bs_bs_banner Pain Medicine 2014; 15: 544–547 Wiley Periodicals, Inc. PROFESSIONALISM AND COMMENTARY Ethics Forum Case Scenario The patient is a 28-year-old single mother with a 10-year history of nonspecific low back pain extending down her posterior thighs bilaterally in a nondermatomal distribution who was referred by her primary care physician for an epidural steroid injection (ESI). The patient’s pain began following a motor vehicle collision and is described as constant, achy, and worse with activity. She is a former office worker on disability. She is being followed by a psychiatrist for mild depression and has no other relevant medical problems. Approximately 1 year ago, she was treated by a different pain physician and failed facet blocks, sacroiliac joint injections, an interlaminar ESI, and what sounds like a bilateral transforaminal ESI. Her magnetic resonance imaging (MRI) shows mild to moderate degenerative changes in the discs and facet joints at L4–5 and L5–S1 but no nerve root compression. Her pain has worsened since her ESIs. She has also tried and failed physical therapy, nonsteroidal anti-inflammatory drugs, muscle relaxants, and adjuvants. She is currently on Oxcyontin 20 mg po TID (Purdue Pharma LP, Stamford, CT, USA) and 5 mg of oxycodone for breakthrough pain being prescribed by her primary care physician, who would like the patient to pursue alternative forms of treatment. Would you perform another ESI on this patient? Pro: I Would Perform Another ESI on This Patient In the case described, the patient complains of chronic low back pain with nondermatomal radiation into the posterior thighs. She has “failed” facets, sacroiliac joint, an interlaminar epidural injection, and was referred for another epidural. This case illustrates multiple issues. Probably first and foremost, should we perform any procedure on this patient? We get paid for “doing stuff” (i.e., injections), and we must constantly guard against doing procedures for the money instead of because we believe them to be useful or effective. We have to balance the potential risks against the potential benefits. In the 2007 American Pain Society (APS) guidelines, Chou et al. [1] found epidurals to be ineffective, but as is unfortunately too common when the reviewers are not interventionalists, they reviewed primarily blindly placed injections and completely ignored the difference in efficacy between caudal, lumbar, and transforaminal epidurals. Interlaminar epidurals specifically treat lumbar radiculopathy, and they are most effective for this indication 544 [2,3]. However, because interlaminar epidurals can provide medication to a wide area, they are often used for “nonspecific” low back, such as in this case, where no specific pathology has been identified. Epidural steroids have been shown to be cost-effective at an average cost of $US351 (£219) [4]. Two injections, which this group recommended, amounted to £8,975 per quality-adjusted life year gained. This patient has had “an” (single) interlaminar epidural as well as possible bilateral transforaminal epidurals. We have no idea of the level and no idea whether or not this was performed under fluoroscopy. A careful history and physical followed by a second carefully placed interlaminar epidural would therefore make sense. A caudal epidural would be another good option in this patient; a caudal has a very low risk of complications, and it has the added benefit of potentially identifying nerve root entrapment due to epidural adhesions (which would not be seen on MRI and could lead to failure of interlaminar epidurals). Although there is limited evidence for long-term relief from lumbar epidural steroid injections, there is significant evidence of short-term relief for a very low risk [3]. If that short-term relief is wisely used, it can provide a window for further diagnostic studies, such as discogram, as well as an opportunity to provide guided rehabilitation. McLain et al. [5] described that “[Epidural] steroids appear to speed the rate of recovery and return to function . . . allowing patients to reduce medication levels and increase activity.” The risk/potential benefit balance therefore supports performing another lumbar epidural. References 1 Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007; 147(7):478–91. 2 Benyamin RM, Manchikanti L, Parr AT, et al. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician 2012;15(4):E363–404. 3 Abdi S, Datta S, Trescot AM, et al. Epidural steroids in the management of chronic spinal pain: A systematic review. Pain Physician 2007;10(1):185– 212. bs_bs_banner Ethics Forum 4 Whynes DK, McCahon RA, Ravenscroft A, Hardman J. Cost effectiveness of epidural steroid injections to manage chronic lower back pain. BMC Anesthesiol 2012;12:26. 5 McLain RF, Kapural L, Mekhail NA. Epidural steroid therapy for back and leg pain: Mechanisms of action and efficacy. Spine J 2005;5(2):191–201. ANDREA TRESCOT, MD Pain and Headache Center Anchorage, Kenai, and Wasilla, Alaska Con: I Would Not Perform Another ESI in This Patient In a perfect world, this patient would receive an ESI, return to work, and stop her opioids. ESIs are relatively safe procedures, containing lower risks than opioid therapy [1,2]. However, the world we live in is not perfect, and the decisions we make need to consider factors such as perceptions from peers and patients, long-term financial implications, and unintended consequences. After weighing the potential risks and benefits in this patient, I would opt not to proceed with another ESI. The patient described previously has multiple risk factors for failing ESI, including disability, depression, opioid use, absence of radicular symptoms, and recent failure of previous ESI [1]. If a strong candidate has a 50% chance of sustaining modest benefit from an ESI, then the chances of this patient deriving meaningful benefit is only a small fraction of that. The integrity and viability of our profession in general, and the effectiveness of ESI in particular, is currently under assault from the media, other specialties [3–5], and thirdparty payers who base reimbursement decisions on costeffectiveness analyses, which often yield negative conclusions [6,7]. Yet the survival of ESI as a treatment has surprisingly little to do with lack of evidence. In fact, the evidence supporting ESI in well-selected candidates is stronger than most medical treatments, including interventions such as sympathetic blocks whose future is not endangered as over two-thirds of more than 50 controlled ESI studies demonstrate at least some efficacy [1]. Rather, it is an outgrowth of negative perceptions among other specialists and increases in the number of procedures performed, which translates into higher payouts at a time in which burgeoning health care costs threaten to undermine our economy [8]. In the future, health care costs allocated to one treatment are likely to come at the expense of resources allocated to different treatments (e.g., chemotherapy) or even resources allotted to other areas, such as education. The negative perceptions are at least partly attributable to our indiscriminate use of injections, which is a function of the growing number of pain practitioners who perform procedures; studies have found a direct correlation between the number of providers per- forming a given procedure and the number of procedures done [9]. Paradoxically, the surge in ESI has mirrored corresponding increases in the number of spine surgeries [10] and has done little to change the upward trajectory of disability claims. I acknowledge that there is a small chance that this patient might benefit from a repeat procedure, although the likelihood that she will return to work is statistically remote. In a world in which issue of cost utility was irrelevant, I might opt to try another injection. However, we do not live in a perfect world, and any decision we make must take into account predictable and potential consequences. If our profession proves incapable of exercising self-restraint, then we must be prepared for outside forces to regulate us. References 1 Cohen SP, Jamison D, Bicket M, et al. Epidural steroids: A comprehensive, evidence-based review. Reg Anesth Pain Med 2013;38:175–200. 2 Crofford LJ. Adverse effects of chronic opioid therapy for chronic musculoskeletal pain. Nat Rev Rheumatol 2010;6:191–7. 3 Armon C, Argoff C, Samuels J, Backonja M. Assessment: Use of epidural steroid injections to treat radicular lumbosacral pain: Report of Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2007;68:723–9. 4 Carragee E, Hurwitz E, Cheng I, et al. Treatment of neck pain: Injections and surgical interventions: Results of the Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders. Spine 2008;33:S153–69. 5 Radcliff K, Hilibrand A, Lurie JD, et al. The impact of epidural steroid injections on the outcomes of patients treated for lumbar disc herniation: A subgroup analysis of the SPORT trial. J Bone Joint Surg Am 2012;94: 1353–8. 6 Karppinen J, Malmivaara A, Kurunlahti M, et al. Periradicular infiltration for sciatica: A randomized controlled trial. Spine 2001;26:1059–67. 7 Arden N, Price C, Reading I, et al. A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: The WEST study. Rheumatology 2005;44:1399–406. 8 Manchikanti L, Pampati V, Falco FJ, Hirsch JA. Assessment of the growth of epidural injections in the medicare population from 2000 to 2011. Pain Physician 2013;16:E349–64. 9 Cherkin DC, Deyo RA, Loeser JD, et al. An international comparison of back surgery rates. Spine 1994;19:1201–6. 545 bs_bs_banner Ethics Forum 10 Friedly J, Chan L, Deyo R. Geographic variation in epidural steroid injection use in medicare patients. J Bone Joint Surg Am 2008;90:1730–7. STEVEN P. COHEN, MD Anesthesiology & Critical Care Medicine and Physical Medicine & Rehabilitation, Johns Hopkins Medical Institutions Baltimore; Anesthesiology, Walter Reed National Military Medical Center Bethesda, Maryland The Needle and the Damage Done? This case scenario is unfortunately common, whereby a patient with chronic pain and disability receives sequential treatment rather than an integrated comprehensive care. Although the question of whether this patient receives an additional ESI is relevant to her specific question, perhaps the more pressing issue is the overall practice pattern of interventionalism at this juncture. Despite taking opposing viewpoints with regard to the case study presented, both Drs. Trescot and Cohen refreshingly address the imperatives of cost utility and put the patient’s well-being ahead of issues of remuneration. This is encouraging, particularly given the criticism in the recent literature regarding the mercenary practice patterns of some interventionalists in the face of questionable evidence basis [1,2]. Although some would question the ethics of placing financial limitations on pain relief, Dr. Cohen notes that we live in an imperfect world, and physicians must become progressively cognizant of cost-effectiveness. Dr. Trescot cited a UK study to support her assertion that ESIs are cost-effective—a study that occurred within a government-funded health care system. More relevant are the results of a recent systematic review that found the mean cost of an ESI to be $505—considerably costlier than the figures cited by Dr. Trescot. The average total reimbursement payment for an ESI was an estimated $1,282 [3], and thus, the cost effectiveness is questionable. Aside from issues of physical safety and clinical efficacy, the financial safety of an additional ESI merits consideration. Health insurance carriers are notorious for limiting the care that patients with chronic pain receive, seeing them not as suffering beings but merely as financial liabilities [4]. A possible unintended consequence of an additional ESI is that this patient may be denied future effective treatment. Aside from cost-effectiveness, Drs. Trescot and Cohen express concerns regarding clinical efficacy, and we agree that patient well-being and quality of life are the primary metrics to be considered. Dr. Trescot acknowledges that the evidence basis for long-term pain relief from ESIs is limited. She briefly mentions the contentious guideline “warfare” that occurred between the American Society of Interventional Pain Physicians (ASIPP) and the APS over the past several years, in which representatives of each organization have criticized the other’s methodology in their systematic reviews of the efficacy of 546 interventional techniques [5,6]. Systematic reviews may be valuable tools for determining the efficacy of an intervention across large patient populations. Unfortunately, they generally do not account for the skills and techniques of the interventionalists or the “outlier” patients that we know derive benefit from interventions that have weak evidence bases. This issue is analogous to the question of the long-term efficacy of chronic opioid therapy addressed in a previous Ethics Forum [7]. Although good evidence supporting the long-term benefits of opioids for chronic noncancer pain is lacking, all of us have anecdotally seen patients who have indeed fared well from this type of treatment. The same is certainly true of ESIs. As Dr. Trescot notes, the safety of ESIs has been established, both by her research group [8] and others [9,10]. Accordingly, the risk/benefit ratio, as she notes, supports the provision of an additional ESI and should be seen as ethical treatment in that it would meet the standards of the bioethical principles of beneficence and nonmaleficence. Despite taking the position that the patient in this case scenario should not receive an additional ESI, Dr. Cohen acknowledges that ESIs have a stronger evidence basis than most medical procedures. Thus, we return to the issues of patient selection and physician technique. Dr. Trescot comments that we do not know whether the patient in question received image-guided injections or not, which is information that is also missing from some of the reviews of ESIs that have been published. Recent reviews of ESI efficacy conducted by ASIPP representatives excluded studies that did not involve image-guided interventions [11–14]; thus, the discrepant findings between their systematic reviews and others may be explained by this divergent methodology. Indeed, Chang and colleagues [15] noted that historically, ESIs have been provided without the benefit of imaging, resulting in erroneous placement in up to 30% of all injections. In a systematic review, the authors [16] noted that studies of “blind” (nonimage-guided) ESIs yielded only limited evidence of efficacy, and their results should not be extrapolated to image-guided approaches. The superiority of image-guided ESIs over blind approaches has been established for over 20 years [17]. Giordano [18] has written, “As steward of knowledge, the physician must use scientific knowledge (episteme), skill and art (techne), balanced by phronesis [practical wisdom] to assess the relative effectiveness, benefit, and burdens of a particular treatment to a unique patient” (p. 7). Clearly, there is no absolute “right” or “wrong” answer to the case dilemma and the positions established by Drs. Trescot and Cohen. As the evidence is strong, it is apparent that all ESIs should be image guided to best ensure safety, efficacy, and value. In this case, we posit that the ethical approach involves respect for the individual patient’s phenomenological needs, which should then be considered within the current state of scientific knowledge as well as the economic realities of pain medicine practice at this time. Ethics Forum References 1 Brenner GJ, Kueppenbender K, Mao J, Spike J. Ethical challenges and interventional pain medicine. Curr Pain Headache Rep 2012;16:1–8. 11 Parr AT, Manchikanti L, Hameed H, et al. Caudal epidural injections in the management of chronic low back pain: A systematic appraisal of the literature. Pain Physician 2012;15:E159–98. 2 Cohen SP, Deyo RA. A call to arms: The credibility gap in interventional pain medicine and recommendations for future research. Pain Med 2013;14:1280–3. 12 Manchikanti L, Buenaventura RM, Manchikanti KN, et al. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Pain Physician 2012;15:E199– 245. 3 Bresnahan BW, Rundell SD, Dagadakis MC, et al. A systematic review to assess comparative effectiveness studies in epidural steroid injections for lumbar spinal stenosis and to estimate reimbursement amounts. PM R 2013;5:705–14. 13 Diwan S, Manchikanti L, Benyamin RM, et al. Effectiveness of cervical epidural injections in the management of chronic neck and upper extremity pain. Pain Physician 2012;15:E405–34. 4 Schatman ME. The role of the health insurance industry in perpetuating suboptimal pain management: Ethical implications. Pain Med 2011;12:415– 26. 14 Benyamin RM, Wang VC, Vallejo R, et al. A systematic evaluation of thoracic interlaminar epidural injections. Pain Physician 2012;15:E497–514. 5 Chou R, Atlas SJ, Loeser JD, et al. Guideline warfare over interventional therapies for low back pain: Can we raise the level of discourse? J Pain 2011; 12:833–9. 15 Chang A, Pochert S, Romano C, et al. Safety of 1,000 CT-guided steroid injections with air used to localize the epidural space. Am J Neuroradiol 2011;32: E175–7. 6 Manchikanti L, Benyamin RM, Falco FJ, et al. Guidelines warfare over interventional techniques: Is there a lack of discourse or straw man? Pain Physician 2012;15:E1–26. 16 Parr AT, Diwan S, Abdi S. Lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain: A systematic review. Pain Physician 2009;12:163–88. 7 Schatman ME, Darnall BD. A pendulum swings awry: Seeking the middle ground on opioid prescribing for chronic non-cancer pain. Pain Med 2013;14:617– 20. 17 Renfrew DL, Moore TE, Kathol MH, et al. Correct placement of epidural steroid injections: Fluoroscopic guidance and contrast administration. Am J Neuroradiol 1991;12:1003–7. 8 Abdi S, Datta S, Trescot AM, et al. Epidural steroids in the management of chronic spinal pain: A systematic review. Pain Physician 2007;10:185–212. 18 Giordano J. Pain, the patient, and the practice of pain medicine: The importance of a core philosophy and virtue-based ethics. In: Schatman ME, ed. Ethical Issues in Chronic Pain Management. New York: Informa Healthcare; 2007:1–13. 9 McGrath GM, Schaefer MP, Malkamaki DM. Incidence and characteristics of complications from epidural steroid injections. Pain Med 2011;12:726– 31. 10 Manchikanti L, Malla Y, Wargo BW, et al. A prospective evaluation of complications of 10,000 fluoroscopically directed epidural injections. Pain Physician 2012;15:131–40. MICHAEL E. SCHATMAN, PhD, CPE,* and BETH D. DARNALL, PhD† *Foundation for Ethics in Pain Care, Bellevue, Washington; †Division of Pain Medicine, Stanford University School of Medicine, Palo Alto, California 547
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