9 points. The other specifications were: power of 80%, an alpha of 5% and a possible loss to follow up of up to 15%.
Therefore, a total of 148 participants (74 per group) were recruited for this study. The estimates used in the sample size calculation were lower than the ones suggested as the minimum clinical important difference in order to increase the precision of the estimates of the effects of the interventions. The statistical analysis was conducted on an intention-to-treat basis, that is participants were analysed in the groups to which they were randomly allocated. Visual inspection of histograms was used to test data normality and all outcomes had normal distributions. The characteristics of the participants were summarised using descriptive statistics. The between-group differences and their respective 95% CIs were calculated using linear mixed models by using NVP-AUY922 supplier group, time and group-versus-time interaction terms. A total of 184 people were screened for this study. Thirty-six were excluded for the reasons presented in Figure 3. The remaining 148 participants were all XL184 evaluated at four weeks (after treatment) and 12
weeks (ie, 0% loss to follow up). Adherence to the eight-planned treatment sessions was high in both groups, with a mean of 7.4 sessions (SD 1.5) in the experimental group and 7.1 sessions (SD 1.9) in the control group. Three participants, who had passed the initial allergy patch test and commenced treatment, had allergic reactions to the Kinesio Tapea and missed some treatments. One of these participants was in the experimental group and two in the control group. All participants recovered from the allergic reactions after the removal of the tape without the need for additional interventions such as antihistamines. The demographic characteristics of the participants are presented in Table 1. The baseline values of the outcome measures are presented Resminostat in the first two columns
of Table 2. The majority of participants were female (78%). The participants had a mean age of 50 years, with an average of two years or more of pain, moderate pain intensity and moderate disability. The groups were comparable at baseline. No significant between-group differences were observed for the primary outcomes of pain intensity and disability at four weeks. There was a significant, but small, difference in favour of the intervention group for the secondary outcome of global perceived effect at four weeks, but not at 12 weeks. No significant between-group differences for the remaining secondary outcomes were detected. These results are presented in Table 2, with individual data presented in Table 3 (see eAddenda for Table 3). After four weeks of treatment, both groups in this trial showed similar reductions in the primary outcomes of pain intensity and disability, with no statistically significant differences between the two treatment conditions.