73
Views
7
CrossRef citations to date
0
Altmetric
Review Articles

Moving towards multiple site outcomes in spinal cord injury pain clinical trials: An issue of clustered observations in trial design and analysis

&

References

  • Bonica JJ. Introduction: semantic, epidemiologic, and educational issues. In: Casey KL (ed.) Pain and central nervous system disease: the central pain syndromes. New York: Raven Press; 1991. p. 13–29.
  • Richards JS, Meredith RL, Nepomuceno C, Fine PR, Bennett G. Psychosocial aspects of chronic pain in spinal cord injury. Pain 1980;8(3):355–66.
  • Elliot TR, Harkins SW. Psychosocial concomitants of persistent pain among persons with spinal cord injuries. Neuro Rehabil 1991;1(4):7–16.
  • Rose M, Robinson J, Ells P, Cole J. Pain following spinal cord injury: results from a postal survey. Pain 1988;34(1):101–2.
  • Budh CN, Hultling C, Lundeberg T. Quality of sleep in individuals with spinal cord injury: a comparison between patients with and without pain. Spinal Cord 2005;43(2):85–95.
  • Widerström-Noga EG, Felipe-Cuervo E, Yezierski RP. Chronic pain after spinal injury: interference with sleep and daily activities. Arch Phys Med Rehabil 2001;82(11):1571–7.
  • Richards JS. Spinal cord injury pain: impact, classification, treatment trends, and implications from translational research. Rehabil Psychol 2005;50(2):99–102.
  • Putzke JD, Richards JS, Hicken BL, DeVivo MJ. Interference due to pain following spinal cord injury: important predictors and impact on quality of life. Pain 2002;100(3):231–42.
  • Lundqvist C, Siösteen A, Blomstrand C, Lind B, Sullivan M. Spinal cord injuries: clinical, functional and emotional status. Spine 1991;16(1):78–83.
  • Denkers MR, Biagi HL, O’Brien AM, Jadad AR, Gauld ME. Dorsal root entry zone lesioning used to treat central neuropathic pain in patients with traumatic spinal cord injury: a systematic review. Spine 2002;27(7):E177–84.
  • Gault D, Morel-Fatio M, Albert T, Fattal C. Chronic neuropathic pain of spinal cord injury: what is the effectiveness of psychocomportemental management? Ann Phys Med Rehabil 2009;52(2):167–72.
  • Fattal C, Kong-A-Siou D, Gilbert C, Ventura M, Albert T. What is the efficacy of physical therapeutics for treating neuropathic pain in spinal cord injury patients? Ann Phys Med Rehabil 2009;52(2):149–66.
  • Attal N, Mazaltarine G, Perrouin-Verbe B, Albert T. Chronic neuropathic pain management in spinal cord injury patients. What is the efficacy of pharmacological treatments with a general mode of administration? (Oral, transdermal, intravenous). Ann Phys Med Rehabil 2009;52(2):124–41.
  • Levendoglu F, Ogün CO, Ozerbil O, Ogün TC, Ugurlu H. Gabapentin is a first line drug for the treatment of neuropathic pain in spinal cord injury. Spine 2004;29(7):743–51.
  • Putzke JD, Richards JS, Kezar L, Hicken B, Ness T. Long-term use of gabapentin for treatment of pain following traumatic spinal cord injury. Clin J Pain 2002;18(2):116–21.
  • Cardenas DD, Warms CA, Turner JA, Marshall H, Brooke MM, Loeser JD. Efficacy of amitriptyline for relief of pain in spinal cord injury: results of a randomized controlled trial. Pain 2002;96(3):365–73.
  • Rintala DH, Holmes SA, Courtade D, Fiess RN, Tastard LV, Loubser PG. Comparison of the effectiveness of amitriptyline and gabapentin on chronic neuropathic pain in persons with spinal cord injury. Arch Phys Med Rehabil 2007;88(12):1547–60.
  • Widerström-Noga EG, Turk DC. Types and effectiveness of treatments used by people with chronic pain associated with spinal cord injuries: influence of pain and psychosocial characteristics. Spinal Cord 2003;41(11):600–9.
  • Warms CA, Turner JA, Marshall HM, Cardenas DD. Treatments for chronic pain associated with spinal cord injuries: many are tried, few are helpful. Clin J Pain 2002;18(3):154–63.
  • Henwood P, Ellis JA. Chronic neuropathic pain in spinal cord injury: the patient's perspective. Pain Res Manag 2004;9(1):39–45.
  • Bryce TN, Ragnarsson KT. Pain after spinal cord injury. Phys Med Rehabil Clin N Am 2000;11(1):157–68.
  • Widerström-Noga E, Biering-Sørensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, et al. The international spinal cord injury pain basic data set. Spinal Cord 2008;46(12):818–23.
  • Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113(1–2):9–19.
  • Jensen MP, Barber J, Romano JM, Hanley MA, Raichle KA, Molton IR, et al. Effects of self-hypnosis training and EMG biofeedback relaxation training on chronic pain in persons with spinal cord injury. Int J Clin Exp Hypn 2009;57(3):239–68.
  • Amr YM. Multi-day low dose ketamine infusion as adjuvant to oral gabapentin in spinal cord injury related chronic pain: a prospective, randomized, double blind trial. Pain Physician 2010;13(3):245–9.
  • Vranken JH, Hollmann MW, van der Vegt MH, Kruis MR, Heesen M, Vos K, et al. Duloxetine in patients with central neuropathic pain caused by spinal cord injury or stroke: a randomized, double-blind, placebo-controlled trial. Pain 2011;152(2):267–73.
  • Heutink M, Post MW, Bongers-Janssen HM, Dijkstra CA, Snoek GJ, Spijkerman DC, et al. The CONECSI trial: results of a randomized controlled trial of a multidisciplinary cognitive behavioral program for coping with chronic neuropathic pain after spinal cord injury. Pain 2012;153(1):120–8.
  • Salinas FA, Lugo LH, García HI. Efficacy of early treatment with carbamazepine in prevention of neuropathic pain in patients with spinal cord injury. Am J Phys Med Rehabil 2012;91(12):1020–7.
  • Tan G, Rintala DH, Jensen MP, Richards JS, Holmes SA, Parachuri R, et al. Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase. J Spinal Cord Med 2011;34(3):285–96.
  • Norrbrink C, Lundeberg T. Acupuncture and massage therapy for neuropathic pain following spinal cord injury: an exploratory study. Acupunct Med 2011;29(2):108–15.
  • Arienti C, Daccò S, Piccolo I, Redaelli T. Osteopathic manipulative treatment is effective on pain control associated to spinal cord injury. Spinal Cord 2011;49(4):515–9.
  • Kang BS, Shin HI, Bang MS. Effect of repetitive transcranial magnetic stimulation over the hand motor cortical area on central pain after spinal cord injury. Arch Phys Med Rehabil 2009;90(10):1766–71.
  • Norrbrink C. Transcutaneous electrical nerve stimulation for treatment of spinal cord injury neuropathic pain. J Rehabil Res Dev 2009;46(1):85–93.
  • Norrbrink C, Lundeberg T. Tramadol in neuropathic pain after spinal cord injury: a randomized, double-blind, placebo-controlled trial. Clin J Pain 2009;25(3):177–84.
  • Rintala DH, Fiess RN, Tan G, Holmes SA, Bruel BM. Effect of dronabinol on central neuropathic pain after spinal cord injury: a pilot study. Am J Phys Med Rehabil 2010;89(10):840–8.
  • Finnerup NB, Grydehøj J, Bing J, Johannesen IL, Biering-Sørensen F, Sindrup SH, et al. Levetiracetam in spinal cord injury pain: a randomized controlled trial. Spinal Cord 2009;47(12):861–7.
  • Soler MD, Kumru H, Pelayo R, Vidal J, Tormos JM, Fregni F, et al. Effectiveness of transcranial direct current stimulation and visual illusion on neuropathic pain in spinal cord injury. Brain 2010;133(9):2565–77.
  • Richardson EJ, Ness TJ, Redden DT, Stewart CC, Richards JS. Effects of nicotine on spinal cord injury pain vary among subtypes of pain and smoking status: results from a randomized, controlled experiment. J Pain 2012;13(12):1206–14.
  • Norrbrink C, Lindberg T, Wahman K, Bjerkefors A. Effects of an exercise programme on musculoskeletal and neuropathic pain after spinal cord injury – results from a seated double-poling ergometer study. Spinal Cord 2012;50(6):457–61.
  • Murray DM. Design and analysis of group randomized trials. New York: Oxford University Press; 1998.
  • Fisher RA. Statistical methods for research workers. 12th ed. Edinburgh: Oliver and Boyd; 1954.
  • Donner A, Klar N. Design and analysis of cluster randomization trials in health research. New York: Oxford University Press; 2000.
  • Ridout MS, Demétrio CG, Firth D. Estimating intraclass correlation for binary data. Biometrics 1999;55(1):137–48.
  • Raudenbush SW, Bryk AS. Hierarchical linear models: application and data analysis methods. 2nd ed. London: Sage; 2002.
  • Brown H, Prescott R. Applied mixed models in medicine. 2nd ed. West Sussex: Wiley; 2006.
  • Liang KY, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika 1986;73(1):13–22.
  • Bieler GS, Williams RL. Cluster sampling techniques in quantal response teratology and developmental toxicity studies. Biometrics 1995;51(2):764–76.
  • Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 2003;106(3):337–45.
  • Melzack R. The short-form McGill pain questionnaire. Pain 1986;30(2):191–7.
  • Richards JS, Hicken BL, Putzke JD, Ness T, Kezar L. Reliability characteristics of the Donovan spinal cord injury pain classification system. Arch Phys Med Rehabil 2002;83(9):1290–4.
  • Putzke JD, Richards JS, Hicken BL, Ness TJ, Kezar L, DeVivo M. Pain classification following spinal cord injury: the utility of verbal descriptors. Spinal Cord 2002;40(3):118–27.
  • Baastrup C, Finnerup NB. Pharmacological management of neuropathic pain following spinal cord injury. CNS Drugs 2008;22(6):455–75.
  • Allison PD. Fixed effects regression methods for longitudinal data using SAS. Cary, NC: SAS Institute; 2005.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.