoholism or drug abuse
- •11. Those who have a serious underlying disease who is receiving active treatment for it
- •12. Pregnant woman, lactating woman, or woman in childbearing years who plans on being pregnant
- •13. Those who can not write informed consent/data by themselves or under the supervision of a guardian/researcher
- •14. Those who are difficult to participate in the trial according to investigator's decision
研究者
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