Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients
Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
single injection of 3ml
St. Michaels Hospital
Toronto, Ontario, Canada
Shoulder pain on movement (SPOM) 0-100mm VAS
Time frame: over 26 weeks
Shoulder pain at night (SPAN) 0-100mm VAS
Time frame: over 26 weeks
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form
Time frame: over 26 weeks
Patient Global Assessment (PGA)
Time frame: over 26 weeks
Shoulder pain rescue medication diary
Time frame: over 26 weeks
Adverse events, concomitant medications, physical exam
Time frame: over 26 weeks
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