Trial Outcomes & Findings for Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology (NCT NCT06102421)
NCT ID: NCT06102421
Last Updated: 2025-05-01
Results Overview
Measured by spatial frequency analysis software from ultrasound picture in mm. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
Recruitment status
COMPLETED
Target enrollment
42 participants
Primary outcome timeframe
Change of initial values at 16 weeks follow up after beginning of the therapy.
Results posted on
2025-05-01
Participant Flow
Participant milestones
| Measure |
Symptomatic Patellar Tendon (Patellar Tendinopathy) Treated by ESWT
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
Healthy Tendon
The asymptomatic tendons of enrolled patient are allocated to this group and are considered healthy based on clinical and ultrasound examination of the patellar tendon.
In this group, no specific treatment will be performed, only patellar tendon morphology will be monitored through time.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Symptomatic Patellar Tendon (Patellar Tendinopathy) Treated by ESWT
n=21 Participants
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
Healthy Tendon
n=21 Participants
The asymptomatic tendons of enrolled patient are allocated to this group and are considered healthy based on clinical and ultrasound examination of the patellar tendon.
In this group, no specific treatment will be performed, only patellar tendon morphology will be monitored through time.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=21 Participants
|
21 Participants
n=21 Participants
|
42 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=21 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
29.8 years
STANDARD_DEVIATION 9.1 • n=21 Participants
|
29.8 years
STANDARD_DEVIATION 9.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=21 Participants
|
5 Participants
n=21 Participants
|
10 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=21 Participants
|
16 Participants
n=21 Participants
|
32 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Czechia
|
21 participants
n=21 Participants
|
21 participants
n=21 Participants
|
42 participants
n=42 Participants
|
|
BMI
|
24.2 kg/m2
STANDARD_DEVIATION 3.2 • n=21 Participants
|
24.2 kg/m2
STANDARD_DEVIATION 3.2 • n=21 Participants
|
24.2 kg/m2
STANDARD_DEVIATION 3.2 • n=42 Participants
|
|
Symptom duration
|
19.6 months
STANDARD_DEVIATION 16.1 • n=21 Participants
|
19.6 months
STANDARD_DEVIATION 16.1 • n=21 Participants
|
19.6 months
STANDARD_DEVIATION 16.1 • n=42 Participants
|
PRIMARY outcome
Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.Measured by spatial frequency analysis software from ultrasound picture in mm. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.
Outcome measures
| Measure |
Symptomatic Patellar Tendon Treated by ESWT - Baseline
n=21 Participants
Baseline values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
Symptomatic Patellar Tendon Treated With ESWT - Follow-up
n=21 Participants
Follow-up values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
|---|---|---|
|
Change in Peak Spatial Frequency Radius at the Site of Pathology
|
2.119 mm
Standard Deviation 0.148
|
2.234 mm
Standard Deviation 0.133
|
PRIMARY outcome
Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.The VISA-P questionnaire is standardized questionnaire for patients with Patellar tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
Outcome measures
| Measure |
Symptomatic Patellar Tendon Treated by ESWT - Baseline
n=21 Participants
Baseline values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
Symptomatic Patellar Tendon Treated With ESWT - Follow-up
n=21 Participants
Follow-up values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
|---|---|---|
|
Change in VISA-P Questionnaire Score
|
68.4 score on a scale
Standard Deviation 8.2
|
83.3 score on a scale
Standard Deviation 7.1
|
PRIMARY outcome
Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.Measured by spatial frequency analysis software from ultrasound picture in mm. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the P6 parameter.
Outcome measures
| Measure |
Symptomatic Patellar Tendon Treated by ESWT - Baseline
n=21 Participants
Baseline values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
Symptomatic Patellar Tendon Treated With ESWT - Follow-up
n=21 Participants
Follow-up values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
|---|---|---|
|
Change in P6 Parameter at the Site of Pathology
|
1.119 mm
Standard Deviation 0.022
|
1.099 mm
Standard Deviation 0.022
|
SECONDARY outcome
Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.Measured by tools in ultrasound machine in mm. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.
Outcome measures
| Measure |
Symptomatic Patellar Tendon Treated by ESWT - Baseline
n=21 Participants
Baseline values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
Symptomatic Patellar Tendon Treated With ESWT - Follow-up
n=21 Participants
Follow-up values
The included patients show signs of unilateral patellar tendinopathy and were included in the study in accordance with the inclusion and exclusion parameters. Data of clinical symptoms and morphological measures of symptomatic patellar tendons of enrolled participants are allocated to this group. Participants will receive a low-energy focused ESWT in accordance with study protocol.
ESWT will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. The energy can vary between 0.12-0.20 mJ/mm2 based on the pain toleration, frequency 5 Hz, total number of shocks 2x2000. The application of the first set of shocks will be semi-static at the location of the largest USG defined pathology in the patellar tendon and the second set of shocks will be performed dynamically to the proximal tendon. These parameters were selected in accordance to ISMST guidelines.
|
|---|---|---|
|
Change in Tendon Diameter at the Place of Maximum Tendon Width
|
4.87 mm
Standard Deviation 0.74
|
4.40 mm
Standard Deviation 0.73
|
Adverse Events
Symptomatic Patellar Tendon (Patellar Tendinopathy) Treated by ESWT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Tendon
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mgr. Jakub Katolicky
Second Faculty of Medicine, Charles University
Phone: +420702088258
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place