Nutrition Impact on PRGF Treatment for Tendinopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

Platelet 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.

Study 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

Primary outcome measure(s)

• Responder and non-responder patient identification at 6 months follow-up. — 0-24 months
  The primary objective of this study is to identify the proportion of responder and non-responder patients with shoulder tendinopathy to treatment with orthobiological "Platelet rich growth factors" PRGF at six month follow up. Responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI, WOOS scores, and Work index.
• Identification of nutritional status of responder and non-responder patients: complete blood count — 0-24 months
  Complete blood count (cell number/dl)
• Identification of nutritional status of responder and non-responder patients: blood glucose — 0-24 months
  Blood glucose (mg/dl)
• Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c) — 0-24 months
  Hemoglobin A1C (HbA1c): mmol/mol
• Identification of nutritional status of responder and non-responder patients: urea — 0-24 months
  Urea: mg/dl
• Identification of nutritional status of responder and non-responder patients: creatinine — 0-24 months
  Creatinine: mg/dl
• Identification of nutritional status of responder and non-responder patients: siderosis — 0-24 months
  siderosis: ug/dl
• Identification of nutritional status of responder and non-responder patients: tryglicerides — 0-24 months
  tryglicerides (mg/dl)
• Identification of nutritional status of responder and non-responder patients: cholesterol — 0-24 months
  Cholesterol (mg/dl)
• Identification of nutritional status of responder and non-responder patients: Cholesterol HDL — 0-24 months
  Cholesterol HDL (mg/dl)
• Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase — 0-24 months
  Glutamate-oxaloacetate transaminase: (U/l)
• Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase — 0-24 months
  Glutamate-pyruvate transaminase: (U/l)
• Identification of nutritional status of responder and non-responder patients: gamma GT — 0-24 months
  Gamma GT: U/l
• Identification of nutritional status of responder and non-responder patients: calcium — 0-24 months
  Calcium: mg/dl
• Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH) — 0-24 months
  Vitamin D (25 OH): ng/ml
• Identification of nutritional status of responder and non-responder patients: ferritin — 0-24 months
  Ferritin (ng/ml)
• Identification of nutritional status of responder and non-responder patients: — 0-24 months
  C reactive protein: (mg/dl)
• Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH) — 0-24 months
  thyroid stimulating hormone (TSH): uIU/ml
• Identification of nutritional status of responder and non-responder patients: Insulin — 0-24 months
  Insulin: uU/ml
• Identification of nutritional status of responder and non-responder patients: Folates — 0-24 months
  Folates (ng/ml)
• Identification of nutritional status of responder and non-responder patients: vitamin B 12 — 0-24 months
  Vitamin B 12 (pg/ml)
• Anthropometric measurement: weight — 0-24 months
  weight (kg) measurement
• Anthropometric measurement: height — 0-24 months
  height (m) measurement
• Anthropometric measurement: waist circumference — 0-24 months
  waist circumference (cm) measurement
• Anthropometric measurement: arm circumference measurements — 0-24 months
  arm circumference measurements (cm)
• Anthropometric measurement: biceps folds measurement — 0-24 months
  biceps folds measurement (mm)
• Anthropometric measurement: triceps folds measurement — 0-24 months
  triceps folds measurement (mm)
• Anthropometric measurement: subscapular folds measurement — 0-24 months
  subscapular folds measurement (mm)
• Anthropometric measurement: suprailiac folds measurement — 0-24 months
  suprailiac folds measurement (mm)

Trial sites (1)

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