Clinical trial NCT06102421: Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology
Official title: Evaluation of the Effectiveness of Extracorporeal Shockwave Therapy in Patients With Patellar Tendinopathy on Its Micromorphology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellar Tendinopathy
Keywords: Patellar Tendinopathy
Extracorporeal Shock Wave Therapy
Ultrasonography
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The monitored population are patients suffering from symptomatic, unilateral, recently untreated patellar tendinopathy lasting at least 3 months, age between 18 - 40 years. They were not diagnosed with a rheumatic, neurological or oncological disease and have no contraindication for ESWT.

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.

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.

Primary outcomes:
measure: 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.
measure: Change in VISA-P Questionnaire Score
timeFrame: Change of initial values at 16 weeks follow up after beginning of the therapy.
measure: Change in P6 Parameter at the Site of Pathology
timeFrame: Change of initial values at 16 weeks follow up after beginning of the therapy.
Secondary outcomes:
measure: Change in Tendon Diameter at the Place of Maximum Tendon Width
timeFrame: Change of initial values at 16 weeks follow up after beginning of the therapy.
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol and 2nd Faculty of Medicine, Charles University
Study officials:
affiliation: University Hospital Motol and 2nd Faculty of Medicine, Charles University
name: Stanislav Machac, PhD
role: STUDY_CHAIR
References: