NCT06102421

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

Completed Results posted Last updated 1 May 2025

What this trial tests

trial testing BTL-6000 FSWT in Patellar Tendinopathy in 42 participants. Completed in 10 April 2024.

Timeline

1 May 2023

Primary endpoint
25 February 2024

10 April 2024

Quick facts

Lead sponsor	University Hospital, Motol
Status	Completed
Study type	OBSERVATIONAL
Enrollment	42
Start date	1 May 2023
Primary completion	25 February 2024
Estimated completion	10 April 2024
Sites	1 location across Czechia

Drugs / interventions tested

• BTL-6000 FSWT

Conditions studied

• Patellar Tendinopathy — all drugs for Patellar Tendinopathy →

Sponsor

University Hospital, Motol

Who can join

Adults 18 to 40, any sex, with Patellar Tendinopathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Peak Spatial Frequency Radius at the Site of Pathology Primary · 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.

Group	Value	95% CI
Symptomatic Patellar Tendon Treated by ESWT - Baseline	2.119	± 0.148
Symptomatic Patellar Tendon Treated With ESWT - Follow-up	2.234	± 0.133

Change in VISA-P Questionnaire Score Primary · 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.

Group	Value	95% CI
Symptomatic Patellar Tendon Treated by ESWT - Baseline	68.4	± 8.2
Symptomatic Patellar Tendon Treated by ESWT - Follow-up	83.3	± 7.1

Change in P6 Parameter at the Site of Pathology Primary · 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.

Group	Value	95% CI
Symptomatic Patellar Tendon Treated With ESWT - Baseline	1.119	± 0.022
Symptomatic Patellar Tendon Treated With ESWT - Follow-up	1.099	± 0.022

Change in Tendon Diameter at the Place of Maximum Tendon Width Secondary · 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.

Group	Value	95% CI
Symptomatic Patellar Tendon Treated by ESWT - Baseline	4.87	± 0.74
Symptomatic Patellar Tendon Treated by ESWT - Follow-up	4.40	± 0.73

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. ESWT is able to change macromorphological and micromorphological parameters in patellar tendinopathy: a prospective cohort study.
   Katolický J, Poklopová P, Bashford G, Katolická T, et al · · 2025 · cited 2× · PMID 40146243 · DOI 10.1097/js9.0000000000002351