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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
Full description
Primary Objective To analyze the effect of Focused Shockwave Treatment in acute indirect hamstring injuries in soccer players.
Secondary Objectives
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).
ii. Masking Procedures: The participants will be blinded to the type of ESWT treatment and the assessor, data managers, statistician and study monitors will be blinded to the allocation. All participants who receive ESWT treatment will be treated using the same device (Duolith® SD-1 STORZ Medical, Switzerland) regardless of what group they are included in. The participants will not be able to predict the allocated group based on the appearance of the ESWT treatment. The blinding will be maintained until the data are locked. For blinding evaluation, allocation guessing will be assessed immediately after the final treatment. Practitioners and assessors will be instructed to treat the participants according to predefined standard operating procedures during the trial to maintain blinding.
MATERIAL AND METHOD Study intervention
Soccer players suffering from indirect acute hamstring injury, will be selected for this study, sign up for an informed consent form, informed about the details of the procedure and the potential risks before treatment and randomized into 2 treatment groups:
All treatments will be performed by the senior authors. In all cases, a focused electromagnetic shockwave device will be used (Duolith® SD-1, STORZ Medical, Switzerland).
The procedure will be performed with the patient in lateral positioning of the decubitus pronus. The treatment area will be prepared with a coupling ultrasound gel to minimize the loss of shockwave energy at the interface between the tip of the applicator and the skin. The inline ultrasonic guide will be used to concentrate the shockwaves on the injury area in the muscle. No local anesthesia will be applied.
STUDY EVALUATIONS Injury size: Evaluation of the three major diameters of the lesion. Grade of repair process (A,B,C,D): 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.
Visual Analogue Scale (VAS): 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.
Lower Extremity Functional Scale (LEFS): 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.
Tegner activity scale: 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 Roles and Maudsley scale: 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.
Likert scale (1-6): 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.
Return to play: Return to Play is the process of deciding when an injured or ill athlete may safely return to practice or competition.
ETHICS/PROTECTION OF HUMAN SUBJECTS
The study monitor or other authorized representatives of the sponsor may inspect all study documents and records required to be maintained by the investigator, including but not limited to the medical records of the study subjects. The clinical study site will permit access to such records.
DATA HANDLING AND RECORD KEEPING The investigator will be responsible for the completeness, accuracy and timeliness of the data reported. All source documents should be completed in a neat, legible manner to ensure the accurate interpretation of data. The Investigator is required to verify the data transcribed onto the database.
The study monitors then have to check the database against the source documents for accuracy and validity as per the monitoring schedule, as applicable.
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60 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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