Condition: Tendinitis of Shoulder · Hyaluronic Acid · Dietary Supplements · Sponsor: I.R.C.C.S. Fondazione Santa Lucia
The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections. The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2). The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality. Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used: Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain …
This description comes directly from the study's public registry record.
Stefano Brunelli, MD · 0651501844 · s.brunelli@hsantalucia.it
Noemi Gentileschi, MD · 0651501845 · n.gentileschi@hsantalucia.it
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| I.R.C.C.S. Fondazione Santa Lucia | Roma, RM, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06379997