Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy: Effectiveness of 5 Nerve Protocols Versus 3 Nerve and 2 Nerve Protocols - A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA): Proprioception of the knee joint
研究概览
简要总结
The main symptom of knee osteoarthritis, which occurs after damage to the joint cartilage with age, is pain, but this symptom often becomes chronic. Current conservative treatments have moderate effects on chronic knee pain and their use is limited due to the risk of side effects. In addition to pain, patients also experience other symptoms.
As a result of the osteoarthritis process, prorioception in the knee is impaired with a decrease in mechanoreceptors, resulting in loss of balance and an increase in the risk of falling.
详细描述
Our aim in this study is; to investigate the superiority and long-term effectiveness of radiofrequency ablation therapy applied with 5 nerves, 3 nerves and 2 nerves on fall risk, balance, proprioception, chronic pain and symptoms in knee osteoarthritis.
Radiofrequency ablation therapy; it is effective in chronic pain by causing nerve damage. Application of radiofrequency ablation therapy on chronic knee pain with different protocols has been reported in the literature with different results.
In the literature, it has been shown that the 5-nerve protocol versus the 3-nerve protocol with the radiofrequency ablation method reduces pain and provides functional improvement in patients with chronic knee osteoarthritis. In another study in the literature, functional and physical performance was examined with a 3-nerve protocol in the same patient group without a control group and was found effective.
To our knowledge, there is no study in the literature evaluating the effectiveness of radiofrequency ablation therapy on fall risk, balance and proprioception after applying different protocols in knee osteoarthritis.
There are few studies in the literature regarding radiofrequency ablation treatment procedures for knee osteoarthritis. In line with this information, it is obvious that more studies are needed on the radiofrequency ablation method. Although this method has been shown to be effective and popular in recent years, since it is an invasive procedure, another aim of ours is to reveal what is the least intervention that will give the most effective results for 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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients and care provider, the physician performing the assessment and the physiotherapist treating the patient will be blind to what procedure is being performed.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30-75
- •Chronic knee pain that lasts at least 6 months
- •Radiographic confirmation of osteoarthritis: Presence of Grade 3 or 4 radiographic changes characterized by significant narrowing in the medial space of the tibiofemoral joint according to the Kellgren-Lawrence classification system
- •Knee pain >40 mm when performing one of the two movements that cause the most severe pain (sitting to standing or going up and down stairs) according to 100 mm VAS
- •50% reduction in VAS with diagnostic genicular nerve block
排除标准
- •Presence of systemic inflammatory disease such as rheumatoid arthritis
- •Previous RFA treatment to the knee or hyaluronic acid or steroid injection to the knee within the last 3 months
- •History of previous knee surgery
- •Clinically significant structural abnormalities other than osteoarthritis that may lead to chronic knee pain
- •Having undergone physical therapy to the knee in the last 6 months or a history of knee trauma
- •Application of other pain treatments
- •Body-Mass İndex <18 and >40 kg/m2
- •Pregnancy
- •Presence of uncontrolled serious illness (cancer, diabetes, etc.), infection, psychiatric disorder, coagulation disorder
结局指标
主要结局
Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA): Proprioception of the knee joint
时间窗: baseline, 1st month and 3rd month
A Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA) will be used to measure proprioception of the knee joint. During the test, participants will be blindfolded to eliminate visual input. Initially, for the preparation set, the participants' knee joint will be passively flexed from 90 degrees to 45 degrees and they will be provided with an understanding of the test angle. During the test, the device will enter isokinetic con/con mode and the participant will be able to actively move the knee. When the participant moves the knee to the test angle, the value will be recorded and the absolute angular error, i.e. the difference between the recorded angle and the target angle (45 degrees), will be determined. The test will be repeated 3 times and the values will be averaged.The farther the measured value is from the target value, the more impaired proprioception is.
Cybex 770, Humac Norm Dynamometer (CSMI, Stoughton, MA, USA): Isokinetic muscle strength of the quadriceps and hamstring muscles
时间窗: baseline, 1st month and 3rd month
Cybex 770, Humac Norm dynamometer (CSMI, Stoughton, MA, USA) will be used to measure the isokinetic muscle strength of the quadriceps and hamstring muscles. During the test, while the knee joint moves from 90 degrees to 0 degrees, 5 maximum contraction repetitions are provided at an angular speed of 60/sec for muscle strength and 15 maximum repetitions of contraction at an angular speed of 180/sec are provided for muscle endurance.10-second rest period is left between repetitions.The preparation set is applied before the test.Afterwards, there is a 2-minute rest period before starting the test.Isokinetic knee extensor and flexor mean peak torque is determined and It is standardized according to body weight(Peak torque/body weight:Newton-metre/kg).Higher values in peak torque indicate better levels of muscle strength and endurance.
HUBER 360 Evolution Device (LPG, Valence, France)
时间窗: baseline, 1st month and 3rd month
HUBER 360 Evolution device will be used in balance-coordination evoluation.The patient will be placed on a multi-axis platform and 4 different tests will be applied.
次要结局
- Romberg Test(baseline, 1st month and 3rd month)
- Single Leg Test(baseline, 1st month and 3rd month)
- Walking(baseline, 1st month and 3rd month)
- Coordination(baseline, 1st month and 3rd month)
- Berg-Balance Test(baseline, 1st month and 3rd month)
- International Falls Efficacy Scale (FES-1)(baseline, 1st month and 3rd month)
- WOMAC Osteoarthritis Index(baseline, 1st month and 3rd month)
- SF-12 (Short Form-12)(baseline, 1st month and 3rd month)
研究者
Bengu Turemenogullari
Principal Investigator
Ankara Etlik City Hospital