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临床试验/NCT07098455
NCT07098455已完成不适用

Comparative Effectiveness of Genicular Nerve Radiofrequency Thermocoagulation and Intra-Articular Pulsed Radiofrequency in the Management of Knee Osteoarthritis Pain

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
NRS

研究概览

简要总结

Osteoarthritis (OA) is a degenerative disease characterized by progressive cartilage deterioration, osteophyte formation, subchondral sclerosis, and a number of biochemical and morphological changes in weight-bearing joints that are affected by genetic, mechanical, and biochemical factors. The prevalence of secondary chronic knee pain in OA is more than 12% in individuals over the age of 60. It is one of the most common musculoskeletal disorders in elderly patients and has become a global health problem. Standard treatments for OA include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, opioids, intra-articular hyaluronic acid, or steroids. In more severe cases, surgical knee arthroplasty should be considered. But long-term use of NSAIDs is associated with stomach bleeding, adverse cardiovascular events, and kidney failure. Opioids are often used, but a large number of side effects are encountered, especially in the elderly. Knee surgery is not always possible and can cause complications such as hematomas, infections, and damage to the surrounding tissue.

Radiofrequency (RF) application (pulsed or continuous) is a neuromodulatory or neurolytic technique that represents an alternative in pain due to osteoarthritis. RF therapy is one of the conservative treatments that has many advantages, such as minimal invasiveness, rapid recovery, and less negative response. Radiofrequency thermocoagulation (RFT) destroys the integrity of peripheral nerves using hyperthermia and thereby blocks the transmission of pain signals, while pulsed radiofrequency (PRF) regulates neurological functions or inhibits the production of immunoinflammatory factors (e.g., IL-1β, TNF-α, IL-6) by using electric fields to affect their production, thereby relieving pain in patients.

Genicular nerve radiofrequency thermocoagulation application and knee intra-articular pulsed radiofrequency application are the two radiofrequency methods routinely applied in the treatment of gonarthrosis-induced pain in our clinic. In this study, it is aimed to evaluate the effectiveness of these two methods and compare their outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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
否

入选标准

  • •Patients over 18 years of age;
  • •Patients who have pain due to knee osteoarthritis
  • •Patients who agree to undergo knee geniculate nerve thermocoagulation or knee intra-articular pulsed radiofrequency therapy and follow-up.

排除标准

  • •Patients using anticoagulants and those with coagulation disorders,
  • •Patients with psychomotor disorders,
  • •Patients who have undergone intra-articular injections, interventional procedures, or surgery for knee osteoarthritis in the last year,
  • •Patients with bacterial infection or infectious discharge in the area to be treated,
  • •Patients with allergies to local anesthetics, and pregnant and breastfeeding patients

研究组 & 干预措施

GNRFT - Genicular Nerve Radiofrequency Ablation

Experimental

Patients in this group will undergo ultrasound-guided genicular nerve radiofrequency ablation.

干预措施: GNRFT- genicular nerve radiofrequency ablation (Procedure)

IAPRF - Intra-articular pulsed radiofrequency

Experimental

KNEE INTRAARTICULAR PULSED RADIOFREQUENCY WILL BE APPLIED TO PATIENTS IN THIS GROUP

干预措施: IAPRF- Intraarticular pulsed radiofrequency (Procedure)

结局指标

主要结局

NRS

时间窗: baseline, at the 3rd month

Pain intensity was measured using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients rated their pain intensity based on their average pain during the defined time frame. Changes in NRS scores over time were used to evaluate treatment response.

次要结局

  • GPE(baseline, 3rd month)
  • WOMAC(baseline; 3rd month)

研究者

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

Ali ÇOŞTU

Principal investigator

Ankara City Hospital Bilkent

研究点 (1)

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