The Efficiency of Radiofrequency Ablation Therapy Applied to the Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Knee Pain Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end initial, 4th week 7th week 24th week pain change
研究概览
简要总结
Radiofrequency application is a treatment method that temporarily prevents the transmission of pain in the nerve where the application is made through the heat emitted by radio waves.Partial inhibition of the functions of the nerves carrying the joint pain sensation with this method is the basis of the treatment.The intermedius genicular nerve carries the sensation of subpatellar pain due to chondromalacia.In this study,investigators aim is to investigate the effect of radiofrequency neurotomy applied to the intermedius genicular nerve, which receives the sensation of the patella, on pain and knee function in patients with a diagnosis of chondromalacia patella who have anterior knee pain that does not resolve despite conservative treatment, under the guidance of ultrasonography.
详细描述
The study was designed as prospective, randomized, controlled trial. 46 people who met the inclusion criteria were randomized into two groups of 23 people. The first group will be designated as Nerve blockage group and nerve blocking program will be applied to these patients. Patients in the second group will be designated as the Radiofrequency group and radiofrequency ablation after the blockade program will be applied in accordance with the radiofrequency ablation protocol.Participants were evaluated with Visual Analogue Scale (VAS), Patello Femoral Pain Severity Scale (PFPSS), Kuala's Patellofemoral Scoring System (KPSS).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female aged >18 years
- •Diagnosis of chondromalacia patella after physical examination and MR imaging
- •Those whose symptoms persist for >3 months
- •Participating in the study voluntarily
排除标准
- •Pregnant patients
- •History of previous knee surgery
- •To have received physical therapy from the knee area in the last 6 months
- •Previous RF treatment or any therapeutic injection of the knee such as steroid, hyaluronic acid within 3 months
- •Those with pain radiating from the waist or hip
- •Patients with neuropathic pain
- •History of tumor, infectious, psychiatric disease, bleeding diathesis
- •History of knee trauma in the last 6 months
- •Those with systemic diseases such as hepatitis, coagulopathy
- •Patients with BMI >40
- •Finding a leg length difference
研究组 & 干预措施
radiofrequency group
the radiofrequency needle will be advanced percutaneously towards the intermedius genicular nerve on the periosteum of the distal femoral shaft region until bone contact is achieved. In addition to imaging the nerve with ultrasound, sensory stimulation at 50 Hz frequency will be applied with a threshold value less than 0.6 V in order to determine its position more accurately. In order to prevent the inactivation of the motor nerves, the relevant nerve will be tested for the absence of fasciculation in the region of the lower extremity compatible with the application with the stimulation with a frequency of 2.0 V and 2 Hz. Before the activation of the radiofrequency generator, an injection of 1 ml of 2% lidocaine will be made, then the radiofrequency electrode will be added to the needle and the temperature level at the tip of the electrode will be increased to 80 degrees for 2 minutes, the procedure will be performed for each genicular nerve.
干预措施: radiofrequency (Procedure)
radiofrequency group
the radiofrequency needle will be advanced percutaneously towards the intermedius genicular nerve on the periosteum of the distal femoral shaft region until bone contact is achieved. In addition to imaging the nerve with ultrasound, sensory stimulation at 50 Hz frequency will be applied with a threshold value less than 0.6 V in order to determine its position more accurately. In order to prevent the inactivation of the motor nerves, the relevant nerve will be tested for the absence of fasciculation in the region of the lower extremity compatible with the application with the stimulation with a frequency of 2.0 V and 2 Hz. Before the activation of the radiofrequency generator, an injection of 1 ml of 2% lidocaine will be made, then the radiofrequency electrode will be added to the needle and the temperature level at the tip of the electrode will be increased to 80 degrees for 2 minutes, the procedure will be performed for each genicular nerve.
干预措施: 2% lidocaine (Drug)
control group
The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.
干预措施: control (Procedure)
control group
The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.
干预措施: 2% lidocaine (Drug)
结局指标
主要结局
Knee Pain Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end initial, 4th week 7th week 24th week pain change
时间窗: Change from Baseline , 4th week 12th week
Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end
次要结局
- Patello Femoral Pain Intensity Scale(Change from Baseline, 4th week 12th week)
研究者
Yasin Demir
Physical Medicine and Rehabilitation Specialist
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital