NCT06102421

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: University Hospital, Motol · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patellar Tendinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-02-25
• Completion: 2024-04-10
• First posted: 2023-10-26
• Last updated: 2025-05-01
• Results posted: 2025-04-11

Locations

1 site across 1 country: Czechia