Obtain real world, post market data to confirm the clinical improvement and safety in patients treated with a single injection of MONOVISC for the symptomatic relief of osteoarthritis in the shoulder joint.
The goal of this study is to demonstrate the clinical improvement and safety in patients treated with MONOVISC for shoulder osteoarthritis. Specifically, this study will provide confirmation to the effectiveness and safety of MONOVISC at relieving shoulder joint pain to 6 months post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A chemically cross-linked sodium hyaluronate supplied as a 4 mL unit dose in a 5 mL glass syringe.
Krajská zdravotní, a.s.
Ústí nad Labem, Czechia
Nzoz Medi-Spatz
Gliwice, Poland
SPORTO
Lodz, Poland
Przychodnia Rodzinna na Sadowej
Torun, Poland
Numerical Rating Scale (NRS) Pain
Mean change in Numerical Rating Scale (NRS) Pain in the Index Shoulder from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
Time frame: From Baseline to 6 Months
Disabilities of Arm, Shoulder & Hand (DASH) Index
Mean change in the Index Shoulder Disabilities of the Arm, Shoulder and Hand (DASH) Index from baseline to 6 months post injection. The DASH Index is a 30-item self-reported questionnaire on pain and function in which the response options are presented as 5-point Likert scales. Scores for each question range from 0=(no pain or disability) to 100=(most severe pain or disability) and are averaged to calculate the final DASH Index score. A negative value for the change in DASH Index score indicates improvement. A larger negative value indicates a higher level of improvement, and a better clinical outcome.
Time frame: From Baseline to 6 Months
Patient Global Assessment (PGA) Score
Mean change from baseline to 6 months in Index Shoulder pain post treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) shoulder is bothering them today . The PGA Score is a validated 11-point Likert scale from 0=No Pain to 10=Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.
Time frame: From Baseline to 6 Months
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
The post-treatment responder rate at 6 months as determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding to treatment indicates better clinical outcomes.
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Time frame: 6 Months
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)
The usage of Rescue Medication (RM) at 6 months post treatment as based on the number of participants that were NOT using acetaminophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.
Time frame: 6 Months