Further secondary outcomes were recovery expectation and pain self efficacy. Recovery expectation was measured using the same question used to determine eligibility, scored from 0 to 10 with a higher score indicating more positive expectations (Iles et al 2009). The minimum clinically important difference for this measure has not been established. Pain self efficacy was measured using the Pain

Self Efficacy Questionnaire, a measure of a person’s confidence to complete specific activities despite their current level of pain (Nicholas, 2007). The Pain Self Efficacy Questionnaire is scored out of a total of 60 points, with a higher score indicating a higher S3I-201 clinical trial level of pain self efficacy. The Pain Self Efficacy Questionnaire has good test-retest reliability over a 3-month period (r = 0.73) ( Nicholas, 2007) and sensitivity to change in patients with chronic low back pain ( Maughan and Lewis, 2010). The minimum clinically important difference for this measure is 11 points ( Maughan and Lewis, 2010). To achieve a power of 80% with 95% confidence to detect a clinically important difference

http://www.selleckchem.com/products/blz945.html of 2.0 points on the Patient Specific Functional Scale (Maughan and Lewis, 2010), assuming a standard deviation of 1.6 points similar to that found in other studies of non-specific low back pain (Stratford et al 1995), 24 participants were required (Buchner et al 2007). A target sample size of 30 was set to allow for some loss to follow up. Outcomes were analysed on an intention-to-treat basis for all available data. To compare the two groups on the primary and secondary outcomes, analysis of covariance (ANCOVA) was applied comparing the means Isotretinoin at 4 and 12 weeks using the baseline scores as covariates (Vickers and Altman, 2001). To evaluate the impact of the

intervention, effect sizes (standardised mean differences) were calculated by dividing the difference in post intervention means by the pooled standard deviation (Hedges g) ( Hedges and Olkin, 1985). An effect size of 0.2 was considered small, 0.5 a medium sized effect, and 0.8 or greater a large effect size ( Cohen, 1992). The primary non-leisure activity score from the Patient Specific Functional Scale was also analysed by calculating the absolute risk reduction and number needed to treat statistic by comparing the proportion in each group achieving a successful return to the specified activity (determined a priori as a score of 7 or higher out of 10 on the Patient Specific Functional Scale) at 12 weeks. Thirty participants were recruited from 185 people screened between January 2008 and March 2010. Four participants (2 from each group) could not be contacted to complete final outcome measures at 12 weeks. The final analysis consisted of 26 participants, 13 from each group. The flow of participants through the trial and reasons for loss to follow-up are illustrated in Figure 1.