Using the SAFE principles when evaluating electrical stimulation therapies for the pain of failed back surgery syndrome

Neuromodulation

Volumn 14, Issue 4, 2011, Pages 299-311

  Krames, Elliot S ^a   Monis, Sayed ^b   Poree, Lawrence ^c   Deer, Timothy ^d,e   Levy, Robert ^f  

^a Pacific Pain Treatment Centers   (United States)

^b Neuro Spine and Headache Pain Management Center   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Center for Pain Relief Inc   (United States)

^e West Virginia University School of Medicine Charleston   (United States)

^f NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Algorithm; continuum of care; failed back surgery syndrome; neuromodulation; pain therapies; SAFE principles; SCS; spinal cord stimulation

Indexed keywords

ANTICONVULSIVE AGENT; ANTIDEPRESSANT AGENT; BACLOFEN; NONSTEROID ANTIINFLAMMATORY AGENT; OPIATE;

ANXIETY; ARACHNOIDITIS; ARTHRODESIS; BEHAVIOR THERAPY; CLINICAL ASSESSMENT TOOL; COGNITIVE THERAPY; CONSERVATIVE TREATMENT; DEPRESSION; DISEASE PREDISPOSITION; ELECTROSTIMULATION; FAILED BACK SURGERY SYNDROME; HEALTH CARE COST; HUMAN; INTERVERTEBRAL DISKECTOMY; JOINT HYPERMOBILITY; JOINT MOBILITY; LAMINECTOMY; LUMBAR DISK HERNIA; NERVE COMPRESSION; NEUROMODULATION; NEUROPATHIC PAIN; PATIENT SATISFACTION; PHYSIOTHERAPY; POSTOPERATIVE HEMORRHAGE; POSTOPERATIVE INFECTION; PULSE GENERATOR; QUALITY OF LIFE; REVIEW; SAFETY,APPROPRIATENESS,FISCAL NEUTRALITY,AND EFFECTIVENESS; SCAR; SPINAL CORD STIMULATION; SPINAL PAIN; SPINE SURGERY; TRANSCUTANEOUS NERVE STIMULATION; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

COST-BENEFIT ANALYSIS; ELECTRIC STIMULATION THERAPY; FAILED BACK SURGERY SYNDROME; HUMANS;

EID: 80051545033     PISSN: 10947159     EISSN: 15251403     Source Type: Journal    
DOI: 10.1111/j.1525-1403.2011.00373.x     Document Type: Review

References (101)

1. Krames E,. Interventional pain management appropriate when less invasive therapies fail to provide adequate analgesia. Med Clin North Am 1999; 83: 787-808. (Pubitemid 29259147)
2. North RB, Kidd D, Shipley J, Taylor R,. SCS versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized controlled trial. Clinical studies. Neurosurgery 2007; 61: 361-369.
3. Kumar K, Malik S, Denny D,. Treatment of chronic pain with scs versus alternative therapies: cost-effectiveness analysis. Neurosurgery 2002; 51: 106-116. (Pubitemid 36331105)
4. Kumar K, Taylor R, Jacques L, et al,. SCS versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain 2008; 132: 179-188. (Pubitemid 47500132)
5. Krames E, Poree L, Deer T, Levy R,. Rethinking algorithms of pain care: the use of the SAFE principles. Pain Med 2009; 10: 1-5.
6. Krames E, Poree L, Deer T, Levy R,. Implementing the SAFE principles for the development of pain medicine therapeutic algorithms that include neuromodulation techniques. Neuromodulation 2009; 12: 104-113. doi: 10.1111/j.1525-1403.2009.00197.x.
7. Deyo RA, Gray DT, Kreuter W, et al,. Unted States trends in lumbar fusion surgery for degenerative conditions. Spine 2005; 30: 1441-1445. (Pubitemid 41760293)
8. Burton CV,. Failed back surgery patients: the alarm bells are ringing. Surg Neurol 2006; 65: 5-6. (Pubitemid 43003421)
9. De Lissovoy G, Brown RE, Halpern M, Hassenbusch SJ, Ross E,. Cost effectiveness of long-term intrathecal morphine for pain associated with failed back syndrome. Clin Ther 1997; 19: 96-112. (Pubitemid 27186442)
10. Straus BN,. Chronic pain of spinal origin: the costs of intervention. Spine 2002; 27: 2614-2619.
11. Wilkinson HA,. The failed back syndrome: etiology and therapy, 2nd ed. Philadelphia: Harper & Row, 1991.
12. Wang MC, Kreuter W, Wolfla C, Maiman D, Deyo R,. Trends and variations in cervical spine surgery in the United States: Medicare Beneficiaries, 1992 to 2005. Spine 2009; 34: 955-961.
13. Deyo RA, Nachemson A, Mirza SK,. Spinal-fusion surgery: the case for restraint. N Engl J Med 2004; 350: 722-726.
14. Keane GP,. Failed low back surgery syndrome. In:, Cole AJ, ed. The low back pain handbook. Philadelphia: Mosby, 1997: 269-281.
15. Quigley MR, Bost J, Maroon JC, Elrifai A, Panahandeh M,. Outcome after microdiscectomy: results of a prospective single institutional study. Surg Neurol 1998; 49: 263-267.
16. Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD,. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine 2009; 34: 1094-1109.
17. Kumar K, Taylor R, Jacques L, et al,. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24 month follow up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery 2008; 63: 762-770.
18. Waguespack A, Schofferman J, Slasar P, Reynolds J,. Etiology of long-term failures of lumbar spine surgery. Pain Med 2002; 3: 18-22. (Pubitemid 34520523)
19. Bolt PM, Wahl MM, Schofferman J,. The roles of the hip, spine, sacroiliac joint, and other structures in patients with persistent pain after back surgery. Semin Spine Surg 2008; 20: 14-19. (Pubitemid 351172799)
20. Martin B, Mirza SK, Comstock B, et al,. Reoperation rates following lumbar spine surgery and the influence of spinal fusion procedures. Spine 2007; 32: 382-387. (Pubitemid 46197482)
21. Katz JN, Lipson SJ, Chang LC, et al,. Seven-to 10-year outcome of decompressive surgery for degenerative lumbar spinal stenosis. Spine 1996; 21: 92-97.
22. Keskimäki I,. Reoperations after lumbar disc surgery: a population-based study of regional and interspecialty variations. Spine 2000; 25: 1500-1508.
23. Ã-sterman H, Sund R, Seitsalo S, Keskimäki I,. Risk of multiple reoperations after lumbar discectomy: a population-based study. Spine 2003; 28: 621-627.
24. Malter AD, Mcneney B, Loeser JD, Deyo RA,. 5-Year reoperation rates after different types of lumbar spine surgery. Spine 1998; 23: 814-820. (Pubitemid 28169210)
25. Loeser JD, Bigos SJ, Fordyce WE, Volinn EP,. Low back pain. In:, Bonica JJ, ed. The management of pain, 2nd ed. Philadelphia: Lea & Febiger, 1990; 1148-1183.
26. North RB, Roark GL,. Spinal cord stimulation for chronic pain. [Review]. Neurosurg Clin North Am 1995; 6: 145-155.
27. North RB, Campbell JN, James CS, et al,. Failed back surgery syndrome: 5-year follow up in 102 patients undergoing repeated operation. Neurosurgery 1991; 28: 685-690.
28. North RB, Ewend MG, Lawton MT, Kidd DH, Piantodosi S,. Failed back surgery syndrome: 5-year lollow-up after spinal cord stimulator implantation. Neurosurgery 1991; 28: 692-699.
29. Krames E,. Spinal cord stimulation: indications, mechanism of action, and efficacy. Curr Pain Headache Rep 1999; 3: 419-426.
30. Linderoth B, Foreman RD,. Physiology of spinal cord stimulation: review and update. Neuromodulation 2002; 2: 150-164.
31. Cui JG, Meyerson BA, Sollevi A, Linderoth B,. Effects of spinal cord stimulation on tactile hypersensitivity in mononeuropathic rats is potentiated by GABA-B and adenosine receptor activation. Neurosci Lett 1998; 247: 183-186. (Pubitemid 28240127)
32. Meyerson BA, Cui J-G, Yakhnitsa V, et al,. Modulation of spinal pain mechanisms by spinal cord stimulation and the potential role of adjuvant pharmacotherapy. Stereotact Funct Neurosurg 1997; 68: 129-140. (Pubitemid 28312105)
33. Larson SJ, Sances A Jr, Riegel DH, et al,. Neurophysiological effects of dorsal column stimulation in man and monkey. J Neurosurg 1974; 41: 217-223.
34. Saade NE, Tabet MS, Soueidan SA, et al,. Supraspinal modulation of nociception in awake rats by stimulation of the dorsal column nuclei. Brain Res 1986; 369: 307-310. (Pubitemid 16047410)
35. Linderoth B, Fedorcsak I, Meyerson BA,. Is vasodilatation following dorsal column stimulation mediated by antidromic activation of small diameter fibers? Acta Neurochir Suppl 1989; 46: 99-101.
36. De Andrede DC, Bendib B, Hattou M, Keravel Y, Nguyean JP, Lefaucheur JP,. Neurophysiological assessment of spinal cord stimulation in failed back surgery syndrome. Pain 2010; 150: 485-491.
37. Melzack K, Wall PD,. Pam mechanism®: a new theory. Science 1965; 150: 971-979.
38. Shealy CM, Mortimer JT, Reswick JB,. Electrical inhibition of pain by stimulation of the dorsal columns. Anesth Analg 1967; 46: 489-491.
39. Rampersaud YR, Moro ERP, Neary MA, et al,. Intraoperative adverse events and related postoperative complications in spine surgery: implications for enhancing patient safety founded on evidence-based protocols. Spine 2006; 31: 1503-1510. (Pubitemid 43880200)
40. Singh G,. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998; 105: 31S-38S. (Pubitemid 28378015)
41. Wolfe MM, Lichtenstein DR, Singh G,. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. N Engl J Med 1999; 340: 1888-1899. (Pubitemid 29272670)
42. Fennerty MB,. NSAID-related gastrointestinal injury: evidence-based approach to a preventable complication. Postgrad Med 2001; 110: 87-89.
43. Daniell HW,. Opioid endocrinopathy in women consuming prescribed sustained-action opioids for control of nonmalignant pain. J Pain 2008; 9: 28-36. (Pubitemid 350309727)
44. Daniell HW,. Hypogonadism in men consuming sustained-action oral opioids. J Pain 2002; 3: 377-384. (Pubitemid 35176459)
45. Daniell HW,. DHEAS deficiency during consumption of sustained-action prescribed opioid-evidence for opioid-induced inhibition of adrenal androgen production. J Pain 2006; 7: 901-907. (Pubitemid 44854733)
46. Panchal SJ, Muller-Schweffe P, Wurzelmann JI,. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int J Clin Pract 2007; 61: 1181-1187. (Pubitemid 46934629)
47. Banning A, Sjogren P,. Cerebral effects of long-term oral opioids in cancer patients measured by continuous reaction time. Clin J Pain 1990; 6: 91-95. (Pubitemid 20342851)
48. Bowen JD, Larson EB,. Drug-induced cognitive impairment. Defining the problem and finding solutions. Drugs Aging 1993; 3: 349-357.
49. Chapman S,. The effects of opioids on driving ability in patients with chronic pain. APS Bull 2001; 11: 1-5.
50. Galski T, Williams JB, Ehle HT,. Effects of opioids on driving ability. J Pain Symptom Manage 2000; 19: 200-208. (Pubitemid 30173234)
51. Wang D, Teichtahl H, Drummer O, et al,. Central sleep apnea in stable methadone maintenance treatment patients. Chest 2005; 128: 1348-1356. (Pubitemid 41324417)
52. Walker JM, Farney RJ, Rhondeau SM, et al,. Chronic opioid use is a risk factor for the development of central sleep apnea and ataxic breathing. J Clin Sleep Med 2007; 3: 455-461. (Pubitemid 47378247)
53. McCrimmon DR, Alheid GF,. On the opiate trail of respiratory depression. Am J Physiol Regul Integr Comp Physiol 2003; 285: R1274-R1275. (Pubitemid 37464386)
54. Okie S,. A flood of opioids, a rising tide of deaths. N Engl J Med 2010; 363: 1981-1985.
55. Brox JI, Sorensen R, Friis A, et al,. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and isc degeneration. Spine 2003; 28: 1913-1921. (Pubitemid 37082653)
56. Fairbank J, Frost H, Wilson-MacDonald J, et al,. Randomized controlled trial to compare surgical stabilization of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilization trial. BMJ 2005; 330: 1485. (Pubitemid 40897258)
57. Fritzell P, Hagg O, Wessberg P, et al,. Swedish lumbar study group. 2001 Volvo Award Winner in clinical studies: lumbar fusion versus non-surgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine 2001; 26: 2521-2532.
58. Ibraham T, Tleyjeh M, Gabbar O,. Surgical versus non-surgical treatment of chronic low back pain: a meta-analysis of randomized trials. Int Orthop 2008; 32: 107-113. (Pubitemid 351170085)
59. Stevens W, Glazer P, Kelly S, et al,. Ophthalmic complications after spinal surgery. Spine 1997; 22: 1319-1324. (Pubitemid 27268534)
60. Kumar K, Wilson JR, Taylor RS, Gupta S,. Complications of SCS, suggestions to improve outcome, and financial impact. J Neurosurg 2006; 5: 191-203. (Pubitemid 47325383)
61. Cameron T,. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20 year review. J Neurosurg Spine 2004; 100: 254-267. (Pubitemid 38294988)
62. Turner JA, Hollingworth W, Comstock BA, Deyo RA,. Spinal ord stimulation for failed back surgery syndrome: outcomes in a workers' compensation setting. Pain 2010; 148: 14-25.
63. Block AR, Ohnmeiss DD, Guyer RD, et al,. the use of presurgical psychological screening to predict the outcome of spine surgery. Spine J 2001; 1: 274-282. (Pubitemid 33634226)
64. North RB, Kidd DH, Zahurak M, James CS, Long DM,. Spinal cord stimulation for chronic intractable pain: experience over two decades. Neurosurgery 1993; 32: 384-395. (Pubitemid 23082100)
65. Long D, Erickson D, Campbell J, North R,. Electrical stimulation of the spinal cord and peripheral nerves for pain control. Appl Neurophysiol 1981; 44: 207-217. (Pubitemid 12175924)
66. De La Porte C, Van de Kelfe E,. SCS in failed back surgery syndrome. Pain 1993; 52: 55-61.
67. Gybels J, Erdine S, Maeyaert J, et al,. A consensus statement prepared by a task force of the European Federation of IASP Chapters (EFIC). Eur J Pain 1998; 2: 203-209.
68. Beltrutti D, Lamberto A, Barolat G, et al,. The psychological assessment of candidates for SCS for chronic pain management. Pain Pract 2004; 4: 204-221.
69. Heckler DR, Gatchel RJ, Lou L, Whitwork T, Bernstein D, Stowell AW,. Presurgical behavioral medicine evaluation (PBME) for implantable devices for pain management: a 1-year prospective study. Pain Pract 2007; 7: 110-122. (Pubitemid 46901547)
70. Cousins MJ,. Foreward. In:, Fordyce WE, ed. Back pain in the workplace: management of disability in nonspecific conditions: a report of the Task Force on Pain in the Workplace of the International Association for the Study of Pain. Seattle, WA: International Association for the Study of Pain Press, 1995: 1-3.
71. Turk DC, Burwinkle TM,. Clinical outcomes, cost-effectiveness, and the role of psychology in treatments for chronic pain sufferers. Prof Psychol Res Pr 2005; 36: 602-610. (Pubitemid 43059077)
72. Catlin A, Cowan C, Heffler S, et al,. National health spending in 2005. Health Affairs 2006; 26: 142-153.
73. Borger C, Smith S, Truffer C, et al,. Health spending projections through 2015: changes on the horizon. Health Affairs 2006; 25: W61-W73. (Pubitemid 43529598)
74. Parker SL, Xu R, McGirt MJ, et al,. Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis. Neurosurg Spine 2010; 12: 178-182.
75. Iglehart JK,. Opinion polls on health care. N Engl J Med 1984; 310: 1616-1620. (Pubitemid 14117347)
76. Blendon RJ, Altman DE,. Public attitudes about health-care costs; a lesson in national schizophrenia. N Engl J Med 1984; 311: 613-616. (Pubitemid 15189226)
77. Bell G, Kidd D, North R,. Cost-effectiveness analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage 1997; 13: 286-295. (Pubitemid 27240681)
78. Willis KD,. A simple approach to outcomes assessment of the therapeutic and cost-benefit success rates for spinal cord stimulation therapy. Anesthesiol Clin North Am 2003; 21: 817-823. (Pubitemid 38031696)
79. Bedder MD, Burchiel K, Larson A,. Cost analysis of two implantable narcotic deliver systems. J Pain Symptom Manage 1991; 6: 368-373.
80. Mueller-Schweffe G, Hassenbusch SJ, Reig E,. Cost effectiveness of intrathecal therapy for pain. Neuromodulation 1999; 2: 77-87.
81. Hassenbusch SJ, Paice JA, Patt RB, Bedder MD, Bell GK,. Cost effectiveness of intrathecal therapy. J Pain Symptom Manage 1997; 14 (Suppl.): S36-S48.
82. Lissovoy G, Brown RE, Halpern M, Hassenbusch SJ, Ross E,. Cost-effectiveness of long-term intrathecal morphine therapy for pain associated with failed back surgery syndrome. Clin Ther 1997; 19: 96-112. (Pubitemid 27186442)
83. 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; 97: 803-810. (Pubitemid 35222400)
84. Andrell P, Ekre O, Eliasson T, et al,. Cost-effectiveness of SCS versus coronary artery bypass grafting in patients with severe angina pectoris-long-term results from the ESBY study. Cardiology 2003; 99: 20-24. (Pubitemid 36206631)
85. Taylor RJ, Taylor RS,. SCS for failed back surgery syndrome: a decision-analytic model and cost-effectiveness analysis. Int J Technol Assess Health Care 2005; 21: 351-358. (Pubitemid 41099216)
86. Taylor RS, Taylor RJ, Van Buyten JP, Buschser E, North R, Bayliss S,. The cost effectiveness of SCS in the treatment of pain: a systemic review of the literature. J Pain Symptom Manage 2004; 27: 370-378. (Pubitemid 38410905)
87. Budd K,. Spinal cord stimulation: a cost benefit study. Neuromodulation 2002; 5: 79-88.
88. Bala M, Riemsma R, Nixon J, Kleijnen J,. Systematic review of the (cost-)effectiveness of spinal cord stimulation for people with failed back surgery syndrome. Clin J Pain 2008; 24: 741-756.
89. Taylor R, Ryan J, O'Donnell R, Eldabe S, Kumar K, North R,. The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain 2010; 26: 463-469.
90. Rosenow JM, Stanton-Hicks M, Rezai AR, Henderson JM,. Failure modes of spinal cord stimulation hardware. J Neurosurg Spine 2006; 5: 183-190. (Pubitemid 47325382)
91. Turner JA, Loeser JD, Deyo RA, Sanders SB,. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain 2004; 108: 137-147. (Pubitemid 38251683)
92. Henderson JM, Schade CM, Sasaki J, Caraway DL, Oakley JC,. Prevention of mechanical failures in implanted SCS systems. Neuromodulation 2006; 9: 183-191. (Pubitemid 44944224)
93. North RB, Kidd DH, Petrucci L, Dorsi MJ,. SCS electrode design: a prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: part II-clinical outcomes. Neurosurgery 2005; 57: 990-996.
94. Follett KA, Boortz-Marx R, Drako JM, et al,. Prevention and management of intrathecal drug delivery and SCS system infections. Anesthesiology 2004; 100: 1582-1594. (Pubitemid 38679330)
95. Hornberger J, Kumar K, Verhulst E, Clark MA, Hernandez J,. Rechargeable SCS versus nonrechargeable system for patients with failed back surgery syndrome: a cost-consequences analysis. Clin J Pain 2008; 24: 244-252. (Pubitemid 351640923)
96. North R, Wetzel FT,. Spinal cord stimulation for chronic pain of spinal origin: a valuable long-term solution. Supplement. Spine 2002; 27: 2584-2591.
97. Ohnmeiss DD, Rashbaum R,. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J 2001; 1: 358-363. (Pubitemid 33378767)
98. Devulder J, DeLaat M, VanBastelaere M, Rolly G,. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom Manage 1997; 13: 296-301. (Pubitemid 27240682)
99. Taylor RS, Van Buyten JP, Buchser E,. Spinal cord stimulation for chronic back and leg pain and failed back surgery syndrome: a systematic review and analysis of prognostic factors. Spine 2005; 30: 152-160. (Pubitemid 40209292)
100. Taylor RS,. Spinal cord stimulation in complex regional pain syndrome and refractory neuropathic back and leg pain/failed back surgery syndrome: results of a systematic review and meta analysis. J Pain Symptom Manage 2006; 31: S13-S19. (Pubitemid 44389547)
101. Eldabe S, Kumar K, Buchser E, Taylor R,. An analysis of the components of pain, function, and health-related quality of life in patients with failed back surgery syndrome treated with spinal cord stimulation or conventional medical management. Neuromodulation 2010; 13: 201-209.