Transcript Use of Epidural Steroid Injections to Treat Radicular Lumbosacral Pain

Practice Parameter: Use of Epidural
Steroid Injections to Treat Radicular
Lumbosacral Pain
(An Evidence-Based Review)
American Academy of Neurology (AAN)
Quality Standards Subcommittee
C Armon, MD; CE Argoff, MD; J Samuels, MD;
M Backonja, MD
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Presentation Objectives
• To identify key issues in the use of
epidural steroid injections to treat radicular
lumbosacral pain
• To make evidence-based
recommendations
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Overview
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Background
Gaps in care
AAN guideline process
Analysis of evidence
Summary
Recommendations for future research
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Background
• Chronic back pain and its associated
disabilities represent an important and
increasing health problem.
• Estimated costs of treatments for spinal
pain for 1990 was at least $13 billion,
growing by 7% each year.
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Background
• In 1998 individuals with back pain
totaled $26.3 billion:
– 42% office visits
– 18% outpatient services
– 17% inpatient care
– 15% prescription drugs
– 4% emergency room visits
– 4% other
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Background
• 1999 Medicare Part B claims for 40.4
million covered individuals were:
– $49.9 million for lumbar epidural steroid
injections
– $8.5 million for lumbar facet or peri-facet joint
injections
– $5.6 million for cervical or thoracic epidural
steroid injections
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Background
• Low back pain may occur without or with
radicular features (the latter sometime
referred to as sciatica).
• Reports of epidural corticosteroid
injections to treat sciatica date back to the
1950’s.
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Background
• A 2004 review by the Technology
Assessment Committee of the Institute for
Clinical Systems Improvement (ICSI)
focused on fluoroscopically
guided,transforaminal epidural steroid
injections in radicular lumbar pain. ICSI’s
evidence-based approach used a rating
system different from AAN’s.
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Background
• ICSI’s Technology Assessment concluded
that there was insufficient evidence to
comment on the efficacy of transforaminal
epidural steroid injections in radicular
lumbar pain.
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Gaps in Care
• Effective treatment for low back pain and
sciatica is difficult.
• The natural history is one of improvement in the
majority of sufferers.
• Providers are unsure what to recommend for
their patients.
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AAN Guideline Process
Clinical Question
Evidence
Conclusions
Recommendations
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Clinical Question
• Question should address an area of
quality concern, controversy, confusion, or
variation in practice
• Question must be answerable with
sufficient scientific data
– Potential to improve clinical care and patient
outcomes
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Literature Search/Review:
Rigorous, Comprehensive, Transparent
Complete
Search
Review abstracts
Review full text
Select articles
Relevant
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AAN Classification for
Evidence
• All studies rated Class I, II, III, or IV
Therapeutic Studies
– Randomization, control, blinding
• Diagnostic Studies
– Comparison to gold standard; spectrum
• Prognostic Studies
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Classification of Evidence for
Therapeutic Intervention
Class 1 – Prospective, randomized, controlled
clinical trials with masked outcome assessment, in
a representative population. The following are
required: a) primary outcome(s) is/are clearly
defined, b) exclusion/inclusion criteria are clearly
defined, c) adequate accounting for drop-outs and
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Classification of Evidence for
Therapeutic Intervention
cross-overs with numbers sufficiently low to make
minimal potential for bias, d) relevant baseline
characteristics are presented and substantially
equivalent among treatment groups or there is
appropriate statistical adjustment for differences.
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Classification of Evidence for
Therapeutic Intervention
Class II – Prospective matched group cohort study
in a representative population with masked
outcome assessment that meets a – d above OR a
RCT in a representative population that lacks one
criterion a – d.
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Classification of Evidence for
Therapeutic Intervention
Class III – All other controlled trials including well
defined natural history controls or patients serving
as own controls in a representative population,
here outcome is independently assessed or
independently derived by objective outcome
measurement.*
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Classification of Evidence for
Therapeutic Intervention
Class IV – Evidence from uncontrolled studies,
case series, case reports, or expert opinion.
*Objective outcome measurement: an outcome measure that is unlikely
to be affected by an observer’s (patient, treating physician, investigator)
expectation or bias (e.g. blood tests, administrative outcome data).
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AAN Level of
Recommendations
• A = Established as effective, ineffective, or
harmful for the given condition in the specified
population
• B = Probably effective, ineffective, or harmful for
the given condition in the specified population
• C = Possibly effective, ineffective, or harmful for
the given condition in the specified population
• U = Data is inadequate or conflicting; given
current knowledge, treatment is unproven
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AAN Level of
Recommendations
• A = Requires two consistent Class I studies
• B = Requires one Class I study or two consistent
Class II studies
• C = Requires one Class II study or two
consistent Class III studies
• U = Studies not meeting criteria for Class I
through Class III
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Clinical Question
• What is the evidence to support use of
epidural steroid injections in radicular
lumbosacral pain to produce pain relief?
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Methods
• Literature Search
– MEDLINE, Cochrane Database
• Were disclosures made
• Risk of bias determined using the AAN
Classification of Therapeutic Evidence for each
study (Class I – IV)
• Strength of practice recommendations linked
directly to level of evidence (Level A – U)
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Literature Search/Review
37 articles
4 articles
2 ICSI review
articles
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Inclusion criteria:
-clear case definition
-clear measure of
outcome
-use of a control group
-randomization
-at least double-blind
study design
-prospective study
design
-adequate statistical
analysis
Literature Search/Review
• Relevant studies graded as Class I – IV
using the AAN Classification of
Therapeutic Evidence
• One study was Class I
• One study was Class II
• One study was Class III
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Literature Search/Review
• One study was Class I for primary
outcome variables at 3 months; was Class
II for pain at earlier time points; and was
Class III for other outcome measures:
multiple analyses; small mean effect size
• ICSI review
– One study was Class I
– One study was Class III
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Evidence-Based Guideline
Recommendations
Good evidence supports
Epidural steroid injections for radicular
lumbosacral pain have shown no impact on
average impairment of function; need for
surgery; or long-term pain relief beyond 3
months. Their routine use for these indications
Is not recommended (Level B – Class I – III).
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Recommendations
Weak evidence supports
Epidural steroid injections may result in some
improvement in radicular lumbosacral pain when
determined between 2 and 6 weeks following the
injection, compared to control treatment (Level C,
Class I – III).
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Recommendations
Insufficient evidence exists
To support or refute data on use of epidural steroid
injections to treat cervical radicular pain. No
recommendation can be made (Level U).
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Principal Findings in
Clinical Perspective
• Amelioration of Pain
– The findings of 4 high quality studies are
consistent, showing the following efficacy
pattern compared to a control group:
• No efficacy at 24 hours
• Some efficacy at 2 to 6 weeks
• No difference or rebound worsening at 3
and 6 mo.
• No difference at one year
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Principal Findings in
Clinical Perspective
• These results support the individual
perception of benefit from epidural steroids
expressed in terms of short-term symptomatic
relief.
• The average effect difference (advantage of
steroids over control treatment) was small,
usually falling short of the value proposed as
a clinically meaningful average difference –
15 mm on the 100 mm visual analogue pain
scale.
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Principal Findings in
Clinical Perspective
• Avoidance of Surgery
– Data on face value are conflicting, with the
better designed studies showing no benefit of
epidural steroids.
– Data do not permit inferring if surgery is
avoided due to:
• The treatment effect of injected steroids
• Placebo effect
• The treatment “buying time’ for a natural
history of improvement
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Principle Findings in
Clinical Perspective
• Data do not address how epidural steroid
injections might compare to other treatment
modalities and the role of patient and provider
characteristics, including temperament and
pain tolerance in selecting among various
treatment options.
• The recommendations gave greater weight to
the data from the better designed studies
showing that epidural steroid injections did not
result in less surgery.
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Principal Findings in
Clinical Perspective
• An uncontrolled study with partial follow-up of
treated patients has identified factors that
predict poor outcome:
• Greater number of previous treatments for
pain
• More medications taken
• Pain not necessarily increased by activity
• Pain increased by coughing
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Principal Findings in
Clinical Perspective
• The same uncontrolled study with partial
follow-up of treated patients has identified
factors that predict no benefit 1 year after
treatment:
• Pain does not interfere with activities
• Unemployment due to pain
• Normal straight leg raising tests before
treatment
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Limitations
• Review is limited by its inability to compare all
techniques and all treatment approaches.
• Review did not assess issues of frequency of
injection or dosage.
• Review did not evaluate operator experience
• Limited ability to generalize the findings.
• Focus on pain relief, guided by the chief
indication for which epidural steroid injections
are used, is a limitation.
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Future Research
• Further studies of the efficacy of epidural
steroids for radicular lumbosacral pain
should be well-designed, meeting specific
criteria (see full guideline).
• Studies of use of epidural steroids to treat
radicular cervical pain should also be welldesigned, meeting similar criteria.
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Future Research
• Principal questions that need to be answered
follow:
– What is the degree of efficacy, expressed in
terms of magnitude of effect, duration of
effect, and percent of patients who achieve
clinically meaningful improvement, in
comparison to alternative treatments?
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Future Research
• Using a controlled design, are there predictors
of lack of efficacy or poor efficacy?
• How many treatments are appropriate, and at
what intervals?
• How frequent are complications, and what are
they?
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Future Research
• Initially, it will be necessary to standardize
some of the variables reflected in the
questions in Table 1 (see full guideline)
such as a specific technical approach, the
minimal competency of the treating
physician, and utilization of additional
therapies.
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To access the full guideline please visit:
AAN.com/Guidelines
Published in Neurology, March 6, 2007 68:723-729
Questions or Comments?
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