Focused Shockwave Treatment in the Recovery Process of Acute Muscle Injuries in Soccer Players
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ultrasound evaluation of the injury size
研究概览
简要总结
The biological principles on which is based Focused Shockwave Treatment (F-ESWT) is has been demonstrated mostly in terms of improvement of Platelet Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor (FGF), Insulin Growth Factor-1 (IGF-1) and Transforming Growth Factor b1 (TGF-b1). Nevertheless, to date Focused Shockwave Treatment is not used in the treatment of acute pathologies and consequently in acute muscle lesion, despite there are no contra-indication in that sense. A recent study of Zissler et al. demonstrate how focused shockwave treatment induce an acceleration of the biological process of recovery during the acute phase of muscle injury in rats, and in 2016 Kisch et al. demonstrate that Focused ESWT enhances blood flow in the muscle of rats and repetitive ESWT extended this beneficial effect. The only clinical trial in humans about acute pathology in muscle was realized by Fleckenstein et al. in 2016, in which demonstrate that a single treatment with F-ESWT causes clinically relevant effects in the relief of pain, increase in force and improvement of pain-associated impairments of daily living in subjects affected by DOMS. However, there are no studies in humans that describe the effect of F-ESWT in muscle injuries. Considering the greater number of evidences about the biological effects of F-ESWT, namely anti-inflammation, neo-vascularization and tissue regeneration and their parallelism in many aspects with one of the most novelty treatment of muscle injuries, as for example the growth factors therapy, the hypothesis is to obtain favorable and better outcomes, both ultrasonographic and clinical, in subjects treated with F-ESWT than in subjects treated with standard treatments.
Study Hypothesis: The hypothesis of our study is that 3 sessions of focused shockwave treatment (1 per week), performed in acute phase of injury (≤ 2 weeks), a total of 3.000 shocks with an energy flux density of 0,12 mJ/mm2 at 5 Hz, can improve the recovery process of acute indirect hamstrings injuries, with results both clinical and ultrasonographic.
Primary Objective To analyze the effect of Focused Shockwave Treatment in acute indirect hamstring injuries in soccer players.
Secondary Objectives
- To analyze the effect of Focused Shockwave Treatment in acute indirect hamstring injuries in soccer players.
- To analyze prognostic factors (demographic, clinical, imaging variables).
详细描述
Primary Objective To analyze the effect of Focused Shockwave Treatment in acute indirect hamstring injuries in soccer players.
Secondary Objectives
- To analyze the effect of Focused Shockwave Treatment in acute indirect hamstring injuries in soccer players.
- To analyze prognostic factors (demographic, clinical, imaging variables). Study Outcome Measures Primary outcome: Repair process, injury size and Return to play Secondary outcomes: Functional scales: VAS, LEFS and Tegner Satisfaction scales: Roles and Maudsley and Likert scale
DESIGN This is a single blind randomized clinical trial that will be conducted in Quirónsalud Barcelona, Spain. The study will enroll patients suffering an acute indirect injury of common tendon of hamstrings, over a 5-months period. The duration of the trial will be of approximately 8 months. This protocol calls for 9 visits to be performed over a 8-weeks period for each patient (see flow-chart). As an intention-to-treat study, data analysis will be based on the randomization of the patients. At Visit 1 (screening visit; T0), patients will first need to provide written signed informed consent before any data is collected or procedures are performed. Then, patients will be screened for eligibility for the study by ascertaining that all inclusion criteria and no exclusion criteria are met. At V1, the Investigator will gather demographic and medical history data and will carry out clinical and ultrasonographic evaluation. The treatment period will consist of three sessions of ESWT, performed one week apart and within 2 weeks from the day of injury. Clinical and ultrasonographic data will continue to be collected during a follow-up period consisting of 9 visits, one per week and performed starting at 1 week from visit 1 (V1;T0). The last follow-up visit will performed at 10 weeks from visit 1 (V1;T0).
Treatment Assignment Procedures i. Randomization Procedures: We will use block randomization, which is commonly used in the two treatment situations where the samples of the two treatments must be equal or equally equal. The process will involve recruiting participants in short blocks and ensuring that half of the participants within each block are assigned to "A" and the other half to "B". Within each block, however, the order of patients will be random. They will be considered blocks of four dimensions: 1. AABB, 2. ABAB, 3. ABBA, 4. BAAB, 5. BABA, 6. BBAA. We will randomly select between these six different blocks for each group of four recruited participants. The random selection will be done using a list of random numbers generated using statistical software (Excel).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years old
- •Informed consent signed
- •Soccer injury
- •Diagnosis of acute indirect common tendon of the hamstring injury
- •Time of diagnosis < 2 weeks after the injury
- •Time to receive the first session of F-ESWT protocol ≤ 2 weeks after the injury
排除标准
- •1 Age < 18 years
- •Direct hamstring injury
- •Time of diagnosis ≥ 2 weeks after the injury
- •Chronic injury or re-injury in the homolateral hamstrings
- •Presence of hematoma in the context of the injury
- •Injury in a different area than common tendon of the hamstring
- •Tumor in the area to be treated
- •Wound in the area to be treated
- •Anti-inflammatory medication after the injury and/or during the period of treatment
- •Coagulation disorders or anticoagulant therapy
- •Local infection
- •Pregnancy
研究组 & 干预措施
Group A (F-ESWT group)
3 sessions, one per week, of electromagnetic focused extracorporeal shockwave treatment (3000 impulses at 0.12 mJ/mm2 per session)
干预措施: F-ESW Treatment (Device)
Group B (placebo group)
3 sessions, one per week, of electromagnetic focused extracorporeal shockwave treatment (3000 impulses at 0.01 mJ/mm2 per session)
干预措施: Placebo F-ESW Treatment (Device)
结局指标
主要结局
Ultrasound evaluation of the injury size
时间窗: 10 Weekly until recovery (maximum of 10 weeks)
Evaluation of the repair process with stages from A to D, where A represented the absence of repair, B a start in the repair process with less than 50 % scar tissue, C advanced repair process with more than 50 % repaired tissue and stage D when complete repair was observed.
Return to play period
时间窗: Weekly until recovery (maximum of 10 weeks)
Return to Play is the process of deciding when an injured or ill athlete may safely return to practice or competition.
Ultrasound evaluation of the injury size
时间窗: Weekly until recovery (maximum of 10 weeks)
Evaluation of the three major diameters of the lesion.
次要结局
- Tegner activity scale(Weekly until recovery (maximum of 10 weeks))
- Roles and Maudsley scale(Weekly until recovery (maximum of 10 weeks))
- Visual Analogue Scale(Weekly until recovery (maximum of 10 weeks))
- Lower Extremity Functional Scale(Weekly until recovery (maximum of 10 weeks))
- Likert scale(Weekly until recovery (maximum of 10 weeks))