CTRI/2020/08/027442尚未招募未知
Efficacy of Fluoroscopy vs Ultrasound Guided Cooled Radiofrequency Genicular Nerve Ablation for Long-term Pain Relief in Chronic Knee Osteoarthritis: A Single-Blind Prospective Randomized Active Control Trial
Central Hospital Garden Reach South Eastern Railway0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Age >= 40 years to <=80 years
- •2.Able to understand the informed consent form and provide written informed consent and able to follow up
- •3.Chronic knee pain for longer than 6 months that interferes with functional activities (for example, ambulation, prolonged standing, etc.)
- •4.Continued pain in the target knee despite at least 3 months of conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs [NSAIDs])
- •5.Radiologic confirmation of arthritis (x-ray/MRI/CT) of OA grade of 2 (mild), 3 (moderate) or 4 (severe) noted within 6 months for the index knee (Kellgren and Lawrence system)
排除标准
- •a.Patient was suffering from advanced systemic disease such as decompensated heart failure, pneumonia, or dementia leaving them too debilitated to participate in follow-up
- •b.Knee had a mechanical injury (e.g., meniscal tear or tendon damage); and/or
- •c.The patient was suffering from a chronic rheumatologic disorder. Evidence of inflammatory arthritis (for example, rheumatoid arthritis) or other systemic inflammatory condition (for example, gout, fibromyalgia) that could cause knee pain
- •d.Evidence of neuropathic pain affecting the index knee
- •e.Previous or pending lower limb amputation
- •f.Hyaluronic acid injection, platelet rich plasma (PRP), stem cell, or arthroscopic debridement/lavage injection into the index knee within 90 days.
- •g.Clinically significant ligamentous laxity of the index knee
- •h.Clinically significant valgus/varus deformities or evidence of pathology (other than osteoarthritis of knee) that materially affects gait or function of the knee or is the underlying cause of the knee pain and/or functional limitations
- •i.Pregnant, nursing or intent on becoming pregnant during the study period
- •j.Allergies to any of the medications to be used during the procedures, including known hypersensitivity (allergy) to hyaluronate preparations or allergies to avian or avian-derived products (including eggs, feathers, or poultry)
- •k.Uncontrolled immunosuppression (e.g. AIDS, cancer, diabetes, etc.)
- •l.Subject currently implanted with pacemaker, stimulator, or defibrillator.
研究者
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