Non-invasive Radiofrequency Diathermy and Supervised Therapeutic Exercise in Patellofemoral Pain Syndrome. A Single Blind Randomized Controlled Trial With a Six-month Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Knee pain
研究概览
简要总结
Introduction: the management of Patellofemoral Pain (PFP) is focused on therapeutic exercise (TE) to improve muscle strength and motor control. Recent studies suggest that the addition of radiofrequency diathermy (RFD) obtain greater short-term improvements in knee pain than TE alone. As there is no follow up data, the aim of this research is to assess the long-term effects of adding RFD to TE on pain, function and quality of life on PFP patients.
Methods: a single-blind randomized controlled trial will be conducted. Participants diagnosed of PFP will be allocated in either a TE group or a RFD+TE one. Sociodemographic data, knee pain, and lower limb function will be collected. Each group will performed 20 min of daily knee and hip supervised TE along three weeks with the addition of ten sessions of RFD for the RFD+TE group.
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)
盲法说明
Participants were unaware of the treatment group. Researchers in charge of assessment were blinded. Investigator in charge of data analysis was blinded about treatments. Only care providers known about the different treatments
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 30 and 50 years old without radiological findings of osteoarthritis.
- •Subjects referring during the last month almost three points of pain in the anterior surface of knee measured with Visual Analogue Scale.
排除标准
- •Subjects with contraindications for the treatment with radiofrequency diathermy (tumors, use of pacemakers or any other implanted electronic device, thrombophlebitis or deep venous thrombosis, pregnancy, fever, active tuberculosis, infections and rheumatoid arthritis).
- •Subjects who have received corticoid or hyaluronic acid or platelet-rich plasma injections treatment in the knee.
结局指标
主要结局
Knee pain
时间窗: Through study completion, an average of 6 months
Pain measured with Visual Analogue Scale
Knee function
时间窗: Through study completion, an average of 6 months
Knee function measured with "Lower Extremity Functional Scale"
次要结局
未报告次要终点
研究者
Alfonso Javier Ibáñez-Vera
Professor of the Department of Health Sciences
University of Jaén