Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology

Study Overview
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Brief Summary
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This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (AT) will be monitored on its micromorphology. It is estimated that at least 20 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes.

Detailed Description
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This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (AT) will be monitored on its micromorphology. It is estimated that at least 20 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes. The research within one patient will last a total of 16 weeks from the initial to the final examination. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software.

Official Title
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Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology

Conditions
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Patellar Tendinopathy

Intervention / Treatment
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* Device: BTL-6000 FSWT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patient shows symptoms of Patellar tendinopathy (pain, swelling and dysfunction in the area of Patellar tendon), which at least partially limit his quality of life during normal or sporting activities, the patient is in the age group of 18-40 years, the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference, the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury), the patient has not undergone any treatment aimed at Patellar tendon in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.) objective US examination of Patellar tendon shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.). Exclusion Criteria: patient has been diagnosed with a rheumatic disease or a disease of the central nervous system patient has any condition which is contraindication for ESWT application patient is aware of mechanical damage to the Patellar tendon as a result of an injury in the past.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focused shockwave therapy<br>Participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 6 Hz, total number of shocks 2x1800. The application of the first set of shocks will be semi-static at the location of the largest USG finding in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines. | Device: BTL-6000 FSWT<br>* The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 6 Hz, total number of shocks 2x1800. The application of the first set of shocks will be semi-static at the location of the largest USG finding in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. In total, it will be applied 4 times with an interval of 7 days.<br>|
| No Intervention: Healthy tendon<br>The asymptomatic tendon is allocated to this group and is considered healthy based on subjective judgment followed by clinical and ultrasound examination of the Patellar tendon. In this group, no specific treatment will be performed, only Patellar tendon morphology will be monitored through time. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak Spatial Frequency Radius at the site of Pathology | Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter. | Change of initial values at 16 weeks follow up after beginning of the therapy. | 
| Change in VISA-P Questionnaire Score | The VISA-P questionnaire is standardized questionnaire for patients with Patellar tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition. | Change of initial values at 16 weeks follow up after beginning of the therapy. | 
| Change in P6 parameter at the site of Pathology | Measured by spatial frequency analysis software from ultrasound picture. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the P6 parameter. | Change of initial values at 16 weeks follow up after beginning of the therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tendon Diameter at the Place of Maximum Tendon Width | Measured by tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools. | Change of initial values at 16 weeks follow up after beginning of the therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patellar Tendinopathy, Extracorporeal Shock Wave Therapy, Ultrasonography