Comparative Study Between Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement of knee osteoarthritis pain
研究概览
简要总结
This study aimed to compare the strength and duration of pain relief, quality of life and analgesic consumption between patients who undergo conventional thermal radiofrequency vs patients who undergo chemical neurolysis on genicular nerves by alcohol in chronic knee osteoarthritis pain.
详细描述
Knee osteoarthritis is a degenerative joint disease characterized by the degradation of the articular cartilage, with many factors implicated in the disease pathogenesis.
Chronic pain of knee osteoarthritis is a common clinical symptom leading to restricted movement, disability, psychological distress, and impaired quality of life.
The targeted genicular nerves are those that had a close topographic relationship with the bone cortical surfaces, such as the femoral epicondyles (Superior medial [SM] and Superior lateral [SL] genicular nerves) and the medial tibial epicondyle (Inferior medial [IM] genicular nerve).
Nerve ablation causes iatrogenic neural degeneration, aiming only for sensory or sympathetic denervation without motor deficits. The nerve ablation methods currently available are performed by either thermal ablation using radiofrequency or chemical ablation using alcohol or phenol.
Chemical neurolysis techniques can be an effective method to accomplish a larger, more thorough lesioning than radiofrequency ablation and are capable of covering the anatomical variability of genicular nerves, so ensuring a better success rate and outcome with less cost and less logistic support.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 40 to 60 years.
- •Both sexes.
- •Stage 3 and 4 knee osteoarthritis in patients who aren't responding to pharmacological treatment and aren't good candidates for knee replacement surgery.
排除标准
- •Neurological disorders (Previous cerebrovascular stroke, neuropathy, or weakness).
- •Bleeding disorders.
- •Infection at or near the injection site.
- •Presence of a pacemaker or defibrillator.
- •Acute knee injury.
- •Unstable knee joint.
研究组 & 干预措施
Group I
Patients received C-arm guided neurolysis of superior medial [SM], superior lateral [SL], and inferior medial [IM] genicular nerves by thermal radiofrequency.
干预措施: Thermal Radiofrequency Neurolysis (Other)
Group II
Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.
干预措施: Alcoholic Neurolysis (Other)
结局指标
主要结局
Improvement of knee osteoarthritis pain
时间窗: 6 months post-procedure
Improvement of knee osteoarthritis pain according to Visual Analogue Scale (VAS). VAS: which was a subjective scale used to quantitatively assess pain (0 = No pain, 10 = Severe pain).
次要结局
- Improvement of quality of life(6 months post-procedure)
- Decrease of analgesic requirements of pain control after neurolysis.(6 months post-procedure)
研究者
Hesham Mahmoud Elsayed Eldamhogy
Resident of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University
