跳至主要内容
临床试验/NCT05303766
NCT05303766Unknown不适用

Comparing the Safety and Effectiveness of Radiofrequency Thermocoagulation on Genicular Nerve, Intraarticular Pulsed Radiofrequency With Steroid Injection in the Pain Management of Knee Osteoarthritis

Assiut University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Numeric rating scale (NRS)

研究概览

简要总结

The aim of this study is to assess the safety and efficacy of radio frequency thermo-coagulation on the genicular nerve (RFTGN) and intra-articular pulsed radio frequency (IAPRF) for Knee Osteoarthritis (KOA) to improve physical activity , range of joint movement , pain intensity and quality of life.

详细描述

After obtaining the consent from patients and being informed about the study and potential risks , all patients were randomly assigned to the RFTGN, IAPRF, and intraarticular steroid injection (IAS) groups. All procedures were performed under the guidance of C-arm X-ray machine. The observation indicators of this study were the numeric rating scale (NRS), Oxford knee scale (OKS), and perceived global effect (GPE). The time points for the assessment were 1-week, 1-month, 3-months, 6-months and 9-months after the treatment.

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 (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with KOA based on the American College of Rheumatology criteria
  • age 18-70 years
  • grade 2 or 3 KOA based on the Kellgren-Lawrence classification
  • patients who did not respond to conservative treatment (physiotherapy, oral NSAIDs, and/or intraarticular injections of hyaluronic acid and corticosteroid) for 3 months
  • duration of knee pain ≥ 3 months
  • numeric rating scale (NRS) ≥ 5 points within 24 h prior to admission.

排除标准

  • grade 1 or 4 KOA based on the Kellgren-Lawrence classification
  • severe liver, kidney, cardiovascular, and respiratory disease
  • abnormal blood coagulation
  • skin infections in the puncture region
  • patients who previously underwent knee arthroscopy, TKA, RFTGN, or IAPRF
  • mental disorders or inability to complete the follow-up observational form
  • patients with bilateral knee pain.

研究组 & 干预措施

RFT group

Experimental

The treatment of the patients in the radio frequency thermo-coagulation of the genicular nerves was conducted under the guidance of C-arm X-ray machine . The C-arm machine showed that the radiofrequency cannula needle was advanced percutaneously towards the periosteal areas connecting the shaft of the femur to bilateral epicondyles and the shaft of the tibia to the medial epicondyle while the lateral image showed that the depth of the needle insertion was about 50% of the diameter of the femur or tibia. The radiofrequency electrodes were connected and tested. These induced abnormal pain around the knee joint at 50 Hz and 0.1-0.3 V, but did not induce contraction of the muscles of the knee joint at 2 Hz and > 2.0 V. The location of the needle tip was confirmed by the C-arm, and 0.5 mL of 1% lidocaine was used for local anesthesia. The temperature of RFT was increased gradually to 70°C for 180 seconds.

干预措施: Radio-frequency ablation (Device)

IAPRF group

Experimental

The puncture site was selected in the middle of the medial or lateral edge of the patella. After local anesthesia was administered with 0.5% lidocaine, the radiofrequency cannula needle was inserted slowly between the patella and femoral condyles. The needle was gradually inserted into the joint cavity, and then a small volume of saline was administered using a syringe. If any resistance was encountered, which indicated that the needle tip was located in a ligament or tendon, the surgeon readjusted the needle tip until the injection proceeded without any significant resistance. After entering the joint cavity, the C-arm x-ray is used confirm that the cannula needle was located in the middle of the joint space. Subsequently, sensory stimulation using 50 Hz/2 Hz was performed at > 2 V, to prevent inducing pain or muscle contraction. Then, an automatic PRF mode ≤ 45 V (≤ 42°C, 2 Hz, pulse width of 20 ms) was administered for 300 seconds.

干预措施: Pulsed Radio-frequency (Device)

IAS group

Experimental

The puncture procedure was similar to that for the IAPRF group. After the cannula needle was inserted to the articular cavity, 1 mL compound betamethasone (2 mg betamethasone sodium phosphate and 5 mg betamethasone dipropionate) was injected. Then, the needle was withdrawn, and the puncture site was dressed aseptically.

干预措施: Intra-articular steroids (Drug)

结局指标

主要结局

Numeric rating scale (NRS)

时间窗: 9 months and after procedure

Using the numerical rating score , a score from ( 0 to 10 ) for evaluation of pain intensity. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Oxford Knee Score

时间窗: 9 months and after procedure

Using oxford knee score for follow up of pain of knee osteoarthritis , a score from 0 to 48 . if the score is 0 to 19 this may indicate sever arthritis , and if it's from 40 to 48 it means satisfactory joint function . This scrore is based on a 12-question report about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks.

次要结局

  • Site of pain(9 months and after procedure)
  • Improvement of knee joint function(9 months and after procedure)
  • Duration of pain free periods(9 months and after procedure)
  • Total consumption of analgesics ( e.g NSAIDS , weak opioids… ect )(9 months and after procedure)

研究者

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

Esraa Mostafa Ali Osman

Principal Investigator

Assiut University

研究点 (1)

Loading locations...

相似试验