Nutrition Impact on PRGF Treatment for Tendinopathy
NCT Number: NCT06536582
Acronym: NUTRITENDON
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Shoulder Tendinopathy|Metabolic Alterations
Interventions: BIOLOGICAL: Platelet rich growth factor injection (autologous product)
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 52
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-02-15
Completion Date: 2027-02-15
Locations: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, Milan, 20173, Italy

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.

Primary Outcome Measures: Responder and non-responder patient identification at 6 months follow-up., 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., 0-24 months|Identification of nutritional status of responder and non-responder patients: complete blood count, Complete blood count (cell number/dl), 0-24 months|Identification of nutritional status of responder and non-responder patients: blood glucose, Blood glucose (mg/dl), 0-24 months|Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c), Hemoglobin A1C (HbA1c): mmol/mol, 0-24 months|Identification of nutritional status of responder and non-responder patients: urea, Urea: mg/dl, 0-24 months|Identification of nutritional status of responder and non-responder patients: creatinine, Creatinine: mg/dl, 0-24 months|Identification of nutritional status of responder and non-responder patients: siderosis, siderosis: ug/dl, 0-24 months|Identification of nutritional status of responder and non-responder patients: tryglicerides, tryglicerides (mg/dl), 0-24 months|Identification of nutritional status of responder and non-responder patients: cholesterol, Cholesterol (mg/dl), 0-24 months|Identification of nutritional status of responder and non-responder patients: Cholesterol HDL, Cholesterol HDL (mg/dl), 0-24 months|Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase, Glutamate-oxaloacetate transaminase: (U/l), 0-24 months|Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase, Glutamate-pyruvate transaminase: (U/l), 0-24 months|Identification of nutritional status of responder and non-responder patients: gamma GT, Gamma GT: U/l, 0-24 months|Identification of nutritional status of responder and non-responder patients: calcium, Calcium: mg/dl, 0-24 months|Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH), Vitamin D (25 OH): ng/ml, 0-24 months|Identification of nutritional status of responder and non-responder patients: ferritin, Ferritin (ng/ml), 0-24 months|Identification of nutritional status of responder and non-responder patients:, C reactive protein: (mg/dl), 0-24 months|Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH), thyroid stimulating hormone (TSH): uIU/ml, 0-24 months|Identification of nutritional status of responder and non-responder patients: Insulin, Insulin: uU/ml, 0-24 months|Identification of nutritional status of responder and non-responder patients: Folates, Folates (ng/ml), 0-24 months|Identification of nutritional status of responder and non-responder patients: vitamin B 12, Vitamin B 12 (pg/ml), 0-24 months|Anthropometric measurement: weight, weight (kg) measurement, 0-24 months|Anthropometric measurement: height, height (m) measurement, 0-24 months|Anthropometric measurement: waist circumference, waist circumference (cm) measurement, 0-24 months|Anthropometric measurement: arm circumference measurements, arm circumference measurements (cm), 0-24 months|Anthropometric measurement: biceps folds measurement, biceps folds measurement (mm), 0-24 months|Anthropometric measurement: triceps folds measurement, triceps folds measurement (mm), 0-24 months|Anthropometric measurement: subscapular folds measurement, subscapular folds measurement (mm), 0-24 months|Anthropometric measurement: suprailiac folds measurement, suprailiac folds measurement (mm), 0-24 months
Secondary Outcome Measures: Responder and non-responder patient identification at 2 months follow-up., The secondary objectives of the study will be:

to Identify the proportion of patients with shoulder tendinopathy responsive and non-responsive to treatment with orthobiological "Platelet rich growth factors" PRGF at two months follow up. For this purpose, responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI scores, WOOS, and Work index., 2-26 months|Responder and non-responder patient identification at 12 months follow-up., The secondary objectives of the study will be:

to Identify the proportion of patients with shoulder tendinopathy responsive and non-responsive to treatment with orthobiological "Platelet rich growth factors" PRGF at twelve months follow up. For this purpose, responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI scores, WOOS, and Work index., 12-36 months|The Platelet rich growth factors "PRGF" product used for the treatment of each patient will be characterizated: extracellular vesicles count, extracellular vesicles count: number/ml, 24-26 months|The PRGF product used for the treatment of each patient will be characterizated: extracellular vesicles marker quantification, Identification of extracellular vesicles markers: Arbitrary Fluorescence Unit, 24-26 months|The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of cytokines: CXCL8, Quantitative analysis of cytokines (CXCL8): pg/ml, 24-26 months|The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of growth factors: G-CSF, Quantitative analysis of growth factors: G-CSF (pg/ml), 24-26 months|The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of resistin, Quantitative analysis of resistin: pg/ml, 24-26 months|The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of P-selectin, Quantitative analysis of P-selectin: pg/ml, 24-26 months
Other Outcome Measures: VAS, VAS: Visual analogue scales for grading of pain. The VAS ranges from 0 (no pain) to 10 (worst pain) ((consists of a 10 cm line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain)), 2-36 months|ASES SCORE, ASES (American Shoulder and Elbow Surgeons) Score: ASES score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function, 2-36 months|Quick Dash Score, Quick Dash (Disabilities of Arm, Shoulder and Hand) score. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment., 2-36 months|SPADI scores, SPADI (Shoulder Pain and Disability Index) scores. It evaluates pain and functional activities. Pain scale: 0 = no pain and 10 = the worst pain imaginable. Disability scale: 0 = no difficulty and 10 = so difficult it requires help. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst)., 2-36 months|WOOS Index, WOOS (Western Ontario Osteoarthritis of the Shoulder) index. 0% is the worst possible result and 100% is the best possible results., 2-36 months|WORC Index, The WORC (Western Ontario Rotator Cuff) Index, is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a RC tendinopathy.

Total final WORC scores can, therefore, range from 0% (lowest functional status level) to 100% (the highest functional status), 2-36 months