Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology

Patellar Tendinopathy Clinical Trial

Official title:

Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06102421
• Other study ID #: EK-980/23
• Status: Enrolling by invitation
• Start date: May 1, 2023
• Est. completion date: April 10, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 (AT) will be monitored on its micromorphology. It is estimated that at least 20 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.

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 (AT) will be monitored on its micromorphology. It is estimated that at least 20 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: April 10, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• the patient shows symptoms of Patellar tendinopathy (pain, swelling and dysfunction in the area of Patellar tendon), which at least partially limit his quality of life during normal or sporting activities,

• the patient is in the age group of 18-40 years,

• the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,

• the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),

• the patient has not undergone any treatment aimed at Patellar tendon in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.)

• objective US examination of Patellar tendon shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).

Exclusion Criteria:

• patient has been diagnosed with a rheumatic disease or a disease of the central nervous system

• patient has any condition which is contraindication for ESWT application

• patient is aware of mechanical damage to the Patellar tendon as a result of an injury in the past.

Related Conditions & MeSH terms

• Patellar Tendinopathy
• Tendinopathy

Intervention

Device:
• BTL-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.

Locations

Country	Name	City	State
Czechia	University Hospital Motol and 2nd Faculty of Medicine, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Spatial Frequency Radius at the site of Pathology	Measured by spatial frequency analysis software from ultrasound picture in mm-1. 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.
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.	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 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.
Secondary	Change in Tendon Diameter at the Place of Maximum Tendon Width	Measured by tools in ultrasound machine in mm2. 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.