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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Patellar Tendinitis
• Intervention / Treatment: Device: Extracorporeal Shock Wave Therapy (ESWT)

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey
    • Yuzuncu Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2022
• Primary Completion (Anticipated): November 28, 2022
• Study Completion (Anticipated): December 19, 2022

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: University of Van YüzüncüYıl

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No