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临床试验/NCT07113028
NCT07113028进行中(未招募)不适用

Comparison of the Effectiveness of Conventional and Pulse Radiofrequency Therapy in Advanced Knee Osteoarthritis in Elderly Patients: An Observational Study

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Numeric Rating Scale-11 (NRS-11): This is an 11-point scale used to describe pain. It is based solely on the patient's ability to perform activities of daily living and can be used for adults and children ages 10 and older.

研究概览

简要总结

Knee osteoarthritis (OA) is a very common joint disease, causing pain and loss of function. Osteoarthritis, including knee OA, is a significant cause of morbidity and disability in older adults and negatively impacts the functionality of individuals over the age of 65. When non-invasive treatments such as medical therapy, physical therapy, and rehabilitation fail to provide adequate pain control, intra-articular injections, geniculate nerve blocks, radiofrequency ablation, and surgical treatments are considered.

Genicular nerve blocks provide short-term pain relief in knee osteoarthritis . Despite various conservative treatments, many patients with chronic knee OA experience severe knee pain before total knee arthroplasty. Genicular nerve block (GNB) and radiofrequency ablation of the geniculate nerves have been shown to be effective in relieving pain and improving knee functionality in patients with chronic knee OA. Intra-articular corticosteroids are used in the treatment of knee OA to rapidly relieve pain, reduce pain within the first three months, and rapidly restore joint function . Both conventional and pulsed radiofrequency treatments have been effective in relieving pain and improving disability in patients with knee OA who have not responded to conservative treatment and have contraindications for surgery. Conventional radiofrequency therapy uses high-frequency alternating current to create thermal lesions. The thermal energy creates a zone of coagulative necrosis that includes the nerves that transmit and/or modulate pain sensation . In pulsed radiofrequency therapy, thermal tissue damage can be minimized by using pulsed high-voltage radiofrequency currents. This allows time for the heat to dissipate and generally maintains the tissue temperature near the electrode below the neurodestructive range. The mechanism by which pulsed radiofrequency provides clinical benefit is not fully understood. It appears to modulate signaling cascades, particularly in C fibers, without affecting nerve conduction in myelinated fibers . As an alternative to the thermal effects of conventional radiofrequency therapy, pulsed radiofrequency therapy has been noted to have fewer potential side effects .

In conclusion, the therapeutic effects of radiofrequency applications on improving pain and functional impairments due to knee osteoarthritis (KOA) have been demonstrated; however, the number of studies evaluating only elderly patients (aged 65 and over) is limited. Studies comparing conventional and pulsed radiofrequency treatments of the genicular nerves and evaluating their effects on geriatric parameters are limited. The primary objective of our study was to compare the effects of conventional and pulsed radiofrequency treatments of the genicular nerves under ultrasound guidance on knee pain and functional assessments in elderly patients, and the secondary objective was to determine their effects on geriatric assessments.

详细描述

The study will be conducted at the Department of Algology at Kanuni Sultan Süleyman Training and Research Hospital by retrospectively reviewing the medical records of patients aged 65 and over diagnosed with knee osteoarthritis who underwent conventional or pulsed radiofrequency (USG)-guided radiofrequency (RF) treatment of the genicular nerves between January 2023 and March 2024. The interventional procedure is performed under sterile conditions, with the patient monitored, supported below the knee, and in slight flexion, adhering to asepsis and antisepsis guidelines. The genicular nerves are visualized using ultrasound guidance, and radiofrequency treatment is administered in conventional or pulsed mode, followed by appropriate sensory and motor stimuli. Demographic data, height, weight, duration of symptoms, comorbidities, analgesic use, pre-treatment and post-treatment 1st and 3rd month Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Numeric Rating Scale-11 (NRS-11), Tinneti Balance, Tinneti gait and performance-oriented mobility assessment (POMA), and timed up and go test will be recorded from the patient files.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Patients who have undergone ultrasound-guided genicular nerve RFT.
  • Patients over the age of 65 who have a diagnosis of knee OA and who cannot achieve adequate pain palliation with conservative treatments.
  • Patients with complete data to be scanned in their files.

排除标准

  • Patients who have received radiofrequency treatments other than those diagnosed with osteoarthritis
  • Patients who have received intra-articular knee injections, PRP, or hyaluronic acid injections in the last 6 months
  • Patients who have undergone knee replacement surgery
  • Patients diagnosed with malignancy
  • Patients who have received steroids for any reason in the last 6 months
  • Patients with radicular pain
  • Connective tissue diseases
  • Serious neurological or psychiatric disorders
  • Mental impairment that prevents adequate communication or cooperation Use of anticoagulant medications

结局指标

主要结局

Numeric Rating Scale-11 (NRS-11): This is an 11-point scale used to describe pain. It is based solely on the patient's ability to perform activities of daily living and can be used for adults and children ages 10 and older.

时间窗: 1 month

次要结局

  • Western Ontario and McMaster Universities. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC consists of five items for pain (score range 0-20), two items for stiffness (score range 0-8), and 17 items for functional limi(1 month)

研究者

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

Halil Ibrahim Altun

pain specialist

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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