Back to resultsComparative Effects of Focused and Unfocused (Radial) ESWT in the Treatment of Patellar Tendinopathy.
Primary Purpose
Patellar Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy (ESWT)
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Tendinitis
Eligibility Criteria
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
Sites / Locations
- Yuzuncu Yil University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
Large-Focused Extracorporeal Shock Wave Therapy
Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy
Sham Extracorporeal Shock Wave Therapy
Arm Description
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05423366
Brief Title
Comparative Effects of Focused and Unfocused (Radial) ESWT in the Treatment of Patellar Tendinopathy.
Official Title
Comparative Effects of Large Focused and Controlled Unfocused (Radial) Extracorporeal Shock Wave Therapies in the Treatment of Patellar Tendinopathy.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2022 (Actual)
Primary Completion Date
November 28, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Large-Focused Extracorporeal Shock Wave Therapy
Arm Type
Active Comparator
Arm Title
Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy
Arm Type
Active Comparator
Arm Title
Sham Extracorporeal Shock Wave Therapy
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy (ESWT)
Intervention Description
The ESWT device is product of Elettronica Pagani, Italy.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Time Frame
at baseline.
Title
Visual Analogue Scale (VAS)
Description
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Time Frame
3 weeks after baseline.
Title
Visual Analogue Scale (VAS)
Description
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Time Frame
7 weeks after baseline.
Title
Visual Analogue Scale (VAS)
Description
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Time Frame
15 weeks after baseline.
Title
Victorian Institute of Sports Assessment-Patella (VISA-P)
Description
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.
Time Frame
at baseline.
Title
Victorian Institute of Sports Assessment-Patella (VISA-P)
Description
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.
Time Frame
3 weeks after baseline.
Title
Victorian Institute of Sports Assessment-Patella (VISA-P)
Description
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.
Time Frame
7 weeks after baseline.
Title
Victorian Institute of Sports Assessment-Patella (VISA-P)
Description
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.
Time Frame
15 weeks after baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Şah
Organizational Affiliation
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuzuncu Yil University
City
Van
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effects of Focused and Unfocused (Radial) ESWT in the Treatment of Patellar Tendinopathy.
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