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

University Hospital, Motol

Status: Completed

Conditions: Patellar Tendinopathy

Treatments: Device: BTL-6000 FSWT

Study type: Observational

Funder types: Other

Identifiers

NCT06102421

EK-980/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

Symptomatic patellar tendon (patellar tendinopathy) treated by ESWT

Description:

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.

Treatment:

Device: BTL-6000 FSWT

Healthy tendon

Description:

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.