Randomized, Double-blinded, Comparison Between Ultrasound-Guided Genicular Nerve Phenol Neurolysis and Intra-articular Steroid Injections
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Pain scores (Numeric Rating Scale) at 3 months
研究概览
简要总结
Genicular nerve neurolysis (GN) constitutes a relatively novel technique, whereby different chemical compounds (i.e. alcohol, phenol) are injected in close proximity to the genicular nerves of the knee joint, with the intention to exert a neurolytic effect by denaturing proteins resulting in Wallerian degeneration distal to the lesion. Based on the preliminary evidence and considering the potential benefits of the technique, we hypothesized that ultrasound-guided genicular chemical neurolysis with phenol is superior in terms of pain relief at 3 months, when compared to intra-articular steroid (IAS) injection.
详细描述
This study will allow us to determine if ultrasound-guided phenol genicular neurolys is superior to intra-articular steroid injection in terms of analgesia and functional outcomes, providing a more effective and long-lasting alternative for patients with chronic knee pain secondary to osteoarthritis
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe knee pain for more than 6 months, defined as Numeric rating scale (NRS) score of 6 and greater, unresponsive to conservative medical treatment
- •Radiological OA grade 2 to 4 (Kellgren-Lawrence scale)
排除标准
- •Previous total knee replacement on the index knee
- •Prior knee radiofrequency ablation on the index knee
- •Connective tissue diseases with knee involvement (e.g. rheumatoid arthritis)
- •Body mass index ≥ 40 kg/m2
- •Uncontrolled coagulopathy, defined as supratherapeutic dose of anticoagulation medication
- •Allergy to local anesthetics
- •Unstable opioid consumption, defined as an increase >10% in dosage during the last 3 months prior to recruitment.
研究组 & 干预措施
Ultrasound-guided Genicular Nerve Phenol Neurolysis
One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves
干预措施: 6% aqueous phenol (Drug)
Ultrasound-guided Genicular Nerve Phenol Neurolysis
One time injection of 1.5 mL of phenol 6% at 3 target locations: superomedial, superolateral and inferomedial genicular nerves
干预措施: Intraarticular Knee Placebo (Drug)
Ultrasound-guided Intraarticular Steroid Injection
Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
干预措施: MethylPREDNISolone 40 MG (Drug)
Ultrasound-guided Intraarticular Steroid Injection
Intraarticular knee injection of 40 mg of methylprednisolone acetate in a volume of 5 mL of saline
干预措施: Genicular Nerve Placebo (Drug)
结局指标
主要结局
Pain scores (Numeric Rating Scale) at 3 months
时间窗: 3 months
Knee pain intensity using Numeric Rating Scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
次要结局
- Pain scores (Numeric Rating Scale) at baseline, 1 and 6 months(baseline, 1 month, 6 months)
- Proportion of patients experiencing a 50% or greater decrease in baseline knee pain scores (NRS)(1 months, 3 months, 6 months)
- WOMAC index(baseline, 1 month, 3 months, 6 months)
- Brief Pain Inventory Score (BPI)(baseline, 1 month, 3 months, 6 months)
- Incidence of adverse events(from injection up to 1 month after intervention)
研究者
Javier Webar
Assistant Professor
University of Manitoba