Such rapid response was strongly predictive of a clinical response to OMT at the week 12 exit visit (PPV, ATM/ATR inhibitor 0.82; 95% CI, 0.52–0.95) ( Table 2). Clinical response at week 12 was maintained in 27 (90%) of the 30 patients who attained an initial clinical response to OMT after four or more scheduled treatment sessions (i.e., at week 6 or later). Forty-two (86%) of the 49 responders to OMT at the week 12 exit visit were stable responders who never dropped below the 50% pain reduction threshold for substantial LBP improvement following their initial clinical response. Sixty-two (65%) patients in the OMT group attained an initial clinical response at weeks 1, 2, 4, 6, 8, or 12; however, only 41 (45%) patients

in the sham OMT group similarly responded (RR, 1.45; 95% CI, 1.11–1.90) (Table 3).

There was a shorter time to attainment of initial clinical response in patients who received OMT vs. those who received sham OMT (log-rank P = 0.003) ( Fig. 3). Among all Selleckchem GSK1120212 95 patients who received OMT, the median time to initial clinical response was 8 weeks. However, among the 62 initial responders to OMT, the median time to initial clinical response was 4 weeks. The median time to initial clinical response to sham OMT was in excess of 12 weeks, as only 41 (45%) patients attained an initial clinical response by week 12. There were 42 (56%) stable responders to OMT vs. 18 (26%) stable responders to sham OMT (RR, 2.12; 95% CI, 1.36–3.30). Among the 54 patients with an initial clinical response to OMT prior to week 12, 13 (24%) relapsed at the week 12 exit visit. By comparison, 18 (51%) of 35 patients who had initially responded to sham OMT relapsed at week 12 (RR,

0.47; 95% CI, 0.26–0.83). Overall, 49 (52%) patients in the OMT group Edoxaban either initially attained or maintained a clinical response at the week 12 exit visit vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36–3.05). There were several notable findings within subgroups; however, none of the subgroup differences relating to clinical response or relapse achieved statistical significance based on P-values for interaction ( Table 4). Co-morbid depression was the only factor associated with a large OMT effect in attaining an initial clinical response and was also prevalent among stable clinical responders to OMT, although the statistical significance of the latter finding was obviated by the small number of observations. Several subgroups also exhibited large OMT effects in attaining a stable clinical response. The largest, significant OMT effects in preventing relapse were observed in patients without co-morbid depression and in patients whose LBP had endured for more than one year. Patients with co-morbid depression exhibited the largest, significant OMT effect with respect to overall efficacy at the week 12 exit visit. A total of 138 (74%) patients completed the study per protocol (Fig. 1).