4.5. Statistical Analysis
NRS, Pain, pain
The statistical analysis of the collected data was performed using the statistical package R 3.5.2 (R foundation, Vienna, Austria). Descriptive analyses were generated for the demographic and clinical variables of the two arms.Categorical variables were summarized using frequency and percentage. Continuous variables were summarized using mean, median standard deviation, minimum, and maximum. To assure that randomization was successful, the following tests were conducted: (1) age and baseline WOMAC Pain comparisons of OT and HA groups by using two-tailed independent sample The primary outcome of this study was the change in the WOMAC LK 3.1 pain score (from baseline to 6 months post-injection). A 2-tailed independent sample Subject-reported outcome measures: WOMAC LK 3.1, KOOS, and NRS Pain were summarized and thoroughly characterized with appropriate descriptive statistics including error measures. Categorical variables were summarized using frequency and percentage. Continuous variables were summarized using mean, median standard deviation, minimum, and maximum.The analysis was performed only on patients who completed follow-up, using a per-protocol analysis method. We also included the analysis performed on all recruited patients, according to the intention-to-treat analysis method.