Phenol Neurolysis of Genicular Nerves for Osteoarthritic Knee Pain
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in NRS pain score from baseline
研究概览
简要总结
As the aging and obese populations continue to increase, there is a rapidly growing number of people at risk for knee osteoarthritis. Treatment typically starts conservatively with analgesics, physical therapy, and bracing. Intra-articular injections with corticosteroids and/or viscosupplementation may also be utilized in those with persistent knee pain. Genicular nerve radiofrequency ablation (GNRFA) is an increasingly employed procedure for refractory osteoarthritic knee pain with promising efficacy for pain relief. However, due to its reliance on expensive equipment, additional staff, and need for specialized rooms (eg. fluoroscopy suite), GNRFA is a costly procedure with limited availability. Chemical neurolysis is an alternative method of nerve ablation using alcohol or phenol utilized in the management of pain. Recent literature has demonstrated good efficacy for pain relief and function with chemical ablation of the genicular nerves using both alcohol and phenol.
This study is a double-blind, randomized, placebo-controlled pilot study to assess the efficacy of phenol neurolysis of the genicular nerves for pain and function due to refractory osteoarthritic knee pain. We hypothesize that a significant improvement in both pain and function will be observed with chemical neurolysis of the genicular nerves using 6% phenol compared to placebo.
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, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Radiographic knee osteoarthritis (Kellgren-Lawrence grade 2-4)
- •Knee pain of moderate intensity or greater (NRS of 4 or greater)
- •Knee pain for 3 months or longer
- •Persistent knee pain despite conservative treatment including oral/topical analgesics, physiotherapy, intra-articular injection with corticosteroid and/or hyaluronic acid
排除标准
- •Prior total or partial knee arthroplasty in the knee(s) to be treated
- •Prior radiofrequency ablation treatment in the affected knee
- •Other rheumatological or connective tissue disease(s) affecting the knee to be treated
- •History of bleeding disorder
- •Any psychiatric or neurologic disease (eg. dementia, brain injury, etc.) that may preclude reliable reporting of symptoms and response to treatment
- •Pregnancy
- •Recent treatment with intraarticular hyaluronic acid, platelet-rich plasma, or corticosteroid injections to the affected knee in the past 3 months
- •Skin or joint infection in the knee(s) to be treated
- •Concomitant radicular pain
研究组 & 干预措施
Treatment Group
6% aqueous phenol, 1.5 mL per target site
干预措施: 6% aqueous phenol (Drug)
Placebo Group
Isotonic saline, 1.5 mL per target site
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Change in NRS pain score from baseline
时间窗: Baseline, 1 month, 3 months, 6 months
Participants' pain will be measured using the numeric rating scale (0-10) prior to the intervention and at 1 month, 3 months, and 6 months after the intervention. Numeric rating scale ranges from 0 (no pain) to 10 (worst pain).
次要结局
- Change in WOMAC score from baseline(Baseline, 1 month, 3 months, 6 months)