Letters
1. US Centers for Disease Control and Prevention. Emergency preparedness and response. http://emergency.cdc.gov/HAN/han00338.asp. Accessed July 28, 2013.
Use of Spinal Injections for Low Back Pain To the Editor Dr Staal and colleagues1 highlighted the overuse of spinal injections for back pain and pointed out “heterogeneity regarding purpose and content of injection therapy has to be considered when evaluating studies of the effects of injection therapy in patients with low back pain.” Unfortunately, they ignored this heterogeneity in concluding, “… injection therapy for low back pain and sciatica can be regarded as having limited clinical benefit.” Back pain is a symptom, not a diagnosis. Predictably, studies of treatments for nonspecific back pain yield poor results, whereas studies of treatments for a specific diagnosis demonstrate high success rates.2 Imagine a systematic review of prescription medications to treat cough. Pooled data from heterogeneous groups (bacterial pneumonia, viral bronchitis, chemical pneumonitis, asthma) might demonstrate poor overall effects. Should antibiotics for bacterial pneumonia then be abandoned? In addition, the authors make a number of inaccurate statements. In their 2008 Cochrane review,3 the Viewpoint authors excluded studies of patients with radiculopathy because of disk herniation. However, they cited this same review in their Viewpoint as evidence that epidural injections are not indicated for radicular pain. The authors also claimed that among published international guidelines “… only 1 guideline, from Belgium, recommends injection therapy.” In fact, the review they cited references multiple guidelines recommending injection therapy.4 The authors used a review by Pinto et al5 to suggest a lack of value for all spinal injections when these authors actually found high-quality evidence “for the short-term effect of epidural corticosteroid injections … for leg pain, back pain, and disability outcomes.” Spinal injections are useful when specific injections are targeted toward specific disorders. Using epidural steroid injections to treat radiculopathy from disk herniation and radiofrequency neurotomy to treat confirmed facet joint pain are 2 examples in which targeted spinal injections have proven benefits for patients with specific anatomic diagnoses.2 Like Staal and colleagues, we decry the overuse of spinal injections and agree that injections should be reserved for those patients most likely to derive benefit. We welcome an evidencebased review of target-specific treatments. David J. Kennedy, MD Ray M. Baker, MD James P. Rathmell, MD Author Affiliations: Department of Orthopedics, Stanford University, Palo Alto, California (Kennedy); Department of Anesthesiology, University of Washington, Seattle (Baker); Department of Anesthesia, Harvard Medical School, Boston, Massachusetts (Rathmell). Corresponding Author: David J. Kennedy, MD, Stanford University, 450 Broadway St, Pavilion C, MC6342, Redwood City, CA 94063 (djkenned @stanford.edu).
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Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kennedy reported receiving institutional grants from Cytonics and Seikagaku; and reimbursement for travel expenses from the North American Spine Society. Dr Baker reported being the president of the North American Spine Society; the immediate past president of the International Spine Intervention Society; being on the boards of Spine-Health.com and the Collaborative Spine Research Foundation; being a consultant to Medtronics and Relievant MedSystems; and holding stock options in Nocimed, Relievant, and Laurimed. No other disclosures were reported. 1. Staal JB, Nelemans PJ, de Bie RA. Spinal injection therapy for low back pain. JAMA. 2013;309(23):2439-2440. 2. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010;11(8):1149-1168. 3. Staal JB, de Bie R, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008;(3):CD001824. 4. Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010;10(6):514-529. 5. Pinto RZ, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. 2012;157(12):865-877.
In Reply Dr Kennedy and colleagues agree that overuse of injection therapy is a concern but disapprove of our claim of insufficient evidence to support the use of spinal injection therapy in low back pain. In their view, our article disregarded heterogeneity of studies. They argue that injections are useful when targeted toward specific spinal disorders. Although the latter assertion is clinically intuitive, it also implies availability of accurate tests that enable clinicians to identify specific anatomic structures as the source of pain (eg, facet joints, intervertebral disks). However, the usefulness of these tests for guiding treatment selection in practice is unclear,1 and it remains challenging to prove that specific interventions are effective in specific subgroups of patients. In our Cochrane review,2 we tried to deal with the heterogeneity of studies by creating clinically meaningful subgroups. None of these comparisons clearly favored injection therapy and another division of subgroups would have produced similar results. Studies on the effects of injections for radicular pain were excluded from our review, but our Viewpoint statement regarding the limited benefit of these injections was based on the meta-analysis by Pinto et al3 and not on our review.2 We agree with Kennedy and colleagues that the picture is different for epidural steroid injection in patients with radicular pain. The meta-analysis by Pinto et al3 showed that these procedures are effective for disability and leg pain, but only in the short-term. Given its small effect size, the utility of epidural steroid injections is questionable. We believe that the currently available evidence suggests that this treatment has limited clinical benefit. Our statement about the lack of recommendations for injections in internationally available multidisciplinary guidelines refers to guidelines for acute and chronic low back pain. Kennedy and colleagues are correct that there are a few guidelines (3 of 6) that include recommendations for injection therapy in cases of back pain with substantial neurological in-
JAMA October 23/30, 2013 Volume 310, Number 16
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Letters
volvement. We apologize for the confusion although our message remains that injection therapy is not recommended for the majority of patients with low back pain according to internationally available guidelines.4 Kennedy and colleagues describe 2 examples of treatments with positive results in specific populations. One is radiofrequency neurotomy for facet joint pain,5 which falls beyond the scope of our Viewpoint. The other example is transforaminal epidural steroid injections in patients with radicular pain as supported by 1 positive study.6 Referring to this particular study is misleading because the previously discussed meta-analysis by Pinto et al also reports 4 other studies on transforaminal epidural steroid injections with smaller and nonsignificant effects.3 Kennedy and colleagues welcome an evidence-based review of target-specific treatments. However, we believe that more valid diagnostic studies are needed to investigate the claim that a diagnosis of nonspecific low back pain can be made more specific. Moreover, methodologically sound randomized clinical trials are required to study the effects of specific injection treatments targeted at suspected sources of the pain. We believe the current evidence does not support the widespread use of injection therapies for low back and radicular pain. J. Bart Staal, PhD Patty J. Nelemans, MD, PhD Rob A. De Bie, PhD Author Affiliations: Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands (Staal); Department of Epidemiology, Caphri Research School, Maastricht, the Netherlands (Nelemans, De Bie). Corresponding Author: J. Bart Staal, PhD, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, the Netherlands (b.staal@iq .umcn.nl). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Hancock MJ, Maher CG, Latimer J, et al. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine J. 2007;16(10):1539-1550. 2. Staal JB, de Bie R, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008;(3):CD001824. 3. Pinto RZ, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. 2012;157(12):865-877. 4. Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010;10(6):514-529. 5. Cohen SP, Huang JH, Brummett C. Facet joint pain—advances in patient selection and treatment. Nat Rev Rheumatol. 2013;9(2):101-116. 6. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010;11(8):1149-1168.
Risks Associated With Opioid Use To the Editor Dr Dowell and colleagues1 discussed the recent increase in opioid-related deaths and attributed it primarily
to increased opioid prescribing for chronic, nonmalignant pain. The authors stated that long-term opioid therapy ultimately leads to tolerance and this in turn triggers opioid dose escalation, which is the major risk factor for opioid overdose. The current clinical model of opioid prescribing is based on individual risk assessment, which the authors consider flawed and ineffective. Instead, they suggested shifting the emphasis to an approach in which opioids are considered risky drugs and their prescribing is limited. Even though there are risks and benefits of long-term opioid therapy, shifting the focus from opioid-related deaths to limited prescribing of these drugs neither protects patients nor helps clinicians manage patients with chronic pain. Management of chronic, nonmalignant pain is complex and difficult. Patients with severe chronic pain have few options, and some are risky as well.2 I agree with Dowell et al that all patients exposed to opioids need judicious prescribing and close follow-up. Opioid therapy can be effective for chronic, nonmalignant pain.3 However, judicious prescribing requires knowledge and experience, and unfortunately the education of medical students in pain management and addiction medicine is lacking.4 Additionally, achieving close follow-up requires manpower and resources, both of which are becoming increasingly more difficult to secure. A better and more systematic approach to treatment of chronic pain and addiction is needed. An approach should be team-based and patient-centered, recognize the intricacies of chronic pain and addiction, and provide treatments that will help patients diminish their reliance on medications. Different models have been proposed and research efforts should focus on finding an optimal approach that is safe and effective and can be used in a community setting.5 Marcin Chwistek, MD Author Affiliation: Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. Corresponding Author: Marcin Chwistek, MD, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported being a member of the data and safety monitoring board at AstraZeneca; a consultant for Guidepoint Global; receiving payment for lectures from Meda Pharmaceuticals, Purdue Pharma, Teva Pharmaceuticals, Archimedes Pharma, and Janssen Pharmaceuticals; and receiving payment for educational presentations from Teva and Meda. 1. Dowell D, Kunins HV, Farley TA. Opioid analgesics—risky drugs, not risky patients. JAMA. 2013;309(21):2219-2220. 2. Coxib and Traditional NSAID Trialists’ (CNT) Collaboration. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382(9894):769-779. 3. de Leon-Casasola OA. Opioids for chronic pain: new evidence, new strategies, safe prescribing. Am J Med. 2013;126(3)(suppl 1):S3-S11. 4. Tauben DJ, Loeser JD. Pain education at the University of Washington School of Medicine. J Pain. 2013;14(5):431-437. 5. Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112.
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JAMA October 23/30, 2013 Volume 310, Number 16
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1. US Centers for Disease Control and Prevention. Emergency preparedness and response. http://emergency.cdc.gov/HAN/han00338.asp. Accessed July 28, 2013.
Use of Spinal Injections for Low Back Pain To the Editor Dr Staal and colleagues1 highlighted the overuse of spinal injections for back pain and pointed out “heterogeneity regarding purpose and content of injection therapy has to be considered when evaluating studies of the effects of injection therapy in patients with low back pain.” Unfortunately, they ignored this heterogeneity in concluding, “… injection therapy for low back pain and sciatica can be regarded as having limited clinical benefit.” Back pain is a symptom, not a diagnosis. Predictably, studies of treatments for nonspecific back pain yield poor results, whereas studies of treatments for a specific diagnosis demonstrate high success rates.2 Imagine a systematic review of prescription medications to treat cough. Pooled data from heterogeneous groups (bacterial pneumonia, viral bronchitis, chemical pneumonitis, asthma) might demonstrate poor overall effects. Should antibiotics for bacterial pneumonia then be abandoned? In addition, the authors make a number of inaccurate statements. In their 2008 Cochrane review,3 the Viewpoint authors excluded studies of patients with radiculopathy because of disk herniation. However, they cited this same review in their Viewpoint as evidence that epidural injections are not indicated for radicular pain. The authors also claimed that among published international guidelines “… only 1 guideline, from Belgium, recommends injection therapy.” In fact, the review they cited references multiple guidelines recommending injection therapy.4 The authors used a review by Pinto et al5 to suggest a lack of value for all spinal injections when these authors actually found high-quality evidence “for the short-term effect of epidural corticosteroid injections … for leg pain, back pain, and disability outcomes.” Spinal injections are useful when specific injections are targeted toward specific disorders. Using epidural steroid injections to treat radiculopathy from disk herniation and radiofrequency neurotomy to treat confirmed facet joint pain are 2 examples in which targeted spinal injections have proven benefits for patients with specific anatomic diagnoses.2 Like Staal and colleagues, we decry the overuse of spinal injections and agree that injections should be reserved for those patients most likely to derive benefit. We welcome an evidencebased review of target-specific treatments. David J. Kennedy, MD Ray M. Baker, MD James P. Rathmell, MD Author Affiliations: Department of Orthopedics, Stanford University, Palo Alto, California (Kennedy); Department of Anesthesiology, University of Washington, Seattle (Baker); Department of Anesthesia, Harvard Medical School, Boston, Massachusetts (Rathmell). Corresponding Author: David J. Kennedy, MD, Stanford University, 450 Broadway St, Pavilion C, MC6342, Redwood City, CA 94063 (djkenned @stanford.edu).
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Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kennedy reported receiving institutional grants from Cytonics and Seikagaku; and reimbursement for travel expenses from the North American Spine Society. Dr Baker reported being the president of the North American Spine Society; the immediate past president of the International Spine Intervention Society; being on the boards of Spine-Health.com and the Collaborative Spine Research Foundation; being a consultant to Medtronics and Relievant MedSystems; and holding stock options in Nocimed, Relievant, and Laurimed. No other disclosures were reported. 1. Staal JB, Nelemans PJ, de Bie RA. Spinal injection therapy for low back pain. JAMA. 2013;309(23):2439-2440. 2. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010;11(8):1149-1168. 3. Staal JB, de Bie R, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008;(3):CD001824. 4. Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010;10(6):514-529. 5. Pinto RZ, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. 2012;157(12):865-877.
In Reply Dr Kennedy and colleagues agree that overuse of injection therapy is a concern but disapprove of our claim of insufficient evidence to support the use of spinal injection therapy in low back pain. In their view, our article disregarded heterogeneity of studies. They argue that injections are useful when targeted toward specific spinal disorders. Although the latter assertion is clinically intuitive, it also implies availability of accurate tests that enable clinicians to identify specific anatomic structures as the source of pain (eg, facet joints, intervertebral disks). However, the usefulness of these tests for guiding treatment selection in practice is unclear,1 and it remains challenging to prove that specific interventions are effective in specific subgroups of patients. In our Cochrane review,2 we tried to deal with the heterogeneity of studies by creating clinically meaningful subgroups. None of these comparisons clearly favored injection therapy and another division of subgroups would have produced similar results. Studies on the effects of injections for radicular pain were excluded from our review, but our Viewpoint statement regarding the limited benefit of these injections was based on the meta-analysis by Pinto et al3 and not on our review.2 We agree with Kennedy and colleagues that the picture is different for epidural steroid injection in patients with radicular pain. The meta-analysis by Pinto et al3 showed that these procedures are effective for disability and leg pain, but only in the short-term. Given its small effect size, the utility of epidural steroid injections is questionable. We believe that the currently available evidence suggests that this treatment has limited clinical benefit. Our statement about the lack of recommendations for injections in internationally available multidisciplinary guidelines refers to guidelines for acute and chronic low back pain. Kennedy and colleagues are correct that there are a few guidelines (3 of 6) that include recommendations for injection therapy in cases of back pain with substantial neurological in-
JAMA October 23/30, 2013 Volume 310, Number 16
Downloaded From: http://jama.jamanetwork.com/ by a Ndsu Library Periodicals User on 05/23/2015
jama.com
Letters
volvement. We apologize for the confusion although our message remains that injection therapy is not recommended for the majority of patients with low back pain according to internationally available guidelines.4 Kennedy and colleagues describe 2 examples of treatments with positive results in specific populations. One is radiofrequency neurotomy for facet joint pain,5 which falls beyond the scope of our Viewpoint. The other example is transforaminal epidural steroid injections in patients with radicular pain as supported by 1 positive study.6 Referring to this particular study is misleading because the previously discussed meta-analysis by Pinto et al also reports 4 other studies on transforaminal epidural steroid injections with smaller and nonsignificant effects.3 Kennedy and colleagues welcome an evidence-based review of target-specific treatments. However, we believe that more valid diagnostic studies are needed to investigate the claim that a diagnosis of nonspecific low back pain can be made more specific. Moreover, methodologically sound randomized clinical trials are required to study the effects of specific injection treatments targeted at suspected sources of the pain. We believe the current evidence does not support the widespread use of injection therapies for low back and radicular pain. J. Bart Staal, PhD Patty J. Nelemans, MD, PhD Rob A. De Bie, PhD Author Affiliations: Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands (Staal); Department of Epidemiology, Caphri Research School, Maastricht, the Netherlands (Nelemans, De Bie). Corresponding Author: J. Bart Staal, PhD, Radboud University Nijmegen Medical Centre, PO Box 9101, 6500 HB Nijmegen, the Netherlands (b.staal@iq .umcn.nl). Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. 1. Hancock MJ, Maher CG, Latimer J, et al. Systematic review of tests to identify the disc, SIJ or facet joint as the source of low back pain. Eur Spine J. 2007;16(10):1539-1550. 2. Staal JB, de Bie R, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008;(3):CD001824. 3. Pinto RZ, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. 2012;157(12):865-877. 4. Dagenais S, Tricco AC, Haldeman S. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. Spine J. 2010;10(6):514-529. 5. Cohen SP, Huang JH, Brummett C. Facet joint pain—advances in patient selection and treatment. Nat Rev Rheumatol. 2013;9(2):101-116. 6. Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010;11(8):1149-1168.
Risks Associated With Opioid Use To the Editor Dr Dowell and colleagues1 discussed the recent increase in opioid-related deaths and attributed it primarily
to increased opioid prescribing for chronic, nonmalignant pain. The authors stated that long-term opioid therapy ultimately leads to tolerance and this in turn triggers opioid dose escalation, which is the major risk factor for opioid overdose. The current clinical model of opioid prescribing is based on individual risk assessment, which the authors consider flawed and ineffective. Instead, they suggested shifting the emphasis to an approach in which opioids are considered risky drugs and their prescribing is limited. Even though there are risks and benefits of long-term opioid therapy, shifting the focus from opioid-related deaths to limited prescribing of these drugs neither protects patients nor helps clinicians manage patients with chronic pain. Management of chronic, nonmalignant pain is complex and difficult. Patients with severe chronic pain have few options, and some are risky as well.2 I agree with Dowell et al that all patients exposed to opioids need judicious prescribing and close follow-up. Opioid therapy can be effective for chronic, nonmalignant pain.3 However, judicious prescribing requires knowledge and experience, and unfortunately the education of medical students in pain management and addiction medicine is lacking.4 Additionally, achieving close follow-up requires manpower and resources, both of which are becoming increasingly more difficult to secure. A better and more systematic approach to treatment of chronic pain and addiction is needed. An approach should be team-based and patient-centered, recognize the intricacies of chronic pain and addiction, and provide treatments that will help patients diminish their reliance on medications. Different models have been proposed and research efforts should focus on finding an optimal approach that is safe and effective and can be used in a community setting.5 Marcin Chwistek, MD Author Affiliation: Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania. Corresponding Author: Marcin Chwistek, MD, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA 19111 ([email protected]). Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported being a member of the data and safety monitoring board at AstraZeneca; a consultant for Guidepoint Global; receiving payment for lectures from Meda Pharmaceuticals, Purdue Pharma, Teva Pharmaceuticals, Archimedes Pharma, and Janssen Pharmaceuticals; and receiving payment for educational presentations from Teva and Meda. 1. Dowell D, Kunins HV, Farley TA. Opioid analgesics—risky drugs, not risky patients. JAMA. 2013;309(21):2219-2220. 2. Coxib and Traditional NSAID Trialists’ (CNT) Collaboration. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382(9894):769-779. 3. de Leon-Casasola OA. Opioids for chronic pain: new evidence, new strategies, safe prescribing. Am J Med. 2013;126(3)(suppl 1):S3-S11. 4. Tauben DJ, Loeser JD. Pain education at the University of Washington School of Medicine. J Pain. 2013;14(5):431-437. 5. Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6(2):107-112.
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JAMA October 23/30, 2013 Volume 310, Number 16
1737
