Effectiveness of US-guided Percutaneous Electrolysis (EPE®) Versus Placebo in Individuals With Plantar Fasciosis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes in disability before and after the intervention
研究概览
简要总结
Scientific evidence of conservative management of individuals with plantar fasciosis is sometimes conflicting. There is evidence that regular exercise programs are effective for this pain condition. The inclusion of other therapeutic modalities is still controversial. Some authors have suggested that the use of US-guided percutaneous electrolysis (EPE®) maybe useful for the management of chronic tendinopathies; however, no study has investigated the potential placebo effect of this intervention. The objective of this randomized clinical trial is to determine the effectiveness of US-guided percutaneous electrolysis (EPE®) versus sham US-guided percutaneous electrolysis for the management of patients with plantar fasciosis for pain, function, and disability.
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 (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
- •insidious onset of sharp pain under the plantar heel surface upon weight bearing after a period of non-weight bearing;
- •plantar heel pain which increases in the morning with the first steps after waking up;
- •symptoms decreasing with slight levels of activity, such as walking.
排除标准
- •prior surgery in the lower extremity;
- •diagnosis of fibromyalgia syndrome;
- •previous physical therapy interventions for the foot region in the previous 6 months
- •lidocaine or other injections in the plantar fascia for the management of pain in the previous 6 months
结局指标
主要结局
Changes in disability before and after the intervention
时间窗: Baseline, one week after the last session, and 3 months after the last session
The Foot and Ankle Ability Measure (FAAM) will be used to determine function and disability of the lower extremity induced by plantar heel pain
次要结局
- Changes in thickness of the plantar fascia(Baseline, one week after the last session, and 3 months after the last session)
- Changes in pain intensity before and after the intervention(Baseline, one week after the last session, and 3 months after the last session)
研究者
César Fernández-de-las-Peñas
Head Division
Universidad Rey Juan Carlos