"Comparison of the Effectiveness of Conventional Radiofrequency Thermocoagulation and Chemical Ablation With Phenol on Articular Branches of Femoral and Obturator Nerves in Chronic Hip Pain"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- NRS (Numerical Rating Scale)
研究概览
简要总结
"In our study, we aimed to compare the effects of conventional radiofrequency thermocoagulation applied to the articular branches of the femoral and obturator nerves with chemical ablation using phenol on hip pain."
详细描述
"Our study is designed as a double-blind, prospective randomized controlled trial. Blinding will be ensured by keeping the researcher performing pain diary follow-ups unaware of which procedure was applied to each patient.
Patients will be randomized using computer-assisted methods. Following approval from the hospital ethics committee, clinical trial registration will be conducted. From 2024 to 2025, patients presenting with chronic hip pain to the Department of Algology at ADU Faculty of Medicine will be divided into two groups. In Group 1, chemical ablation of the femoral and obturator nerve branches with phenol under ultrasound guidance will be performed. In Group 2, conventional radiofrequency thermocoagulation of the articular branches of the femoral and obturator nerves under ultrasound guidance will be applied.
During the study, pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, 2 hours post-procedure, and at 1 month and 3 months post-procedure for both Group 1 and Group 2. The WOMAC scale will be used to evaluate their functional capacity."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be older than 18 years old. Written consent must be obtained. Have had chronic hip pain for more than 3 weeks. -
排除标准
- •Major psychiatric illness Presence of lumbar radicular pain or referred pain in the patient Patients using anticoagulant agents Patients with infection in the area where the procedure will be performed Those with allergy to local anesthetics Those allergic to phenol or betamethasone Pregnant women Scheduled for surgery
研究组 & 干预措施
radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves
Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points.
干预措施: Sedative (Drug)
Chemical ablation with phenol
Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points. Before the procedure, the femoral artery was visualized with a linear ultrasound probe to prevent arterial injury by entering 2 cm lateral to the femoral artery. Following this, a mixture of 2.5 cc of 0.05% bupivacaine and 2.5 cc of 6% phenol was applied, and a lesion was created for 90 seconds at 80°.
干预措施: Sedative (Drug)
结局指标
主要结局
NRS (Numerical Rating Scale)
时间窗: postoperative third month
We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months. A 50% reduction in NRS will be considered statistically significant
次要结局
- WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index )(postoperative third month)
研究者
Akylai Dosieva
doctor
Aydin Adnan Menderes University