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

NCT ID: NCT06102421

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-04-10

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

BTL-6000 FSWT

Intervention Type: 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.

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: lead

Responsible Party

Stanislav Machač, Ph.D

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanislav Machac, PhD

Role: STUDY_CHAIR

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

Locations

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

Prague, , Czechia

Countries

Czechia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EK-980/23

Identifier Type: -

Identifier Source: org_study_id