Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for pain
研究概览
简要总结
Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.
The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.
The proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with diagnosis of plantar fasciitis agreeing to participate
- •Over 18 years old
- •Able to wear unit and keep data up-to-date records of use
- •Agree to forgo additional treatments during the study period
排除标准
- •Patients who have refused, are unable to give or have withdrawn consent
- •Patients with heel pain present less than 3 months
研究组 & 干预措施
Control
Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled.
干预措施: Sham pulsed radio-frequency electromagnetic device (Device)
Actipatch
Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy
干预措施: ActiPatch PRFE Device (Device)
结局指标
主要结局
Visual Analog Scale (VAS) for pain
时间窗: 4 Weeks Follow-up
次要结局
- Visual analog scale for pain(26 weeks)
- Foot and ankle disability index(26 weeks)
- Tegner activity scale(26 weeks)