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临床试验/NCT05447624
NCT05447624已完成不适用

The Effect of Radiofrequency Ablation on the Results of the Genicular Nerve Number in the Treatment of Knee Osteoarthritis

Marmara University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年1月2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
42
试验地点
1
主要终点
Numeric Rating Scale

研究概览

简要总结

Knee osteoarthritis is a disease that increases in frequency with age and decreases the quality of life and physical activity by leading to a decrease in pain and joint range of motion. Basically, the articular cartilage is affected and clinically pain, joint stiffness, crepitation and effusion are seen. In imaging techniques applied with weight-bearing, varying degrees of joint narrowing are observed, although it is more common in the medial. Treatment options include conservative approaches such as weight loss, physical therapy, analgesics, or invasive approaches such as intra-articular injections, peripheral nerve blocks, joint-sparing surgery or total knee replacement. Surgical operation should be considered in the treatment when conservative treatments are insufficient. However, the advanced age of this patient group and the large number of comorbidities reduce the possibility of surgical operation. Although treatment cannot be cured in knee osteoarthritis, the aim of the treatment is to decrease the pain, increase the patient's quality of life and physical capacity, and slow down the progression of the disease.

Although the radiofrequency ablation (RFA) technique has been used since the 1970s, the first application area was trigeminal neuralgia. Later, its use in neck and back pain became widespread, but the first randomized controlled study on its use in knee osteoarthritis was Choi et al. Made by in 2011. The purpose of radiofrequency ablation applied to the genicular nerves that receive the sensation of the knee joint capsule is to prevent sensory transmission and reduce the sensation of pain by creating axonal damage to these nerves. Since the use of RFA in knee osteoarthritis is relatively new, studies on the development of the technique continue. Fluoroscopy device or ultrasonography can be used as imaging method to show target nerves or to place the RFA electrode in the correct localization.

The investigators hypothesis; based on the more prominent medial involvement in knee osteoarthritis, the conventional RFA procedure applied to the 3 genicular nerves (SMGN, IMGN, SLGN) is not superior to the RFA procedure applied to the medial SMGN and IMGN branches.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Be over 50 years old and under 80 years old
  • •Symptom duration is at least 3 months
  • •Pre-procedure NRS score of more than 6
  • •Kellgren-Lawrence stage 3-4
  • •Failure to respond to conservative treatments
  • •Having given consent to participate in the study
  • •The patient's ability to speak and read and write Turkish

排除标准

  • •Body mass index of 41 kg/m2 or more
  • •Acute knee injury
  • •Chronic pain syndrome (fibromyalgia syndrome, chronic fatigue syndrome, etc.)
  • •Lumbar radicular pain
  • •Uncontrolled diabetes mellitus
  • •Presence of bleeding diathesis
  • •Hemodynamic instability
  • •Pacemaker presence
  • •History of septic arthritis or active local or systemic infection
  • •Having a history of surgery on the knee to be treated
  • •Intra-articular injection of the knee within 3 months
  • •Cognitive impairment
  • •Presence of genu valgus deformity
  • •Presence of secondary knee osteoarthritis (due to trauma, rheumatoid arthritis, systemic inflammatory diseases such as gout, kinetic chain disorder due to congenital hip dislocation)

研究组 & 干预措施

Patients undergoing ablation of two of the genicular nerve branches

Active Comparator

干预措施: Radiofrequency ablation of genicular nerves (Procedure)

Patients undergoing ablation of three of the genicular nerve branches

Active Comparator

干预措施: Radiofrequency ablation of genicular nerves (Procedure)

结局指标

主要结局

Numeric Rating Scale

时间窗: 3 months

It is a scale on which patients score their pain between 0 and 10, with 0 = "no pain" and 10 = "worst pain imaginable"

次要结局

  • use of analgesic drugs(3 months)
  • WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)(3 months)
  • SF-36 (Short Form-36)(3 months)
  • TUG (Timed Up and Go Test)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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