Phenol Neurolysis of Genicular Nerves for Chronic Knee Pain Following Total Knee Arthroplasty: a Pilot Prospective, Randomized, Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Oxford Knee Score
研究概览
简要总结
Chronic knee pain from osteoarthritis (OA) is commonly treated with total knee arthroplasty (TKA) when conservative therapies fail to provide pain relief. More than 600,000 TKAs are performed in the U.S. annually, a number that continues to increase. A logistic-regression model suggests that the incidence rate of TKA will increase by 143% in the United States by 2050 compared to 2012. Although TKA is successful in reducing knee pain and joint stiffness in most cases, it can be associated with a 7-35% incidence of persistent refractory post-surgical knee pain.
Aim:
To determine whether chemical neurolysis of the genicular nerves with 6% aqueous phenol is non-inferior in reducing knee pain as compared to corticosteroid injection of the genicular nerves, in patients with refractory chronic knee pain for more than 6 months after total knee replacement.
Hypothesis:
Chemical neurolysis of genicular nerves with phenol will provide equal or superior pain relief than corticosteroid genicular nerve injections at 3 months, as measured by the Oxford Knee Score.
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
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 40-95 years
- •Patients with knee pain, on average > 4 (NRS) persisting more than 6 months after TKA
- •Willingness to undergo image guided diagnostic nerve block and the study intervention
排除标准
- •Pain score (NRS) < 4 at time of study enrollment
- •Conditions that preclude the diagnostic block or the study intervention (e.g., irreversible coagulopathy or bleeding disorder, allergic reaction/contraindication to local anesthetic, contrast dye, steroids, and/or phenol, pregnancy, severe or uncontrolled medical illness).
- •Evidence of indolent infection of the knee prosthesis (elevated C-reactive protein assessed when clinically indicated)
- •Inability to write, speak, or read in English
- •Pregnancy
研究组 & 干预措施
Treatment Group: Phenol injection
6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target sites
干预措施: Phenol Injection (Drug)
Control Group: Methylprednisolone injection
Methylprednisolone acetate 10 mg with 2 mL preservative free saline and 0.5 mL iopamidol 300 will be injected at each of the target site
干预措施: Methylprednisolone Injection (Drug)
结局指标
主要结局
Oxford Knee Score
时间窗: 3 months
Oxford Knee Score is a tool which measures 6 post operative items (pain,flexion contracture, extension lag, total range of flexion, alignment of varus and valgus,stability (antero-posterior and mediolateral). The scoring is: below 60 is poor, scoring 60-69 fair, scoring 70-79 good, 80-100 excellent.
次要结局
- Opioid analgesic use at 3 months(3 months)
- PROMIS Sleep Disturbance Short Form 4a(6 Months)
- Numeric Rating Scale Score(6 months)
- Non-opioid analgesic use at 3 months(3 Months)
- Oxford Knee Score(6 Months)
- Hospital Anxiety and Depression Scale(6 Month)
- Opioid analgesic use at 6 months(6 months)
- Non-opioid analgesic use at 6 months(6 Months)
- PROMIS Pain Interference Short Form 6b(6 Months)
- Patients Global Impression of Change(6 Months)
- PROMIS Pain Intensity Short Form 3a(6 Months)
研究者
David Walega
Principal Investigator
Northwestern University