Clinical trial NCT03210766 - References

FBSS — Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain

Citation(s)

•   Abeloos L, De Witte O, Riquet R, Tuna T, Mathieu N
  [Long-term outcome of patients treated with spinal cord stimulation for therapeutically refractory failed back surgery syndrome: a retrospective study]. Neurochirurgie. 2011 Jul;57(3):114-9. doi: 10.1016/j.neuchi.2011.07.001. Epub 2011 Sep 9. French.
•   Atkinson TM, Rosenfeld BD, Sit L, Mendoza TR, Fruscione M, Lavene D, Shaw M, Li Y, Hay J, Cleeland CS, Scher HI, Breitbart WS, Basch E
  Using confirmatory factor analysis to evaluate construct validity of the Brief Pain Inventory (BPI). J Pain Symptom Manage. 2011 Mar;41(3):558-65. doi: 10.1016/j.jpainsymman.2010.05.008. Epub 2010 Dec 4.
•   Attal N, Bouhassira D
  Pharmacotherapy of neuropathic pain: which drugs, which treatment algorithms? Pain. 2015 Apr;156 Suppl 1:S104-14. doi: 10.1097/01.j.pain.0000460358.01998.15. Review.
•   Baber Z, Erdek MA
  Failed back surgery syndrome: current perspectives. J Pain Res. 2016 Nov 7;9:979-987. eCollection 2016. Review.
•   Babson KA, Sottile J, Morabito D
  Cannabis, Cannabinoids, and Sleep: a Review of the Literature. Curr Psychiatry Rep. 2017 Apr;19(4):23. doi: 10.1007/s11920-017-0775-9. Review.
•   Baron R, Binder A, Wasner G
  Neuropathic pain: diagnosis, pathophysiological mechanisms, and treatment. Lancet Neurol. 2010 Aug;9(8):807-19. doi: 10.1016/S1474-4422(10)70143-5. Review.
•   Bisogno T, Hanus L, De Petrocellis L, Tchilibon S, Ponde DE, Brandi I, Moriello AS, Davis JB, Mechoulam R, Di Marzo V
  Molecular targets for cannabidiol and its synthetic analogues: effect on vanilloid VR1 receptors and on the cellular uptake and enzymatic hydrolysis of anandamide. Br J Pharmacol. 2001 Oct;134(4):845-52.
•   Blumenthal DE, Malemud CJ
  Recent strategies for drug development in fibromyalgia syndrome. Expert Rev Neurother. 2016 Dec;16(12):1407-1411. Epub 2016 Jul 14. Review.
•   Booz GW
  Cannabidiol as an emergent therapeutic strategy for lessening the impact of inflammation on oxidative stress. Free Radic Biol Med. 2011 Sep 1;51(5):1054-61. doi: 10.1016/j.freeradbiomed.2011.01.007. Epub 2011 Jan 14. Review.
•   Boswell MV, Hansen HC, Trescot AM, Hirsch JA
  Epidural steroids in the management of chronic spinal pain and radiculopathy. Pain Physician. 2003 Jul;6(3):319-34.
•   Burton CV, Kirkaldy-Willis WH, Yong-Hing K, Heithoff KB
  Causes of failure of surgery on the lumbar spine. Clin Orthop Relat Res. 1981 Jun;(157):191-9.
•   Campos AC, Moreira FA, Gomes FV, Del Bel EA, Guimarães FS
  Multiple mechanisms involved in the large-spectrum therapeutic potential of cannabidiol in psychiatric disorders. Philos Trans R Soc Lond B Biol Sci. 2012 Dec 5;367(1607):3364-78. doi: 10.1098/rstb.2011.0389. Review.
•   Casarotto PC, Gomes FV, Resstel LB, Guimarães FS
  Cannabidiol inhibitory effect on marble-burying behaviour: involvement of CB1 receptors. Behav Pharmacol. 2010 Jul;21(4):353-8.
•   Chan CW, Peng P
  Failed back surgery syndrome. Pain Med. 2011 Apr;12(4):577-606. doi: 10.1111/j.1526-4637.2011.01089.x. Epub 2011 Apr 4. Review.
•   Choi HS, Chi EH, Kim MR, Jung J, Lee J, Shin JS, Ha IH
  Demographic characteristics and medical service use of failed back surgery syndrome patients at an integrated treatment hospital focusing on complementary and alternative medicine: a retrospective review of electronic medical records. Evid Based Complement Alternat Med. 2014;2014:714389. doi: 10.1155/2014/714389. Epub 2014 Nov 4.
•   Clark AJ, Lynch ME, Ware M, Beaulieu P, McGilveray IJ, Gourlay D
  Guidelines for the use of cannabinoid compounds in chronic pain. Pain Res Manag. 2005 Autumn;10 Suppl A:44A-6A. Review.
•   Costa B, Giagnoni G, Franke C, Trovato AE, Colleoni M
  Vanilloid TRPV1 receptor mediates the antihyperalgesic effect of the nonpsychoactive cannabinoid, cannabidiol, in a rat model of acute inflammation. Br J Pharmacol. 2004 Sep;143(2):247-50. Epub 2004 Aug 16.
•   Duggal N, Mendiondo I, Pares HR, Jhawar BS, Das K, Kenny KJ, Dickman CA
  Anterior lumbar interbody fusion for treatment of failed back surgery syndrome: an outcome analysis. Neurosurgery. 2004 Mar;54(3):636-43; discussion 643-4.
•   Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S
  Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. Epub 2007 Dec 11.
•   Esmer G, Blum J, Rulf J, Pier J
  Mindfulness-based stress reduction for failed back surgery syndrome: a randomized controlled trial. J Am Osteopath Assoc. 2010 Nov;110(11):646-52. Erratum in: J Am Osteopath Assoc. 2011 Jan;111(1):3. J Am Osteopath Assoc. 2011 Jul;111(7):424.
•   Esposito G, Scuderi C, Valenza M, Togna GI, Latina V, De Filippis D, Cipriano M, Carratù MR, Iuvone T, Steardo L
  Cannabidiol reduces Aß-induced neuroinflammation and promotes hippocampal neurogenesis through PPAR? involvement. PLoS One. 2011;6(12):e28668. doi: 10.1371/journal.pone.0028668. Epub 2011 Dec 5.
•   Fernández-Ruiz J, Sagredo O, Pazos MR, García C, Pertwee R, Mechoulam R, Martínez-Orgado J
  Cannabidiol for neurodegenerative disorders: important new clinical applications for this phytocannabinoid? Br J Clin Pharmacol. 2013 Feb;75(2):323-33. doi: 10.1111/j.1365-2125.2012.04341.x. Review.
•   Finnerup NB, Sindrup SH, Jensen TS
  The evidence for pharmacological treatment of neuropathic pain. Pain. 2010 Sep;150(3):573-81. doi: 10.1016/j.pain.2010.06.019.
•   Hayakawa K, Mishima K, Hazekawa M, Sano K, Irie K, Orito K, Egawa T, Kitamura Y, Uchida N, Nishimura R, Egashira N, Iwasaki K, Fujiwara M
  Cannabidiol potentiates pharmacological effects of Delta(9)-tetrahydrocannabinol via CB(1) receptor-dependent mechanism. Brain Res. 2008 Jan 10;1188:157-64. Epub 2007 Oct 12.
•   Hussain A, Erdek M
  Interventional pain management for failed back surgery syndrome. Pain Pract. 2014 Jan;14(1):64-78. doi: 10.1111/papr.12035. Epub 2013 Feb 3. Review.
•   Izzo AA, Borrelli F, Capasso R, Di Marzo V, Mechoulam R
  Non-psychotropic plant cannabinoids: new therapeutic opportunities from an ancient herb. Trends Pharmacol Sci. 2009 Oct;30(10):515-27. doi: 10.1016/j.tips.2009.07.006. Epub 2009 Sep 2. Review. Erratum in: Trends Pharmacol Sci. 2009 Dec;30(12):609.
•   Kat'uch V, Pataky F, Kat'uchová J, Gajdos M, Radonak J
  [Surgical management of the failed back surgery syndrome (FBSS) using posterior lumbar interbody fusion (PLIF) with posterior transpedicular stabilization]. Rozhl Chir. 2010 Aug;89(7):450-8. Slovak.
•   Kathmann M, Flau K, Redmer A, Tränkle C, Schlicker E
  Cannabidiol is an allosteric modulator at mu- and delta-opioid receptors. Naunyn Schmiedebergs Arch Pharmacol. 2006 Feb;372(5):354-61. Epub 2006 Feb 18.
•   Katz JA, Swerdloff MA, Brass SD, Argoff CE, Markman J, Backonja M, Katz N
  Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology. Neurology. 2015 Apr 7;84(14):1503-4. doi: 10.1212/WNL.0000000000001485.
•   Kehlet H, Jensen TS, Woolf CJ
  Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review.
•   Khosravi MB, Azemati S, Sahmeddini MA
  Gabapentin versus naproxen in the management of failed back surgery syndrome; a randomized controlled trial. Acta Anaesthesiol Belg. 2014;65(1):31-7.
•   Kim SB, Lee KW, Lee JH, Kim MA, An BW
  The effect of hyaluronidase in interlaminar lumbar epidural injection for failed back surgery syndrome. Ann Rehabil Med. 2012 Aug;36(4):466-73. doi: 10.5535/arm.2012.36.4.466. Epub 2012 Aug 27.
•   Krishna M, Pollock RD, Bhatia C
  Incidence, etiology, classification, and management of neuralgia after posterior lumbar interbody fusion surgery in 226 patients. Spine J. 2008 Mar-Apr;8(2):374-9. Epub 2006 Dec 22.
•   Kumar K, Hunter G, Demeria DD
  Treatment of chronic pain by using intrathecal drug therapy compared with conventional pain therapies: a cost-effectiveness analysis. J Neurosurg. 2002 Oct;97(4):803-10.
•   Lynch ME, Campbell F
  Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Br J Clin Pharmacol. 2011 Nov;72(5):735-44. doi: 10.1111/j.1365-2125.2011.03970.x. Review.
•   Lynch ME, Ware MA
  Cannabinoids for the Treatment of Chronic Non-Cancer Pain: An Updated Systematic Review of Randomized Controlled Trials. J Neuroimmune Pharmacol. 2015 Jun;10(2):293-301. doi: 10.1007/s11481-015-9600-6. Epub 2015 Mar 22. Review.
•   Maier C, Baron R, Sommer C
  [Neuropathic pain. How to open the blackbox]. Schmerz. 2015 Oct;29(5):479-80, 482-5. doi: 10.1007/s00482-015-0028-y. Review. German.
•   Manniche C, Asmussen K, Lauritsen B, Vinterberg H, Karbo H, Abildstrup S, Fischer-Nielsen K, Krebs R, Ibsen K
  Intensive dynamic back exercises with or without hyperextension in chronic back pain after surgery for lumbar disc protrusion. A clinical trial. Spine (Phila Pa 1976). 1993 Apr;18(5):560-7.
•   North RB, Kidd D, Shipley J, Taylor RS
  Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007 Aug;61(2):361-8; discussion 368-9. Erratum in: Neurosurgery. 2009 Apr;64(4):601.
•   O'Connor AB, Dworkin RH
  Treatment of neuropathic pain: an overview of recent guidelines. Am J Med. 2009 Oct;122(10 Suppl):S22-32. doi: 10.1016/j.amjmed.2009.04.007. Review.
•   Pazos MR, Mohammed N, Lafuente H, Santos M, Martínez-Pinilla E, Moreno E, Valdizan E, Romero J, Pazos A, Franco R, Hillard CJ, Alvarez FJ, Martínez-Orgado J
  Mechanisms of cannabidiol neuroprotection in hypoxic-ischemic newborn pigs: role of 5HT(1A) and CB2 receptors. Neuropharmacology. 2013 Aug;71:282-91. doi: 10.1016/j.neuropharm.2013.03.027. Epub 2013 Apr 12.
•   Pertwee RG
  Targeting the endocannabinoid system with cannabinoid receptor agonists: pharmacological strategies and therapeutic possibilities. Philos Trans R Soc Lond B Biol Sci. 2012 Dec 5;367(1607):3353-63. doi: 10.1098/rstb.2011.0381. Review.
•   Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW; Leiden-The Hague Spine Intervention Prognostic Study Group
  Surgery versus prolonged conservative treatment for sciatica. N Engl J Med. 2007 May 31;356(22):2245-56.
•   Russo EB, Burnett A, Hall B, Parker KK
  Agonistic properties of cannabidiol at 5-HT1a receptors. Neurochem Res. 2005 Aug;30(8):1037-43.
•   Ryberg E, Larsson N, Sjögren S, Hjorth S, Hermansson NO, Leonova J, Elebring T, Nilsson K, Drmota T, Greasley PJ
  The orphan receptor GPR55 is a novel cannabinoid receptor. Br J Pharmacol. 2007 Dec;152(7):1092-101. Epub 2007 Sep 17.
•   Sciubba DM, Gokaslan ZL
  Spinal cord stimulation for failed back surgery syndrome--does it work and is it cost-effective? Nat Clin Pract Neurol. 2008 Sep;4(9):472-3. doi: 10.1038/ncpneuro0865. Epub 2008 Jul 22.
•   Shapiro CM
  The failed back surgery syndrome: pitfalls surrounding evaluation and treatment. Phys Med Rehabil Clin N Am. 2014 May;25(2):319-40. doi: 10.1016/j.pmr.2014.01.014. Review.
•   Simon A, Seizeur R, Person H, Forlodou P, Dam Hieu P, Besson G
  [Anterior lumbar interbody fusion for treatment of failed back surgery syndrome: a retrospective study of 46 cases]. Neurochirurgie. 2009 Jun;55(3):309-13. doi: 10.1016/j.neuchi.2008.09.003. Epub 2008 Dec 16. French.
•   Slipman CW, Shin CH, Patel RK, Isaac Z, Huston CW, Lipetz JS, Lenrow DA, Braverman DL, Vresilovic EJ Jr
  Etiologies of failed back surgery syndrome. Pain Med. 2002 Sep;3(3):200-14; discussion 214-7.
•   Stout SM, Cimino NM
  Exogenous cannabinoids as substrates, inhibitors, and inducers of human drug metabolizing enzymes: a systematic review. Drug Metab Rev. 2014 Feb;46(1):86-95. doi: 10.3109/03602532.2013.849268. Epub 2013 Oct 25. Review.
•   Thomson S
  Failed back surgery syndrome - definition, epidemiology and demographics. Br J Pain. 2013 Feb;7(1):56-9. doi: 10.1177/2049463713479096.
•   Tomycz ND, Ortiz V, Moossy JJ
  Simultaneous intrathecal opioid pump and spinal cord stimulation for pain management: analysis of 11 patients with failed back surgery syndrome. J Pain Palliat Care Pharmacother. 2010 Dec;24(4):374-83. doi: 10.3109/15360288.2010.523066.
•   Torrance N, Smith BH, Bennett MI, Lee AJ
  The epidemiology of chronic pain of predominantly neuropathic origin. Results from a general population survey. J Pain. 2006 Apr;7(4):281-9.
•   Tsang CC, Giudice MG
  Nabilone for the Management of Pain. Pharmacotherapy. 2016 Mar;36(3):273-86. doi: 10.1002/phar.1709. Epub 2016 Feb 29. Review.
•   Van Buyten JP, Al-Kaisy A, Smet I, Palmisani S, Smith T
  High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation. 2013 Jan-Feb;16(1):59-65; discussion 65-6. doi: 10.1111/ner.12006. Epub 2012 Nov 30.
•   Waguespack A, Schofferman J, Slosar P, Reynolds J
  Etiology of long-term failures of lumbar spine surgery. Pain Med. 2002 Mar;3(1):18-22.
•   Walitt B, Klose P, Fitzcharles MA, Phillips T, Häuser W
  Cannabinoids for fibromyalgia. Cochrane Database Syst Rev. 2016 Jul 18;7:CD011694. doi: 10.1002/14651858.CD011694.pub2. Review.
•   Ware MA, Doyle CR, Woods R, Lynch ME, Clark AJ
  Cannabis use for chronic non-cancer pain: results of a prospective survey. Pain. 2003 Mar;102(1-2):211-6.
•   Wong CB, Chen WJ, Chen LH, Niu CC, Lai PL
  Clinical outcomes of revision lumbar spinal surgery: 124 patients with a minimum of two years of follow-up. Chang Gung Med J. 2002 Mar;25(3):175-82.
•   Zencirci B
  Analgesic efficacy of oral gabapentin added to standard epidural corticosteroids in patients with failed back surgery. Clin Pharmacol. 2010;2:207-11. doi: 10.2147/CPAA.S12126. Epub 2010 Sep 30.
•   Zuardi AW, Shirakawa I, Finkelfarb E, Karniol IG
  Action of cannabidiol on the anxiety and other effects produced by delta 9-THC in normal subjects. Psychopharmacology (Berl). 1982;76(3):245-50.

Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain

Details for clinical trial NCT03210766