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

NCT06102421 | Completed Results

• 1 other identifier: EK-980/23
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinopathy

Keywords

Patellar Tendinopathy; Extracorporeal Shock Wave Therapy; Ultrasonography

Outcome Measures

Primary Outcomes (3)

• 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 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 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 Outcomes (1)

• 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.

Study Arms (2)

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

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.

Interventions

BTL-6000 FSWT DEVICE

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.

Symptomatic patellar tendon (patellar tendinopathy) treated by ESWT

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

University Hospital Motol and 2nd Faculty of Medicine, Charles University

Prague, Czechia

Location

Results Point of Contact

• Title: Mgr. Jakub Katolicky
• Organization: Second Faculty of Medicine, Charles University

jakubkatolicky@gmail.com

+420702088258

Study Officials

• Stanislav Machac, PhD

  University Hospital Motol and 2nd Faculty of Medicine, Charles University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: May 1, 2023
• Primary Completion: February 25, 2024
• Study Completion: April 10, 2024
• Last Updated: May 1, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-04

Locations

CZ (1)