KCT0009324尚未招募Unknown
Feasibility, Safety, and Effectiveness of Ultrasound-guided Acupotomy Treatment for Degenerative Lumbar Spinal Stenosis: a pilot randomized controlled trial
Pusan National University Korean Medicine Hospital0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) aged 40 years and older but younger than 75 years
- •2) confirmed to have lumbar spinal stenosis on imaging examination (CT or MRI)
- •- In cases where there is no existing imaging data or re-imaging is necessary, L-spine CT examination will be performed
- •3) pain or discomfort in the lumbar, lower limb, or buttock = VAS 40mm
- •4) Individuals who have clinical manifestations of lumbar spinal stenosis, such as neurogenic claudication or symptoms that change with posture
- •5) Individuals who have received a final diagnosis of lumbar spinal stenosis based on comprehensive physical examination, medical history, and imaging examination results
- •6) Individuals who voluntarily decide to participate after being informed of the study purpose and procedure and provide written informed consent
排除标准
- •1) Individuals diagnosed with congenital or developmental lumbar spinal stenosis
- •2) Individuals diagnosed with spinal disorders other than lumbar spinal stenosis, which may cause lower back pain and radiating pain (e.g., vertebral tumors, Cauda equina syndrome, spinal infections, ankylosing spondylitis)
- •3) Individuals with lower extremity arterial stenosis or occlusion that can induce claudication
- •4) Individuals with major structural issues of the spine (acute thoracolumbar vertebral fracture, spinal dislocation, spondylolisthesis)
- •5) Individuals with a history of spinal surgery, such as spinal fusion or laminectomy
- •6) Individuals taking anticoagulants or antiplatelet drugs, or with bleeding disorders that may affect hemostasis
- •7) Individuals with acupuncture hypersensitivity, metal allergies, severe atopic dermatitis, keloid skin, or other skin hypersensitivity
- •8) Individuals with chronic diseases (e.g., chronic kidney disease, diabetic neuropathy, stroke and myocardial infarction, dementia, epilepsy) that may affect treatment outcomes or research results
- •9) Individuals taking medications (e.g., steroids, immunosuppressants) that may affect treatment outcomes or research results
- •10) Individuals with significant neuropsychiatric medical history or current illness
- •11) Individuals with a history of alcoholism or drug abuse
- •12) Pregnant or lactating women or those planning to become pregnant
- •13) Individuals who are unable to self-report consent/data or require assistance from a caregiver/researcher to do so
- •14) Other individuals deemed inappropriate by the clinical research coordinator
研究者
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