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

Patellar Tendinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05423366
• Other study ID #: University of Van YüzüncüYil
• Status: Completed
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: December 19, 2022

Study information

• Verified date: January 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 19, 2022
• Est. primary completion date: November 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patellar Tendinitis
• Tendinopathy

Intervention

Device:
• Extracorporeal Shock Wave Therapy (ESWT)
The ESWT device is product of Elettronica Pagani, Italy.

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse	at baseline.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.