Abstract

Purpose: We conducted post-hoc analyses of OA patients in the Hyalgan® Use in Painful Shoulder (HUPS) Study to investigate application of the OMERACT-OARSI treatment response criteria to these findings, reported previously. To our knowledge this is the first application of these criteria to hyaluronan use in patients with pain associated with OA of the shoulder. Methods: We investigated application of Proposition D of the OMERACT-OARSI criteria to both pain on movement (100-mm VAS, n=286) and night pain (n=285) in OA patients from the HUPS ITT population. Patients who received either 3 or 5 weekly injections of sodium hyaluronate (HYL) were pooled for this analysis and compared to those who received 5 weekly injections of phosphate-buffered saline (PBS). For both of these pain parameters, the Shoulder Rating Questionnaire (SRQ) daily activities scale served as the function domain, and SRQ VAS served as the global assessment domain. Both the 2and 3-level responder definitions were used. Results: For VAS pain on movement (HYL, n=192; PBS, n=94), HYL patients demonstrated greater treatment response than PBS in both the 2-level (131/192, 68% vs. 50/94, 53%) and 3level (high responder, 100/192 [52%] vs. 32/94 [34%]; moderate responder, 31/192 [16%] vs. 18/94 [19%]) responder definitions. These results were consistent for VAS night pain in both the 2-level and 3-level responder definitions. Conclusions: Our application of the OMERACT-OARSI treatment responder criteria to the HUPS study further support the effectiveness of HYL in patients suffering from pain on movement and/or night pain associated with OA of the shoulder.

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