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This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (PT) will be monitored on its micromorphology. It is estimated that at least 21 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes.
This work is designed as a prospective cohort study, in which the effects of low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Patellar tendinopathy (PT) will be monitored on its micromorphology. It is estimated that at least 21 patients will participate. In addition, there will be a small control group of healthy tendons which will be monitored to observe magnitude of natural changes.
The research within one patient will last a total of 16 weeks from the initial to the final examination. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-6000 FSWT | Device | Low-energy focused extracorporeal shockwave therapy 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Spatial Frequency Radius at the Site of Pathology | 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. | Change of initial values at 16 weeks follow up after beginning of the therapy. |
| Change in VISA-P Questionnaire Score | 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. | Change of initial values at 16 weeks follow up after beginning of the therapy. |
| Change in P6 Parameter at the Site of Pathology | 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. | Change of initial values at 16 weeks follow up after beginning of the therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tendon Diameter at the Place of Maximum Tendon Width | 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. | Change of initial values at 16 weeks follow up after beginning of the therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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The monitored population are patients suffering from symptomatic, unilateral, recently untreated patellar tendinopathy lasting at least 3 months, age between 18 - 40 years. They were not diagnosed with a rheumatic, neurological or oncological disease and have no contraindication for ESWT.
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| Name | Affiliation | Role |
|---|---|---|
| Stanislav Machac, PhD | University Hospital Motol and 2nd Faculty of Medicine, Charles University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Motol and 2nd Faculty of Medicine, Charles University | Prague | Czechia |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Peak Spatial Frequency Radius at the Site of Pathology | 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. | Posted | Mean | Standard Deviation | mm | Change of initial values at 16 weeks follow up after beginning of the therapy. |
|
16 weeks
No adverse effects (serious or others) were reported during treatment, after treatment and also during follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mgr. Jakub Katolicky | Second Faculty of Medicine, Charles University | +420702088258 | jakubkatolicky@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2023 | Jun 14, 2024 | Prot_SAP_000.pdf |
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|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Symptom duration | Mean | Standard Deviation | months |
|
| OG001 | Symptomatic Patellar Tendon Treated With ESWT - Follow-up | 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. |
|
|
| Primary | Change in VISA-P Questionnaire Score | 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. | Posted | Mean | Standard Deviation | score on a scale | Change of initial values at 16 weeks follow up after beginning of the therapy. |
|
|
|
| Primary | Change in P6 Parameter at the Site of Pathology | 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. | Posted | Mean | Standard Deviation | mm | Change of initial values at 16 weeks follow up after beginning of the therapy. |
|
|
|
| Secondary | Change in Tendon Diameter at the Place of Maximum Tendon Width | 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. | Posted | Mean | Standard Deviation | mm | Change of initial values at 16 weeks follow up after beginning of the therapy. |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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