Comparison of the Effectiveness of Pulsed Radiofrequency Therapy and Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- KOOS
研究概览
简要总结
This study is intended to prove the efficacy and safety of ultrasound-guided pulsed radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis.
详细描述
Knee osteoarthritis is a serious epidemiologic problem. Non-surgical methods are shown limited efficacy in relieving chronic knee pain in patients in advanced stages of knee osteoarthritis. The knee prosthesis is a successful treatment for many patients with advanced knee osteoarthritis. Still, there are important numbers of patients, which are not appropriate candidates for such surgery treatment or refused surgery for any reason. For them, any treatment which could relieve pain in their knee would have a good impact on their quality of life. Interventions like adductor canal block(ACB) and pulsed radiofrequency therapy (PRF) have demonstrated good results. In this study, investigators compare the effectiveness of these two methods. Official approval from the ethics committee of the Republic of Slovenia was obtained for this study. After being informed about the research and potential risks, all patients giving written informed consent will undergo an orthopedic examination and those with a confirmed diagnosis of knee osteoarthritis that lasted more than 6 months will be included in the study. All participants were randomly divided into two groups. Participants in the first group receive single shot ACB and participants in the second group receive PRF therapy at the same point. Before starting all patients filled the Knee injury and osteoarthritis outcome(KOOS) form and estimated the maximal and minimal intensity of pain in the knee. They repeat self-assessment of pain, in the same manner, using 11 points numeric rating score(NRS) 1 month, 3, and six months after the blockade or PRF therapy. Measurement of maximum voluntary isometric contraction of the quadriceps muscle (MVIC), time up and go test(TUG), and 30s stand-up chair test are performed by a physiotherapist before a block of adductor canal on both legs,1 hour, 1 month, 3 months and 6 months after a block or PRF therapy.The adductor canal blockl is performed by the same trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and 100 mcg of Clonidine mixed in the same syringeAfterof the study participants filled the Knee injury and osteoarthritis outcome(KOOS) form once again.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose of the Knee osteoarthritis confirmed by orthopedic examination
- •K-L grades 3 and 4
- •A sufficient level of education to understand study procedures
- •Be able to communicate with site personnel
- •Age >45 years
- •Exclusion Criteria :
- •Any cardiovascular, hepatic, or renal conditions that would compromise participation, in the opinion of the investigator
- •Severe neurologic conditions interfere with a knee condition
- •Narcotic dependent (opioid intake of more than 3 months and more than 30 mg of daily oral morphine equivalents)
- •Coexisting severe hematological disorder or deranged coagulation parameters
- •Psychiatric illnesses
- •Allergy to any of the drugs used in the study
- •Infection or malignancy at the site of the block
- •Any active systemic infection
- •Implanted electronic devices like spinal cord stimulators, cardiac pacemakers or similar
排除标准
- 未提供
结局指标
主要结局
KOOS
时间窗: Baseline ,1 hour,1 month, 3 month and 6 months
The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block \[ Time Frame: Baseline and 1 month following adductor canal block \] KOOS is valid,reliable outcome measure in patients with knee osteoarthritis. usually used following knee surgery.This method is recognised as useful also in other and nonsurgical knee treatment.Shortened version widely used in North America is western Ontario and McMaster Universities Index(WOMAC)
Pain intensity
时间窗: Baseline ,1 hour,1 month, 3 month and 6 months
Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS 0-11) ;Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain.
次要结局
- Maximum voluntary isometric contraction of quadriceps muscle (MVIC)(Baseline ,1 hour,1 month, 3 month and 6 months)
- Timed up to go test (TUG)(Baseline ,1 hour,1 month, 3 month and 6 months)
- 30 seconds stand up chair test (30 s SCT)(Baseline ,1 hour,1 month, 3 month and 6 months)
- Satisfaction of patient(Baseline ,1 hour,1 month, 3 month and 6 months)
- Range of knee motion (ROM)(Baseline ,1 hour,1 month, 3 month and 6 months)
研究者
Mensur Salihovic
Principal Investigator
University Medical Centre Ljubljana