A Controlled Comparison of Pulsed Radiofrequency Vs Physical Therapy on Treating Chronic Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy
研究概览
简要总结
It is estimated that nearly 27 million US adults have osteoarthritis (OA) and suffer from pain . Pulsed Radio Frequency (PRF) is one method that has been successfully used in treatment of various etiologies of pain. However there are limited studies and research that prove its effectiveness in treating articular pain. The proposed study's primary aim is determining if PRF is an effective treatment for chronic osteoarthritic knee pain. This study hypothesizes that PRF has analgesic properties immediately after treatment and at least 3 months afterwards compared to control treatment with physical therapy.
Additionally this research project addresses several other objectives including:
- Provide a controlled study to determine the effectiveness of PRF for intra-articular pain
- Determine how effective PRF is 1 month and 3 months after treatment for articular pain.
- Further scientific evidence on the overall effectiveness of PRF
- Provide evidence that PRF likely has other mechanism of action besides direct nerve stimulation of inhibitory pain pathways.
- Compare the effectiveness of PRF vs Physical Therapy in treating chronic knee 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18
- •Radiologic evidence of Kellgren-Lawrence knee arthritis between levels 1-3
- •Satisfy the American College of Rheumatology criteria for knee osteoarthritis.
排除标准
- •Failure to satisfy inclusion criteria
- •Existence of general contraindications against percutaneous knee intervention including (e.g. infection, hemorrhagic diathesis, anticoagulated patients)
- •Patients with pacemaker or stimulator implants
- •Metallic hardware located in the treatment knee of choice
- •High clinical suspicion for alternative diagnosis other than Knee Osteoarthritis
- •VA defined vulnerable populations (e.g. adults with cognitive impairments, mentally retarded, non-english speaking, severe psychiatric disorders, prisoners, terminally ill patient, employees, homeless, pregnant).
- •Any patient that would not be able to follow up at 1 and 3 months after intervention.
- •Any patient unwilling to receive physical therapy
结局指标
主要结局
VAS pain scores and Western Ontario and McMaster Universities Arthritis Index (WOMAC) with pulsed radiofrequency vs physical therapy
时间窗: 3 months
The Study will measure VAS pain scores (0-10) at initial consult, 1 month, and 3 months. Additionally the study will document functional changes using the WOMAC questionnaire at initial evaluation and 3 months.
次要结局
- Safety of pulsed radiofrequency for knee pain treatment(3 months)
研究者
Ravi Mirpuri
University Of California Resident Physician
VA Long Beach Healthcare System