A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury

Diana D. Cardenas, Edward C. Nieshoff, Kota Suda, Shin Ichi Goto, Luis Sanin, Takehiko Kaneko, Jonathan Sporn, Bruce Parsons, Matt Soulsby, Ruoyong Yang, Ed Whalen, Joseph M. Scavone, Makoto M. Suzuki, Lloyd E. Knapp

Research output: Contribution to journalArticle

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Abstract

Objective: To assess the efficacy and tolerability of pregabalin for the treatment of central neuropathic pain after spinal cord injury (SCI). Methods: Patients with chronic, below-level, neuropathic pain due to SCI were randomized to receive 150 to 600 mg/d pregabalin (n = 108) or matching placebo (n = 112) for 17 weeks. Pain was classified in relation to the neurologic level of injury, defined as the most caudal spinal cord segment with normal sensory and motor function, as above, at, or below level. The primary outcome measure was duration-adjusted average change in pain. Key secondary outcome measures included the change in mean pain score from baseline to end point, the percentage of patients with $30% reduction in mean pain score at end point, Patient Global Impression of Change scores at end point, and the change in mean pain-related sleep interference score from baseline to end point. Additional outcome measures included the Medical Outcomes Study-Sleep Scale and the Hospital Anxiety and Depression Scale. Results: Pregabalin treatment resulted in statistically significant improvements over placebo for all primary and key secondary outcome measures. Significant pain improvement was evident as early as week 1 and was sustained throughout the treatment period. Adverse events were consistent with the known safety profile of pregabalin and weremostly mild tomoderate in severity. Somnolence and dizziness were most frequently reported. Conclusions: This study demonstrates that pregabalin is effective and well tolerated in patients with neuropathic pain due to SCI. Classification of evidence: This study provides Class I evidence that pregabalin, 150 to 600 mg/d, is effective in reducing duration-adjusted average change in pain compared with baseline in patients with SCI over a 16-week period (p = 0.003, 95% confidence interval = 20.98, 20.20).

Original languageEnglish
Pages (from-to)533-539
Number of pages7
JournalNeurology
Volume80
Issue number6
DOIs
StatePublished - Feb 5 2013
Externally publishedYes

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Neuralgia
Spinal Cord Injuries
Pain
Outcome Assessment (Health Care)
Sleep
Placebos
Nervous System Trauma
Dizziness
Pregabalin
Cord
Spinal Cord
Therapeutics
Anxiety
Confidence Intervals
Depression
Safety

ASJC Scopus subject areas

  • Clinical Neurology
  • Arts and Humanities (miscellaneous)

Cite this

Cardenas, D. D., Nieshoff, E. C., Suda, K., Goto, S. I., Sanin, L., Kaneko, T., ... Knapp, L. E. (2013). A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury. Neurology, 80(6), 533-539. https://doi.org/10.1212/WNL.0b013e318281546b

A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury. / Cardenas, Diana D.; Nieshoff, Edward C.; Suda, Kota; Goto, Shin Ichi; Sanin, Luis; Kaneko, Takehiko; Sporn, Jonathan; Parsons, Bruce; Soulsby, Matt; Yang, Ruoyong; Whalen, Ed; Scavone, Joseph M.; Suzuki, Makoto M.; Knapp, Lloyd E.

In: Neurology, Vol. 80, No. 6, 05.02.2013, p. 533-539.

Research output: Contribution to journalArticle

Cardenas, DD, Nieshoff, EC, Suda, K, Goto, SI, Sanin, L, Kaneko, T, Sporn, J, Parsons, B, Soulsby, M, Yang, R, Whalen, E, Scavone, JM, Suzuki, MM & Knapp, LE 2013, 'A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury', Neurology, vol. 80, no. 6, pp. 533-539. https://doi.org/10.1212/WNL.0b013e318281546b
Cardenas DD, Nieshoff EC, Suda K, Goto SI, Sanin L, Kaneko T et al. A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury. Neurology. 2013 Feb 5;80(6):533-539. https://doi.org/10.1212/WNL.0b013e318281546b
Cardenas, Diana D. ; Nieshoff, Edward C. ; Suda, Kota ; Goto, Shin Ichi ; Sanin, Luis ; Kaneko, Takehiko ; Sporn, Jonathan ; Parsons, Bruce ; Soulsby, Matt ; Yang, Ruoyong ; Whalen, Ed ; Scavone, Joseph M. ; Suzuki, Makoto M. ; Knapp, Lloyd E. / A randomized trial of pregabalin in patients with neuropathic pain due to spinal cord injury. In: Neurology. 2013 ; Vol. 80, No. 6. pp. 533-539.
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