- Email: [email protected]
The Relationship Between Repeated Epidural Steroid Injections and Subsequent Opioid Use and Lumbar Surgery
2221
LETTERS TO THE EDITOR
laminar, caudal, and transforaminal approaches and found transforaminal injections to be somewhat more effective than either caudal or interlaminar injections.3 Another pilot study comparing laminar to caudal ESIs found no difference between the 2 approaches.4 Unfortunately, the 2 references provided by the authors to support the belief that caudal injections are superior to interlaminar injections are similar review articles, both published in the Pain Physician by some of the same authors, that include no randomized, controlled trials that directly compare the 2 approaches (the pilot study was included).4-6 In our study, 85% of the injections performed in the VA system were either interlaminar or caudal injections. In response to the author’s suggestion that our findings may not relate to transforaminal injections, we reanalyzed our data separating the 15% of patients who underwent transforaminal injections. In fact, we found that the conclusions remained the same whether examining all injections together or isolating transforaminal injections versus caudal or interlaminar injections. For example, 63% of all patients undergoing transforaminal injections used opioids prior to their ESI as compared to 65% of patients after their transforaminal injection. Patients undergoing greater than 3 transforaminal injections were also less likely to discontinue opioid use following their ESIs (8% vs 11%, P⬍.000) and more likely to start opioids following their ESIs (18% vs 12%, P⬍.000). These findings are consistent with those of the group as a whole as published in our study. The authors also claim that we “invoke a 3-epidural philosophy which has long been eliminated.” Our study does not endorse any philosophy regarding the frequency or number of epidurals that is appropriate in clinical practice. In fact, there is sparse published data to determine the most effective frequency and intervals for performing ESIs in any population. Our data simply suggests that patients who receive more than 3 epidurals are more likely to undergo subsequent surgery and are less likely to discontinue use of opioids. Our data demonstrates that the vast majority of patients (91%) in this 2-year time period received 3 or fewer ESIs. Among the entire population, 52% of patients received only 1 injection, 24% of patients received 2 injections, and 14% of patients received 3 injections. We agree with the authors that patients presenting to interventional pain practices often have severe, dysfunctional chronic pain and are frequently already on opioids. In our study, nearly two thirds of the veteran patients were on opioids prior to the ESI. The authors state that published studies demonstrate that no intervention (including surgery, injections, and implantable devices) has an effect on opioid use in these patients. This, as well as our data, supports the conclusion that interventions such as ESIs may not be effective or be the appropriate intervention for these particular patients. Further research on the utility of injections and other treatment modalities for patients with chronic LBP is clearly warranted. Finally, the authors suggest that “the hypothesis must be opposite,” that is, that ESI use is common among patients using opioids rather than opioids being common in patient undergoing ESIs. Our hypotheses (as stated in the article) were actually that opioid use would decrease following ESIs and that those people who underwent more frequent ESIs would have less subsequent opioid use and lumbar surgery. Contrary to our hypotheses, in this patient population, we found that overall opioid use did not change and that patients undergoing more frequent injections had higher rates of subsequent surgery and were less likely to stop taking opioids. As we did not examine all patients in the VA who use opioids, it is impossible to conclude from this data that ESIs are common among people using opioids. Intuitively, it does not make sense that injections would be common among all persons taking opioids, as many of these patients do not even suffer from LBP.
We hope that data such as these will prompt new questions, new research, and professional self-scrutiny rather than reflexive defense of current practices. Appropriate patient care is derived from careful use of evidence; our data suggest a need for better studies on efficacy and patient selection for spinal injections. Janna Friedly, MD Department of Rehabilitation Medicine Center for Comparative Effectiveness, Cost and Outcomes Research University of Washington Seattle, WA Isuta Nishio, MD, PhD VA Puget Sound Health Care System Seattle, WA Disclosure: No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. References 1. Carrino J, Morrison W, Parker L, Schweitzer M, Levin D, Sunkshine J. Spinal injection procedures: volume, distribution, and reimbursement in the U.S. Medicare populations from 1993 to 1999. Radiology 2002;225:723-9. 2. Anderberg L, Annertz M, Persson L, Brandt L, Saveland H. Transforaminal steroid injections for the treatment of cervical radiculopathy: a prospective and randomised study. Eur Spine J 2007;16:321-8. 3. Ackerman WE 3rd, Ahmad M. The efficacy of lumbar epidural steroid injections in patients with lumbar disc herniations. Anesth Analg 2007;104:1217-22, tables of contents. 4. McGregor AH, Anjarwalla NK, Stambach T. Does the method of injection alter the outcome of epidural injections? J Spinal Disord 2001;14:507-10. 5. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007;10:7-111. 6. Manchikanti L, Singh V, Derby R, et al. Reassessment of evidence synthesis of occupational medicine practice guidelines for interventional pain management. Pain Physician 2008;11: 393-482.
doi:10.1016/j.apmr.2008.08.208
The Relationship Between Repeated Epidural Steroid Injections and Subsequent Opioid Use and Lumbar Surgery I would like to commend Friedly et al1 for their excellent article. It confirms what we observe in clinical practice on a daily basis: the overuse of opioids in the management of chronic low back pain (CLBP). Opioid overuse and abuse has become a national public health issue. Americans comprise 4.6% of the world’s population and consume 80% of the global opioid supply.2,3 Unfortunately, motivational factors for using these medications often include drug abuse, diversion, and chemical coping, not just medical need. These are particularly important in the population studied where psychiatric diagnoses are so highly prevalent.4 Arch Phys Med Rehabil Vol 89, November 2008
2222
LETTERS TO THE EDITOR
Despite the larger percentage of patients using opiates after epidural steroid injection (ESI), the conclusion that “overall opioid use did not decrease”1(p1012) may be misleading. This finding implies failure of ESIs when clearly this is not the case, as demonstrated by 16% of patients discontinuing opioids. In our experience, any intervention (even definitive treatment approaches) in patients already using opioids chronically is not followed by reduction in opioid use. The use of opioids after ESI may be an expected and perhaps reasonable treatment option for patients in whom the procedure fails to provide adequate analgesia. In general, opioids in the setting of CLBP should be used when all other modalities have failed. In this study, 62% of the patients who were not using opioids before undergoing ESI were not using these medications afterwards. These spinal injections may have prevented starting medical management with opioids. The fact that patients who received a larger number of ESIs were more likely to be using opioids and to undergo surgery after the injections than those who received less ESIs is not surprising. It may reflect the usual course of rational clinical practice: when an ESI fails to provide adequate analgesia, additional injections may be tried (using the same or a different approach/level) before considering abandoning this treatment modality and moving to a different modality. Similar to the axiom of any other conservative or nonsurgical modality that may prevent the need for surgical intervention in some patients, any of these modalities (including ESI) is not expected to prevent surgery in all. That would be analogous to physical therapy and nonsteroidal anti-inflammatory drugs preventing the need for joint replacement in advanced degenerative joint disease. A more valuable statistic would be to see how many patients who were using opioids before surgery continue using opioids after surgery, as is commonly seen in pain management practices. The cost of ESIs and lumbar spine surgery can be easily calculated; however, the cost of chronic opioid use, in the face of the current epidemic in which adherence monitoring must be performed, is likely to be astronomical but very difficult to calculate. Last but not least, opioids have not been proven to be an effective treatment for CLBP in controlled studies,5 and a large proportion of patients seen in this setting may claim inefficacy or even worsening of their symptoms after ESI in order to justify their claim for receiving opioids. Ramon L. Cuevas-Trisan, MD, FABPMR, FABPM VAMC West Palm Beach West Palm Beach, FL [email protected] Disclosure: No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. References 1. Friedly J, Nishio I, Bishop MJ, Maynard C. The relationship between repeated epidural steroid injections and subsequent opioid use and lumbar surgery. Arch Phys Med Rehabil 2008;89:1011-5. 2. Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and non-medical use of opioids. Pain Physician 2008;11: S63-89. 3. Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA 2007;297:249-51. 4. Edlund MJ, Steffick D, Hudson T, Harris KM, Sullivan M. Risk factors for clinically recognized opioid abuse and dependence Arch Phys Med Rehabil Vol 89, November 2008
among veterans using opioids for chronic non-cancer pain. Pain 2007;129:355-62. 5. Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low back pain. Cochrane Database Syst Rev 2007;(3): CD004959.
doi:10.1016/j.apmr.2008.08.207
The Authors Respond We thank you for giving us the opportunity to respond to Dr. Cuevas-Trisan’s thoughtful commentary on our recent study of epidural steroid injection (ESI) use in the Veteran’s Affairs (VA) population. We would like to expound on several issues raised in this letter. We agree that opioid use and abuse is a significant national health issue and the use of opioids for chronic pain is escalating dramatically in the United States.1,2 The author states that our article confirms that there is overuse of opioids for chronic low back pain (CLBP). While this may be true, and our data demonstrates that a majority of VA patients receiving ESIs are using opioids both before and after ESIs, we are unable to draw the conclusion that there is overuse of opioids as this was not an opioid efficacy study. However, our data suggests that there is not an associated overall decrease in opioid use following ESIs as one might expect if ESIs are providing adequate analgesia for CLBP. The author states that this conclusion that opioid use did not decrease is misleading as 16% of patients discontinued opioid use following ESI. This raises the question, what is the definition of a treatment success? If 100 patients on opioids are treated with ESIs for low back pain (LBP), is the discontinuation of opioids in 16 of those patients considered a success? What is the appropriate number needed to treat with ESIs? The answer to this question depends on the risks, benefits, and costs associated with the treatment as well as patient and provider values and beliefs. The author also asserts that they often do not see a reduction in opioid use with any intervention for persons with chronic pain. This is an interesting statement and raises another important question. If none of the interventions are successful at reducing opioid use in these patients, is it appropriate to use these interventions in these patients? Perhaps this indicates that these patients are not appropriate candidates for these treatments and that we are not approaching this difficult problem of chronic pain in the most effective way. The author also asserts that a reduction in opioid use is often not observed, even with “definitive” treatments such as lumbar surgery. However, the use of lumbar surgery for CLBP is also controversial, with mixed results in terms of efficacy, despite a rapid rise in its use3,4 and thus should not be considered a definitive treatment for chronic LBP. The author states that as 62% of patients who were not using opioids prior to the ESI did not use opioids after the ESI, the ESIs may have, in fact, prevented patients from starting opioids. This is certainly 1 possibility, however, our study design does not allow for an analysis of this issue. This issue should be studied in further depth. The author also suggests that patients who receive more frequent ESIs followed by opioids “may reflect the usual course of rational clinical practice: when an ESI fails to provide adequate analgesia, additional injections may be tried.” This practice may be common; however, the rationale for providing repeat treatments, with potential complications, side effects, and substantial costs that prove to be ineffective the first time
LETTERS TO THE EDITOR
laminar, caudal, and transforaminal approaches and found transforaminal injections to be somewhat more effective than either caudal or interlaminar injections.3 Another pilot study comparing laminar to caudal ESIs found no difference between the 2 approaches.4 Unfortunately, the 2 references provided by the authors to support the belief that caudal injections are superior to interlaminar injections are similar review articles, both published in the Pain Physician by some of the same authors, that include no randomized, controlled trials that directly compare the 2 approaches (the pilot study was included).4-6 In our study, 85% of the injections performed in the VA system were either interlaminar or caudal injections. In response to the author’s suggestion that our findings may not relate to transforaminal injections, we reanalyzed our data separating the 15% of patients who underwent transforaminal injections. In fact, we found that the conclusions remained the same whether examining all injections together or isolating transforaminal injections versus caudal or interlaminar injections. For example, 63% of all patients undergoing transforaminal injections used opioids prior to their ESI as compared to 65% of patients after their transforaminal injection. Patients undergoing greater than 3 transforaminal injections were also less likely to discontinue opioid use following their ESIs (8% vs 11%, P⬍.000) and more likely to start opioids following their ESIs (18% vs 12%, P⬍.000). These findings are consistent with those of the group as a whole as published in our study. The authors also claim that we “invoke a 3-epidural philosophy which has long been eliminated.” Our study does not endorse any philosophy regarding the frequency or number of epidurals that is appropriate in clinical practice. In fact, there is sparse published data to determine the most effective frequency and intervals for performing ESIs in any population. Our data simply suggests that patients who receive more than 3 epidurals are more likely to undergo subsequent surgery and are less likely to discontinue use of opioids. Our data demonstrates that the vast majority of patients (91%) in this 2-year time period received 3 or fewer ESIs. Among the entire population, 52% of patients received only 1 injection, 24% of patients received 2 injections, and 14% of patients received 3 injections. We agree with the authors that patients presenting to interventional pain practices often have severe, dysfunctional chronic pain and are frequently already on opioids. In our study, nearly two thirds of the veteran patients were on opioids prior to the ESI. The authors state that published studies demonstrate that no intervention (including surgery, injections, and implantable devices) has an effect on opioid use in these patients. This, as well as our data, supports the conclusion that interventions such as ESIs may not be effective or be the appropriate intervention for these particular patients. Further research on the utility of injections and other treatment modalities for patients with chronic LBP is clearly warranted. Finally, the authors suggest that “the hypothesis must be opposite,” that is, that ESI use is common among patients using opioids rather than opioids being common in patient undergoing ESIs. Our hypotheses (as stated in the article) were actually that opioid use would decrease following ESIs and that those people who underwent more frequent ESIs would have less subsequent opioid use and lumbar surgery. Contrary to our hypotheses, in this patient population, we found that overall opioid use did not change and that patients undergoing more frequent injections had higher rates of subsequent surgery and were less likely to stop taking opioids. As we did not examine all patients in the VA who use opioids, it is impossible to conclude from this data that ESIs are common among people using opioids. Intuitively, it does not make sense that injections would be common among all persons taking opioids, as many of these patients do not even suffer from LBP.
We hope that data such as these will prompt new questions, new research, and professional self-scrutiny rather than reflexive defense of current practices. Appropriate patient care is derived from careful use of evidence; our data suggest a need for better studies on efficacy and patient selection for spinal injections. Janna Friedly, MD Department of Rehabilitation Medicine Center for Comparative Effectiveness, Cost and Outcomes Research University of Washington Seattle, WA Isuta Nishio, MD, PhD VA Puget Sound Health Care System Seattle, WA Disclosure: No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. References 1. Carrino J, Morrison W, Parker L, Schweitzer M, Levin D, Sunkshine J. Spinal injection procedures: volume, distribution, and reimbursement in the U.S. Medicare populations from 1993 to 1999. Radiology 2002;225:723-9. 2. Anderberg L, Annertz M, Persson L, Brandt L, Saveland H. Transforaminal steroid injections for the treatment of cervical radiculopathy: a prospective and randomised study. Eur Spine J 2007;16:321-8. 3. Ackerman WE 3rd, Ahmad M. The efficacy of lumbar epidural steroid injections in patients with lumbar disc herniations. Anesth Analg 2007;104:1217-22, tables of contents. 4. McGregor AH, Anjarwalla NK, Stambach T. Does the method of injection alter the outcome of epidural injections? J Spinal Disord 2001;14:507-10. 5. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007;10:7-111. 6. Manchikanti L, Singh V, Derby R, et al. Reassessment of evidence synthesis of occupational medicine practice guidelines for interventional pain management. Pain Physician 2008;11: 393-482.
doi:10.1016/j.apmr.2008.08.208
The Relationship Between Repeated Epidural Steroid Injections and Subsequent Opioid Use and Lumbar Surgery I would like to commend Friedly et al1 for their excellent article. It confirms what we observe in clinical practice on a daily basis: the overuse of opioids in the management of chronic low back pain (CLBP). Opioid overuse and abuse has become a national public health issue. Americans comprise 4.6% of the world’s population and consume 80% of the global opioid supply.2,3 Unfortunately, motivational factors for using these medications often include drug abuse, diversion, and chemical coping, not just medical need. These are particularly important in the population studied where psychiatric diagnoses are so highly prevalent.4 Arch Phys Med Rehabil Vol 89, November 2008
2222
LETTERS TO THE EDITOR
Despite the larger percentage of patients using opiates after epidural steroid injection (ESI), the conclusion that “overall opioid use did not decrease”1(p1012) may be misleading. This finding implies failure of ESIs when clearly this is not the case, as demonstrated by 16% of patients discontinuing opioids. In our experience, any intervention (even definitive treatment approaches) in patients already using opioids chronically is not followed by reduction in opioid use. The use of opioids after ESI may be an expected and perhaps reasonable treatment option for patients in whom the procedure fails to provide adequate analgesia. In general, opioids in the setting of CLBP should be used when all other modalities have failed. In this study, 62% of the patients who were not using opioids before undergoing ESI were not using these medications afterwards. These spinal injections may have prevented starting medical management with opioids. The fact that patients who received a larger number of ESIs were more likely to be using opioids and to undergo surgery after the injections than those who received less ESIs is not surprising. It may reflect the usual course of rational clinical practice: when an ESI fails to provide adequate analgesia, additional injections may be tried (using the same or a different approach/level) before considering abandoning this treatment modality and moving to a different modality. Similar to the axiom of any other conservative or nonsurgical modality that may prevent the need for surgical intervention in some patients, any of these modalities (including ESI) is not expected to prevent surgery in all. That would be analogous to physical therapy and nonsteroidal anti-inflammatory drugs preventing the need for joint replacement in advanced degenerative joint disease. A more valuable statistic would be to see how many patients who were using opioids before surgery continue using opioids after surgery, as is commonly seen in pain management practices. The cost of ESIs and lumbar spine surgery can be easily calculated; however, the cost of chronic opioid use, in the face of the current epidemic in which adherence monitoring must be performed, is likely to be astronomical but very difficult to calculate. Last but not least, opioids have not been proven to be an effective treatment for CLBP in controlled studies,5 and a large proportion of patients seen in this setting may claim inefficacy or even worsening of their symptoms after ESI in order to justify their claim for receiving opioids. Ramon L. Cuevas-Trisan, MD, FABPMR, FABPM VAMC West Palm Beach West Palm Beach, FL [email protected] Disclosure: No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. References 1. Friedly J, Nishio I, Bishop MJ, Maynard C. The relationship between repeated epidural steroid injections and subsequent opioid use and lumbar surgery. Arch Phys Med Rehabil 2008;89:1011-5. 2. Manchikanti L, Singh A. Therapeutic opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and non-medical use of opioids. Pain Physician 2008;11: S63-89. 3. Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA 2007;297:249-51. 4. Edlund MJ, Steffick D, Hudson T, Harris KM, Sullivan M. Risk factors for clinically recognized opioid abuse and dependence Arch Phys Med Rehabil Vol 89, November 2008
among veterans using opioids for chronic non-cancer pain. Pain 2007;129:355-62. 5. Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low back pain. Cochrane Database Syst Rev 2007;(3): CD004959.
doi:10.1016/j.apmr.2008.08.207
The Authors Respond We thank you for giving us the opportunity to respond to Dr. Cuevas-Trisan’s thoughtful commentary on our recent study of epidural steroid injection (ESI) use in the Veteran’s Affairs (VA) population. We would like to expound on several issues raised in this letter. We agree that opioid use and abuse is a significant national health issue and the use of opioids for chronic pain is escalating dramatically in the United States.1,2 The author states that our article confirms that there is overuse of opioids for chronic low back pain (CLBP). While this may be true, and our data demonstrates that a majority of VA patients receiving ESIs are using opioids both before and after ESIs, we are unable to draw the conclusion that there is overuse of opioids as this was not an opioid efficacy study. However, our data suggests that there is not an associated overall decrease in opioid use following ESIs as one might expect if ESIs are providing adequate analgesia for CLBP. The author states that this conclusion that opioid use did not decrease is misleading as 16% of patients discontinued opioid use following ESI. This raises the question, what is the definition of a treatment success? If 100 patients on opioids are treated with ESIs for low back pain (LBP), is the discontinuation of opioids in 16 of those patients considered a success? What is the appropriate number needed to treat with ESIs? The answer to this question depends on the risks, benefits, and costs associated with the treatment as well as patient and provider values and beliefs. The author also asserts that they often do not see a reduction in opioid use with any intervention for persons with chronic pain. This is an interesting statement and raises another important question. If none of the interventions are successful at reducing opioid use in these patients, is it appropriate to use these interventions in these patients? Perhaps this indicates that these patients are not appropriate candidates for these treatments and that we are not approaching this difficult problem of chronic pain in the most effective way. The author also asserts that a reduction in opioid use is often not observed, even with “definitive” treatments such as lumbar surgery. However, the use of lumbar surgery for CLBP is also controversial, with mixed results in terms of efficacy, despite a rapid rise in its use3,4 and thus should not be considered a definitive treatment for chronic LBP. The author states that as 62% of patients who were not using opioids prior to the ESI did not use opioids after the ESI, the ESIs may have, in fact, prevented patients from starting opioids. This is certainly 1 possibility, however, our study design does not allow for an analysis of this issue. This issue should be studied in further depth. The author also suggests that patients who receive more frequent ESIs followed by opioids “may reflect the usual course of rational clinical practice: when an ESI fails to provide adequate analgesia, additional injections may be tried.” This practice may be common; however, the rationale for providing repeat treatments, with potential complications, side effects, and substantial costs that prove to be ineffective the first time