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

NCT04123782 | Completed DMC

• 1 other identifier: REHAB-2019-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Muscle Injury

Outcome Measures

Primary Outcomes (3)

• Ultrasound evaluation of the injury size

  Evaluation of the three major diameters of the lesion.

  Weekly until recovery (maximum of 10 weeks)

• Ultrasound evaluation of the injury size

  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.

  10 Weekly until recovery (maximum of 10 weeks)

• Return to play period

  Return to Play is the process of deciding when an injured or ill athlete may safely return to practice or competition.

  Weekly until recovery (maximum of 10 weeks)

Secondary Outcomes (5)

• Visual Analogue Scale

  Weekly until recovery (maximum of 10 weeks)

• Lower Extremity Functional Scale

  Weekly until recovery (maximum of 10 weeks)

• Tegner activity scale

  Weekly until recovery (maximum of 10 weeks)

• Roles and Maudsley scale

  Weekly until recovery (maximum of 10 weeks)

• Likert scale

  Weekly until recovery (maximum of 10 weeks)

Study Arms (2)

Group A (F-ESWT group)

ACTIVE COMPARATOR

3 sessions, one per week, of electromagnetic focused extracorporeal shockwave treatment (3000 impulses at 0.12 mJ/mm2 per session)

Device: F-ESW Treatment

Group B (placebo group)

PLACEBO COMPARATOR

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

Interventions

F-ESW Treatment DEVICE

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).

Group A (F-ESWT group)

Placebo F-ESW Treatment DEVICE

Very low concentration of F-ESW.

Group B (placebo group)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Garcia Cugat: lead

Study Sites (1)

Fundacion Garcia Cugat

Barcelona, 08023, Spain

Location

Study Officials

• Montse Garcia

  Fundación García Cugat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: October 11, 2019
• Study Start: June 29, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)