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Pain Physician 2009; 12:163-188 • ISSN 1533-3159

Systematic Review

Lumbar Interlaminar Epidural Injections


in Managing Chronic Low Back and Lower
Extremity Pain: A Systematic Review
Allan T. Parr, MD1, Sudhir Diwan, MD2, and Salahadin Abdi, MD, PhD3

Background: Low back pain with or without lower extremity pain is the most common problem
among chronic pain disorders with significant economic, societal, and health impact. Epidural injec-
From: 1Premier Pain Center, tions are one of the most commonly performed interventions in the United States in managing chronic
Covington, LA; 2New York low back pain. However the evidence is highly variable among different techniques utilized – namely
Presbyterian Hospital, Weill interlaminar, caudal, transforaminal – and for various conditions, namely – intervertebral disc hernia-
Cornell Medical College, New
tion, spinal stenosis, and discogenic pain without disc herniation or radiculitis.
York, NY; and 3University
of Miami, Miller School of Study Design: A systematic review of lumbar interlaminar epidural injections with or without
Medicine, Miami, FL.
steroids.
Dr. Parr is Medical Director of Objective: To evaluate the effect of lumbar interlaminar epidural injections with or without steroids
Premier Pain Center,
in managing various types of chronic low back and lower extremity pain emanating as a result of disc
Covington, LA.
Dr. Diwan is Director of Pain herniation or radiculitis, spinal stenosis, and chronic discogenic pain.
Medicine in the Department
Methods: Review of the literature and methodologic quality assessment were performed accord-
of Anesthesiology, New York
Presbyterian Hospital, and the ing to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques
Director of the Tri-Institutional for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for obser-
Pain Fellowship Program, Weill vational studies.
Cornell Medical College,
New York, NY.
The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the
Dr. Abdi is Professor and Chief, U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions.
Division of Pain Medicine, Data sources included relevant literature of the English language identified through searches of PubMed
Department of Anesthesiology,
and EMBASE from 1966 to November 2008, and manual searches of bibliographies of known primary
Perioperative Medicine and
Pain Management, University and review articles. Results of analysis were performed for multiple conditions separately.
of Miami, Miller School of
Outcome Measures: The primary outcome measure was pain relief (short-term relief = up to 6
Medicine, Miami, FL.
months and long-term > 6 months). Secondary outcome measures were improvement in functional
Address correspondence: status, psychological status, return to work, and reduction in opioid intake.
Allan T. Parr, MD
Medical Director Results: The available literature included only blind epidural injections without fluoroscopy. The in-
Premier Pain Center dicated evidence is positive (Level II-2) for short-term relief of pain of disc herniation or radiculitis uti-
7015 Highway 190, lizing blind interlaminar epidural steroid injections with lacking of evidence with Level III for long-term
Service Road, Suite 101 relief for disc herniation and radiculitis. The evidence is lacking with Level III for short and long-term
Covington, LA 70433 relief for spinal stenosis and discogenic pain without radiculitis or disc herniation utilizing blind epidu-
E-mail: alparr@alparr.com
ral injections.
Disclaimer: There was no Limitations: The limitations of this study include paucity of literature, lack of quality evidence, lack
external funding in the
of fluoroscopic procedures, and lack of applicable evidence in contemporary interventional pain man-
preparation of this manuscript.
Conflict of interest: None. agement practices.
Conclusion: The evidence based on this systematic review is limited for blind interlaminar epidurals in
Manuscript received: 11/7/2008
Accepted for publication: managing all types of pain except for short-term relief of pain secondary to disc herniation and radiculitis.
12/5/2008 This evidence does not represent contemporary interventional pain management practices and also the
evidence may not be extrapolated to fluoroscopically directed lumbar interlaminar epidural injections.
Free full manuscript:
www.painphysicianjournal.com Key words: Chronic low back pain, lower extremity pain, disc herniation, radiculitis, spinal stenosis,
discogenic pain, lumbar interlaminar epidural injections, caudal epidural injections, transforaminal epi-
dural injections, epidural steroids, local anesthetic

Pain Physician 2009: 12:1:163-188

www.painphysicianjournal.com
Pain Physician: January/February 2009:12:163-188

L ow back pain with or without lower extremity


pain is the most common problem among
chronic pain disorders with significant economic,
societal, and health impact (1-12). Chronic low back
pain is a multifactorial disorder with many possible
cific approach requiring the smallest volume to reach
the primary site of pathology.
However, epidural procedures continue to be con-
troversial regarding their effectiveness, indications,
and medical necessity (1,58-73). The evidence is highly
etiologies. Kuslich et al (13) identified intervertebral variable based on the reviewer with ratings ranging
discs, facet joints, ligaments, fascia, muscles, and nerve from indeterminate to moderate in various publica-
root dura as tissues capable of transmitting pain in the tions. The majority of the literature on lumbar inter-
low back. A widespread interest was created in the disc laminar epidurals appears to be negative. The first
as a source of pain in American literature by Mixter systematic review of the effectiveness of epidural ste-
and Barr (14) in 1934 with their hallmark description roid injections was performed by Kepes and Duncalf
of the herniated nucleus pulposus. In addition, in 1985 (61) which concluded that the rationale for
Mixter and Ayers (15), just one year after the original epidural and systemic steroids had not been proven.
description in 1934, demonstrated that radicular pain However, in a follow-up systematic review in 1986,
can occur without disc herniation. Subsequently, Benzon (73), utilizing the same studies, concluded that
numerous investigators (16-24) have described pain mechanical causes of low back pain, especially those
syndromes emanating from lumbar intervertebral disc accompanied by signs of nerve root irritation, may re-
without mechanically compressing neural structures. spond to epidural steroid injections. The differences in
Consequently, the pathophysiology of spinal radicular the conclusions of Kepes and Duncalf (61) and Benzon
pain is a subject of ongoing research and controversy (73) may have been due to the fact that Kepes and
and discogenic pain has assumed a major role as a Duncalf (61) included studies on systematic steroids,
cause of non-specific low back pain, beyond the more whereas Benzon (73) limited his analysis to studies on
specific cause of disc herniation. Thus, in addition epidural steroid injections only.
to the mechanical component, inflammation of Bogduk et al (59) extensively reviewed caudal,
the compressed nerve root is an important factor interlaminar, and transforaminal epidural injections,
in the pathophysiology of radicular and discogenic including all of the literature available at that time.
pain (22,24-31). Other proposed etiologies include They concluded that the results of lumbar interlami-
neural compression with dysfunction and vascular nar epidural steroids strongly refute the utility of
compromise (32-36). Further, neurotoxicity has been epidural steroids in acute sciatica. Bogduk (60) up-
attributed to many agents including phospholipase dated their recommendations in 1999, recommending
A2 (PLA2) and tumor necrosis factor (TNFα) which may against epidural steroids by the lumbar route because
play an essential role in intervertebral disc-induced effective treatment required too high a number for
nerve root damage (18,26-30,37-40). successful treatment. In 1995, Koes et al (62) reviewed
Intervertebral disc herniation, spinal stenosis, in- 12 trials of lumbar and caudal epidural steroid injec-
tervertebral disc degeneration without disc herniation, tions (combined together) and reported positive re-
degenerative spondylolisthesis with stenosis, and post sults from only 6 studies, concluding that there was
lumbar surgery syndrome are the most common diag- no evidence for epidural steroids in managing lumbar
noses of low back and leg symptoms (14-21,41-51). radicular pain. Their updated review (63) with 15 trials
Epidural injections are the most commonly per- arrived at similar conclusions that there was no evi-
formed interventions in the United States in man- dence that epidural steroid injections are effective in
aging chronic low back pain (52-58). Among several patients with chronic back pain without sciatica. Over-
approaches available to access the lumbar epidural all, the evidence for lumbar interlaminar epidural ste-
space, the lumbar interlaminar approach is the most roid injections is limited in managing pain secondary
commonly used, the other 2 being the lumbar transfo- to disc herniation. However, available evidence is even
raminal approach and caudal approach (1,58,59). The inferior in managing axial low back pain and lumbar
interlaminar approach has been touted as its entry can spinal stenosis (58,65,66).
be directed more closely to the assumed site of pa- The underlying mechanism of action of epidurally
thology, requiring less volume than the caudal route administered local anesthetic and steroid injections is
and it is less risky compared to the transforaminal ap- not well understood. However, multiple hypotheses
proach which is considered to be a more target-spe- have been presented indicating pain relief by vari-

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Lumbar Interlaminar Epidural Injections

ous mechanisms both by steroids and local anesthet- analysis was assessed by modified Cochrane review cri-
ics (74-87). In fact, the effect of local anesthetic with teria with weighted scores (Table 1) (62) for random-
or without steroids has been reported to be the same ized trials and the Agency for Healthcare Research
in epidural injections in clinical studies (88-91), facet and Quality (AHRQ) quality criteria for assessment of
joint nerve blocks (78-80), as well as in an experimen- observational studies (Table 2) (92) with consensus-
tal evaluation of nerve root infiltration (87). based weighted scoring developed by the guidelines
Due to the ongoing controversy and lack of signifi- committee of the American Society of Interventional
cant evidence, this systematic review is undertaken to Pain Physicians (ASIPP) utilized in multiple evaluations
evaluate the effects of lumbar interlaminar epidural (70,93-97).
injections in managing chronic low back and lower ex- Only the studies scoring at least 50 of 100 on
tremity pain secondary to lumbar disc herniation and weighted scoring criteria were utilized for analysis.
radiculitis, spinal stenosis, and chronic low back pain of Each study was evaluated by 2 physicians for stat-
discogenic origin without radiculitis or disc herniation. ed criteria and any disagreements were resolved by a
third physician.
Methods If there was a conflict of interest with the reviewed
manuscripts with authorship or any other type of con-
Literature Search flict, the involved authors did not review the manu-
A comprehensive literature search was conduct- scripts for quality assessment or evidence synthesis.
ed which included the search of databases including
PubMed and EMBASE from 1966 through November Clinical Relevance
2008, Cochrane database, Clinical Trial Registry, sys- Clinical relevance of the included studies was
tematic reviews, narrative reviews, and cross-referenc- evaluated according to 5 questions recommended by
es to the reviews published in the English language. the Cochrane Back Review Group (66,98-100).
The search strategy emphasized chronic low back Table 3 shows the clinical relevance questions.
pain of discogenic origin with a focus on lumbar epi- Each question was scored positive (+) if the clinical
dural injections. Search terminology included lumbar relevance item was met, negative (–) if the item was
intervertebral disc, disc-related pain, spinal stenosis, not met, and unclear (?) if data were not available to
and lumbar epidural injections. answer the question.
In the recent Cochrane review of “Injection Ther-
Selection Criteria apy for Subacute and Chronic Low Back Pain” (66)
The review focused on randomized trials and ob- the authors considered a 20% improvement in pain
servational studies, and reports of complications. The scores (98) and a 10% improvement in functioning
population of interest was patients suffering with outcomes (99) to be clinically important. The current
chronic low back pain for at least 3 months. Only lum- study utilized stricter criteria than general systematic
bar interlaminar epidural injections with or without reviews and previous systematic reviews. Any relief of
steroids were evaluated. All the studies providing ap- 6 months or less was considered as short-term, where-
propriate management with outcome evaluations of 6 as Cochrane reviews (66) and others have considered
months or longer and statistical evaluations were re- 6 weeks as short-term and longer than 6 weeks as
viewed. Reports without appropriate diagnosis, non- long-term. We also utilized methodologic quality as-
systematic reviews, book chapters, and case reports sessment criteria (66) for minimum inclusion, thus this
were excluded. systematic review is expected to provide robust results
with stricter criteria. However, in contrast to many
Outcome Parameters other systematic reviews, we have not excluded ob-
The outcome measures were of documented pain servational studies and included only quality observa-
relief at various points in time, functional assessment, tional studies with scores of 50 or more on a scale of
and other outcomes including psychological improve- 0–100 based on AHRQ criteria. This improves the gen-
ment, return to work, and change in opioid intake. eralizability of the systematic review and the interven-
tion. However, in interventional pain management
Methodologic Quality Assessment settings, significant improvement has been defined
The quality of each individual article used in this as 50% or more relief, whereas significant improve-

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Pain Physician: January/February 2009:12:163-188

Table 1. Modified and weighted Cochrane methodologic quality assessment criteria.

Weighted
CRITERION
Score (points)
1. Study population 35
A Homogeneity 2
B Comparability of relevant baseline characteristics 5
C Randomization procedure adequate 4
D Drop-outs described for each study group separately 3
E < 20% loss for follow-up 2
< 10% loss for follow-up 2
F > 50 subject in the smallest group 8
> 100 subjects in the smallest group 9
2. Interventions 25
G Interventions included in protocol and described 10
H Pragmatic study 5
I Co-interventions avoided or similar 5
J Placebo-controlled 5
3. Effect 30
K Patients blinded 5
L Outcome measures relevant 10
M Blinded outcome assessments 10
N Follow-up period adequate 5
4. Data-presentation and analysis 10
O Intention-to-treat analysis 5
P Frequencies of most important outcomes presented for each treatment group 5
TOTAL SCORE 100

Adapted from Koes BW et al. Efficacy of epidural steroid injections for low-back pain and sciatica: A systematic review of randomized clinical
trials. Pain 1995; 63:279-288 (62).

ment in disability has been defined as a 40% or more ry outcome measure was statistically significant at the
decrease in disability scores in multiple publications conventional 5% level. In a negative study, no differ-
(78-80,88-91,101-104). ence was reported between the study treatments or
no improvement from baseline. Further, the outcomes
Analysis of Evidence were judged at the reference point with positive or
Quality analysis was conducted using 5 levels of negative results reported at 3 months, 6 months, and
evidence, ranging from Level I to III with 3 subcatego- one year.
ries in Level II, as illustrated in Table 4 (105). For observational studies, a study was judged to
Grading recommendations were based on Guyatt be positive if the epidural injection therapy was ef-
et al’s criteria as illustrated in Table 5 (106). fective, with outcomes reported at the reference
point with positive or negative results at 3 months, 6
Outcome of the Studies months, and one year. Relief of 6 months or less was
A study is judged to be positive if the epidural considered as short-term and relief of longer than 6
injection therapy was effective, either with a placebo months was considered as long-term.
control or active control in randomized trials. This in- The data will be analyzed separately for disc her-
dicates that the difference in the effect for the prima- niation and/or radiculopathy, discogenic pain with

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Lumbar Interlaminar Epidural Injections

Table 2. Modified AHRQ quality assessment criteria for observational studies.


CRITERION Weighted Score (points)
1. Study Question 2
• Clearly focused and appropriate question
2. Study Population 8
• Description of study population 5
• Sample size justification 3
3. Comparability of Subjects 22
• Specific inclusion/exclusion criteria for all groups 5
• Criteria applied equally to all groups 3
• Comparability of groups at baseline with regard to disease status and prognostic factors 3
• Study groups comparable to non-participants with regard to confounding factors 3
• Use of concurrent controls 5
• Comparability of follow-up among groups at each assessment 3
4. Exposure or Intervention 11
• Clear definition of exposure 5
• Measurement method standard, valid and reliable 3
• Exposure measured equally in all study groups 3
5. Outcome measures 20
• Primary/secondary outcomes clearly defined 5
• Outcomes assessed blind to exposure or intervention 5
• Method of outcome assessment standard, valid and reliable 5
• Length of follow-up adequate for question 5
6. Statistical Analysis 19
• Statistical tests appropriate 5
• Multiple comparisons taken into consideration 3
• Modeling and multivariate techniques appropriate 2
• Power calculation provided 2
• Assessment of confounding 5
• Dose-response assessment if appropriate 2
7. Results 8
• Measure of effect for outcomes and appropriate measure of precision 5
• Adequacy of follow-up for each study group 3
8. Discussion 5
• Conclusions supported by results with possible biases and limitations taken into consideration
9. Funding or Sponsorship 5
• Type and sources of support for study
TOTAL SCORE 100
Adapted and modified from West S et al. Systems to Rate the Strength of Scientific Evidence, Evidence Report, Technology Assessment No. 47.
AHRQ Publication No. 02-E016 (92).

Table 3. Clinical relevance questions.


A) Are the patients described in detail so that you can decide whether they are comparable to those that you see in your practice?
B) Are the interventions and treatment settings described well enough so that you can provide the same for your patients?
C) Were all clinically relevant outcomes measured and reported?
D) Is the size of the effect clinically important?
E) Are the likely treatment benefits worth the potential harms?
Source: Staal JB et al. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev 2008; 3:CD001824 (66).
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Pain Physician: January/February 2009:12:163-188

Table 4. Quality of evidence developed by USPSTF.

I: Evidence obtained from at least one properly randomized controlled trial

II-1: Evidence obtained from well-designed controlled trials without randomization


Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one
II-2:
center or research group
Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled
II-3: experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded
as this type of evidence
Opinions of respected authorities, based on clinical experience descriptive studies and case reports or reports of
III:
expert committees
Adapted from the U.S. Preventive Services Task Force (USPSTF) (105).

Table 5. Grading recommendations.

Grade of Recommendation/ Benefit vs Risk and Methodological Quality of


Description Burdens Supporting Evidence Implications
1A/strong recommendation, high- Benefits clearly outweigh RCTs without important limitations Strong recommendation,
quality evidence risk and burdens, or vice or overwhelming evidence from can apply to most patients in
versa observational studies most circumstances without
reservation
1B/strong recommendation, moder- Benefits clearly outweigh RCTs with important limitations Strong recommendation,
ate quality evidence risk and burdens, or vice (inconsistent results, methodologi- can apply to most patients in
versa cal flaws, indirect, or imprecise) or most circumstances without
exceptionally strong evidence from reservation
observational studies

1C/strong recommendation, low- Benefits clearly outweigh Observational studies or case series Strong recommendation but
quality or very low-quality evidence risk and burdens, or vice may change when higher qual-
versa ity evidence becomes available
2A/weak recommendation, high- Benefits closely balanced RCTs without important limitations Weak recommendation, best
quality evidence with risks and burden or overwhelming evidence from action may differ depending
observational studies on circumstances or patients’
or societal values

2B/weak recommendation, moderate- Benefits closely balanced RCTs with important limitations Weak recommendation, best
quality evidence with risks and burden (inconsistent results, methodologi- action may differ depending
cal flaws, indirect, or imprecise) or on circumstances or patients’
exceptionally strong evidence from or societal values
observational studies

2C/weak recommendation, low-qual- Uncertainty in the esti- Observational studies or case series Very weak recommendations;
ity or very low-quality evidence mates of benefits, risks, other alternatives may be
and burden; benefits, risk, equally reasonable
and burden may be closely
balanced
Adapted from Guyatt G et al. Grading strength of recommendations and quality of evidence in clinical guidelines. Report
from an American College of Chest Physicians task force. Chest 2006; 129:174-181 (106).

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Lumbar Interlaminar Epidural Injections

predominantly low back pain, and spinal stenosis. Results


Studies performed under fluoroscopy were given
priority. A literature search was carried out for lumbar in-
Observational studies were only included in the terlaminar epidural injections as shown in Fig. 1.
evidence synthesis if there were less than 4 random- Our search strategy yielded multiple studies eval-
ized trials meeting inclusion criteria for each category uating the effectiveness of interlaminar epidural in-
as described above. If a study included more than one jections with or without steroids. These included 20
type of patient and the analysis in the study was con- randomized or double-blind trials (107-126) and 30
sidered separately for both conditions, that study was observational studies (127-156).
included for all the conditions.

Computerized and manual search of


literature
n = 1,647

Non-duplicate titles
n = 1,617

Articles excluded by title and/or Potential articles


abstract n = 350
n = 1,267

Abstracts reviewed
n = 350

Abstracts excluded
n = 252 Full manuscripts not available
n=8

Full manuscripts reviewed


n = 90

Manuscripts considered for inclusion


Systematic reviews = 8
Randomized trials = 20
Observational studies = 30

Fig. 1. The flow diagram illustrating randomized trials, observational studies, and systematic reviews evaluating caudal
epidural injections.

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Pain Physician: January/February 2009:12:163-188

Randomized Trials focused on diabetic polyneuropathy and intrac-


table post-herpetic neuralgia.
Methodologic Quality Assessment ♦ Buchner et al (120) was excluded as they evalu-
Of the 20 randomized trials, 11 studies met in- ated only inpatients.
clusion criteria (107-111,115,116,122,123,125,126). Of ♦ Multiple evaluations (107,111,113,114,116,121-
these, 6 studies met the inclusion criteria to be included 124) were excluded for lack of evaluation of long-
for methodological assessment (108-110,115,125,126). term outcomes.
Reasons for exclusion were as follows: Methodological quality criteria are illustrated
♦ Serrao et al (112) was excluded as they studied the in Table 6 showing all the randomized clinical trials
effects of subarachnoid and epidural midazolam. evaluating the effectiveness of lumbar interlaminar
♦ Two studies (117,118) were excluded since they epidural injections. The quality assessment criteria

Table 6. Methodological assessment of randomized trials evaluating the effectiveness of lumbar interlaminar epidural injections.

WEIGHTED Arden Carette Cuckler Wilson- Snoek Ridley


CRITERION SCORE et al et al et al MacDonald et al et al
(points) (126) (108) (110) et al (125) (109) (115)
Study population
A Homogeneity 2 2 2 2 2 2 2
B Comparability of relevant baseline 5 5 5 4 5 3 4
characteristics
C Randomization procedure adequate 4 4 4 4 4 4 2
D Drop-outs described for each study group 3 3 3 3 3 3 —
separately
E < 20% loss for follow-up 2 — — 2 2 2 2
< 10% loss for follow-up 2 — — 2 2 2 —
F > 50 subject in the smallest group 8 8 8 — — — —
> 100 subjects in the smallest group 9 9 — — — — —
Interventions
G Interventions included in protocol and 10 10 10 10 10 10 10
described
H Pragmatic study 5 — — 5 — — —
I Co-interventions avoided or similar 5 — — — — 5 —
J Placebo-controlled 5 5 5 — — 5 5
Effect
K Patients blinded 5 5 5 3 5 3 3
L Outcome measures relevant 10 10 10 2 10 8 4
M Blinded outcome assessments 10 10 10 10 10 10 10
N Follow-up period adequate 5 5 5 5 5 5 5
Data-presentation and analysis
O Intention-to-treat analysis 5 5 5 5 5 5 —
P Frequencies of most important outcomes 5 5 5 3 5 5 —
presented for each treatment group
TOTAL SCORE 100 86 77 60 68 72 47
Methodological criteria and scoring adapted from Koes BW et al. Efficacy of epidural steroid injections for low-back pain and sciatica: A system-
atic review of randomized clinical trials. Pain 1995; 63:279-288 (62).

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Lumbar Interlaminar Epidural Injections

ranged from 47 to 86 with 5 of 6 trials meeting inclu- Methodologic Quality Assessment


sion criteria. Methodologic quality assessment was performed
on the studies evaluating either spinal stenosis or dis-
Clinical Relevance Assessment cogenic pain. No observational studies were included
Table 7 illustrates the clinical relevance of random- for disc herniation or radiculitis as 6 randomized trials
ized trials. The scores were 3 of 5 for all the trials. (108-110,115,125,136) met inclusion criteria.
Among the observational studies meeting the in-
Inclusion Criteria clusion criteria for evidence synthesis, one evaluation
Of the 5 studies meeting inclusion criteria for evi- studied chronic discogenic low back pain without ra-
dence synthesis, 4 of them (108,109,125,126) included diculitis (148) and one study evaluated spinal stenosis
patients with disc herniation and sciatica, whereas (150). Of all the studies meeting inclusion criteria, only
one study (110) included patients with acute herniat- one study by Butterman (148) was performed under
ed nucleus pulposus or spinal stenosis of longer than fluoroscopy. There was only one study meeting inclu-
6 months. sion criteria evaluating the role of epidural steroid in-
There were no randomized trials evaluating the jections in spinal stenosis.
patients either with spinal stenosis alone or with Methodologic quality assessment criteria are illus-
chronic low back pain of discogenic origin without trated in Table 8. Butterman (148) scored 75, whereas
radiculitis. Campbell et al (150) scored 53, thus both of them met
inclusion criteria.
Observational Studies
Of the 30 observational studies (127-156), 2 Disc Herniation and Radiculitis
studies were excluded as they were not related Of the studies meeting inclusion criteria (108-
to the lumbar interlaminar procedure (139,146). 110,126,127), Cuckler et al (110) studied patients with
One study was excluded due to factor analysis either acute herniated nucleus pulposus or spinal ste-
rather than outcome assessment (138). Five stud- nosis of greater than 6 months. Of the 73 patients with
ies were excluded due to short-term follow up back pain included in the study, 34 were secondary to
(129,141,143,149,155). One study (131) was excluded acute herniated nucleus pulposus, whereas 37 patients
due to short-term relief and the procedure was be- were secondary to spinal stenosis reducing the sample
ing performed in an inpatient setting. Seven studies size (110). Wilson-MacDonald et al (125) included 32
were excluded due to non-availability of full manu- patients with spinal stenosis, with 43 patients with
scripts or data for methodology quality assessment disc herniation. All other studies evaluated the role of
(127,130,132,133,144,153,154). epidural injections in sciatica or radiculitis.

Table 7. Assessment of clinical relevance of randomized clinical trials evaluating the effectiveness of lumbar interlaminar epidural
injections.
Arden et Carette et Cuckler et Wilson- Snoek et
al (126) al (108) al (110) MacDonald al (109)
(125)
A) «Are the patients described in detail so that you can decide + + + + +
whether they are comparable to those that you see in your practice?
B) «Are the interventions and treatment settings described well - - - - -
enough so that you can provide the same for your patients?
C) «Were all clinically relevant outcomes measured and reported? + + + + +
D) «Is the size of the effect clinically important? + + + + +
E) «Are the likely treatment benefits worth the potential harms? - - - - -
TOTAL CRITERIA MET 3/5 3/5 3/5 3/5 3/5

+ = positive; - = negative; ? = unclear


Scoring adapted from Staal JB et al. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev 2008; 3:CD001824 (66).

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Pain Physician: January/February 2009:12:163-188

Table 8. Methodological assessment of observational studies evaluating the effectiveness of lumbar interlaminar epidural injections.
Weighted
Butterman Campbell et
CRITERION Score
(148)* al (150)
(points)
1. Study Question 2 2 2
• Clearly focused and appropriate question 2 2
2. Study Population 8 5 5
• Description of study population 5 5 5
• Sample size justification 3 -- --
3. Comparability of Subjects for All Observational Studies 22 14 5
• Specific inclusion/exclusion criteria for all groups 5 5 5
• Criteria applied equally to all groups 3 3 --
• Comparability of groups at baseline with regard to disease status and prognostic factors 3 3 --
• Study groups comparable to non-participants with regard to confounding factors 3 -- --
• Use of concurrent controls 5 -- --
• Comparability of follow-up among groups at each assessment 3 3 --
4. Exposure or Intervention 11 11 6
• Clear definition of exposure 5 5 5
• Measurement method standard, valid and reliable 3 3 1
• Exposure measured equally in all study groups 3 3 --
5. Outcome measures 20 15 10
• Primary/secondary outcomes clearly defined 5 5 5
• Outcomes assessed blind to exposure or intervention 5 -- --
• Method of outcome assessment standard, valid and reliable 5 5 --
• Length of follow-up adequate for question 5 5 5
6. Statistical Analysis 19 10 10
• Statistical tests appropriate 5 5 5
• Multiple comparisons taken into consideration 3 3 3
• Modeling and multivariate techniques appropriate 2 2 2
• Power calculation provided 2 -- --
• Assessment of confounding 5 -- --
• Dose-response assessment if appropriate 2 -- --
7. Results 8 8 5
• Measure of effect for outcomes and appropriate measure of precision 5 5 2
• Adequacy of follow-up for each study group 3 3 3
8. Discussion 5 5 5
• Conclusions supported by results with possible biases and limitations taken into
5 5
consideration
9. Funding or Sponsorship 5 5 5
• Type and sources of support for study 5 5
TOTAL SCORE 100 75 53
*Performed utilizing fluoroscopy

Adapted and modified from West S et al. Systems to Rate the Strength of Scientific Evidence, Evidence Report, Technology Assessment No. 47.
AHRQ Publication No. 02-E016 (92).

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Lumbar Interlaminar Epidural Injections

Study Characteristics Cuckler et al (110) performed a prospective, ran-


Table 9 shows the characteristics of randomized domized, double-blind study of the use of epidural ste-
trials of lumbar interlaminar epidural injections evalu- roids in the treatment of lumbar radicular pain. They
ating disc herniation and radiculitis. Surprisingly, none included 73 patients with a clinical diagnosis of either
of the studies were performed under fluoroscopy. acute herniated nucleus pulposus or spinal stenosis

Table 9. Characteristics of published randomized trials of blind lumbar interlaminar epidural injections in managing disc hernia-
tion and radiculitis.
Conclusion(s)
Short-term
Study/Methods Participants Intervention(s) Outcome(s) Result(s) relief ≤ 6 mos.
Long-term
relief > 6 mos.
Wilson-Mac- 93 pts. with MRI evidence of a Experimental: Timing: 6 wks, 24 In the first 5 wks Positive short-term
Donald et al disc prolapse, spinal stenosis, orepidural injection of mos. after epidural and negative long-
2005 (125) a combination. bupivacaine 0.5% (40 Outcome measures: injection a useful term relief
Pts. had lumbosacral nerve root mg) with methyl- Oswestry Disability improvement in
Randomized, pain which had not resolved prednisolone 80 mg. index, pain relief. nerve root symp-
controlled within 6 wks minimum. Control: intramuscu- toms was seen.
trial lar injection of 0.5%
32 pts. with 18 into the epidural (40 mg) bupiva-
group and 14 in the control group caine with 80 mg
had spinal stenosis only, whereas methylprednisolone.
3 pts. in the epidural group and
15 pts. in control group had a
combined disc herniation and
spinal stenosis.
Arden et al 2005 228 pts. with unilateral sciatica. Experimental: Timing: 3, 6, 12, 26, Lumbar epidural Negative short- and
(126) triamcinolone 80 mg and 52 weeks. steroid injection long-term relief
and 10 mL of 0.25% Outcome measures: produced a statisti-
Double-blind, bupivacaine. Oswestry disability cally significant
randomized Control: interspinous index, Likert scale, improvement in
placebo con- injection with 2 mL of SF-36, VAS. function over pla-
trolled: TRIM normal saline. cebo in 3 wks. By 6
wks, benefit lost.
Carette et al 1997 158 pts. with sciatica due to a Experimental: meth- Timing: 6 wks., 3 Significant Positive short-term
(108) herniated nucleus pulposus. ylprednisolone acetate mos., 12 mos. improvement was and negative long-
Randomized, Treatment group: 78 (80 mg and 8 mL of Outcome measures: seen in leg pain in term relief
double-blind Placebo group: 80 isotonic saline) need for surgery, the methylpred-
trial Oswestry Disability nisolone group
Control: isotonic scores. after 6 weeks, with
saline 1 mL no difference after
Frequency: 3 epidural 3 and 12 mos.
injections 3 wks. apart.
Cuckler et al 73 pts. with back pain due to Experimental: 80 mg Timing: 24 hrs and There was no Negative short-term
1985 (110) either acute herniated nucleus (2 mL) of methylpred- an average of 20 significant short- and long-term relief
Randomized, pulposus or spinal stenosis of > 6 nisolone + 5 mL of mos. term or long-term
double-blind mos. Experimental: 42 Control: procaine 1%. Outcome measures: improvements
trial 3.1 Control group: 2 subjective improve- between both
mL saline + 5 mL of ment, need for groups.
procaine 1%. surgery.
Snoek et al 1977 51 pts. with lumbar root Experimental: 80 mg Timing: 3 days and No statistically Negative short-term
(109) compression documented by of methylprednisolone an average of 14 significant differ- and long-term relief
Randomized trial neurological deficit and a con- (2 mL). mos. ences were noted
cordant abnormality noted on Control: 2 mL of Outcome measures: in either group.
myelography. normal saline Pain, sciatic nerve
Experimental: 27 Control: 24 Frequency: single stretch tolerance.
injection.

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Pain Physician: January/February 2009:12:163-188

between November 1978 and 1980. All the procedures results of this study may not provide any value in con-
were performed without fluoroscopy. Ninety percent temporary interventional pain management.
of the epidural injections were performed by a single Carette et al’s (108) study has been described as the
anesthesiologist in a lateral decubitus position, be- best study evaluating the role of epidural steroids in
tween the third and fourth lumbar vertebra, lying on managing sciatica due to herniated nucleus pulposus.
the side of the painful limb. Either 2 mL of sterile wa- However, this study also contains numerous deficien-
ter containing 80 mg of methylprednisolone acetate cies. Between October 1992 and January 1996, they
combined with 5 mL of 1% procaine or 2 mL of saline enrolled 158 patients with 78 patients in the meth-
combined with 5 mL of 1% procaine was injected. The ylprednisolone group and 80 patients in the placebo
authors stated that neither the treating physician, nor group. The patients received injections of either 80
the patient was informed of the contents of the initial mg (2 mL) of methylprednisolone acetate mixed with
injection until July 1981; however, they have not de- 8 mL of isotonic saline) or 1 mL of isotonic saline in the
scribed the concealment process. They also provided a epidural space according to the technique described
second injection if there had been less than 50% im- by Barry and Kendall (172), without fluoroscopy, in a
provement 24 hours after the first injection with meth- physiatric practice, dating back to 1962. The proce-
ylprednisolone acetate and procaine in a non-blind dure was performed without fluoroscopy in the later-
fashion. Further, they defined a short-term successful al decubitus position and isotonic saline was adminis-
result as subject to improvement of 75% or more as tered, in fact, into the epidural space. No information
judged by the patient 24 hours after injection. Any- is available with regards to the effect of injection of
thing less than 75% was considered as short-term fail- an inert substance into the epidural space. Further,
ure. Further, they described all patients who received the disadvantages of the spread of the drug, level of
a second injection as having a failed result. They also the injection, lack of ventral placement of the drug,
defined any patient who had laminectomy during the and lack of fluoroscopy fail to generalize the results to
period of follow-up (which was over 20 months) as a contemporary interventional pain management prac-
long-term failed result. They did not provide any spe- tice. The results showed that at 3 weeks, the Oswes-
cial exercise program or other physical therapy. The try Disability Index (ODI) score had improved slightly
long-term results showed 25 (61%) of 41 patients who better in the methylprednisolone group compared to
received an epidural steroid injection as the first injec- the placebo group, along with significant differences
tion reported some degree of improvement, while 20 noted with finger-to-floor distance (P = 0.006) and
(62.5%) of the 32 patients who received placebo injec- sensory deficits (P = 0.003), which were greater in the
tion reported some degree of improvement. methylprednisolone group. However, after 6 weeks,
These authors utilized a flawed process by consid- the only significant difference was the improvement
ering local anesthetic injection as a placebo. Conse- in leg pain, which was greater in the methylpredniso-
quently, this is not an efficacy trial, but it is an equiva- lone group (P = 0.03). After 3 months, there were no
lency or non-inferiority trial (78-80,88-91). Further, significant differences between the groups. Further,
the effectiveness of local anesthetics has been dem- at 12 months, the cumulative probability of back sur-
onstrated and shown to be equal to steroids, both gery was 25.8% in the methylprednisolone group and
in clinical and experimental studies (78-80,87-91,157- 24.8% in the placebo group. The authors concluded
162). Further, when multiple variables are considered, that even though epidural injections of methylpred-
the procedure was performed with a blind technique nisolone may afford short-term improvement in leg
between L3 and L4 in the lateral decubitus position pain and sensory deficits in patients with sciatica due
with the affected side down with inability to reach the to a herniated nucleus pulposus, this treatment offers
targeted area in almost half of the patients (147,163- no significant functional benefit, nor does it reduce
171). Other flaws of this study include small sample the need for surgery compared to saline epidural in-
size, poor methodology, and inadequate outcome jection. However two-thirds of the patients in both
assessments. Statistically detailed data were not pro- groups avoided surgery.
vided to calculate the patients receiving greater than Arden et al (126) in a study published in 2005
50% relief at any point in the evaluation. Further, evaluated the effectiveness and predictors of re-
evaluation was performed only at 2 points. Thus, the sponse to lumbar epidural corticosteroid injections

174 www.painphysicianjournal.com
Lumbar Interlaminar Epidural Injections

in patients with sciatica, in a 12-month, multi-center, again illustrating the disadvantages of including pa-
double-blind, randomized, placebo-controlled, paral- tients with acute problems. Another outcome was that
lel-group trial in 4 secondary pain-care clinics in the neurological symptoms and signs tended to improve
Wessex Region of the United Kingdom. They recruited throughout the trial, even though, at the end of the
228 patients, aged 18 to 70 years, presenting to ortho- study, 44.8% of the patients still had decreased sen-
paedic, rheumatology, and pain clinics at the partici- sation and 24.6% decreased power. The authors de-
pating hospitals with a clinical diagnosis of unilateral scribe that for the first time, a single large randomized
sciatica between 4 weeks and 18 months duration. Of controlled trial confirmed that epidural injections of
these, one-third of the patients were acute and two- corticosteroids offered short-term relief of symptoms
thirds were chronic. All the injections were performed in patients with sciatica at 3 weeks; however, they do
by anesthetists experienced in the procedure. The de- not offer any medium- or long-term benefit in terms
tails of the procedure are not provided, hence, it is of symptoms, function, return to work, or the need for
assumed they were performed blindly without fluo- surgery. Further, the authors ignored many of the fun-
roscopy and in the lateral position between L3-4 or damental principles of contemporary interventional
L4-5. The active group received epidural steroids via pain management, namely that no injections should
the lumbar route of 80 mg of triamcinolone aceton- be repeated unless the pain returns, the effect of ste-
ide and 10 mL of 0.25% bupivacaine at weeks 0, 3, roids generally last approximately 4–6 weeks, and, by
and 6. The placebo group received injections of 2 mL failing to use fluoroscopy, potentially providing non-
of normal saline into the intraspinous ligament. Sixty targeted injections in approximately 50% to 80% of
patients achieved a 75% improvement on the ODI the patients.
before week 6 and therefore did not receive 3 injec- Snoek et al (109) studied 51 patients with lumbar
tions. The patients were assessed at 3, 6, 12, 26, and root compression documented by neurological deficit
52 weeks, with the primary outcome measure being and a concordant abnormality noted on myelography.
the ODI and the criterion of response being a reduc- They compared the effects of 80 mg of methylpred-
tion of 75% from baseline, with secondary outcome nisolone (2 mL) and 2 mL of normal saline injected
measures of visual analog scale (VAS) and the Short- into the epidural space by the lumbar route. They
Form-36 (SF-36) questionnaire, etc. Based on the avail- found no significant differences between the 2 groups
able literature, a reduction of 75% from baseline on with respective relief of pain and a variety of physical
the ODI is an unusual and unrealistic outcome mea- parameters.
sure as the literature considers a clinically important Wilson-MacDonald et al (125) compared lumbar epi-
difference as an improvement of 4 points to 15 points dural steroid injections to interspinous ligament steroid
(102-104,173-175). Even then, they reported a statis- injections, to assess whether the epidural location of the
tically significant improvement in self-reported func- steroid was responsible for the subsequent effects. Nine-
tion compared with placebo at 3 weeks. At the same ty-three patients with back and leg pain and MRI evi-
time they reported that lumbar epidural corticoste- dence of a prolapsed disc who had been offered surgery
roid injections did not produce a significant improve- were randomized to receive either a blind lumbar epi-
ment in VAS leg pain, but did increase the number of dural (44 patients) or an injection into the interspinous
patients reporting any improvement in leg pain using ligament (48 patients). Each patient was injected with 8
the Likert scale (61% versus 40%, P < 0.01). However, mL 0.5% bupivacaine and 80 mg of methylprednisolone.
they reported that by 6 weeks the benefit of epidu- There was no difference in the rate of subsequent sur-
ral steroids was lost, and at all subsequent visits there gery through the period of follow up.
were no differences between the groups on any mea-
sures of outcome. At 52 weeks, 32.5% of the active Effectiveness
group and 29.6% of the placebo group had achieved a As shown in Table 10, of the 5 randomized trials
75% improvement in ODI. Consequently, this result in (blind lumbar interlaminar epidurals) included in the
both placebo and treatment group probably related evidence synthesis, 2 were positive for short-term and
to the natural course of the disease. Further, they also 5 of them providing long-term results were negative
reported that after 12 months, 26 patients were pain for long-term relief of more than 6 months.
free, with no difference between treatment groups,

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Pain Physician: January/February 2009:12:163-188

Table 10. Results of randomized trials of effectiveness of blind lumbar interlaminar epidural steroid injections in managing disc
herniation and radiculitis.

Pain Relief Results


Study Methodological Short-term Long-term
Study Participants <3
Characteristics Quality Scoring 3 mos. 6 mos. 12 mos. relief relief
mos.
≤ 6 mos. > 6 mos.
Wilson-
MacDonald 43
RA 68 SIT NSD NSD NSD P N
et al 2005
(125)
Arden et al
RA,DB,PC 86 228 75% NSD NSD NSD N N
2005 (126)
C = 80
Carette et al
RA,DB,PC 77 T = 78 SIT NSD NSD NSD P N
1997 (108)

C = 31
Cuckler et al
RA,DB 60 T = 42 NSD NSD NSD NSD N N
1985 (110)

C = 24
Snoek et al
RA 72 T = 27 NSD NSD NSD NSD N N
1977 (109)

RA = randomized; DB = double blind; PC = placebo controlled; C = control; T = treatment; SIT = significant improvement in treatment group;
NSD = no significant difference; P = positive; N = negative; NA = not available

Spinal Stenosis were also 18 (control = 15, epidural = 3) patients with


Two blind lumbar interlaminar randomized trials disc herniation and stenosis. Patients were treated
(110,125) and one blind lumbar interlaminar obser- either with an epidural steroid injection or an intra-
vational study (150) evaluating spinal stenosis were muscular injection of local anesthetic and steroids.
identified. Even though the results were negative, there was no
significant difference in any of the groups on a long-
Study Characteristics term basis. However, there was a significant reduction
Cuckler et al (110) included 37 patients from a in pain early on in those having an epidural steroid
sample of 73 patients with spinal stenosis of longer injection.
than 6 months. They injected in a randomized, dou- Campbell et al (150) in 2007 published results
ble blind fashion either 7 mL of methylprednisolone of the correlation of spinal canal dimensions to effi-
acetate and procaine or 7 mL of physiological saline cacy of epidural steroid injections in spinal stenosis.
solution and procaine. No statistically significant dif- They included 84 patients in the study, 50 required
ference was observed between the control and exper- surgical decompression after epidural steroid injec-
imental patients. Long-term follow-up, averaging 20 tion and 34 patients improved after epidural ste-
months, failed to demonstrate the efficacy of a second roid injection. All the patients received lumbar in-
injection of epidural steroids administered to the pa- terlaminar epidural injections. They concluded that
tients whose pain did not respond within 24 hours to spinal canal dimension is not predictive of success
an injection of either 80 mg of methylprednisolone ac- or failure of epidural steroid injection in patients
etate combined with 5 mL of 1% procaine or 2 mL of with spinal stenosis. The study has been criticized
sterile saline combined with 5 mL of 1% procaine. The that, on the basis of the study protocol, these con-
multiple disadvantages of this study and various flaws clusions may lead to confusion, rather than clarifica-
are described in the disc herniation section. tion (171). Further, patients received epidural ste-
Wilson-MacDonald et al (125) evaluated 18 pa- roid injections once a week in a series of 3 for 3
tients in the epidural group and 14 patients in the weeks, and the injections were performed without
control group with spinal stenosis only. Further, there fluoroscopic guidance, using an interlaminar ap-

176 www.painphysicianjournal.com
Lumbar Interlaminar Epidural Injections

proach, and were performed by 3 anesthesiologists Campbell et al (150) have demonstrated that epi-
from a single pain management clinic. Campbell et dural steroid injections performed blindly with an
al (150) did not describe the volume of injectate nor interlaminar approach in a series of 3 injections may
the site of the injection. Further, routinely 3 epidur- still be effective. Consequently, the study illustrates
als were performed without any consideration as to that epidural steroids may be significantly effective
whether the prior injection provided any relief or in spinal stenosis if they are performed with the ap-
not, or if the patient continued to have pain or not. propriate delivery of medication to the target site
There were also other deficiencies with the presen- with a specific approach under fluoroscopy.
tation of the data. Overall it appears that 40% of Table 11 shows the characteristics of the studies
the patients did not require decompression. Thus, of lumbar interlaminar epidurals in managing spinal
it could be considered as to be a success. Basically, stenosis included in the evidence synthesis.

Table 11. Characteristics of published studies of blind lumbar interlaminar epidural injections in managing spinal stenosis.

Study/Methods Participants Intervention(s) Outcome(s) Result(s) Conclusion(s)


Short-term
relief ≤ 6 mos.
Long-term
relief > 6 mos.
Cuckler et al 1985 73 pts. with back pain due to Experimental: 80 mg Timing: 24 hrs There was no signifi- Negative short-
(110) either acute herniated nucleus (2 mL) of methylpred- and an average of cant short-term or term and long-
Randomized, pulposus or spinal stenosis nisolone + 5 mL of 20 mos. long-term improve- term relief
double-blind of > 6 mos. Experimental: 42 procaine 1%. Outcome mea- ments between both
trial Control: 3.1 Control group: 2 sures: subjective groups.
mL saline + 5 mL of improvement,
procaine 1%. need for surgery.
Wilson-MacDonald 93 pts. with MRI evidence of a Experimental: Timing: 6 wks, 24 In the first 5 wks af- Negative short-
et al 2005 (125) disc prolapse, spinal stenosis, epidural injection of mos.  Outcome ter epidural injection and long-term
Randomized, or a combination. bupivacaine 0.5% (40 measures: Os- a useful improve- relief
controlled trial Pts. had lumbosacral nerve mg) with methyl- westry Disability ment in nerve root
root pain which had not re- prednisolone 80 mg. index, pain relief. symptoms was seen.
solved within 6 wks minimum. Control: intramuscu-
lar injection of 0.5%
32 pts. with 18 in the epidu- (40 mg) bupiva-
ral group and 14 in the control caine with 80 mg
group had spinal stenosis only, methylprednisolone.
whereas 3 pts. in the epidu-
ral group and 15 pts. in control
group had a combined disc
herniation and spinal stenosis.
Campbell et al 84 patients with lumbar spinal Pts. received an 24-month fol- Spinal canal dimen- Short-term not
2007 (150) stenosis. epidural steroid injec- low-up being sion is not predictive available and long-
tion once a week for differentiated into of success or failure term negative
Observational 3 weeks performed patients requiring of lumbar interlami-
study without fluoroscopic surgery and those nar epidural steroid
assistance, using an not requiring injections in pts. with
interlaminar approach surgery. spinal stenosis. The
performed by 3 anes- results showed 50 pts.
thesiologists from a requiring surgical
single pain manage- decompression and
ment clinic. 34 pts. improved
after epidural steroid
injection; 3 injections
performed blindly in
a series were effective
in approximately 40%
of the pts. in avoiding
surgery.

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Pain Physician: January/February 2009:12:163-188

Effectiveness correlated with patient outcome scores. Patients re-


Of the 3 evaluations studying the effectiveness of ceived either interlaminar or transforaminal epidural
blind lumbar interlaminar epidural injections in spinal steroid injections, all of which were performed under
stenosis, none were shown to be positive for short- fluoroscopy; however, the proportion of patients re-
term or long-term relief. ceiving interlaminar epidural steroid injections is not
Table 12 shows the results of 3 studies evaluating described. However, this study over a period of 2 years
the effectiveness of blind lumbar interlaminar epidu- had an extensive dropout rate of 60%. Ultimately, at
ral injections in managing chronic low back or lower 2 years, 49 of the 139 patients (35%) in this group had
extremity pain of spinal stenosis. undergone a fusion. Of the patients who had imple-
mented endplate changes (n = 93), approximately
Chronic Low Back Pain of Discogenic Origin one-half of the patients expressed a positive opinion
without Radiculitis or Disc Herniation as to whether the epidural steroid injection was suc-
There were no randomized trials in the evalu- cessful in the treatment of their symptoms during the
ation of low back pain without disc herniation or first 3 months. Over subsequent follow-up periods,
radiculitis. the success rate declined. The use of pain medication
However, there was one observational study avail- was found generally to have decreased during follow-
able evaluating the effect of spinal steroid injections up periods. The outcome scores for pain and disabil-
for degenerative disc disease under fluoroscopy, which ity showed significant improvement for back and leg
included intradiscal injections as well as interlaminar pain (VAS and pain drawing) (P < 0.001).
epidural injections (148). Epidural steroid injections Of the 139 patients who did not have inflamma-
were performed in 93 patients with degenerative disc tory endplate changes and were treated with epidural
disease and inflammatory endplate changes and in 139 steroid injections, 98 had not changed treatment after
patients without inflammatory endplate changes. The 3 month follow-up. Patients’ self assessment of success
patients with inflammatory endplate changes (n = 78) slowly declined over time so that after one year, only
or without inflammatory endplate changes (n = 93), all 32 of the original 139 patients in this group considered
of whom were considered fusion candidates, under- their injection therapy to have been successful. How-
went discography with or without intradiscal steroid ever, a significant improvement in all outcome scales
in a randomized fashion. Pain and function were pro- was found at all follow-up periods for those patients
spectively determined by a self-administered outcome who did not drop out (P < 0.001).
survey (VAS pain, ODI, pain diagram [PD], and opinion A comparison of the 2 epidural steroid groups
of success) before and after the patients’ injections for (inflammatory versus non-inflammatory endplates)
a 2-year follow-up. MRI and discography results were revealed greater improvement for ODI scores for the

Table 12. Results of published studies of effectiveness of blind lumbar interlaminar epidural steroid injections in managing
spinal stenosis.
Pain Relief Results
Study Methodological Short- Long-
Study Participants <3 3 6 12 term term
Characteristics Quality Scoring
mos. mos. mos. mos. relief relief >
≤ 6 mos. 6 mos.
Cuckler et al
RA,DB 60 37 NSD NSD NSD NSD N N
1985 (110)
Wilson-
MacDonald et al RA 68 32 SI NSD NSD NSD P N
2005 (125)
Campbell et al
O 53 84 NA NA NA 40% NA N
2007 (150)
RA = randomized; DB = double blind; O = observational; C = control; T = treatment; SI = significant improvement; NSD = no significant differ-
ence; P = positive; N = negative; NA = not available

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Lumbar Interlaminar Epidural Injections

patients with inflammatory endplates at one to 3 and pain without disc herniation and radiculitis, the evi-
4 to 6 month follow-up periods and pain drawing at dence is Level III with 2C/weak recommendation, oth-
the 4 to 6 month follow-up period. In addition, epidu- er alternatives may be equally reasonable.
ral steroid injection patients in the subgroup without
inflammatory endplates were found to be using less Complications
pain medication in the early post treatment period. The common complications of interlaminar epidu-
In addition, dropout rates were greater, although not ral injections are of 2 types: those related to the needle
significantly, for those without inflammatory end- placement, and those related to drug administration
plates at all follow-up periods. The authors concluded (1,58,59,147,163-171,178). Infectious complications in-
that patients may have short-term benefit by epidural clude epidural abscess, meningitis, and osteomyelitis/
steroid injection without disc herniation or stenosis. discitis. Epidural hematomas are potentially the most
Overall, 25% to 35% of patients with chronic low back serious of the epidural injection complications. Epi-
pain resulting from degenerative disc disease had im- dural hematomas can develop spontaneously even in
proved pain and function after epidural steroid injec- patients with no evidence of any bleeding tendency,
tion at 2-year follow-up. anticoagulation, or traumatic needle insertion. Neu-
rological injuries are an uncommon complication that
Effectiveness can occur when performing lumbar epidural steroid
Only one observational study (148) showed mod- injections. Other complications include increased pain,
erate results with short-term positive results and with seizures, chemical meningitis, dural puncture, subdu-
negative long-term results in patients with chronic ral air, pneumocephalus, transient blindness, retinal
low back pain of discogenic origin without radiculitis necrosis, chorioretinopathy, hiccups, flushing, and ar-
or disc herniation. terial gas embolism (178-194). Side effects related to
the administration of steroids are generally attributed
Cost Effectiveness either to the chemistry or the pharmacology of the
In evaluations of cost effectiveness, Manchikanti steroids (195-199). The major theoretical complica-
et al (176) and Price et al (177) concluded that in- tions of corticosteroid administration include suppres-
terlaminar epidural steroid injections were not cost sion of pituitary adrenal axis, hypercorticism, Cush-
effective. ing’s syndrome, osteoporosis, avascular necrosis of the
bone, steroid myopathy, epidural lipomatosis, weight
Level of Evidence gain (200), fluid retention, and hyperglycemia.
The evidence-based on USPSTF criteria (105) is The most commonly used steroids in neural block-
Level II-2 for blind lumbar interlaminar epidural injec- ade in the United States, methylprednisolone acetate,
tions for short-term relief in managing chronic low triamcinolone acetamide, and betamethasone acetate
back and lower extremity pain secondary to lumbar and phosphide mixture, have all been shown to be
disc herniation and/or radiculitis. The evidence is Level safe at epidural therapeutic doses in both clinical and
III for blind lumbar interlaminar epidural injections in experimental studies. It has been shown that at thera-
managing low back pain of spinal stenosis, and chron- peutic doses of epidural steroids administered, com-
ic low back pain of discogenic origin without disc her- plications were not noted (199).
niation or radiculitis. Finally, radiation exposure is also a potential prob-
lem with damage to eyes, skin, and gonads (201-204).
Recommendations
Based on Guyatt et al’s criteria (106), the recom-
Discussion
mendation for disc herniation and radiculitis for blind This systematic review of blind lumbar interlami-
lumbar interlaminar epidural injections is 1C, a strong nar epidural injections in managing chronic low back
recommendation which may change when higher pain and lower extremity pain of disc herniation or
quality evidence becomes available for short-term re- radiculitis showed an indicated evidence of Level II-
lief. However, for long-term relief, the recommenda- 2 for short-term relief with evidence lacking with
tion is 2B, with weak recommendation, with best ac- Level III for long-term relief. The evidence is lacking
tion differing depending on circumstances or patients’ with Level III for spinal stenosis and discogenic pain.
or societal values. For spinal stenosis and discogenic We have not evaluated the evidence for lumbar post-

www.painphysicianjournal.com 179
Pain Physician: January/February 2009:12:163-188

laminectomy syndrome as this is not a commonly per- they were negative or inconclusive for all other condi-
formed procedure and is considered unsafe with an tions and for long-term relief for disc herniation and
interlaminar approach. The recommendation provid- radiculitis.
ed for short-term relief in disc herniation, based on The evidence here is inferior compared to cau-
Guyatt et al’s (106) criteria is 1C/strong recommenda- dal epidural with or without steroids (95,96). Further,
tion which may change when higher quality evidence when the injections were performed under fluoros-
becomes available for short-term management for copy, caudal epidurals showed superior results (88-91)
patients with lumbar disc herniation and radiculitis. in all conditions, including discogenic pain without
The recommendation is 2B/weak recommendation for disc herniation, spinal stenosis, and post surgery syn-
long-term management of patients with disc hernia- drome. Even blind injections showed superior results
tion and radiculitis, with best action differing depend- with cervical epidurals in the management of chronic
ing on circumstances or patients’ or societal values. neck pain. One of the reasons may be that the tar-
For low back and lower extremity pain secondary to get delivery of steroids is much easier in the cervi-
spinal stenosis and disc degeneration without disc her- cal epidural space than in the lumbar epidural space
niation or radiculitis, the recommendation is 2C/very (74,95,205,206). Thus, the results of this evaluation
weak recommendation, where other alternatives may with all flawed evidence, even though it looks appro-
be equally reasonable. priate based on the methodologic quality assessment,
In addition to the paucity of available literature may not be utilized in contemporary clinical practice
meeting inclusion criteria, all of the included studies of interventional pain management.
followed flawed methodology without target deliv- Target site concentration of the administered
ery of steroids, delivering them without fluoroscopy, drug including steroids depends on multiple injec-
performing the procedures frequently between L3/4 tion variables including the route of administration.
and occasionally L4/5 in the lateral position, with poor Interlaminar epidural injections are considered to be
assessment of outcomes application and analysis. The non-specific. Steroids may be prevented from migrat-
disadvantages of this approach without fluoroscopy ing from the posterior epidural space to the anterior
include dilution of the injectate, extra epidural place- or ventral epidural space by the presence of epidural
ment of the needle, intravascular placement of the ligaments or scar tissue, with interlaminar adminis-
needle, preferential cranial flow of the solution, pref- tration. The extra epidural placement of the needle,
erential posterior flow of the solution, difficult place- which may go unrecognized without fluoroscopic
ment (with increased risks in post-surgical patients), guidance, is of paramount importance with the in-
difficult placement below L4-L5 interspace, deviation terlaminar approach (147,163-171). Other disadvan-
of needle to non-dependent side, dural puncture, and tages of the interlaminar approach include erroneous
trauma to spinal cord. There was a paucity of litera- placement of the needle, which may miss the targeted
ture in the evaluation of spinal stenosis, whereas there interspace without fluoroscopic guidance; preferen-
was only one observational study available in evaluat- tial cranial flow of the solution in the epidural space;
ing chronic discogenic pain without disc herniation or deviation of the needle to the non-dependent side;
radiculitis. difficulty entering the epidural space and delivery of
The ultimate results of this systematic review are injectate below L5, for S1 nerve root involvement; po-
similar to previous systematic reviews and guidelines. tential risk of dural puncture and post-lumbar punc-
However, in this evaluation we attempted to evalu- ture headache; and finally, the rare, but serious risk
ate the evidence separately for disc herniation and ra- of spinal cord trauma (147,163-171). It is a well-known
diculitis, spinal stenosis, and chronic discogenic pain, fact that disc herniation mostly involves L4-L5 and L5-
whereas others have evaluated by combining multiple S1 discs and the preferential flow to higher levels by
conditions and multiple techniques (caudal and trans- placing the needle at L3-4 obviates the entire philoso-
foraminal) into one category. In addition, in this study phy of target delivery. Advocates of fluoroscopic guid-
we have expanded the definition of short-term relief ance point to several studies which have shown that
to 6 months or less, whereas long-term relief is de- in as many as 30% of the lumbar epidural injections
fined as longer than 6 months -– a robust measure. by experienced injectionists, the epidural space was
Even then, the results were only positive for short- misidentified (147,163-169). In fact, Botwin et al (169)
term relief for disc herniation and radiculitis, whereas in their prospective evaluation of epidurography con-

180 www.painphysicianjournal.com
Lumbar Interlaminar Epidural Injections

trast patterns in fluoroscopically guided lumbar inter- extensively studied interlaminar, caudal, and transfo-
laminar epidural injections found that dorsal contrast raminal epidural injections, including all the literature
spread occurred in all patients, whereas ventral spread available at the time, and concluded that the balance
was present in only 36% of the patients. In addition, of published evidence supports the therapeutic use
they also showed that the mean number of vertebral of caudal epidurals. In 1995, Koes et al (62) reviewed
levels of cephalad spread was 1.28 and caudal spread 12 trials of lumbar and caudal epidural steroid injec-
was 0.88. In another study (170), the spread was uni- tions and reported positive results from only 6 studies.
lateral 45% of the time and the contrast spread was However, a review of their analysis showed that there
anterior only 43% to 51% of the time based on the were 5 studies for caudal epidural steroid injections
needle position, indicating over 49% of the time it and 7 studies for lumbar epidural steroid injections
was posterior. and 5 of the 7 studies for lumbar interlaminar were
The results of this systematic review are similar negative. Their updated analysis (63) with the inclu-
to previous systematic reviews and guideline synthe- sion of 15 trials also arrived at the same conclusions.
ses (1,45-52). However, while some previous reviews Multiple other investigators (62,65,66) also have pro-
(1,58,70) evaluated the evidence based on the route vided differing conclusions, all negative. In general,
of administration — namely caudal, transforaminal, or criticism against systematic reviews in the past has
lumbar interlaminar, others (62,65,66) have evaluated been directed toward methodology, small size of the
by combining multiple conditions and multiple tech- study populations, and other limitations, including
niques into one category, invariably leading to wrong long-term follow-up and outcome parameters on the
conclusions (71,72,207). Further, in this study we have available literature. Further, paucity of literature has
expanded the definition of short-term relief to 6 been a factor in the systematic evaluation of evidence
months or less, whereas long-term relief is defined as for the effectiveness of epidural injections.
longer than 6 months, providing robust evidence. In
addition, this is the first systematic review of the effec-
Conclusion
tiveness of lumbar interlaminar epidural steroid injec- This systematic review of blind lumbar interlami-
tions as a separate category for lumbar interlaminar, nar epidural injections in managing chronic low back
spinal stenosis, and discogenic chronic low back pain. pain and lower extremity pain of disc herniation or ra-
The debate concerning caudal epidural ste- diculitis showed an indicated evidence of Level II-2 for
roid injections has been nurtured since the 1970s short-term relief with lacking of evidence with Level III
(1,58,59,62,65,66,70). The first systematic review of for long-term relief and lacking of evidence with Level
the effectiveness of caudal epidural steroid injections III for short- and long-term relief for spinal stenosis
was performed by Kepes and Duncalf in 1985 (61). and discogenic pain. Caution must be exercised in the
They concluded that the rationale for epidural and interpretation of these findings as all the studies in-
systematic steroids was not proven. However, in 1986, cluded in this evaluation are blind interlaminar epi-
Benzon (73), utilizing the same studies, concluded dural injections and do not represent contemporary
that mechanical causes of low back pain, especially interventional pain management practice.
those accompanied by signs of nerve root irritation,
may respond to epidural steroid injections. Thus, this
Acknowledgements
illustrates that systematic reviews can be, and have The authors wish to thank the editorial board of
been, providing different results based on the evalua- Pain Physician, for review and criticism in improving
tors. More recently, ACOEM guidelines (68,69) provid- the manuscript; Vidyasagar Pampati, MSc, statistician;
ed negative evidence for lumbar interlaminar epidu- Sekar Edem for assistance in search of literature; and
ral injections. The debate concerning epidural steroid Tonie M. Hatton and Diane E. Neihoff, transcription-
injections took center stage in the 1980s and 1990s ists (Pain Management Center of Paducah), for their
with multiple publications (59,63). Bogduk et al (59) assistance in the preparation of this manuscript.

www.painphysicianjournal.com 181
Pain Physician: January/February 2009:12:163-188

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