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NCT Number: NCT06102421

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.

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Key information

Conditions

Patellar Tendinopathy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Prague, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

  2. Change in VISA-P Questionnaire Score

    Time frame: 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.

  3. Change in P6 Parameter at the Site of Pathology

    Time frame: 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.

Secondary outcomes

  1. Change in Tendon Diameter at the Place of Maximum Tendon Width

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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