Comparing oral supplements to hyaluronic acid injections for shoulder pain
Efficacy of Oral Hyaluronic Acid and Collagen Supplementation Compared With Hyaluronic Acid Infiltration Treatment in Rotator Cuff Tendinopathies: A Prospective Study
This study is testing whether taking a daily oral supplement or getting hyaluronic acid injections is better for relieving shoulder pain and improving movement in people with rotator cuff tendinopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06379997 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an oral nutraceutical supplement containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in improving functional outcomes and reducing pain in patients with rotator cuff tendinopathy. Participants will receive an initial intra-articular injection of triamcinolone acetonide and will then be divided into two groups: one will take the oral supplement daily for 56 days, while the other will receive a series of hyaluronic acid injections. The study aims to determine which treatment provides better relief from shoulder pain and improves mobility.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing persistent shoulder pain for at least 2 months with ultrasound or MRI evidence of rotator cuff lesions.
Not a fit: Patients with traumatic shoulder injuries, severe arthrosis, or those who have had recent corticosteroid or hyaluronic acid treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a non-invasive treatment option for patients suffering from rotator cuff tendinopathy.
How similar studies have performed: Other studies have shown promising results with similar nutraceutical approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persistent shoulder pain lasting for at least 2 months unresponsive to conservative treatment (nonsteroidal anti-inflammatory drugs \[NSAIDs\] and rehabilitation) * Ultrasound or MRI evidence of a rotator cuff lesion without complete tendon rupture * Limited active range of motion (ROM) in the shoulder Exclusion Criteria: * Traumatic shoulder injury as the cause of pain * History of shoulder dislocation, fracture, or previous shoulder surgery * Presence of signs indicating ligamentous instability * Severe shoulder arthrosis, adhesive capsulitis, or calcific tendinitis * Previous infiltrative treatment with corticosteroids, hyaluronic acid, or collagen within the past 6 months * Diagnosis of rheumatic or neoplastic diseases * Ongoing therapy with anticoagulants * Cervical radiculopathy * Pregnancy * History of heart, kidney, or liver failure * Cognitive impairment
Where this trial is running
Roma, RM
- I.R.C.C.S. Fondazione Santa Lucia — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Brunelli, MD
- Email: s.brunelli@hsantalucia.it
- Phone: 0651501844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.