Ultrasound-guided Pulsed Radiofrequency Stimulation of the Tibial Nerve for Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline of pain on 4th, 8th and 12th weeks after treatment.
研究概览
简要总结
Although there are many conservative method for plantar fasciitis, patients might spend 2 years to achieve resolution. Recent study have shown that pulsed radiofrequency (PRF) lesioning of peripheral nerve can alleviate kinds of pain condition. However there are no studies of PRF lesioning of the tibial nerve in patients with plantar fascilitis by using ultrasound-guided (UG) techniques.
详细描述
Patients with unilateral plantar Fasciitis will be enrolled and randomized into intervention and control group. One dose of sono-guided PRF is applied in the intervention group and xylocaine in control group. Outcome measurements included visual analog scale (VAS)、foot health status questionnaire and the thickness of plantar fascile measured by musculoskeletal ultrasonography at different follow-up frame (4th week, 2nd month, 3rd month after treatment).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heel pain more than 3 months
- •Age more than 20 year-old
- •The increased thickness of plantar fascile (>4mm) measured by sonography
- •Must be conscious
- •Not receive steroid or other injection in plantar fascile in past 6 months
排除标准
- •Cancer of any site
- •Coagulopathy
- •Pregnancy
- •Inflammation status
研究组 & 干预措施
pulsed mode radiofrequency
Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. One dose of PRF was given in tibial nerve behine the medial ankle in intervention group.
干预措施: Pulsed radiofrequency (PRF) (Device)
Xylocaine
2 c.c xylocaine was given in tibial nerve behind the medial ankle in control group.
干预措施: Xylocaine (Drug)
结局指标
主要结局
Change from baseline of pain on 4th, 8th and 12th weeks after treatment.
时间窗: Baseline , 4th, 8th and 12th weeks after treatment.
Using the Visual analog scale (VAS) and subscore of foot health status questionnaire to measure the pain scale before treatment and multiple time frame after treatment.
次要结局
- Change from baseline of functional improvement on 4th, 8th and 12th after treatment.(Baseline , 4th, 8th and 12th weeks after treatment.)
- Change from baseline of thickness of plantar fascile on 4th, 8th and 12th weeks after treatment.(Baseline , 4th, 8th and 12th weeks after treatment.)
研究者
Yung-Tsan Wu
Attending Physician
Tri-Service General Hospital