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临床试验/NCT06520371
NCT06520371已完成不适用

Comparison of Percutaneous and Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain: A Randomized Controlled Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Degree of pain

研究概览

简要总结

This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.

详细描述

Osteoarthritis (OA) is a progressive degenerative joint disease that affects the joint cartilage and surrounding tissues. It mostly affects the weight-bearing joints, and in this respect, the knee joint is one of the joints that is most affected.

Radiofrequency (RF) treatment has been used for several painful conditions such as trigeminal neuralgia, cancer pain, and spinal pain. To destroy nerves or disrupt the transmission of pain signals, originally using producing heat lesions, RF current is applied to the trigeminal ganglion, the spinothalamic tracts of the spinal cord, the medial branches of posterior rami, and the dorsal root ganglion. In addition to these, there have been a few attempts to apply RF current for the treatment of painful conditions of joints of the extremities.

Percutaneous radiofrequency ablation (RFA) of articular sensory nerves has recently emerged as an attractive and minimally invasive approach to treat chronic pain due to large-joint osteoarthritis in select patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old.
  • Both sexes.
  • Patients with knee osteoarthritis.
  • Previous conservative treatments longer than 3 months.
  • Visual analog scale (VAS)≥
  • Radiological osteoarthritis grades 3 and 4 according to the Kellgren-Lawrence grading system (0 = none, 1 = doubtful, 2 = minimal, 3 = moderate, and 4 = severe).

排除标准

  • Prior knee surgery.
  • Allergies to local anesthetics.
  • Connective tissue diseases affect the knee.
  • Serious neurologic or psychiatric disorders.
  • Injection with steroids or hyaluronic acids during the previous 3 months.
  • History of septic arthritis.
  • Sciatic pain.
  • Cardiac pacemaker users.
  • Anticoagulant medications.
  • Prior electroacupuncture treatment.

结局指标

主要结局

Degree of pain

时间窗: 12th week post-procedure

Degree of pain will be assessed using visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and ten means the worst pain). VAS will be assessed pre-procedure and post-procedure 2nd, 6th, and 12th week.

次要结局

  • Patient satisfaction(12th week post-procedure)
  • Incidence of adverse events(12th week post-procedure)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores(12th week post-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (2)

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