KCT0009539招募中Unknown
Clinical study of a deeply-inserted acupotomy applied to Hyeopcheok points compared to a usual western-medicine care for lumbosacral radiculopathy : safety, effectiveness, cost-effectiveness
Catholic Kwandong University International St.Mary's Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 60
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
- 19(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1) Adult men and women aged 19-85 years.
- •2) Patients diagnosed with spondylosis with lumbosacral disc disorder (injury), spinal stenosis, or lumbosacral radiculopathy through radiological examination [magnetic resonance imaging (MRI) or computed tomography (CT)] within 6 months prior to participation in the clinical trial (in case of patients suspected of lumbosacral radiculopathy but with no imaging records at the time of screening test, MRI or CT scans are performed to check whether they meet the diagnostic criteria).
- •3) Patients with symptoms related to lumbosacral radiculopathy, such as radiological pain, muscle weakness, and paresthesia of the lower extremities or those diagnosed with radiculopathy of the lumbosacral spine through a physical examination.
- •4) Patients with low back or lower extremity pain due to lumbosacral radiculopathy with NRS 4 or higher
- •5) Patients who could read, understand, and answer the symptom questionnaire.
- •6) Patients who volunteered to participate and approved the written consent of the IRB while agreeing to the clinical trial plan and follow-up.
排除标准
- •1) Patients with a history of spinal surgeries, such as lumbar spine intrametallic fixation and spinal fusion, or those who have undergone past spinal surgery but continue to have related pain.
- •2) Patients with cauda equina syndrome or motor paralysis and neurological symptoms, which are expected to be difficult to treat with conservative therapy and require surgical treatment.
- •3) Patients undergoing drug treatments, such as strong opioid therapy, for pain control.
- •4) Patients who have been treated with Korean medicine within 2 weeks prior to the start of study baseline (however, patients who have been treated at another institution within that time period for reasons other than the indication for this study, as determined by the investigator, may be eligible to participate in this study).
- •5) Patients who have experienced side effects or hypersensitivity reactions after nerve block therapy in the past.
- •6) Patients with acupuncture hypersensitivity, metal allergy, severe atopy, keloid skin, and other skin sensitivities.
- •7) Patients with hemophilia.
- •8) Patients who are taking drugs that can cause hemostasis, such as anticoagulants, antiplatelet drugs, aspirin, etc., wherein it is not possible to stop the drug during the clinical trial period, according to the judgment of the clinical trial practitioner.
- •9) Patients who participated in other clinical studies within 30 days prior to the screening of the current clinical study and received investigational drugs, including placebos.
- •10) Patients with psychotic disorders, alcoholics, and drug addicts.
- •11) Pregnant women, lactating women, and women of childbearing potential who are not willing to use contraception during the clinical trial.
- •12) Patients who are judged to be inappropriate for participation in clinical trials by the clinical trial practitioner.
研究者
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