Patellar Tendinopathy
Conditions
Keywords
Patellar Tendinopathy, Extracorporeal Shock Wave Therapy, Ultrasonography
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBTL-6000 FSWT
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.
Sponsors
University Hospital, Motol
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Patient is a recreational athlete performing intensive sport activity loading patellar tendon (running, jumping, strength training etc.) at least 3 days in a week for minimum of 1 hour per session, * is in age between 18-40 years, * has a patellar tendon pain, which limits (at least in part) the quality of normal daily or sports activities, * has clinical manifestation of patellar tendinopathy (pain and impaired function) confirmed by clinician, * has symptoms only in one leg, the other one is asymptomatic.
Exclusion criteria
* Any contraindication for ESWT is present (according to International Society for Medical Shockwave Treatment (ISMST) consensus at https://shockwavetherapy.org), * Patient is aware of any symptomatic mechanical tendon damage in the past (e.g., partial or complete rupture in relation to the injury), * neurological, oncological, or systemic disease (e.g., neuropathy, lupus or rheumatic arthritis) coexists, * is/was already treated for PT elsewhere (e.g., platelet-rich plasma therapy, physiotherapy) * is using blood thinning medications or statins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Spatial Frequency Radius at the Site of Pathology | 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. |
| Change in VISA-P Questionnaire Score | 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. |
| Change in P6 Parameter at the Site of Pathology | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tendon Diameter at the Place of Maximum Tendon Width | 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. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Healthy Tendon | Symptomatic Patellar Tendon (Patellar Tendinopathy) Treated by ESWT | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants | 42 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 9.1 | 29.8 years STANDARD_DEVIATION 9.1 | 29.8 years STANDARD_DEVIATION 9.1 |
| BMI | 24.2 kg/m2 STANDARD_DEVIATION 3.2 | 24.2 kg/m2 STANDARD_DEVIATION 3.2 | 24.2 kg/m2 STANDARD_DEVIATION 3.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Czechia | 21 participants | 21 participants | 42 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
| Symptom duration | 19.6 months STANDARD_DEVIATION 16.1 | 19.6 months STANDARD_DEVIATION 16.1 | 19.6 months STANDARD_DEVIATION 16.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
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.
Time frame: Change of initial values at 16 weeks follow up after beginning of the therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic Patellar Tendon Treated by ESWT - Baseline | Change in P6 Parameter at the Site of Pathology | 1.119 mm | Standard Deviation 0.022 |
| Symptomatic Patellar Tendon Treated With ESWT - Follow-up | Change in P6 Parameter at the Site of Pathology | 1.099 mm | Standard Deviation 0.022 |
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.
Time frame: Change of initial values at 16 weeks follow up after beginning of the therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic Patellar Tendon Treated by ESWT - Baseline | Change in Peak Spatial Frequency Radius at the Site of Pathology | 2.119 mm | Standard Deviation 0.148 |
| Symptomatic Patellar Tendon Treated With ESWT - Follow-up | Change in Peak Spatial Frequency Radius at the Site of Pathology | 2.234 mm | Standard Deviation 0.133 |
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.
Time frame: Change of initial values at 16 weeks follow up after beginning of the therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic Patellar Tendon Treated by ESWT - Baseline | Change in VISA-P Questionnaire Score | 68.4 score on a scale | Standard Deviation 8.2 |
| Symptomatic Patellar Tendon Treated With ESWT - Follow-up | Change in VISA-P Questionnaire Score | 83.3 score on a scale | Standard Deviation 7.1 |
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.
Time frame: Change of initial values at 16 weeks follow up after beginning of the therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symptomatic Patellar Tendon Treated by ESWT - Baseline | Change in Tendon Diameter at the Place of Maximum Tendon Width | 4.87 mm | Standard Deviation 0.74 |
| Symptomatic Patellar Tendon Treated With ESWT - Follow-up | Change in Tendon Diameter at the Place of Maximum Tendon Width | 4.40 mm | Standard Deviation 0.73 |