Comparative safety review of current treatment options for chronic low back pain and unmet needs: a narrative review

References

• Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017Feb18;389(10070):736–747.
   PubMed Web of Science ®Google Scholar
• Wu A, March L, Zheng X, et al. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299.
   PubMed Web of Science ®Google Scholar
• Spears CA, Hodges SE, Kiyani M, et al. Healthcare resource utilization and management of chronic, refractory low back pain in the United States. Spine (Phila Pa 1976). 2020 May 21;45(20):E1333–E1341. (Phila Pa 1976).
   PubMed Web of Science ®Google Scholar
• Tucker HR, Scaff K, McCloud T, et al. Harms and benefits of opioids for management of non-surgical acute and chronic low back pain: a systematic review. Br J Sports Med. 2020 Jun;54(11):664.
   PubMed Web of Science ®Google Scholar
• Petzke F, Klose P, Welsch P, et al. Opioids for chronic low back pain: an updated systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks of double-blind duration. Eur J Pain. 2020 Mar;24(3):497–517.
   PubMed Web of Science ®Google Scholar
• Margarit C, Roca R, Inda MD, et al. Sex bias and genotype influence on opioid safety profile in chronic low back pain. Clin J Pain. 2020 Jun;36(6):420–429.
   PubMed Web of Science ®Google Scholar
• Abdel Shaheed C, Maher CG, Buchbinder R, et al. Efficacy and harms of orally, intramuscularly or intravenously administered glucocorticoids for sciatica: a systematic review and meta-analysis. Eur J Pain. 2020 Mar;24(3):518–535.
   PubMed Web of Science ®Google Scholar
• McDonough AK, Curtis JR, Saag KG. The epidemiology of glucocorticoid-associated adverse events. Curr Opin Rheumatol. 2008 Mar;20(2):131–137.
   PubMed Web of Science ®Google Scholar
• Knezevic NN, Jovanovic F, Voronov D, et al. Do corticosteroids still have a place in the treatment of chronic pain? Front Pharmacol. 2018;9:1229.
   PubMed Web of Science ®Google Scholar
• Friedman BW, Esses D, Solorzano C, et al. A randomized placebo-controlled trial of single-dose IM corticosteroid for radicular low back pain. Spine (Phila Pa 1976). 2008 Aug 15;33(18):E624–9. (Phila Pa 1976).
   PubMed Web of Science ®Google Scholar
• Candido KD, Rana MV, Sauer R, et al. Concordant pressure paresthesia during interlaminar lumbar epidural steroid injections correlates with pain relief in patients with unilateral radicular pain. Pain Physician. 2013 Sep-Oct;16(5):497–511.
   PubMed Web of Science ®Google Scholar
• Nguyen C, Boutron I, Baron G, et al. Intradiscal glucocorticoid injection for patients with chronic low back pain associated with active discopathy: a randomized trial. Ann Intern Med. 2017 Apr 18;166(8):547–556.
   PubMed Web of Science ®Google Scholar
• Abdel Shaheed C, Maher CG, Williams KA, et al. Efficacy, tolerability, and dose-dependent effects of opioid analgesics for low back pain: a systematic review and meta-analysis. JAMA Intern Med. 2016 Jul 1;176(7):958–968.
   PubMed Web of Science ®Google Scholar
• Ballantyne JC. Avoiding opioid analgesics for treatment of chronic low back pain. JAMA. 2016Jun14;315(22):2459–2460.
   PubMed Web of Science ®Google Scholar
• Kawamata M, Iseki M, Kawakami M, et al. Efficacy and safety of controlled-release oxycodone for the management of moderate-to-severe chronic low back pain in Japan: results of an enriched enrollment randomized withdrawal study followed by an open-label extension study. J Pain Res. 2019;12:363–375.
   PubMed Web of Science ®Google Scholar
• Hale ME, Fleischmann R, Salzman R, et al. Efficacy and safety of controlled-release versus immediate-release oxycodone: randomized, double-blind evaluation in ptients with chronic back pain. Clin J Pain. 1999 Sep;15(3):179–183.
   PubMed Web of Science ®Google Scholar
• Kopecky EA, Vaughn B, Lagasse S, et al. Tolerability, safety, and effectiveness of oxycodone DETERx in elderly patients >/=65 years of age with chronic low back pain: a randomized controlled trial. Drugs Aging. 2017 Aug;34(8):603–613.
   PubMed Web of Science ®Google Scholar
• Katz N, Kopecky EA, O’Connor M, et al. A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. Pain. 2015 Dec;156(12):2458–2467.
   PubMed Web of Science ®Google Scholar
• Markman J, Meske DS, Kopecky EA, et al. Analgesic efficacy, safety, and tolerability of a long-acting abuse-deterrent formulation of oxycodone for moderate-to-severe chronic low back pain in subjects successfully switched from immediate-release oxycodone. J Pain Res. 2018;11:2051–2059.
   PubMed Web of Science ®Google Scholar
• Wen W, Sitar S, Lynch SY, et al. A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain. Expert Opin Pharmacother. 2015;16(11):1593–1606.
   PubMed Web of Science ®Google Scholar
• Hale ME, Ma Y, Malamut R. Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: safety, maintenance of analgesia, and abuse potential. J Opioid Manag 2016 May-Jun. ;12(2):139–147.
   PubMedGoogle Scholar
• Hale ME, Zimmerman TR, Eyal E, et al. Efficacy and safety of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in patients with moderate-to-severe chronic low back pain. J Opioid Manag 2015 Nov-Dec. ;11(6):507–518.
   PubMedGoogle Scholar
• Rauck RL, Nalamachu S, Wild JE, et al. Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: a randomized double-blind, placebo-controlled study. Pain Med. 2014 Jun;15(6):975–985.
   PubMed Web of Science ®Google Scholar
• Chu LF, D’Arcy N, Brady C, et al. Analgesic tolerance without demonstrable opioid-induced hyperalgesia: a double-blinded, randomized, placebo-controlled trial of sustained-release morphine for treatment of chronic nonradicular low-back pain. Pain 2012 Aug;153(8):1583–1592.
   PubMed Web of Science ®Google Scholar
• Hale M, Khan A, Kutch M, et al. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010 Jun;26(6):1505–1518.
   PubMed Web of Science ®Google Scholar
• Hale ME, Nalamachu SR, Khan A, et al. Effectiveness and gastrointestinal tolerability during conversion and titration with once-daily OROS(R) hydromorphone extended release in opioid-tolerant patients with chronic low back pain. J Pain Res. 2013;6:319–329.
   PubMed Web of Science ®Google Scholar
• Webster LR, Smith MD, Mackin S, et al. Comparative effects of morning vs. evening dosing of extended-release hydromorphone on sleep physiology in patients with low back pain: a pilot study. Pain Med. 2015 Mar;16(3):460–471.
   PubMed Web of Science ®Google Scholar
• Hale ME, Ahdieh H, Ma T, et al. Efficacy and safety of OPANA ER (oxymorphone extended release) for relief of moderate to severe chronic low back pain in opioid-experienced patients: a 12-week, randomized, double-blind, placebo-controlled study. J Pain. 2007 Feb;8(2):175–184.
   PubMed Web of Science ®Google Scholar
• Katz N, Rauck R, Ahdieh H, et al. A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain. Curr Med Res Opin. 2007 Jan;23(1):117–128.
   PubMed Web of Science ®Google Scholar
• Etropolski MS, Okamoto A, Shapiro DY, et al. Dose conversion between tapentadol immediate and extended release for low back pain. Pain Physician. 2010 Jan-Feb;13(1):61–70.
   PubMed Web of Science ®Google Scholar
• Vorsanger GJ, Xiang J, Gana TJ, et al. Extended-release tramadol (tramadol ER) in the treatment of chronic low back pain. J Opioid Manag. 2008 Mar-Apr. ;4(2):87–97.
   PubMedGoogle Scholar
• Schnitzer TJ, Gray WL, Paster RZ, et al. Efficacy of tramadol in treatment of chronic low back pain. J Rheumatol. 2000 Mar;27(3):772–778.
   PubMed Web of Science ®Google Scholar
• Gimbel J, Spierings EL, Katz N, et al. Efficacy and tolerability of buccal buprenorphine in opioid-experienced patients with moderate to severe chronic low back pain: results of a phase 3, enriched enrollment, randomized withdrawal study. Pain. 2016 Nov;157(11):2517–2526.
   PubMed Web of Science ®Google Scholar
• Gordon A, Callaghan D, Spink D, et al. Buprenorphine transdermal system in adults with chronic low back pain: a randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase. Clin Ther. 2010 May;32(5):844–860.
   PubMed Web of Science ®Google Scholar
• Steiner DJ, Sitar S, Wen W, et al. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011 Dec;42(6):903–917.
   PubMed Web of Science ®Google Scholar
• Gordon A, Rashiq S, Moulin DE, et al. Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain. Pain Res Manag. 2010 May-Jun;15(3):169–178.
   PubMed Web of Science ®Google Scholar
• Rauck RL, Hale ME, Bass A, et al. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Pain. 2015 Sep;156(9):1660–1669.
   PubMed Web of Science ®Google Scholar
• Cloutier C, Taliano J, O’Mahony W, et al. Controlled-release oxycodone and naloxone in the treatment of chronic low back pain: a placebo-controlled, randomized study. Pain Res Manag. 2013 Mar-Apr;18(2):75–82.
   PubMed Web of Science ®Google Scholar
• Vondrackova D, Leyendecker P, Meer W, et al. Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain. 2008 Dec;9(12):1144–1154.
   PubMed Web of Science ®Google Scholar
• Ueberall MA, Mueller-Schwefe GH. Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine for the treatment of chronic low back pain: results of a 12 week prospective, randomized, open-label blinded endpoint streamlined study with prolonged-release preparations. Curr Med Res Opin. 2015;31(7):1413–1429.
   PubMed Web of Science ®Google Scholar
• Webster LR, Butera PG, Moran LV, et al. Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain. J Pain. 2006 Dec;7(12):937–946.
   PubMed Web of Science ®Google Scholar
• Allan L, Richarz U, Simpson K, et al. Transdermal fentanyl versus sustained release oral morphine in strong-opioid naive patients with chronic low back pain. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2484–2490. (Phila Pa 1976).
   PubMed Web of Science ®Google Scholar
• Christoph A, Eerdekens MH, Kok M, et al. Cebranopadol, a novel first-in-class analgesic drug candidate: first experience in patients with chronic low back pain in a randomized clinical trial. Pain 2017 Sep;158(9):1813–1824.
   PubMed Web of Science ®Google Scholar
• Baron R, Jansen JP, Binder A, et al. Tolerability, safety, and quality of life with tapentadol prolonged release (PR) compared with oxycodone/naloxone PR in patients with severe chronic low back pain with a neuropathic component: a randomized, controlled, open-label, phase 3b/4 trial. Pain Pract. 2016 Jun;16(5):600–619.
   PubMed Web of Science ®Google Scholar
• Baron R, Martin-Mola E, Muller M, et al. Effectiveness and safety of tapentadol prolonged release (PR) versus a combination of tapentadol PR and pregabalin for the management of severe, chronic low back pain with a neuropathic component: a randomized, double-blind, phase 3b study. Pain Pract. 2015 Jun;15(5):455–470.
   PubMed Web of Science ®Google Scholar
• Buynak R, Shapiro DY, Okamoto A, et al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study. Expert Opin Pharmacother. 2010 Aug;11(11):1787–1804. .
   PubMed Web of Science ®Google Scholar
• Hale ME, Dvergsten C, Gimbel J. Efficacy and safety of oxymorphone extended release in chronic low back pain: results of a randomized, double-blind, placebo- and active-controlled phase III study. J Pain. 2005 Jan;6(1):21–28.
   PubMed Web of Science ®Google Scholar
• Rauck RL, Bookbinder SA, Bunker TR, et al. A randomized, open-label study of once-a-day AVINZA (morphine sulfate extended-release capsules) versus twice-a-day OxyContin (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: the extension phase of the ACTION trial. J Opioid Manag. 2006 Nov-Dec. ;2(6):325–8, 331–3.
   Google Scholar
• Steiner D, Munera C, Hale M, et al. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163–1173.
   PubMed Web of Science ®Google Scholar
• Lilly E FDA approves cymbalta® for the management of chronic musculoskeletal pain [Last accessed 2020 December 23]. Available from: https://investor.lilly.com/static-files/c5a45faf-219c-4899-ad6b-d453c918ad8e
   Google Scholar
• Ferreira GE, McLachlan AJ, Lin CC, et al. Efficacy and safety of antidepressants for the treatment of back pain and osteoarthritis: systematic review and meta-analysis. BMJ 2021 Jan 20;372:m4825.
   PubMed Web of Science ®Google Scholar
• Konno S, Oda N, Ochiai T, et al. Randomized, double-blind, placebo-controlled phase iii trial of duloxetine monotherapy in japanese patients with chronic low back pain. Spine (Phila Pa 1976). 2016 Nov 15;41(22):1709–1717. (Phila Pa 1976).
   PubMed Web of Science ®Google Scholar
• Skljarevski V, Ossanna M, Liu-Seifert H, et al. A double-blind, randomized trial of duloxetine versus placebo in the management of chronic low back pain. Eur J Neurol. 2009 Sep;16(9):1041–1048.
   PubMed Web of Science ®Google Scholar
• Skljarevski V, Desaiah D, Liu-Seifert H, et al. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578–85. (Phila Pa 1976).
   PubMed Web of Science ®Google Scholar
• Skljarevski V, Zhang S, Desaiah D, et al. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. J Pain. 2010 Dec;11(12):1282–1290.
   PubMed Web of Science ®Google Scholar
• Schukro RP, Oehmke MJ, Geroldinger A, et al. Efficacy of duloxetine in chronic low back pain with a neuropathic component: a randomized, double-blind, placebo-controlled crossover trial. Anesthesiology 2016 Jan;124(1):150–158.
   PubMed Web of Science ®Google Scholar
• Schliessbach J, Siegenthaler A, Butikofer L, et al. Effect of single-dose imipramine on chronic low-back and experimental pain. A randomized controlled trial. PLoS One. 2018;13(5):e0195776.
   PubMed Web of Science ®Google Scholar
• van den Driest JJ, Sma B-Z, Bindels PJE, et al. Amitriptyline for musculoskeletal complaints: a systematic review. Fam Pract. 2017 Apr 1;34(2):138–146.
   PubMed Web of Science ®Google Scholar
• Urquhart DM, Wluka AE, van Tulder M, et al. Efficacy of Low-Dose Amitriptyline for Chronic Low Back Pain: a Randomized Clinical Trial. JAMA Intern Med. 2018 Nov 1;178(11):1474–1481.
   PubMed Web of Science ®Google Scholar
• Katz J, Pennella-Vaughan J, Hetzel RD, et al. A randomized, placebo-controlled trial of bupropion sustained release in chronic low back pain. J Pain. 2005 Oct;6(10):656–661.
   PubMed Web of Science ®Google Scholar
• Atkinson HJ, Slater MA, Williams RA, et al. A placebo-controlled randomized clinical trial of nortriptyline for chronic low back pain. Pain 1998 Jun;76(3):287–296.
   PubMed Web of Science ®Google Scholar
• Gould HM, Atkinson JH, Chircop-Rollick T, et al. A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain 2020 Jun;161(6):1341–1349.
   PubMed Web of Science ®Google Scholar
• Marks DM, Pae CU, Patkar AA. A double-blind, placebo-controlled, parallel-group pilot study of milnacipran for chronic radicular pain (sciatica) associated with lumbosacral disc disease. Prim Care Companion CNS Disord. 2014;16(4). https://doi.org/10.4088/PCC.14m01658.
   Google Scholar
• Atkinson JH, Slater MA, Capparelli EV, et al. Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: a preliminary concentration-controlled trial. J Clin Psychopharmacol. 2007 Apr;27(2):135–142.
   PubMed Web of Science ®Google Scholar
• Schreiber S, Vinokur S, Shavelzon V, et al. A randomized trial of fluoxetine versus amitriptyline in musculo-skeletal pain. Isr J Psychiatry Relat Sci. 2001;38(2):88–94.
   PubMed Web of Science ®Google Scholar
• Mazza M, Mazza O, Pazzaglia C, et al. Escitalopram 20 mg versus duloxetine 60 mg for the treatment of chronic low back pain. Expert Opin Pharmacother. 2010 May;11(7):1049–1052.
   PubMed Web of Science ®Google Scholar
• Atkinson JH, Slater MA, Wahlgren DR, et al. Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain 1999 Nov;83(2):137–145.
   PubMed Web of Science ®Google Scholar
• Finnerup NB, Attal N, Haroutounian S, et al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162–173. .
   PubMed Web of Science ®Google Scholar
• Knezevic NN, Jovanovic F, Candido KD, et al. Oral pharmacotherapeutics for the management of peripheral neuropathic pain conditions - a review of clinical trials. Expert Opin Pharmacother. 2020 Dec;21(18):2231-2248.
   PubMed Web of Science ®Google Scholar
• Baron R, Freynhagen R, Tolle TR, et al. The efficacy and safety of pregabalin in the treatment of neuropathic pain associated with chronic lumbosacral radiculopathy. Pain 2010 Sep;150(3):420–427.
   PubMed Web of Science ®Google Scholar
• Shanthanna H, Gilron I, Rajarathinam M, et al. Benefits and safety of gabapentinoids in chronic low back pain: a systematic review and meta-analysis of randomized controlled trials. PLOS Med. 2017 Aug;14(8):e1002369.
   PubMed Web of Science ®Google Scholar
• Atkinson JH, Slater MA, Capparelli EV, et al. A randomized controlled trial of gabapentin for chronic low back pain with and without a radiating component. Pain 2016 Jul;157(7):1499–1507.
   PubMed Web of Science ®Google Scholar
• Khoromi S, Patsalides A, Parada S, et al. Topiramate in chronic lumbar radicular pain. J Pain. 2005 Dec;6(12):829–836.
   PubMed Web of Science ®Google Scholar
• Muehlbacher M, Nickel MK, Kettler C, et al. Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study. Clin J Pain. 2006 Jul-Aug;22(6):526–531.
   PubMed Web of Science ®Google Scholar
• Oliveira CB, Maher CG, Pinto RZ, et al. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791–2803.
   PubMed Web of Science ®Google Scholar
• Enthoven WT, Roelofs PD, Deyo RA, et al. Non-steroidal anti-inflammatory drugs for chronic low back pain. Cochrane Database Syst Rev. 2016 Feb 10;2:CD012087.
   PubMed Web of Science ®Google Scholar
• Machado GC, Maher CG, Ferreira PH, et al. Non-steroidal anti-inflammatory drugs for spinal pain: a systematic review and meta-analysis. Ann Rheum Dis. 2017 Jul;76(7):1269–1278.
   PubMed Web of Science ®Google Scholar
• Katz N, Ju WD, Krupa DA, et al. Efficacy and safety of rofecoxib in patients with chronic low back pain: results from two 4-week, randomized, placebo-controlled, parallel-group, double-blind trials. Spine (Phila Pa 1976). 2003. May1. 28. (Phila Pa 1976). ;(9):851–858; discussion 859.
   PubMed Web of Science ®Google Scholar
• Yang JH, Suk KS, Lee BH, et al. Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: prospective, Randomized, Single Center, Open-Label Clinical Trials. Yonsei Med J. 2017 May;58(3):637–643.
   PubMed Web of Science ®Google Scholar
• Birbara CA, Puopolo AD, Munoz DR, et al. Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability–a randomized, placebo-controlled, 3-month trial. J Pain. 2003 Aug;4(6):307–315.
   PubMed Web of Science ®Google Scholar
• Pallay RM, Seger W, Adler JL, et al. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257–266.
   PubMed Web of Science ®Google Scholar
• Zerbini C, Ozturk ZE, Grifka J, et al. Efficacy of etoricoxib 60 mg/day and diclofenac 150 mg/day in reduction of pain and disability in patients with chronic low back pain: results of a 4-week, multinational, randomized, double-blind study. Curr Med Res Opin. 2005 Dec;21(12):2037–2049.
   PubMed Web of Science ®Google Scholar
• Coats TL, Borenstein DG, Nangia NK, et al. Effects of valdecoxib in the treatment of chronic low back pain: results of a randomized, placebo-controlled trial. Clin Ther. 2004 Aug;26(8):1249–1260.
   PubMed Web of Science ®Google Scholar
• Rossi M, Ianigro G, Liberatoscioli G, et al. Eperisone versus tizanidine for treatment of chronic low back pain. Minerva Med.2012 Jun;103(3):143–149.
   Google Scholar
• Schliessbach J, Vuilleumier PH, Siegenthaler A, et al. Analgesic effect of clobazam in chronic low-back pain but not in experimentally induced pain. Eur J Pain. 2017 Sep;21(8):1336–1345.
   PubMed Web of Science ®Google Scholar
• Levi-Montalcini R, Angeletti PU. Essential role of the nerve growth factor in the survival and maintenance of dissociated sensory and sympathetic embryonic nerve cells in vitro. Dev Biol. 1963 Mar;6:653–659.
   PubMed Web of Science ®Google Scholar
• Garcia-Cosamalon J, Del Valle ME, Calavia MG, et al. Intervertebral disc, sensory nerves and neurotrophins: who is who in discogenic pain? J Anat. 2010 Jul;217(1):1–15.
   PubMed Web of Science ®Google Scholar
• Gimbel JS, Kivitz AJ, Bramson C, et al. Long-term safety and effectiveness of tanezumab as treatment for chronic low back pain. Pain 2014 Sep;155(9):1793–1801.
   PubMed Web of Science ®Google Scholar
• Markman JD, Bolash RB, McAlindon TE, et al. Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety. Pain 2020 May 19;161(9):2068–2078.
   Web of Science ®Google Scholar
• Sanga P, Polverejan E, Wang S, et al. Efficacy, safety, and tolerability of fulranumab as an adjunctive therapy in patients with inadequately controlled, moderate-to-severe chronic low back pain: a randomized, double-blind, placebo-controlled, dose-ranging, dose-loading phase ii study. Clin Ther. 2016 Jun;38(6):1435–1450.
   PubMed Web of Science ®Google Scholar
• Devers A, Galer BS. Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. Clin J Pain. 2000 Sep;16(3):205–208.
   PubMed Web of Science ®Google Scholar
• Dalpiaz AS, Lordon SP, Lipman AG. Topical lidocaine patch therapy for myofascial pain. J Pain Palliat Care Pharmacother. 2004;18(3):15–34.
   PubMedGoogle Scholar
• Hines R, Keaney D, Moskowitz MH, et al. Use of lidocaine patch 5% for chronic low back pain: a report of four cases. Pain Med. 2002 Dec;3(4):361–365.
   PubMed Web of Science ®Google Scholar
• Santana JA, Klass S, Felix ER, et al. Effectiveness and Safety of 5% Transdermal Lidocaine Patch for Chronic Low Back Pain: a Narrative Review. Pm R. 2020 Mar 18;12(12):1260–1267.
   PubMedGoogle Scholar
• Argoff CE, Galer BS, Jensen MP, et al. Effectiveness of the lidocaine patch 5% on pain qualities in three chronic pain states: assessment with the Neuropathic Pain Scale. Curr Med Res Opin. 2004;20(Suppl 2):S21–8.
   PubMed Web of Science ®Google Scholar
• Galer BS, Gammaitoni AR, Oleka N, et al. Use of the lidocaine patch 5% in reducing intensity of various pain qualities reported by patients with low-back pain. Curr Med Res Opin. 2004;20(Suppl 2):S5–12.
   PubMed Web of Science ®Google Scholar
• Gimbel J, Linn R, Hale M, et al. Lidocaine patch treatment in patients with low back pain: results of an open-label, nonrandomized pilot study. Am J Ther 2005 Jul-Aug. ;12(4):311–319.
   PubMedGoogle Scholar
• White WT, Patel N, Drass M, et al. Lidocaine patch 5% with systemic analgesics such as gabapentin: a rational polypharmacy approach for the treatment of chronic pain. Pain Med. 2003 Dec;4(4):321–330.
   PubMed Web of Science ®Google Scholar
• Castro E, Dent D. A comparison of transdermal over-the-counter lidocaine 3.6% menthol 1.25%, Rx lidocaine 5% and placebo for back pain and arthritis. Pain Manag. 2017 Nov;7(6):489–498.
   PubMed Web of Science ®Google Scholar
• Chrubasik S, Weiser T, Beime B. Effectiveness and safety of topical capsaicin cream in the treatment of chronic soft tissue pain. Phytother Res. 2010 Dec;24(12):1877–1885.
   PubMed Web of Science ®Google Scholar
• Predel HG, Ebel-Bitoun C, Peil B, et al. Efficacy and safety of diclofenac + capsaicin gel in patients with acute back/neck pain: a multicenter randomized controlled study. Pain Ther. 2020 Jun;9(1):279–296.
   PubMed Web of Science ®Google Scholar
• O’Donnell JB, Ekman EF, Spalding WM, et al. The effectiveness of a weak opioid medication versus a cyclo-oxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drug in treating flare-up of chronic low-back pain: results from two randomized, double-blind, 6-week studies. J Int Med Res 2009 Nov-Dec. ;37(6):1789–1802.
   PubMed Web of Science ®Google Scholar
• Burgher AH, Hoelzer BC, Schroeder DR, et al. Transforaminal epidural clonidine versus corticosteroid for acute lumbosacral radiculopathy due to intervertebral disc herniation. Spine (Phila Pa 1976). 2011 Mar 1;36(5):E293–300. (Phila Pa 1976).
   PubMed Web of Science ®Google Scholar
• Uberall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study. Curr Med Res Opin. 2012 Oct;28(10):1617–1634.
   PubMed Web of Science ®Google Scholar
• Kalita J, Kohat AK, Misra UK, et al. An open labeled randomized controlled trial of pregabalin versus amitriptyline in chronic low backache. J Neurol Sci. 2014 Jul 15;342(1–2):127–132.
   PubMed Web of Science ®Google Scholar
• Kivitz AJ, Gimbel JS, Bramson C, et al. Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain. Pain 2013 Jul;154(7):1009–1021.
   PubMed Web of Science ®Google Scholar
• Katz N, Borenstein DG, Birbara C, et al. Efficacy and safety of tanezumab in the treatment of chronic low back pain. Pain 2011 Oct;152(10):2248–2258.
   PubMed Web of Science ®Google Scholar
• Cohen SP, Hanling S, Bicket MC, et al. Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study. BMJ 2015 Apr 16;350(apr16 26):h1748.
   PubMed Web of Science ®Google Scholar
• Sakai Y, Ito K, Hida T, et al. Pharmacological management of chronic low back pain in older patients: a randomized controlled trial of the effect of pregabalin and opioid administration. Eur Spine J. 2015 Jun;24(6):1309–1317.
   PubMed Web of Science ®Google Scholar
• Khoromi S, Cui L, Nackers L, et al. Morphine, nortriptyline and their combination vs. placebo in patients with chronic lumbar root pain. Pain 2007 Jul;130(1–2):66–75.
   PubMed Web of Science ®Google Scholar
• Romano CL, Romano D, Bonora C, et al. Pregabalin, celecoxib, and their combination for treatment of chronic low-back pain. J Orthop Traumatol. 2009 Dec;10(4):185–191.
   PubMedGoogle Scholar
• Pota V, Barbarisi M, Sansone P, et al. Combination therapy with transdermal buprenorphine and pregabalin for chronic low back pain. Pain Manag. 2012 Jan;2(1):23–31.
   PubMedGoogle Scholar
• Machado GC, Maher CG, Ferreira PH, et al. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials. BMJ 2015 Mar 31;350(mar31 2):h1225.
   PubMed Web of Science ®Google Scholar
• Peloso PM, Fortin L, Beaulieu A, et al. Analgesic efficacy and safety of tramadol/acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol. 2004 Dec;31(12):2454–2463.
   PubMed Web of Science ®Google Scholar
• Lee JH, Lee CS, Ultracet ERSG. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain. Clin Ther. 2013 Nov;35(11):1830–1840.
   PubMed Web of Science ®Google Scholar
• Ruoff GE, Rosenthal N, Jordan D, et al. Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study. Clin Ther. 2003 Apr;25(4):1123–1141.
   PubMed Web of Science ®Google Scholar
• Schiphorst Preuper HR, Geertzen JH, van Wijhe M, et al. Do analgesics improve functioning in patients with chronic low back pain? An explorative triple-blinded RCT. Eur Spine J. 2014 Apr;23(4):800–806.
   PubMed Web of Science ®Google Scholar
• Enke O, New HA, New CH, et al. Anticonvulsants in the treatment of low back pain and lumbar radicular pain: a systematic review and meta-analysis. CMAJ. 2018 Jul 3;190(26):E786–E793.
   PubMed Web of Science ®Google Scholar
• Abdel Shaheed C, Maher CG, Williams KA, et al. Efficacy and tolerability of muscle relaxants for low back pain: systematic review and meta-analysis. Eur J Pain. 2017 Feb;21(2):228–237.
   PubMed Web of Science ®Google Scholar
• Wilson N, Kariisa M, Seth P, et al. Drug and Opioid-Involved Overdose Deaths - United States, 2017-2018. MMWR Morb Mortal Wkly Rep. 2020 Mar 20;69(11):290–297.
   PubMed Web of Science ®Google Scholar
• Harden RN, Gagnon CM, Graciosa J, et al. Negligible analgesic tolerance seen with extended release oxymorphone: a post hoc analysis of open-label longitudinal data. Pain Med. 2010 Aug;11(8):1198–1208.
   PubMed Web of Science ®Google Scholar
• Portenoy RK, Raffaeli W, Torres LM, et al. Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients. J Opioid Manag 2010 Sep-Oct. ;6(5):319–328.
   PubMedGoogle Scholar
• Vydra D, McCormick Z, Clements N, et al. Current trends in steroid dose choice and frequency of administration of epidural steroid injections: a survey study. Pm R. 2020 Jan;12(1):49–54.
   PubMedGoogle Scholar
• Manchikanti L, Pampati V, Boswell MV, et al. Analysis of the growth of epidural injections and costs in the Medicare population: a comparative evaluation of 1997, 2002, and 2006 data. Pain Physician. 2010 May-Jun;13(3):199–212. .
   PubMed Web of Science ®Google Scholar
• Manchikanti L, Pampati V, Soin A, et al. Trends of expenditures and utilization of facet joint interventions in fee-for-service (FFS) medicare population from 2009-2018. Pain Physician. 2020 May;23(3S):S129–S147.
   PubMed Web of Science ®Google Scholar
• Sanapati J, Manchikanti L, Atluri S, et al. Do regenerative medicine therapies provide long-term relief in chronic low back pain: a systematic review and metaanalysis. Pain Physician. 2018 Nov;21(6):515–540.
   PubMed Web of Science ®Google Scholar
• Suntsov V, Jovanovic F, Knezevic E, et al. Can Implementation of genetics and pharmacogenomics improve treatment of chronic low back pain? Pharmaceutics 2020 Sep 21;12(9):894.
   PubMed Web of Science ®Google Scholar