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Compares treatment options for Tendinitis of Shoulder
Official title Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies
ClinicalTrials.gov ID: NCT06379997
What this study is testing
What is Intra-articular infiltration?
Intra-articular infiltration is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for tendinitis of shoulder.
Also referred to as Hyalotend.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- Persistent shoulder pain lasting for at least 2 months unresponsive to conservative treatment (nonsteroidal anti-inflammatory drugs [NSAIDs] and...
- Ultrasound or MRI evidence of a rotator cuff lesion without complete tendon rupture
- Limited active range of motion (ROM) in the shoulder
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Roma, RM, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, RM, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.