Pro: I Would Perform Another ESI on This Patient

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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
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[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.
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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.
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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
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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
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