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临床试验/NCT03379883
NCT03379883Unknown不适用

Combined Ultrasound Guided Genicular Nerve and Intra-articular Pulsed Radiofrequency Versus Intra-articular Platelet Rich Plasma Injection for Chronic Knee Osteoarthritis; A Comparative Study

Mansoura University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
2
主要终点
Pain score

研究概览

简要总结

The social impact of degenerative diseases such as articular cartilage pathology and osteoarthritis (OA) is steadily increasing, because of the continued rise in the mean age of the active population. A variety of noninvasive solutions have been proposed for pain treatment, improvement in function and disability, and ultimately, modification of the course of severe cartilage lesions and OA, with variable success rates. Intra articular and genicular nerves radiofrequency (RF) is a minimally invasive technique that usually aims at the neuropathic pain. One important mechanism for the chronic pain mediated by OA is peripheral sensitization, which increases the transmission of pain signals. Through conduction block in pain-transmitting nerve fibers by thermal damage, RF could ease pain without destroying the antennal nerve. The role of growth factors (GFs) in chondral repair is now widely investigated in vitro and in vivo.

Platelet-rich plasma (PRP) is a simple, low cost, and minimally invasive method that allows one to obtain from the blood a natural concentrate of autologous GFs.

详细描述

The aim of this study is to compare the efficacy of intra articular Platelet Rich Plasma (PRP) injection versus combined ultrasound guided intra articular and genicular nerve pulsed radiofrequency on chronic knee pain in patients with knee osteoarthritis.

The regeneration capacity of cartilage is limited because of its isolation from systemic regulation and its lack of vessels and nerve supply. Osteoarthritis (OA) has a major impact on functioning and independence and ranks among the top 10 causes of disability worldwide

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

Single blind (investigator) study

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients experienced unilateral lesion with a history of chronic (≥4 months)
  • Pain or swelling of the knee and imaging findings (radiography or magnetic resonance imaging [MRI]) of degenerative changes of the joint
  • Patients shall to be clinically unresponsive to conservative treatment modalities

排除标准

  • Rheumatic diseases
  • Coagulopathies
  • Severe cardiovascular diseases
  • Infections
  • Immunosuppression
  • Patients receiving anticoagulants
  • Use of non-steroidal anti-inflammatory drugs in the 5 days before blood donation
  • Hemoglobin concentration less than 10 g/dl
  • Platelet count less than 150,000/cubic mm.

结局指标

主要结局

Pain score

时间窗: For 6 months after intervention

The intensity of pain at rest will be measured with a 10-cm visual analogue scale (VAS-pain). (VAS) identifying 0 as no pain and 10 as worst imaginable pain.

次要结局

  • Knee function(For 6 months after intervention)
  • Patient satisfaction(For 6 months after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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