Pain relief and functional improvement in patients with neuropathic pain associated with spinal cord injury: an exploratory analysis of pregabalin clinical trials
Authors Sadosky A, Parsons B, Emir B, Nieshoff EC
Received 7 October 2015
Accepted for publication 28 January 2016
Published 15 June 2016 Volume 2016:9 Pages 405—416
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Kerui Gong
Peer reviewer comments 3
Editor who approved publication: Professor Michael Schatman
Alesia Sadosky,1 Bruce Parsons,1 Birol Emir,1 Edward C Nieshoff2
1Pfizer Inc., New York, NY, 2Rehabilitation Institute of Michigan, Detroit, MI, USA
Background: Characterizing relationships between pain relief and function can inform patient management decisions. This analysis explored graphically the relationship between pain relief and functional improvement in patients with neuropathic pain associated with spinal cord injury in two clinical trials of pregabalin.
Methods: This was a post hoc analysis of two randomized, double-blind, clinical trials in patients who were treated with pregabalin (n=181) or placebo (n=172) for neuropathic pain associated with spinal cord injury. The bivariate relationship between percent pain relief and absolute change in the functional outcomes with placebo and pregabalin was evaluated graphically using scatter plots, and loess curves illustrated the extent of the relationship between pain and function. Linear trend analysis evaluated the statistical significance of these relationships using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT)-based thresholds of pain reduction (<15%, 15% <30%, 30% to <50%, and ≥50%). Outcome measures included modified Brief Pain Inventory pain interference with function in one of the studies and the Medical Outcomes Study Sleep Scale (an 11-point Numeric Rating Scale) and the Hospital Anxiety and Depression Scale (HADS) for the pooled studies.
Results: Data ellipses showed a shift with pregabalin relative to placebo toward greater improvement with increasing pain relief for all outcome measures except HADS. Loess curves suggested a relationship between increased pain relief and improved function except for HADS, with the clearest relationship observed for sleep. Linear trend analysis showed significant relationships between pain and Medical Outcomes Study Sleep Scale (P<0.0001) and between pain and function on the modified Brief Pain Inventory Interference Index and most individual items (P<0.05).
Conclusion: Greater functional improvements were generally achieved at higher levels of clinically significant pain reduction. Pregabalin resulted in shifts from placebo toward greater functional improvement with greater pain relief.
Keywords: spinal cord injury, neuropathic pain, function, sleep, pregabalin
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