CompletedNot Applicable

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

Czechia42 participantsStarted 2023-05-01

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Peak Spatial Frequency Radius at the Site of Pathology

Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.

Change in VISA-P Questionnaire Score

Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.

Change in P6 Parameter at the Site of Pathology

Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.

Trial details

NCT IDNCT06102421

SponsorUniversity Hospital, Motol

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-25

Results submitted2024-09-16

View on ClinicalTrials.gov More Patellar Tendinopathy trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Peak Spatial Frequency Radius at the Site of Pathology

Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.

Change in VISA-P Questionnaire Score

Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.

Change in P6 Parameter at the Site of Pathology

Timeframe: Change of initial values at 16 weeks follow up after beginning of the therapy.