Multicentre, independent assessment study on SYNOLIS VA 40/80 over a period of 24 weeks
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Three 2mL injections of SYNOLIS VA 40/80, one week apart
SPORTO oddzial na ulicy Miedzianej
Lodz, Poland
SPORTO oddzial na ulicy Książka (2nd site location)
Lodz, Poland
Carolina Medical Center
Warsaw, Poland
Difference in total Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit.
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Time frame: 168 days
Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis (WOMAC) pain severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Time frame: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) functional severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Time frame: up to 168 days
Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) stiffness severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
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Time frame: up to 168 days
Pain at walking on a 100 mm VAS
Time frame: up to 168 days
Percentage of subjects using analgesics
New NSAID / analgesics drugs usage
Time frame: up to 168 days
Measurement of relief satisfaction by the patient
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Time frame: 168 days
Measurement of therapeutic efficacy by the investigator (assessor)
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Time frame: 168 days