Back to Journals » Journal of Pain Research » Volume 9

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: Dr 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

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]


Other articles by this author:

Characterizing individual painDETECT symptoms by average pain severity

Sadosky A, Koduru V, Bienen EJ, Cappelleri JC

ClinicoEconomics and Outcomes Research 2016, 8:361-366

Published Date: 26 July 2016

Characterizing neuropathic pain profiles: enriching interpretation of painDETECT

Cappelleri JC, Koduru V, Bienen EJ, Sadosky A

Patient Related Outcome Measures 2016, 7:93-99

Published Date: 5 July 2016

Cost-effectiveness analysis of pregabalin for treatment of chronic low back pain in patients with accompanying lower limb pain (neuropathic component) in Japan

Igarashi A, Akazawa M, Murata T, Taguchi T, Sadosky A, Ebata N, Willke R, Fujii K, Doherty J, Kobayashi M

ClinicoEconomics and Outcomes Research 2015, 7:505-520

Published Date: 7 October 2015

Effectiveness of pregabalin for the treatment of chronic low back pain with accompanying lower limb pain (neuropathic component): a non-interventional study in Japan

Taguchi T, Igarashi A, Watt S, Parsons B, Sadosky A, Nozawa K, Hayakawa K, Yoshiyama T, Ebata N, Fujii K

Journal of Pain Research 2015, 8:487-497

Published Date: 5 August 2015

A cross-sectional study examining the psychometric properties of the painDETECT measure in neuropathic pain

Cappelleri JC, Koduru V, Bienen EJ, Sadosky A

Journal of Pain Research 2015, 8:159-167

Published Date: 15 April 2015

Measurement properties of painDETECT by average pain severity

Cappelleri JC, Bienen EJ, Koduru V, Sadosky A

ClinicoEconomics and Outcomes Research 2014, 6:497-504

Published Date: 6 November 2014

Pain severity and the economic burden of neuropathic pain in the United States: BEAT Neuropathic Pain Observational Study

Schaefer C, Sadosky A, Mann R, Daniel S, Parsons B, Tuchman M, Anschel A, Stacey BR, Nalamachu S, Nieshoff E

ClinicoEconomics and Outcomes Research 2014, 6:483-496

Published Date: 29 October 2014

Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States

Parsons B, Schaefer C, Mann R, Sadosky A, Daniel S, Nalamachu S, Stacey BR, Nieshoff EC, Tuchman M, Anschel A

Journal of Pain Research 2013, 6:459-469

Published Date: 17 June 2013

Impact of reducing dosing frequency on adherence to oral therapies: a literature review and meta-analysis

Srivastava K, Arora A, Kataria A, Cappelleri JC, Sadosky A, Peterson AM

Patient Preference and Adherence 2013, 7:419-434

Published Date: 20 May 2013

Burden of illness associated with painful diabetic peripheral neuropathy among adults seeking treatment in the US: results from a retrospective chart review and cross-sectional survey

Sadosky A, Schaefer C, Mann R, Bergstrom F, Baik R, Parsons B, Nalamachu S, Nieshoff E, Stacey BR, Anschel A, Tuchman M

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2013, 6:79-92

Published Date: 8 February 2013

Association of patient-rated severity with other outcomes in patients with painful diabetic peripheral neuropathy

Taylor-Stokes G, Pike J, Sadosky A, Chandran A, Toelle T

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2011, 4:401-408

Published Date: 5 December 2011