Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies

Launched by I.R.C.C.S. FONDAZIONE SANTA LUCIA · Apr 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for shoulder pain caused by rotator cuff tendinopathy, which is a condition affecting the shoulder tendons. The researchers want to see if taking an oral supplement that contains Collagen, Hyaluronic Acid, Vitamin C, and Manganese is as effective as receiving injections of hyaluronic acid directly into the shoulder joint. To participate in the trial, individuals must have had persistent shoulder pain for at least two months that hasn't improved with other treatments like anti-inflammatory medications or physical therapy. They should also have evidence of a rotator cuff issue from imaging tests, but not a complete tendon rupture.

Participants will receive an injection of a corticosteroid medication to help with pain and inflammation and will then be divided into two groups. One group will take the oral supplement daily for 56 days, while the other group will receive three injections of hyaluronic acid over the same period. Throughout the trial, researchers will assess pain levels and shoulder function at several points to see how well each treatment works. This study aims to provide better options for individuals struggling with shoulder pain, especially if previous treatments haven't helped.

Gender

ALL

Eligibility 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