N/A
N=42
Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology
Patellar Tendinopathy
Bottom Line
View on ClinicalTrials.gov: NCT06102421 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Peak Spatial Frequency Radius at the Site of Pathology — 2.119; 2.234 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- BTL-6000 FSWT (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Motol
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Spatial Frequency Radius at the Site of Pathology |
2.119; 2.234 | — |
| PRIMARY Change in VISA-P Questionnaire Score |
68.4; 83.3 | — |
| PRIMARY Change in P6 Parameter at the Site of Pathology |
1.119; 1.099 | — |
| SECONDARY Change in Tendon Diameter at the Place of Maximum Tendon Width |
4.87; 4.40 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT06102421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.