Evaluating how nutrition affects treatment outcomes for shoulder tendinopathy
Official title: Nutrition as a Risk Factor and Predictor of Treatment Outcome With Plasma Rich Growth Factors for Shoulder Tendinopathy
Run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT06536582 · Data updated 2026-11-12
This study is trying to see how nutrition affects the success of a treatment for shoulder tendinopathy using platelet-rich growth factors in people with different body weights.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | February 15, 2024 |
| Main results expected | August 15, 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | August 5, 2024 |
| Trial ID | NCT06536582 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 18 to 70 with shoulder tendinopathy who are undergoing PRGF treatment.
✕Probably not a fit
Patients with significant comorbidities such as heart, kidney, or oncological diseases, as well as those unable to follow the study protocol, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the relationship between nutritional status and clinical outcomes in patients with shoulder tendinopathy treated with platelet-rich growth factors (PRGF). It will involve additional procedures such as blood sampling, food questionnaires, and anthropometric measurements to evaluate the nutritional profile of participants. The study will enroll 46 patients, divided into two groups based on their body mass index (BMI), to determine the proportion of responders and non-responders to the PRGF treatment at a six-month follow-up.
Why it matters
Potential benefit: If successful, this study could help identify optimal nutritional conditions that enhance the effectiveness of PRGF treatment for shoulder tendinopathy.
How similar studies have gone: While the correlation between nutrition and treatment outcomes in tendinopathy is explored in literature, this specific approach using PRGF and nutritional assessment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Milan, Italy Recruiting
Study contacts
- Study coordinator: Paola De Luca, PhD
- Email: deluca.paola@grupposandonato.it
- Phone: +39 3921385179
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.