Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study.
Eric Noël, Philippe Hardy, Frank-Wolfgang Hagena...
https://pubmed.ncbi.nlm.nih.gov/19945321/Actively Recruiting
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-02-12
84
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are evaluating the pain relief effects of two types of shoulder joint injections for patients with moderate to severe osteoarthritis. The trial compares an injection called Cingal, which combines sodium hyaluronate and triamcinolone, against a standard cortisone injection containing triamcinolone. The study aims to determine if Cingal provides better pain control and functional improvement in the shoulder than cortisone alone. The study involves 84 patients randomly assigned to receive a single injection of either Cingal 4 mL, containing 88 mg of hyaluronic acid and 18 mg of triamcinolone hexacetonide or cortisone 40 mg of triamcinolone with 4 mL of bupivacaine 0.25%. Before treatment, all participants undergo shoulder X-rays and MRI scans. The injection is performed under fluoroscopy by a radiologist. After treatment, patients complete electronic questionnaires and maintain a medication diary at 1, 3, and 6 months. Participants will be monitored through pain assessments using the visual analogue scale VAS at 1, 3, and 6 months after injection, which is the primary outcome at 3 months. Functional ability is evaluated with QuickDash questionnaires at the same time points. Medical history, demographic data, and baseline questionnaires are collected before injection to measure changes over time. The study follows patients for six months to assess both pain relief and shoulder function after treatment.
CONDITIONS
Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
F
Fidaa Al-Shakfa, M.Sc, MBA
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single treatment visit
Participants receive a single shoulder infiltration injection of either Cingal (a combination of hyaluronic acid and triamcinolone hexacetonide) or cortisone (triamcinolone) under fluoroscopy.
1 treatment visit (in-person)
Duration - 6 months
Participants complete electronic questionnaires and maintain a medication diary to assess pain and functional abilities over time after the injection.
Questionnaires sent at 1, 3, and 6 months post-injection (remote)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Lead Sponsor