Effect of subacromial sodium hyaluronate injection on rotator cuff disease: A double-blind placebo-controlled clinical trial.
Alireza Moghtaderi, Sepideh Sajadiyeh, Saeid Khosrawi...
https://pubmed.ncbi.nlm.nih.gov/24524035/Actively Recruiting
Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2024-08-29
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are investigating the effectiveness of an oral supplement containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese compared to intra-articular hyaluronic acid injections for adults with shoulder rotator cuff tendinopathy. This condition causes shoulder pain and functional impairment, often due to degenerative changes in tendon structure. The study aims to see if the oral supplement can reduce pain and improve shoulder function as well as the injected treatment. The study includes 50 adults with persistent shoulder pain and imaging evidence of rotator cuff tendinopathy. All participants receive one corticosteroid injection triamcinolone acetonide 40 mg. They are then randomly assigned to either take one vial per day of the oral supplement for 56 days or receive three weekly intra-articular injections of hyaluronic acid. The oral supplement group starts the treatment the day after enrollment, while the injection group receives treatments without ultrasound guidance. Participants will be assessed at four time points before corticosteroid injection baseline, seven days after starting oral supplementation or before the first hyaluronic acid injection, mid-cycle of oral treatment or seven days after the last injection, and at the end of the 56-day oral cycle or 28 days after the last injection. Pain is measured using the Numeric Rating Scale NRS for pain at rest, during movement, and at night. Shoulder function is evaluated with the Shoulder Disability Questionnaire SDQ. Safety and side effects will be recorded throughout the study.
CONDITIONS
Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies
S
Stefano Brunelli, MD
N
Noemi Gentileschi, MD
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I.R.C.C.S. Fondazione Santa Lucia
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive either daily oral supplementation with Collagen, Hyaluronic Acid, Vitamin C, and Manganese for 56 days, or three weekly intra-articular hyaluronic acid injections over 3 weeks.
3 weekly visits for injections or daily oral supplement intake with follow-up assessments
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor