Nutrition Impact on PRGF Treatment for Tendinopathy

ConditionsShoulder Tendinopathy Metabolic Alterations

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-70

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

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Male and female

Age ≥18 years and ≤ 70 years

Patients presenting shoulder tendinopathy

Signing of the Informed Consent of the Regain observational study

Disqualifiers

Pregnancy (ascertained by self-declaration), breastfeeding

Inability to follow the study protocol

Heart, kidney, oncological disease

Neuropsychiatric disease

Trial population

Male and female patients, between 18 and 70 years old suffering from shoulder tendinopathy undergoing a conservative regenerative medicine procedure with autologous PRGF at the IRCCS Galeazzi-Sant'Ambrogio Hospital of Milan and participants at the observational study "Use of patients- Reported Outcome Measures (PROM), objective clinical assessments and biomolecular technologies for monitoring patients undergoing treatments regenerative medicine" \[REGAIN\] will be enrolled for this study. 46 patients will be needed: 1. 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF; 2. 23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI\>25, who undergo the PRGF treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Platelet rich growth factor injection (autologous product)
Biological/Vaccine
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.

Treatment groups

52 Participants

are divided into 2 treatment groups

Group A: Normal weight patients1 intervention

Group B: Over weight patients1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

0-24 months

Identification of nutritional status of responder and non-responder patients: complete blood count

Complete blood count (cell number/dl)

Time frame

0-24 months

Identification of nutritional status of responder and non-responder patients: blood glucose

Blood glucose (mg/dl)

Time frame

0-24 months

Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c)

Hemoglobin A1C (HbA1c): mmol/mol

Time frame

0-24 months

Secondary outcomes

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.

Time frame

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.

Time frame

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

Time frame

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

Time frame

24-26 months

Other outcomes

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))

Time frame

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

Time frame

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.

Time frame

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).

Time frame

2-36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

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