### Patient Results Description  
As seen in Figure 6, at month 3 in the treatment program, the pain as assessed by the VAS scores decreased considerably from the baseline in both groups, with a larger and sharper effect observed in the PG from 5.730 \(\pm\) 0.450 to 2.108 \(\pm\) 0.614 (\(p=0.5\)). A more moderate improvement was observed from months 3 to 6. Beyond 6 months, the VAS scores started to plateau in both groups but remained better in the PG patients receiving the combination treatment. From a clinical perspective, the patients in the PG that underwent the combined approach (HA+ PT) no longer experienced noticeable pain or morning stiffness as early as 3 months into the treatment period. In contrast, while a pain decrease was evident in the CG patients, as observed by the improved VAS scores, intermittent morning stiffness was still experienced throughout the study period. The within-group effect size for the VAS score \(\Omega_{\text{VAS}}\) between the two groups was statistically significant (\(p<0.0001\)), with a \(\Omega_{\text{VA}}\) of 3.757 \(\pm\) 0.683 in the PG compared with the \(\Omega_{\text{VAS}}\) of 2.750 \(\pm\) 0.683 in the CG group. Figure 5: Histogram representation for the weight distribution of the control group (CG) and the pilot group (PG). \begin{table}
\begin{tabular}{c c c c c c c c c c} \hline
**CG vs. PG** & **Mean Group 1** & **Mean Group 2** & **\(t\)-Value** & **df** & \(p\) & **t Separ. Var. Est.** & **df** & \(p\) **2-Sided** & **Std. Dev. Group 1** & **Std. Dev. Group 2** \\ \hline CG Weight (kg) vs. & 83.4 & 83.89189 & \(-\)0.13462 & 50 & 0.893455 & \(-\)0.11851 & 20.50209 & 0.906819 & 14.54451 & 10.75429 \\ PG Weight (kg) & & & & & & & & & \\ \hline \end{tabular}
\end{table} 
Table 3: Characteristics of the \(t\)-test results. At the baseline, the mean (\(\pm\) SD) WOMAC scores reported were 64.6 \(\pm\) 4.08 in the CG and 64.5 \(\pm\) 2.99 in the PG. Notably, at only 3 months into the study, the mean scores were significantly improved to 56.7 \(\pm\) 5 in the CG and 48.27 \(\pm\) 2.13 in the PG (mean between-group difference: 16.19 points; 95% confidence interval), finding favoring of the combination of VS with HA and PT. At the study's endpoint in 12 months, the scores were improved in both groups, with the mean between-group difference remaining significant (7.08 points; 95% confidence interval) (Figure 7). This translated into a significant improvement in pain and discomfort when the PT regimes were added to the pharmacological treatment, highlighting the importance of a combined, multimodal approach for the management of pain in KOA patients. From a clinical perspective, both groups of patients obtained considerably good results from the perspective of WOMAC classification. Both groups registered in the first stage (first 3 months) an improvement in functional mobility and walking, followed by significant improvement in the quality of life at the 12-month endpoint. These results validate the efficiency of the IA infiltration with Kombihylan(r) in patients with KOA, yet the PG recorded superior results from the first 3 months, thus separating the two groups of patients until the end of the study. When calculating the within-group effect size, \(\Omega\)WOMAC in the PG was 41.22 \(\pm\) 3.65, and in the CG, it was 34.75 \(\pm\) 3.36, with a significant statistical difference between groups as \(p<\) 0.0001. Figure 6: Evolution of pain over time in the control group (\(n\) = 15) and pilot group (\(n\) = 37), measured on a visual analog scale (VAS) at inclusion (initial point) and every 3 months up to 12 months. Figure 7: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total scores over the 12-month follow-up period. WOMAC total scores range from 0 to 96, with higher scores indicating worse pain, function, and stiffness. The values in parentheses are 95% confidence intervals (also indicated by the I bars). All 52 participants were included in the analysis in the CG (\(n\) = 15) and PG (\(n\) = 37).