Efficacy of Applying Shock Waves Combined With Leg Stretching in Patients With Plantar Fasciitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Pain intenisty VAS
研究概览
简要总结
The aim of this study is to evaluate the efficacy of a combination treatment consisting of ESWT and stretching of different muscles in the lower body compared to ESWT treatment alone in patients with plantar fasciitis.
详细描述
Background: Plantar fasciitis is the most common cause of pain in the heel of the foot, manifested by the presence of pain in the antero-internal part of the calcaneus. Currently, there is ample evidence of the efficacy of both shock waves and stretching in their treatment, however, no study has proven what results are obtained by combining the application of shock waves with stretching in different leg muscles.
Objectives: The main objective of the study is to compare the effects of OC treatment in conjunction with leg-length stretches against shock waves alone in reducing pain in patients with PF. The secondary objectives will be to observe the effects of both treatments on disability and activity limitation in both the short and medium term.
Materials and Methods
A double-blind randomized clinical trial will be conducted. A total of 52 subjects (26 in each group) will participate in the study, divided into one group that will undergo shockwave therapy plus real stretching (experimental group) and another that will undergo shockwave therapy plus placebo stretching (control group). The primary variable of the study will be pain, and secondary variables will include changes in disability and activity limitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Presence of pain in the medial area of the sole of the foot lasting 3 or more months.
- •Being diagnosed with plantar fasciitis by one of the physical therapists participating in the study.
- •Have a pain level equal to or greater than 3 on the Visual Analogue Scale (VAS).
排除标准
- •Presence of bilateral plantar fasciitis.
- •Signs of neurological abnormalities.
- •Infections and malignant tumors.
- •History of presence of dysfunction in the lower extremity.
- •Pregnant women
- •Have been treated with shock waves in the previous 12 months.
结局指标
主要结局
Pain intenisty VAS
时间窗: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
To evaluate the difference in pain after the intervention. We are going to use the Visual Analogue Scale, being 0 the better result and 10 the worst possible.
Pain intensity PSFP
时间窗: Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention
We are also to use the Pain Scale for Plantar Fasciitis in their section for pain measure. The minimum score is 0 (better) and the maximum 100 (worst).
次要结局
- Disability(Baseline (week 0), 8 weeks after baseline, 3 months after intervention and 12 months after intervention)
研究者
Guillem Serrabassa Ureña
Principal investigator
University of Alcala