Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Evaluation of X-Ray
研究概览
简要总结
Fifth metatarsal stress fracture is a failure of a healthy metatarsal bone subject to repetitive microdamages. It has a high prevalence in soccer players and is classified as a high-risk stress fracture. Based on Torg classification, the treatment options may be conservative or surgical. The recent increase of evidences about Shock Wave Treatment in different bone pathologies, including stress fractures, suggests the possibility to use this conservative intervention option also in patients candidate for surgery. This randomized clinical trial included 18 soccer players diagnosed of proximal fifth metatarsal stress fracture, randomly matched in Surgery group and Shock Wave group. Patients of Surgery group were treated with intramedullary screw fixation; patients of Shock Wave group received 3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses. Patients of both groups were followed monthly until their return to play (RTP) using radiography, Visual Analogue Scale (VAS), Tegner Activity Level Scale and AOFAS score.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male soccer players, aged over 18 years.
- •Diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings
- •Fracture occurred during soccer practice
- •Informed consent signed
排除标准
- •To be under 18 years old
- •Traumatic fracture
- •Fracture occurred out of soccer practice
- •Patients with metatarsal shaft, neck or head fracture
- •Patients with contraindication to receive surgical treatment
- •Patients with contraindication to receive shock wave treatment
- •Patients that refuse the informed consent
结局指标
主要结局
Evaluation of X-Ray
时间窗: Follow up until recovery (maximum of 6 months)
X-Ray study
Period until return to play
时间窗: Follow up until recovery (maximum of 6 months)
When the patient can start the previous to injury activity
次要结局
- Evaluation of Visual Analogue Scale(Follow up until recovery (maximum of 6 months))
- American Orthopedic Foot and Ankle Score(Follow up until recovery (maximum of 6 months))
- Evaluation of Tegner activity scale(Follow up until recovery (maximum of 6 months))