Patellar TendinitisNCT05423366
Comparative Effects of Focused and Unfocused (Radial) ESWT in the Treatment of Patellar Tendinopathy.
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Patellar Tendinitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellar Tendinitis
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2022to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Patellar Tendinitis
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy (ESWT)Device
The ESWT device is product of Elettronica Pagani, Italy.
| Study group | Role | What they receive |
|---|---|---|
| Large-Focused Extracorporeal Shock Wave Therapy | Active comparator | Not described Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy | Active comparator | Not described Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Sham Extracorporeal Shock Wave Therapy | Sham comparator | Not described Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Measured: at baseline.
Visual Analogue Scale (VAS)
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start16 Sep 2022
- Primary completion28 Nov 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
- Investigators
- Volkan Şah, Principal investigator, Yüzüncü Yıl Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423366
- Sponsor's protocol ID
- University of Van YüzüncüYıl
- Status last verified
- Jan 2023
- First submitted
- 14 Jun 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Large Focused and Controlled Unfocused (Radial) Extracorporeal Shock Wave Therapies in the Treatment of Patellar Tendinopathy.
- ClinicalTrials.gov ID
- NCT05423366
- Acronym / sponsor ID
- University of Van YüzüncüYıl
- Conditions
- Patellar Tendinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 28 Nov 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Large-Focused Extracorporeal Shock Wave Therapy | Active comparator | Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy | Active comparator | Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Sham Extracorporeal Shock Wave Therapy | Sham comparator | Device: Extracorporeal Shock Wave Therapy (ESWT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave Therapy (ESWT)The ESWT device is product of Elettronica Pagani, Italy. | Device | Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy, Large-Focused Extracorporeal Shock Wave Therapy, Sham Extracorporeal Shock Wave Therapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: at baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Visual Analogue Scale (VAS)
Time frame: 3 weeks after baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Visual Analogue Scale (VAS)
Time frame: 7 weeks after baseline.
patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse
Visual Analogue Scale (VAS)
Time frame: 15 weeks after baseline.
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)
Time frame: at baseline.
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)
Time frame: 3 weeks after baseline.
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)
Time frame: 7 weeks after baseline.
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)
Time frame: 15 weeks after baseline.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Patellar Tendinitis
Recruiting
Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk
Patellar Tendinitis, Jumper's Knee
Recruiting
Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendinitis
Shock Wave Threapy for Patellar Tendinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volkan Şah principal investigator
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Patellar Tendinitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: at baseline.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.