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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.
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 colleagues
1
highlighted the overuse
of spinal injections for back pain and pointed out “heteroge-
neity regarding purpose and content of injection therapy has
to be considered when evaluating studies of the effects of in-
jection therapy in patients with low back pain.” Unfortu-
nately, they ignored this heterogeneity in concluding, “… in-
jection therapy for low back pain and sciatica can be regarded
as having limited clinical benefit.
Back pain is a symptom, not a diagnosis. Predictably, stud-
ies of treatments for nonspecific back pain yield poor results,
whereas studies of treatments for a specific diagnosis dem-
onstrate high success rates.
2
Imagine a systematic review of
prescription medications to treat cough. Pooled data from
heterogeneous groups (bacterial pneumonia, viral bronchi-
tis, 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 state-
ments. In their 2008 Cochrane review,
3
the Viewpoint au-
thors excluded studies of patients with radiculopathy be-
cause 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 interna-
tional guidelines “… only 1 guideline, from Belgium, recom-
mends injection therapy.” In fact, the review they cited refer-
ences multiple guidelines recommending injection therapy.
4
The authors used a review by Pinto et al
5
to suggest a lack
of value for all spinal injections when these authors actually
found high-quality evidence “for the short-term effect of epi-
dural corticosteroid injections … for leg pain, back pain, and
disability outcomes.
Spinal injections are useful when specific injections are tar-
geted toward specific disorders. Using epidural steroid injec-
tions to treat radiculopathy from disk herniation and radio-
frequency neurotomy to treat confirmed facet joint pain are 2
examples in which targeted spinal injections have provenben-
efits 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 derivebenefit. We welcome an evidence-
based 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).
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, TriccoAC, 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 in-
jection 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 disre-
garded 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 in-
terventions are effective in specific subgroups of patients.
In our Cochrane review,
2
we tried to deal with the hetero-
geneity of studies by creating clinically meaningful sub-
groups. None of these comparisons clearly favored injection
therapy and another division of subgroups would have pro-
duced similar results. Studies on the effects of injections for
radicular pain were excluded from our review, but our View-
point statement regarding the limited benefit of these injec-
tions was based on the meta-analysis by Pinto et al
3
and not
on our review.
2
We agree with Kennedy and colleagues that the picture is
different for epidural steroid injection in patients with radicu-
lar pain. The meta-analysis by Pinto et al
3
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 epi-
dural steroid injections is questionable. We believethat the cur-
rently available evidence suggests that this treatment has lim-
ited clinical benefit.
Our statement about the lack of recommendations for in-
jections in internationally available multidisciplinary guide-
lines refers to guidelines for acute and chronic low back pain.
Kennedy and colleagues are correct that there are a few guide-
lines (3 of 6) that include recommendations for injection
therapy in cases of back pain with substantial neurological in-
Letters
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volvement. We apologize for the confusion although our mes-
sage remains that injection therapy is not recommended for
the majority of patients with low back pain according to in-
ternationally available guidelines.
4
Kennedy and colleagues describe 2 examples of treat-
ments with positive results in specific populations. One is radio-
frequency neurotomy for facet joint pain,
5
which falls be-
yond the scope of our Viewpoint. The other example is
transforaminal epidural steroid injections in patients with ra-
dicular pain as supported by 1 positive study.
6
Referring to this
particular study is misleading because the previously dis-
cussed meta-analysis by Pinto et al also reports 4 other stud-
ies on transforaminal epidural steroid injections with smaller
and nonsignificant effects.
3
Kennedy and colleagues welcome an evidence-based re-
view 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 wide-
spread use of injection therapies for low back and radicular
pain.
J. Bart Staal, PhD
Patty J. Nelemans, MD, PhD
RobA.DeBie,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. Systematicreview 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, TriccoAC, 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 colleagues
1
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 ulti-
mately 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 shiftingthe em-
phasis 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 opi-
oid 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. Manage-
ment 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 opi-
oids need judicious prescribing and close follow-up. Opioid
therapy can be effective for chronic, nonmalignant pain.
3
How-
ever, judicious prescribing requires knowledge and experi-
ence, and unfortunately the education of medical students in
pain management and addiction medicine is lacking.
4
Addi-
tionally,achiev ingclose follow-up requires manpower and re-
sources, both of which are becoming increasingly more diffi-
cult 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. Differ-
ent models have been proposed and research efforts should
focus on finding an optimal approach that is safe and effec-
tive and can be used in a community setting.
5
Marcin Chwistek, MD
Author Affiliation: Department of Medical Oncology, FoxChase Cancer Center,
Philadelphia, Pennsylvania.
Corresponding Author: Marcin Chwistek, MD, FoxChase Cancer Center, 333
Cottman Ave, Philadelphia, PA 19111 (marcin.chwistek@fccc.edu).
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, TevaPharmaceuticals, Archimedes Pharma,
and Janssen Pharmaceuticals; and receiving payment for educational
presentations from Tevaand Meda.
1. Dowell D, Kunins HV, Farley TA. Opioid analgesics—risky drugs, not risky
patients. JAMA. 2013;309(21):2219-2220.
2. Coxib and TraditionalNSAID 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)(suppl1):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.
Letters
jama.com JAMA October 23/30,2013 Volume 310, Number 16 1737
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... Imaging, although important for exclusion of dangerous disease, more often than not does not correlate with the patient's symptoms and is heavily overutilized without any proven clinical benefit. 79,103 Diagnostic/therapeutic interventions, like nerve blocks with local anesthetics, remain difficult to interpret and are of controversial clinical benefit, 28,72,131,132 and surgery such as discectomy for radiculopathy, has no proven long-term benefit over medical therapy alone. 78 Although acute pain syndromes have rather defined treatment algorithms (eg, nerve blocks and short course of opioids for postsurgical pain, and nonsteroidal anti-inflammatory drugs, muscle relaxants, and light physical activity for acute low back strain), treatment choices on the basis of the length of a chronic pain condition are purely empirical with few data to guide us. ...
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Unlabelled: The past few decades have witnessed a huge leap forward in our understanding of the mechanistic underpinnings of pain, in normal states where it helps protect from injury, and also in pathological states where pain evolves from a symptom reflecting tissue injury to become the disease itself. However, despite these scientific advances, chronic pain remains extremely challenging to manage clinically. Although the number of potential treatment targets has grown substantially and a strong case has been made for a mechanism-based and individualized approach to pain therapy, arguably clinicians are not much more advanced now than 20 years ago, in their capacity to either diagnose or effectively treat their patients. The gulf between pain research and pain management is as wide as ever. We are still currently unable to apply an evidence-based approach to chronic pain management that reflects mechanistic understanding, and instead, clinical practice remains an empirical and often unsatisfactory journey for patients, whose individual response to treatment cannot be predicted. In this article we take a common and difficult to treat pain condition, chronic low back pain, and use its presentation in clinical practice as a framework to highlight what is known about pathophysiological pain mechanisms and how we could potentially detect these to drive rational treatment choice. We discuss how present methods of assessment and management still fall well short, however, of any mechanism-based or precision medicine approach. Nevertheless, substantial improvements in chronic pain management could be possible if a more strategic and coordinated approach were to evolve, one designed to identify the specific mechanisms driving the presenting pain phenotype. We present an analysis of such an approach, highlighting the major problems in identifying mechanisms in patients, and develop a framework for a pain diagnostic ladder that may prove useful in the future, consisting of successive identification of 3 steps: pain state, pain mechanism, and molecular target. Such an approach could serve as the foundation for a new era of individualized/precision pain medicine. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)-American Pain Society (APS) Pain Taxonomy (AAPT) includes pain mechanisms as 1 of the 5 dimensions that need to be considered when making a diagnostic classification. The diagnostic ladder proposed in this article is consistent with and an extension of the AAPT. Perspective: We discuss how identifying the specific mechanisms that operate in the nervous system to produce chronic pain in individual patients could provide the basis for a targeted and rational precision medicine approach to controlling pain, using chronic low back pain as our example.
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The effectiveness of injection therapy for low-back pain is still debatable. Heterogeneity of target tissue, pharmacological agent and dosage generally found in randomized controlled trials (RCTs) points to the need for clinically valid comparisons in a literature synthesis. To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low-back pain. We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE and EMBASE databases from January 1999 to March 2007 for relevant trials reported in English, French, German, Dutch and Nordic languages. We also screened references from trials identified. RCTs on the effects of injection therapy involving epidural, facet or local sites for subacute or chronic low-back pain were included. Studies which compared the effects of intradiscal injections, prolotherapy or Ozone therapy with other treatments, were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded. Two review authors independently assessed the quality of the trials. If study data were clinically and statistically too heterogeneous to perform a meta-analysis, we used a best evidence synthesis to summarize the results. The evidence was classified into five levels (strong, moderate, limited, conflicting or no evidence), taking into account the methodological quality of the studies. 18 trials (1179 participants) were included in this updated review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender- and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics and a variety of other drugs. The methodological quality of the trials was limited with 10 out of 18 trials rated as having a high methodological quality. Statistical pooling was not possible due to clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy. There is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.
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Transforaminal injection of steroids is used to treat lumbar radicular pain. Not known is whether the route of injection or the agent injected is significant. A prospective, randomized study compared the outcomes of transforaminal injection of steroid and local anesthetic, local anesthetic alone, or normal saline, and intramuscular injection of steroid or normal saline. Patients and outcome evaluators were blinded as to agent administered. The primary outcome measure was the proportion of patients who achieved complete relief of pain, or at least 50% relief, at 1 month after treatment. Secondary outcome measures were function, disability, patient-specified functional outcomes, use of other health care, and duration of relief beyond 1 month. A significantly greater proportion of patients treated with transforaminal injection of steroid (54%) achieved relief of pain than did patients treated with transforaminal injection of local anesthetic (7%) or transforaminal injection of saline (19%), intramuscular steroids (21%), or intramuscular saline (13%). Relief of pain was corroborated by significant improvements in function and disability, and reductions in use of other health care. Outcomes were equivalent for patients with acute or chronic radicular pain. Over time, the number of patients who maintained relief diminished. Only some maintained relief beyond 12 months. The proportions of patients doing so were not significantly different statistically between groups. Transforaminal injection of steroids is effective only in a proportion of patients. Its superiority over other injections is obscured when group data are compared but emerges when categorical outcomes are calculated. Over time, the proportion of patients with maintained responses diminishes.