Patellar Tendinopathy (Refractory Cases)
Conditions
Interventions
Extracorporeal shock wave therapy ESWT was administered using a diffuse type shock wave device PHYSIO SHOCKMASTER Sakai Medical Japan. Shock waves were delivered to the affected patellar tendon at
Sponsors
Nippon Sport Science University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion must meet all of the following criteria: Competitive athletes aged 18 to 50 years Diagnosis of chronic patellar tendinopathy with symptoms persisting for 3 months or longer and refractory to prior conservative treatment, including physiotherapy or exercise based rehabilitation Presence of localized tenderness at the inferior pole of the patella or pain during active knee extension At least one imaging abnormality consistent with chronic patellar tendinopathy identified on MRI or ultrasonography, including tendon thickening, hypoechoic regions, or intratendinous hyperintensity on STIR sequences Ability to provide written informed consent after receiving a full explanation of the study
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: Presence of systemic disease that may affect tendon healing, including diabetes mellitus, rheumatoid arthritis, active infection, coagulopathy, immunosuppression, hemoglobin level less than 11 g per dL, or platelet count less than 150000 per mm3 Current treatment with antiplatelet agents or anticoagulant therapy History of intra articular steroid injection or knee surgery within the past 3 months Use of nonsteroidal anti inflammatory drugs within 5 days prior to treatment Pregnancy Malignant tumor Known allergy to local anesthetics Presence of other knee disorders that may influence clinical outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the change in the Victorian Institute of Sport Assessment Patella (VISAP) score from baseline to 24 weeks after completion of treatment. The VISAP score is a validated patient-reported outcome measure specific to patellar tendinopathy that assesses pain, functional limitations in daily activities, and sport-related performance. Assessments will be conducted at baseline and at 4, 8, 12, and 24 weeks following the final treatment session. The primary endpoint is defined as the change in VISAP score between baseline and 24 weeks. To provide a comprehensive assessment of functional recovery, additional patient reported outcome measures, including the visual analog scale (VAS) for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, and Lysholm score, will be collected at the same time points and analyzed as supportive measures to the primary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include pain intensity, knee functional outcomes, imaging findings, and return-to-sport status. Pain intensity will be assessed using the visual analog scale (VAS) at baseline and at 4, 8, 12, and 24 weeks following completion of treatment. Knee functional outcomes will be evaluated using the Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, and Lysholm score at the same assessment time points to analyze longitudinal functional changes. Structural tendon changes will be assessed using magnetic resonance imaging (MRI) with short tau inversion recovery (STIR) sequences, measuring lesion length on sagittal images and lesion width and thickness on axial images. Ultrasonographic evaluation will include measurement of hypoechoic lesion area and assessment of intratendinous vascularity using color Doppler imaging. Imaging assessments will be performed at baseline, 12 weeks, and 24 weeks. Return-to-sport outcomes will be evaluated at the final 6-month follow-up using a self-reported questionnaire assessing return to sport participation, return to pre-injury performance level, presence of pain during sport activity, and recurrence. | — |
Countries
Japan
Contacts
Public ContactYUKI SHIMIZU
Nippon Sport Science University Faculty of Health and Medical Sciences
Outcome results
None listed