RecruitingNCT06536582

Nutrition Impact on PRGF Treatment for Tendinopathy

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

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

52 participants

Start Date

Feb 15, 2024

Study Type

OBSERVATIONAL

Conditions

Shoulder tendinopathy Metabolic Alterations

Summary

Given the close correlation reported in the literature between onset and progression of tendon pathology in subjects affected by the alteration of metabolic disorders such as obesity, diabetes mellitus and lipidic metabolic alterations, with the present study the association between the nutritional state, metabolic profile and clinical outcome of patients following treatment with blood-derived orthobiological for shoulder tendinopathies will be evaluated. The primary aim of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with "Platelet rich growth factors" PRGF at six months follow up and the correlation with their nutritional status.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

Male and female
Age ≥18 years and ≤ 70 years
Patients presenting shoulder tendinopathy
Signing of the Informed Consent of the Regain observational study
Signature of informed consent of the present study.

Exclusion Criteria5

Pregnancy (ascertained by self-declaration), breastfeeding
Inability to follow the study protocol
Heart, kidney, oncological disease
Neuropsychiatric disease
Other conditions that, at the discretion of the investigator or physician, exclude enrollement

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Interventions

BIOLOGICALPlatelet rich growth factor injection (autologous product)

All patients will undergo two PRGF injections, one at recruitment and one 14 days after the first injection. The injection site will be the shoulder with tendinopathy.