Evaluation of Platelet-Rich Plasma (PRP) Treatment in Tendinopathies

Condition(s) studied

Investigational drug(s) / intervention(s)

Platelet rich plasma (PRP): A minimal description of the standard PRP preparation and administration protocol will be included to document clinical variability and enable comparative analyses. Across all participating centers, the following variables will be systematically recorded: Type of PRP used (leukocyte-rich vs. leukocyte-poor), with standardized coding Preparation method (single vs. double centrifugation), including specification of the device used Injected volume Anatomical site and administration technique (ultrasound-guided whenever feasible) Number of treatment sessions and interval between sessions

Study summary

This multicenter, prospective, observational study, based on real-world evidence (RWE), aims to evaluate the efficacy and safety of Platelet-Rich Plasma (PRP) treatment across four types of tendinopathies: patellar, Achilles, epicondylar, and plantar fasciosis. Data collection and analysis will be conducted using the BioSmartData® platform, including hematology analyzers for PRP characterization, clinical variables, treatment protocols, and longitudinal assessment of therapeutic response.

Eligibility

Primary outcome measure(s)

• Visual Analog Scale — From baseline up to 12 months post-treatment
• VISA-P — baseline, 1 month, 3 months, 6 months and 12 months
  Change in pain and functional limitation assessed using the Victorian Institute of Sport Assessment-Patella (VISA-P) questionnaire. Scores range from 0 to 100, with higher scores indicating better function and lower pain levels.
• VISA-A — baseline, 1 month, 3 months, 6 months and 12 months
  The VISA-A is an eight item questionnaire measures Achilles tendon pain and function, with scores ranging from 0 to 100 (higher scores indicating better function).
• Patient Rated Tennis Elbow Evaluation Scale — baseline, 1 month, 3 months, 6 months and 12 months
  The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item self-report questionnaire designed to measure pain and functional disability in patients with lateral epicondylitis (tennis elbow). It includes a 5-item pain subscale and a 10-item function subscale, providing a total score out of 100 to assess, evaluate, and monitor recovery.
• Foot Function Index — baseline, 1 month, 3 months, 6 months and 12 months
  The Foot Function Index (FFI) is a 23-item, self-administered questionnaire designed to measure the impact of foot pathology on function, assessing pain, disability, and activity limitation. It uses a 0-10 Likert scale for items within three subscales, with higher total percentages (0-100%) indicating greater, more severe pain and dysfunction.

Trial sites (5)

Other trials for the same condition