"Comparison of Shockwave Application on the Sole of the Foot Vs. the Back of the Leg in the Treatment of Plantar Fasciitis: a Clinical Trial."
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- pain (EVA scale)
研究概览
简要总结
The study focuses on plantar fasciitis, one of the most common causes of non-traumatic foot and ankle pain, with an estimated prevalence of 10%. Its objective is to evaluate the effectiveness of shock wave therapy applied along the course of the sciatic nerve in treating plantar fasciitis, comparing its effects on pain, foot-ankle functionality, and quality of life.
Forty-eight subjects will be recruited and randomly assigned to two groups: one will receive local shock wave therapy, while the other will receive therapy along the sciatic nerve. Data will be collected at four points in time: before the intervention, one week after, one month after, and three months after, with blinded data collection.
Pain, foot-ankle functionality, and quality of life will be measured. Data analysis will be performed using SPSS 29.0, applying ANOVA and other tests depending on the normality of the data. Differences will be estimated with a 95% confidence interval and a p-value < 0.05.
详细描述
Introduction
Plantar fasciitis is one of the most common causes of non-traumatic ankle-foot pain. The exact prevalence is unknown, but it is estimated to be around 10%.
Objective
To evaluate the efficacy of applying shock waves along the course of the sciatic nerve in the treatment of plantar fasciitis and its effect on pain, as well as to assess changes in ankle-foot functionality and quality of life.
Material and Methods
Forty-eight subjects who meet the inclusion criteria will be recruited and randomly assigned to each intervention group. The control group will receive local shock wave therapy, while the experimental group will receive shock wave therapy along the course of the sciatic nerve.
Data Collection: Data will be collected at four different times: before the intervention, one week after, one month after, and three months after. The data collection will be carried out by a team member who will be blinded to the group to which the subject belongs. The dependent variables to be measured are pain (VAS scale), ankle-foot functionality (FFI), and quality of life (SF12).
Data Analysis: The data analysis will use SPSS 29.0. Normality of variables will be assessed, and descriptive analyses will be conducted. Initial homogeneity between groups will be compared, and ANOVA and other tests will be applied according to normality and homoscedasticity. Differences and percentage changes will be calculated, estimating effect size, with a 95% CI and p < .05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •having been diagnosed with plantar fasciitis, experiencing pain related to the condition for at least 1 month, and being between 18 and 65 years of age.
排除标准
- •being pregnant, having a pacemaker, presenting with rheumatoid arthritis, or having coagulation disorders.
结局指标
主要结局
pain (EVA scale)
时间窗: 3 months
Assess changes in pain in plantar fasciitis after treatments
ankle-foot functionality (FFI)
时间窗: 3 months
assess the improvement in ankle-foot functionality after treatment.
quality of life (SF12)
时间窗: 3 months
assess the improvement in the patient\'s quality of life after treatment.
次要结局
未报告次要终点
研究者
Paula Fernández Martín
graduate university degree
University of Alcala