The Effect of Intra-articular Pulsed Radiofrequency in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
研究概览
简要总结
Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.
The purpose of this study is to investigate the effect of intra-articular PRF in osteoarthritis.
详细描述
Pulsed radiofrequency (PRF) is designed to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue. In contrast with conventional radiofrequency, PRF is controlled below 42°C without damage to nerves and many studies have shown its benefits in pain relief for certain kinds of chronic pain conditions. For lessening pain of certain joint arthropathy, the direct nerve block by application of PRF is difficult and complicated because the supplying nerve of joint is complex or small. Hence, some authors perform intra-articular PRF on the chronic painful joint for example, knee osteoarthritis, atlantoaxial joint, cervical facet joint sacroiliac joint, scapholunate and shoulder joint and the excellent long-term effects are reported.
However, the definite effect of intra-articular PRF for osteoarthritis from current published studies are insufficiently proved because of small patient numbers and lack of placebo-controlled design. The purpose of this study is to investigate the effect of intra-articular PRF in 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30-75 year-old
- •Clear consciousness
- •No receive steroid injection, hyaluronic acid, platelet rich plasma in past 6 months
- •The pain (VAS) more than 4
- •Symptom duration at least 6 months
排除标准
- •Joint contracture
- •Coagulopathy
- •Pregnancy
- •Status of Pacemaker
- •Inflammation status
- •Operative history of treated joint
结局指标
主要结局
Change from baseline of pain on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
时间窗: Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
次要结局
- Change from baseline of range of motion on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.(Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.)
- Change from baseline in severity of symptoms and functional status on1st, 2th, 4th, 8th,12th and 16th weeks after treatment.(Pre-treatment, 1st, 2th, 4th, 8th,12th and 16th weeks after treatment.)
- Change from baseline of strength on 4th, 8th,12th and 16th weeks after treatment.(Pre-treatment 4th, 8th,12th and 16th weeks after treatment.)
研究者
Yung-Tsan Wu
Attending Physician, Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital