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Focused Shockwave Treatment in the Recovery Process of Acute Muscle Injuries in Soccer Players

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ClinicalTrials.gov Identifier: NCT04123782
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Garcia Cugat

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Muscle Injury Device: F-ESW Treatment Device: Placebo F-ESW Treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Focused Shockwave Treatment in the Recovery Process of Acute Muscle Injuries in Soccer Players
Actual Study Start Date : June 29, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : November 15, 2019

Arm Intervention/treatment
Active Comparator: 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)
Device: F-ESW Treatment
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).

Placebo Comparator: Group B (placebo group)
3 sessions, one per week, of electromagnetic focused extracorporeal shockwave treatment (3000 impulses at 0.01 mJ/mm2 per session)
Device: Placebo F-ESW Treatment
Very low concentration of F-ESW.




Primary Outcome Measures :
  1. Ultrasound evaluation of the injury size [ Time Frame: Weekly until recovery (maximum of 10 weeks) ]
    Evaluation of the three major diameters of the lesion.

  2. Ultrasound evaluation of the injury size [ Time Frame: 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.

  3. Return to play period [ Time Frame: 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.


Secondary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: Weekly until recovery (maximum of 10 weeks) ]
    The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain. The VAS provides a continuous scale for magnitude estimation and consists of a straight line, the ends of which are defined in terms of the extreme limits of pain experience. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain experienced. This gives the greatest freedom to choose pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.

  2. Lower Extremity Functional Scale [ Time Frame: Weekly until recovery (maximum of 10 weeks) ]
    The Lower Extremity Functional Scale (LEFS) is a sensitive and reliable outcome measure that has commonly been used in patients with hip and knee dysfunction. The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.

  3. Tegner activity scale [ Time Frame: Weekly until recovery (maximum of 10 weeks) ]
    Tegner activity level scale is a graduated list of activities of daily living, recreation and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity (before injury). The score varies from 0-10. A score of 0 represents sick leave or disability pension, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6. Score can only be achieved if the person participates in recreational or competitive sport.

  4. Roles and Maudsley scale [ Time Frame: Weekly until recovery (maximum of 10 weeks) ]
    The RM scale is a subjective 4-point patient assessment of pain and limitations of activity. The RM score has been used extensively at centers throughout the world to assess outcome after SWT. On the scale, 1 point indicates an excellent result with the patient having no symptoms. Two points indicate a good result with the patient significantly improved from the pretreatment condition and satisfied with the result. Three points indicate a fair result with the patient somewhat improved from the pretreatment condition and partially satisfied with the treatment outcome. Four points indicate a poor outcome with symptoms identical or worse than the pretreatment condition and dissatisfaction with the treatment result.

  5. Likert scale [ Time Frame: Weekly until recovery (maximum of 10 weeks) ]
    Degree of recovery compared with baseline, measured on a 6-point Likert scale (completely recovered to much worse). Success rates will be calculated by dichotomizing responses. Subjects who will report themselves completely recovered or much improved will be counted as successes, and subjects who will report themselves somewhat improved, same, worse, or much worse will be counted as failures.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123782


Contacts
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Contact: Silvia Ramón 669404974 sramon@comb.cat
Contact: Patricia Laiz 637075327 patricia.laiz.boada@gmail.com

Locations
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Spain
Fundacion Garcia Cugat Recruiting
Barcelona, Spain, 08023
Contact: Montserrat Garcia Balletbo    +34 93 217 22 52    montse.garcia@sportrauma.com   
Sponsors and Collaborators
Fundación Garcia Cugat
Investigators
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Study Chair: Montse Garcia Fundación García Cugat

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Responsible Party: Fundación Garcia Cugat
ClinicalTrials.gov Identifier: NCT04123782     History of Changes
Other Study ID Numbers: REHAB-2019-01
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Wounds and Injuries