We considered that a ‘moderate’ improvement would be enough for typical patients to consider that the intervention in this study is worthwhile. A total of 90 participants would provide 80% power to detect a difference between groups of 6 points on the modified Oswestry scale as significant at a two-sided significance level, assuming a standard deviation of 10 points (Fritz et al 2005, Childs et al 2004). To allow for some loss to followup, we increased the original sample to 100. However, since initial loss to follow-up was very low, study recruitment was closed CX-5461 mw at
89 participants. Analyses were conducted using the intention-to-treat principle including data from all randomised participants wherever it could be obtained. Significance for analyses was set at p < 0.05. Data samples were examined for normality using the Kolmogorov-Smirnov test MK-2206 ic50 and Q-Q plots. Repeated measures ANOVA was used to examine for differences
between groups for Oswestry Disability Index score, VAS, SF-36, and ratings of interference with work and satisfaction with life, with Bonferroni adjustment used for multiple comparisons. Student t-tests were used to compare global rating of change and satisfaction with the intervention between treatment and control groups. The Wilcoxon signed ranks test was used to compare the number of physiotherapy treatments following the intervention period between groups. Pearson’s chi-square test was used to compare groups for the number of participants who were able to manage their acute low back pain without the need to take medication. Between January 2009 and April 2010, 101 volunteers were screened for eligibility. Of these 89 were deemed eligible, gave
informed consent, and were randomised: 44 to the experimental group and 45 to the control group. The flow of participants through the trial, including reasons for exclusion and Rutecarpine loss to follow-up, is presented in Figure 1. The baseline characteristics of participants are shown in Table 1 and the first two columns of Table 2. No important differences in these characteristics were noted between the experimental and control groups. A single physiotherapist with a postgraduate degree in manual therapy and 15 years of experience using Strain-Counterstrain treatment provided all interventions to both experimental and control groups and remained blind to primary and secondary outcome measures throughout the trial. In each group, all participants attended two 30-min intervention sessions per week for two consecutive weeks. All participants received the study intervention as originally allocated.