Comparative Effects of Focused and Unfocused (Radial) ESWT in the Treatment of Patellar Tendinopathy.

Study Overview
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Brief Summary
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There is no scientific study in the literature regarding the use of different extracorporeal shock wave therapies (ESWT) in the treatment of patellar tendinopathy. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in the treatment of patellar tendinopathy.

Official Title
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Comparative Effects of Large Focused and Controlled Unfocused (Radial) Extracorporeal Shock Wave Therapies in the Treatment of Patellar Tendinopathy.

Conditions
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Patellar Tendinitis

Intervention / Treatment
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* Device: Extracorporeal Shock Wave Therapy (ESWT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Engaging in active sports, being 18 years or older, history of activity-related knee pain in the patellar tendon or patellar insertion, symptoms lasting longer than 8 weeks (non-acute), VISA-P score less than 80 before treatment, pain during knee loading on tendon or tendon it remains isolated in the limited part of the bone junction and does not spread to the entire patellar region (to differentiate patellar tendinopathy and patellofemoral pain). Exclusion Criteria: Being under the age of 18, acute knee or acute patellar tendon injury, chronic inflammatory joint diseases (rheumatoid arthritis, etc.), using immunosuppressive or corticosteroid medication in the last 6 months, previous knee surgery (in the anterior cruciate ligament or patellar tendon), knee in the last 1 month local (corticosteroid) injection, contraindications for ESWT treatment (eg pregnancy, malignancy, coagulopathy), previous ESWT treatment

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Large-Focused Extracorporeal Shock Wave Therapy<br> | Device: Extracorporeal Shock Wave Therapy (ESWT)<br>* The ESWT device is product of Elettronica Pagani, Italy.<br>|
| Active Comparator: Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy<br> | Device: Extracorporeal Shock Wave Therapy (ESWT)<br>* The ESWT device is product of Elettronica Pagani, Italy.<br>|
| Sham Comparator: Sham Extracorporeal Shock Wave Therapy<br> | Device: Extracorporeal Shock Wave Therapy (ESWT)<br>* The ESWT device is product of Elettronica Pagani, Italy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse | at baseline. | 
| Visual Analogue Scale (VAS) | patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse | 3 weeks after baseline. | 
| Visual Analogue Scale (VAS) | patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse | 7 weeks after baseline. | 
| Visual Analogue Scale (VAS) | patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse | 15 weeks after baseline. | 
| Victorian Institute of Sports Assessment-Patella (VISA-P) | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy. | at baseline. | 
| Victorian Institute of Sports Assessment-Patella (VISA-P) | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy. | 3 weeks after baseline. | 
| Victorian Institute of Sports Assessment-Patella (VISA-P) | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy. | 7 weeks after baseline. | 
| Victorian Institute of Sports Assessment-Patella (VISA-P) | The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy. | 15 weeks after baseline. |