KCT0008557招募中Unknown
Add-on effect and safety of pharmacopuncture therapy and acupotomy in the treatment of patients with lumbar spinal stenosis : a pragmatic assessor-blinded, randomized, controlled trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 104
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 structural problems in the spine that may cause lower back pain and radiating pain (e.g., acute thoracolumbar fractures, spinal dislocation, spondylolisthesis)
- •4) Individuals with a history of spinal surgery, such as spinal fusion or laminectomy
- •5) Individuals taking anticoagulants or antiplatelet drugs, or with bleeding disorders that may affect hemostasis
- •6) Individuals with acupuncture hypersensitivity, metal allergies, severe atopic dermatitis, keloid skin, or other skin hypersensitivity
- •7) 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
- •8) Individuals taking medications (e.g., steroids, immunosuppressants) that may affect treatment outcomes or research results
- •9) Individuals with significant neuropsychiatric medical history or current illness
- •10) Individuals with a history of alcoholism or drug abuse
- •11) Pregnant or lactating women or those planning to become pregnant
- •12) Individuals who are unable to self-report consent/data or require assistance from a caregiver/researcher to do so
- •13) Other individuals deemed inappropriate by the clinical research coordinator
研究者
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