Comparison of Heated vs. Pulsed Radiofrequency Treatment of the Genicular Nerves for Osteoarthritis Knee Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Knee pain reduction
研究概览
简要总结
This is a prospective, randomised, interventional, double blinded study to compare the clinical outcomes of thermal vs. pulsed radiofrequency (RF) treatment of the genicular nerves in patients with painful osteoarthritis (OA) of the knee.
Population: 60 patients, aged 50 and above, with painful OA of the knee. Interventional measures: Pulsed or heated RF treatment of the genicular nerves of the involved knee.
Outcome measures: primary - fraction of patients experiencing improvement of 50% or higher in their average pain rating during stair climbing.
secondary - improved quality of life
- improved functional capacity
- comparison of side effects and adverse events
- change in the consumption of analgesic medications
详细描述
Pre-intervention assessment Pain intensity during stairs climbing using VAS 1-100 numerical rating scale. Analgesics consumption. Quality of life using WOMAC questionaires. A physician will further examine them and will enroll them signing an informed concent.
A diagnostic block with lidocaine 2% (2ml for each nerve - total volume of 6ml per knee) of 3 genicular nerves (upper medial and lateral and lower medial branches) will be performed, guided either by ultrasound or by fluoroscopy.
Participants will be asked to fill in a VAS questionnaire shortly (up to one hour) after undergoing the diagnostic blocks.
Participants achieving a relief of >50% in pain intensity during stairs climbing will be considered to have responded to the diagnostic block and will be randomized.
Randomization
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologically proven OA of knee with a
- •Kellgren-Lawrence scale (K-L score) of 3 to
- •Clinically proven OA of knee with an Oxford knee score of 0 to 30 (representing moderate to severe OA).
- •Chronic knee pain due to the OA of knee (>3 months) of at least moderate severity by a Visual Analogue Scale (VAS) 4 and above.
- •Signed informed consent
排除标准
- •Acute knee pain
- •Disease that preclude per clinician decision interventional treatment.
- •Allergic reaction to the injected substances (triamcinolone, lidocaine)
- •Injections to the knee during the 3 months preceding recruitment
- •Distorted knee intervention due to any cause, which interferes with the radiological identification of targeted RF sites.
- •Anticoagulation treatment that cannot be stopped.
结局指标
主要结局
Knee pain reduction
时间窗: 3 months
Reduction in knee pain during stairs climbing by at least 50% in a 1-10 Numerical Rating Scale (NRS) pain severity score and a comparison between the 2 techniques outcomes.
次要结局
- quality of life measurements improvement(3 months)
- Adverse events(3 months)
研究者
Rimma Geller, MD
Staff pain physician
Rambam Health Care Campus