Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060783) titled 'Clinical Study Evaluating the Effects of Platelet-Rich Plasma Therapy and Extracorporeal Shock Wave Therapy for Refractory Patellar Tendinopathy' on Feb. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Nippon Sport Science University

Condition: Condition - Patellar Tendinopathy (Refractory Cases) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to prospectively evaluate the effects of platelet-rich plasma (PRP) therapy, extracorporeal shock wave therapy (ESWT), and their combined application on clinical symptoms and tendon structural characteristics in athletes with refractory patellar tendinopathy.

This study aims to compare longitudinal changes in functional recovery and imaging outcomes among treatment groups and to explore whether the combined biological stimulation provided by PRP and mechanical stimulation induced by ESWT may be associated with treatment response and progression toward return to sport within a conservative treatment strategy. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 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 2500 shocks per session with a frequency of 8 Hz and pressure of 2.4 to 4.0 bar.

Treatment was performed once weekly for three sessions over 3 weeks.

All participants additionally underwent a standardized eccentric rehabilitation program throughout the intervention and follow up period.

The total observation period was 24 weeks. Interventions/Control_2 - Platelet-rich plasma (PRP) therapy was performed using autologous blood processed with the ACP double-syringe system (Arthrex Japan).

PRP was injected into the affected patellar tendon under ultrasound guidance. PRP injections were administered three times at 2 week intervals over a 6 week treatment period.

All participants performed a standardized eccentric rehabilitation program during the intervention and follow-up period. The total follow-up duration was 24 weeks.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key 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 Key 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 Target Size - 10

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2021 Year 04 Month 10 Day Date of IRB - 2021 Year 04 Month 16 Day Anticipated trial start date - 2021 Year 06 Month 02 Day Last follow-up date - 2026 Year 03 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069535

Disclaimer: Curated by HT Syndication.