The sample size was based on having 80% power to detect a 33% difference in the prevalence of ‘improvement’ between groups (p ≤ 0.05). This translates to a NNT ≤3, which was considered a clinically important treatment effect for changing the short-term natural history of nerve-related neck and arm pain. Assuming a prevalence of ‘improvement’ in the control group of 10% and an overall drop-out rate of 10%,
the trial required 84 participants (experimental = 56, control = 28). Participants were recruited from July 2009 through July 2011. Of the 587 volunteers who responded to recruitment advertisements, 60 entered the trial. Although the a priori sample size was 84, recruitment stopped at 60 because time constraints did not learn more allow data collection to extend beyond two years. The flow of participants through
the trial and reasons ABT-199 clinical trial for the loss to follow-up of two participants from the experimental group (5%) and two from the control group (10%) are presented in Figure 1. Participants’ baseline characteristics are presented in Table 1. Those in the experimental group had their symptoms for longer and were more likely to be using medication. Control group participants were slightly more likely to report symptoms below the elbow and that arm symptoms were worse than neck symptoms. There were no important differences between groups in baseline scores for neck pain, arm pain, or Neck Disability Index. Follow-up visits for some participants occurred at three weeks rather than four, but there was no significant difference in the time from baseline to follow-up between mafosfamide the experimental (mean 24 days, SD 4) and control (mean 25 days, SD 2) groups. All participants who completed follow-up received treatment as described except for one (3%) in the experimental group and one (5%) in the control group. The experimental group participant received only three treatments, which meant that the 38 participants in this group who completed follow-up received 151 treatments. Between treatments three and four, this participant experienced an exacerbation of symptoms related to an unusual amount of heavy lifting at work. The participant exhibited two abnormal neurological
signs when assessed prior to the fourth treatment and therefore was not treated. The exacerbation and neurological signs were not related to neural tissue management in the opinion of the participant and physiotherapist and had resolved when the participant attended follow-up less than a week later. The control group participant attended four chiropractic treatments. Global Rating of Change scores indicated that neither participant was ‘improved’ or ‘worse’ at follow-up. These participants were analysed with their assigned group. The distribution and frequency of Global Rating of Change scores at follow-up are presented in Figure 2. The experimental intervention changed the short-term natural history of nerve-related neck and arm pain.