6 PAF-study: results of a randomized controlled trial 157 Secondary outcomes Clinical healing of the fissure In the PFPT group, the fissure was healed in 55.7% of the patients vs 21.4% in control group at 8-week follow-up (p<0.001). At 20-week follow-up healing of the fissure did not further improve in the PFPT but was healed in 60% in the control group after treatment (p<0.001). No significant differences were found in fissure healing between groups at 20-week follow-up (p= 0.333) (Table 2). Pain Regarding the analysis of repeated measures, the PFPT group was found to be more effective for reducing VAS pain score compared to control group (p<0.001) (Figure 2, Table 2). The mean estimated difference between groups at 8 weeks from baseline was -2.47; 95% CI. -3.05 to -1.89 (p<0.001). At 20 weeks no significance in mean difference in VAS pain scores was found between groups (-0.17; 95%CI. -.89 to .54; p=0.425) (Table 2). VAS pain was significantly reduced in both the PFPT and the control group at 8 weeks from baseline (p<0.001). At 20-week follow-up, VAS pain in PFPT-group and control group further decreased and remained significant from baseline (p<0.001) (Table 2). Pelvic floor function Dyssynergia measured with digital rectal examination was found in 67.1% in the PFPT group vs 78.6% in control group before treatment. After intervention at 8 weeks from baseline, dyssynergia was found in 25.7% in the PFPT group vs in 64.3% in control group (p<0.001). At 20-week follow-up, when both groups received treatment, the difference in dyssynergia was no longer significant between groups (p=0.964) (Table 2). At baseline, dyssynergia measured with the balloon expulsion test was found in 38.6% in PFPT group vs 45.7% in control group. After 20 weeks no significance was found in dyssynergia measured with the balloon expulsion test in the PFPT group vs the control group (p=0.566) (Table 2). Increased pelvic floor muscle tone measured with digital rectal examination was found in 87.1% of the patients in the PFPT group vs 81.4% in control group before treatment. After intervention at 8 weeks from baseline, increased pelvic floor muscle tone was found in 28.6% in the PFPT group vs 77.1 % in the control group (p<0.05). At 20-week follow-up no significance was found in increased pelvic floor muscle tone between the two groups after treatment (p=0.750) (Table 2).
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