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临床试验/NCT03473899
NCT03473899Unknown不适用

A Prospective, Randomized, Double-blind, Placebo Controlled Single Centre Trial to Assess the Efficacy and Safety of rESWT Combined With a Specific Rehabilitation Program for Acute Hamstring Muscle Complex Injury Type 3b in Athletes

Kinef Kinesiología Deportiva2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Individual time (days) necessary to return to play.

研究概览

简要总结

This study tests the hypothesis that the combination of radial extracorporeal shock wave therapy performed with the Swiss DolorClast device (Electro Medical Systems, Nyon, Switzerland) and a specific rehabilitation program (hereafter, "rESWT + RP") is effective and safe in treatment of acute hamstring muscle complex injury Type 3b, and is statistically significantly more effective than the combination of sham-rESWT and RP (hereafter, "sham-rESWT + RP").

详细描述

Acute injuries of the hamstring muscle complex (HMC) are frequently observed in various sports disciplines both in elite and recreational sport, and are the most common injury in soccer. Despite intensive research into prevention and management of acute HMC injury during the last decade epidemiological data show no decline in injury and re-injury rates. In this regard a recent study prospectively observed 374 Danish elite soccer players during a 12-month period and registered 46 first-time and eight recurrent HMC injuries (incidence rates: 12.3% [first-time injuries] and 2% [recurrent injuries]). Statistically significantly more players experienced a first-time acute HMC injury during a match than during training. Moreover, among 32 players who suffered from acute HMC injury in a period of 12 months before the study, eight players incurred an injury that fulfilled the criteria for a recurrent injury (incidence: 25%). Approximately two thirds of the first-time injuries were categorized as moderate, with time to return to play between 8 to 28 days.

Anatomical and functional aspects of the HMC predispose it to injury, including the fact that the muscles cross two joints and undergo eccentric contraction during the gait and running cycle.

Acute HMC injury typically occurs through an eccentric mechanism at the terminal stages of the swing phase of running. The long head of the biceps femoris (LHBF) muscle is most commonly affected, and within the LHBF muscle, the proximal myotendinous junction and proximal locations are most commonly affected.

The diagnosis of acute HMC injury is based on the presence of acute-onset pain in the posterior thigh, and presence of the triad of pain on contraction, stretching and palpation. Imaging has a role in confirming the site of injury and characterizing its extent, providing some prognostic information and helping plan treatment. In this regard both magnetic resonance imaging (MRI) and ultrasonography (US) have been shown to be effective for identification of hamstring strains and tendinopathy. Both MRI and US provide detailed information about the HMC with respect to localization and characterization of injury. Several clinical, MRI and US determinants were established that are associated with a longer recovery time in nonoperative management of acute HMC injury. However, it is important to realize that for an individual HMC injury none of these MRI and US determinants show a direct correlation with the time to return to play. Accordingly, the prognosis of HMC injuries should not be guided by imaging findings alone.

Precise classification of acute HMC injury has important implications for treatment and prognosis (i.e., time to return to play), as outlined in detail below. There are anatomical differences between a Type 3a injury (minor partial muscle tear ≤ 5 mm; intrafascicle/bundle-tear) and a Type 3b injury (moderate partial muscle tear > 5 mm; interfascicle/bundle-tear).

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 (Participant, Outcomes Assessor)

盲法说明

A medical assistant at the clinic of the Principal Investigator will allocate interventions by means of opaque sealed envelopes that will be marked according to the allocation schedule. The medical assistant will be unaware of the size of the blocks.

The randomized intervention assignment as outlined above will be concealed from both patients and health care staff until recruitment will be complete and irrevocable.

Patients will be blinded in this study. The assessor will be blinded in this study. The assessor is the person who will assess the outcome of treatment during follow up. In this study, the assessor will be a medical assistant at the clinic of the Principal Investigator.

The therapist will not be blinded in this study. The therapist is the person who will administer either rESWT or sham-rESWT to the patient. In this study, the therapist will be the Principal Investigator.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (both male and female) with clinical and ultrasonographic diagnosis of acute HMC injury Type 3b
  • Age range: between 18 and 35 years
  • Physical conditions for rehabilitation (i.e., no surgery required)
  • Willingness of the patient to participate in the study, and written informed consent signed and personally dated by the patient
  • No contraindications for rESWT

排除标准

  • Children and teenagers below the age of 18
  • Adults aged >35 years old
  • Patients with clinical and ultrasonographic diagnosis of acute HMC injury Type 3b who got injured more than seven days before potential enrollment into this study
  • Patients with clinical and ultrasonographic diagnosis of acute HMC injury Type 3A or Type 4
  • Bilateral acute HMC injury (Types 3A, 3B or 4)
  • Proven or suspected HMC injury (Types 3A, 3B or 4) of the same lower limb in the time period of six months before potential enrollment into this study
  • Muscle injury caused by external impact on the back of the affected thigh
  • Surgery on the affected lower limb in the time period of one year before potential enrollment into this study
  • Acute or chronic lumbar pathology (because some cases of thigh pain may relate to spinal pathology)
  • No willingness of the patient to participate in this study, and/or written informed consent not signed and not personally dated by the patient
  • Contraindications of rESWT, i.e., treatment of pregnant patients, treatment of patients with blood-clotting disorders (including local thrombosis), treatment of patients treated with oral anticoagulants, treatment of patients with local bacterial and/or viral infections/inflammations, treatment of patients with local tumors, and treatment of patients treated with local corticosteroid applications in the time period of six weeks before the first rESWT session (if applicable).

研究组 & 干预措施

rESWT + RP

Active Comparator

Device: rESWT

干预措施: rESWT (Device)

sham-rESWT + RP

Placebo Comparator

Device: sham-rESWT

干预措施: Sham-rESWT (Device)

结局指标

主要结局

Individual time (days) necessary to return to play.

时间窗: From date of randomization until the date of return to play, up to six months

Individual treatment success is defined as the possibility to return to play, fulfilling all criteria specified by Van de Horst et al. (Sports Med 2016;46(6):899-912). Accodingly, the primary outcome measure is the number of days until "yes" (return to play possible according to the criteria established by Van de Horst et al., 2016) will be achieved.

次要结局

  • Individual patient's satisfaction(Six months after randomization)
  • Presence or absence of re-injury(From date of randomization up to six months)

研究者

发起方
Kinef Kinesiología Deportiva
申办方类型
Other
责任方
Sponsor

研究点 (2)

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