Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy

What this Trial Is About

Researchers are investigating how nutritional status and metabolic factors like obesity and diabetes affect the outcome of treating shoulder tendinopathy with blood-derived orthobiological therapy called Platelet Rich Growth Factors (PRGF). This observational study aims to identify how many patients respond to PRGF treatment at six months and how their nutrition relates to treatment success. The study also seeks to understand the characteristics of the PRGF product and its association with patient nutritional profiles. Participants will be adults aged 18 to 70 with shoulder tendinopathy who receive two PRGF injections: one at enrollment and a second 14 days later. The study divides patients into two groups based on body mass index (BMI): normal weight (BMI 18.5 to 25) and overweight (BMI over 25). Additional blood tests, food questionnaires, and measurements will evaluate nutritional status alongside clinical assessments over up to 24 months. During the study, researchers will track patient responses using various shoulder function and pain scores, blood tests including glucose and vitamin levels, and anthropometric measures such as waist and arm circumference. PRGF samples will be analyzed for biological markers linked to inflammation and nutrition. Follow-up assessments occur at 2, 6, 12, and up to 36 months to monitor outcomes and correlate these with nutritional and metabolic data, helping to identify ideal nutritional conditions for treatment success.

Nutrition Impact on PRGF Treatment for Tendinopathy