Its purpose was to evaluate the feasibility of i ultrasonography US and range of motion ROM parameters as objective measurements to correlate the improvement of knee mobility with its pain reduction; ii the planned recruitment monthly rate to estimate the resources for the main study.
This open-label pilot trial was performed in an orthopedic clinic Timisoara, Romania.
Exclusion criteria osteoarthritis guidelines inflammatory arthritic condition; oral corticosteroids within 4 weeks; intra-articular injections of HA or corticosteroids within 3 months; anti-inflammatory osteoarthritis guidelines chondroprotective drugs within 2 weeks. Following protocol, 8 patients administered for 8 weeks Syalox® Plus River Pharma, Italy a product based on HA of high molecular weight.
US parameters improved from baseline, even if no statistically significant differences were found. ROM and VAS at rest, on moving and on pressing values improved significantly at week 4 and 8 in comparison with baseline.
The correlation between objective improvement of knee mobility and subjective pain reduction was documented. The KOOS subscales scores evidenced statistically significant differences during the study. No adverse event.
US and ROM can be used as objective measurements to correlate improvement of knee mobility with pain reduction. The recruitment capability evidenced a realistic estimation of time and budget for the main study. Keywords: Pilot trial; feasibility study; knee osteoarthritis; hyaluronic acid; outcome assessment Issue:Volume 70, Issue 9 Pages: