Figures & data
Figure 1 Patient disposition.
Notes:
*Choice of therapy determined by the clinical judgment of the treating physician; #the full analysis set consisted of subjects who had at least one evaluable observation from any of the patient-reported outcomes, and only evaluable subjects who contributed to the particular outcome were evaluated in each analysis.
Table 1 Baseline demographic and clinical characteristics of the treatment groups
Figure 2 Change from baseline in sleep disturbance, assessed using the Pain-Related sleep interference scale (PRSIS).
Note:
*P<0.05 versus usual care.
Abbreviation: LS, least-squares.
Abbreviation: LS, least-squares.
Figure 3 Efficacy of treatment for pain assessed using a pain numerical rating scale (NRS).
Notes: (A) Change from baseline. (B) Proportions of patients at week 8 (last observation carried forward) reporting clinically relevant improvements in pain. *P<0.05 versus usual care.
Abbreviation: LS, least-squares.
Abbreviation: LS, least-squares.
Figure 4 Change from baseline in function, assessed by the Roland-Morris Disability Questionnaire (RMDQ).
Note:
*P<0.05 versus usual care.
Abbreviation: LS, least-squares.
Abbreviation: LS, least-squares.
Figure 5 Global impression of change at week 8 from the perspectives of (A) the clinician, assessed using the Clinician Global Impression of Change (CGI-C), and (B) the patient, assessed using the Patient Global Impression of Change (PGI-C).
Notes: Categories are collapsed into “Improved”, consisting of “minimally improved”, “much improved”, and “very much improved”, and “Worsened”, consisting of “minimally worse”, “much worse”, and “very much worse”. Differences between pregabalin and usual care were significant for the full set of categories on the CGI-C and PGI-C (both P<0.05).
Table 2 Treatment-related adverse events (AEs) in the pregabalin group (n=157)