Results
A total of 60 patients were randomized into group A (n = 20), group B (n = 20) or Group C (n = 20) (Figure 1 flowchart). The demographic and clinical baseline characteristics of the 3 groups were well balanced (Table 1). As regards primary outcome measures, 2-way ANOVA showed a significant group (F=19.521; p<0.001) and time (F=66.129; p<0.001) effect for VAS score while no significant group*time interaction was found (F=2.708; p=0.03).
Post hoc analysis revealed that VAS scores were significantly lower than baseline values at the end of the therapy. At this time, however, patients in group C displayed the best results when compared with other groups. Patients in group A and in group C, but not those in group B maintained lower pain level at T2 than at baseline, with significant lower VAS values in Group C (Table 2).
Two-way ANOVA showed a significant group (F=14.854; p<0.001) and time (F=47.262; p<0.001) effect for Womac pain subscale while no significant group*time interaction was found (F=1.687; p=0.155). Post hoc analysis revealed that WOMAC pain scores were significantly lower than baseline values at the end of the therapy. At this time, however, patients in group C displays the best results when compared with other groups. Patients in all groups maintained lower pain level at T2 than at baseline, with significant lower VAS values in Group C when compared with Groups A and B (Table 2).
Regarding WOMAC joint stiffness scores, 2-way ANOVA showed a significant group (F=8.521; p<0.001) and time (F=13.344; p<0.001) effect for VAS score while no significant group*time interaction was found (F=1.777; p=0.136). Post hoc analysis revealed that WOMAC joint stiffness scores were significantly lower than baseline values at the end of the therapy and at 1-month follow-up in group B and C, but not in group A (Table 2). A significant group (F=19.325; p<0.001) and time (F=17.725; p<0.001), but not group*time interaction (F=1.961; p=0.103) effect for WOMAC disability subscore was found. WOMAC disability scores were significantly lower than baseline values at the end of the therapy and at 1-month follow-up in group B and C, but not in group A (Table 2).
As regards US measurements, the maximum axial area did not change as a consequence of the treatment in any of the three groups (F=1.334; p=0.259). Contrarily, sagittal area measurements were influenced by time (F=10.027; p<0.01) at 2-way ANOVA. Post hoc analysis revealed significant differences between pre- and post-treatment evaluation in Group B and Group C, but not in Group A (Table 3).
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