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

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.

Study Overview

• Status: Completed
• Conditions: Patellar Tendinopathy
• Intervention / Treatment: Device: BTL-6000 FSWT

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.

• Study Type: Observational
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • University Hospital Motol and 2nd Faculty of Medicine, Charles University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University Hospital, Motol
• Investigators: Study Chair: Stanislav Machac, PhD, University Hospital Motol and 2nd Faculty of Medicine, Charles University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): February 25, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasonography; Extracorporeal Shock Wave Therapy; Patellar Tendinopathy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: EK-980/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No