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Background: Cervical spinal stenosis is a common disease that results in considerable morbidity
and disability. There are multiple modalities of treatments, including surgical interventions and
multiple interventional techniques including epidural injections. The literature on the effectiveness
of cervical epidural steroids is sporadic. Emerging evidence for cervical interlaminar epidurals for
various conditions in the cervical spine is positive; however, the effect of fluoroscopic epidural
injections in cervical spinal stenosis has not been studied.
Study Design: A randomized, double-blind, active control trial.
Setting: A private interventional pain management practice, a specialty referral center in the
United States.
Objectives: To evaluate the effectiveness of cervical interlaminar epidural injections with local
anesthetic with or without steroids in the management of chronic neck pain with upper extremity
pain in patients with cervical central spinal stenosis.
Methods: Patients with cervical central spinal stenosis were randomly assigned to one of 2 groups:
injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone.
Sixty patients were included in this analysis. Randomization was performed by computer-generated
random allocation sequence by simple randomization.
Outcomes Assessment: Multiple outcome measures were utilized including the Numeric
Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with
assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was
defined as a 50% or more reduction of NRS or NDI scores.
Results: Significant pain relief was seen in 73% in Group I and 70% in Group II, in Group II
showing both significant pain relief and functional status improvements. Group I’s average relief
per procedures was 11.3 ± 5.8 weeks; for Group II it was 8.6 ± 3.6 weeks, whereas after initial 2
procedures, average relief was 13.7 ± 8.7 weeks in Group I, and 13.6 ± 4.7 weeks in Group II. In
the successful group, the average total relief in a one-year period was 42.2 ± 14.7 weeks in Group
I and 34.3 ± 13.4 weeks in Group II, with 76% in Group I and 77% in Group II.
Limitations: Study limitations include the lack of a placebo group and that this is a preliminary
report of only 60 patients, 30 in each group.
Conclusion: Patients who have chronic function-limiting pain that is secondary to cervical central
stenosis might receive relief with cervical interlaminar epidurals of local anesthetic, whether with
or without steroids.
Key words: Chronic neck pain, cervical disc herniation, cervical stenosis, cervical central stenosis,
cervical epidural injections, epidural steroids, local anesthetics
CLINICAL TRIAL: NCT01071369
Pain Physician 2012; 15:E59-E70
Randomized Trial
Fluoroscopic Epidural Injections in Cervical
Spinal Stenosis: Preliminary Results of a
Randomized, Double-Blind, Active Control Trial
From: 1Pain Management Center
of Paducah, Paducah, KY; and
2University of Louisville, Louisville,
KY
Dr. Manchikanti is Medical
Director of the Pain Management
Center of Paducah, Paducah, KY
and Associate Clinical Professor,
Anesthesiology and Perioperative
Medicine, University of Louisville,
Louisville, KY.
Dr. Malla is an Interventional Pain
Physician at the Pain Management
Center of Paducah, Paducah, KY.
Kimberly A. Cash is a Research
Coordinator at the Pain
Management Center of Paducah,
Paducah, KY.
Carla D. McManus is a Nursing
Administrator at the Pain
Management Center of Paducah,
Paducah, KY.
Vidyasagar Pampati is a Statistician
at the Pain Management Center of
Paducah, Paducah, KY.
Address correspondence:
Laxmaiah Manchikanti, MD
2831 Lone Oak Road
Paducah, KY 42003
E-mail: drlm@thepainmd.com
Disclaimer: There was no external
funding in the preparation of this
manuscript.
Conflict of interest: None.
Manuscript received: 11/10/2011
Accepted for publication:
12/16/2011
Free full manuscript:
www.painphysicianjournal.com
Laxmaiah Manchikanti, MD1,2, Yogesh Malla, MD1, Kimberly A. Cash, RT1,
Carla D. McManus, RN1, and Vidyasagar Pampati, MSc1
www.painphysicianjournal.com
Pain Physician 2012; 15:E59-E70 • ISSN 2150-1149
Pain Physician: January/February 2012; 15:E59-E70
E60 www.painphysicianjournal.com
along with inappropriate methodology, leading to in-
appropriate conclusions (1,20). A Cochrane review of
medicinal and injection therapies for mechanical neck
disorders (37) have shown no significant evidence for
cervical epidural injections. However, the role of epi-
dural injections in managing chronic persistent pain of
cervical spinal stenosis has not been evaluated.
Evaluating the role of cervical interlaminar epi-
dural injections with or without steroids in a certain
patient population is the present study’s purpose—
specifically, in patients who have chronic, function-
limiting neck pain and disability secondary to central
cervical spinal stenosis. This preliminary report de-
scribes data from 60 patients who have completed a
one year follow-up; the full report will have data on
120 patients.
Methods
The present study was performed in the United
States in a private pain management practice and
specialty referral center. Consolidated Standards of
Reporting Trials (CONSORT) guidelines were followed
(44). The Institutional Review Board (IRB) approved
the study’s protocol; the study is registered with the
U.S. Clinical Trial Registry, NCT01071369.
Participants
New patients presenting for interventional pain
management were recruited for the study and as-
signed to one of two groups.
Interventions
Both groups received cervical interlaminar epi-
dural injections. Group I patients received 5 mL of
0.5% lidocaine; Group II received 4 mL of 0.5% li-
docaine mixed with 1 mL or 6 mg of nonparticulate
betamethasone.
The IRB-approved protocol and informed consent,
which describe the study in detail, were given to the
patients.
Pre-enrollment Evaluation
A pre-enrollment evaluation was conducted.
Data collected during the evaluation included work
status, demographic data, opioid intake, physical ex-
amination, medical and surgical history with coexist-
ing disease(s), Numeric Rating Scale (NRS) pain rating
scores, functional status assessment with the Neck Dis-
ability Index (NDI), and radiologic investigations.
Chronic recurrent neck pain in adults is
common. The 12-month prevalence is 30% to
50%; intense pain and disability are seen in
14% of adults (1-3). Common causes include cervical
spondylosis, cervical disc herniation, cervical stenosis,
cervical facet joint arthritis, radiculopathy, and cervical
discogenic abnormalities (4-7).
Cervical spinal stenosis is a common disease that
results in considerable morbidity and disability (8-10).
Degenerative change is the most common cause of
cervical stenosis and can be due to disc herniation, os-
teophyte formation, or a combination of both, namely
disc-osteophyte complex (8). Tandem spinal stenosis
(TSS) is a degenerative disease that describes a double
stenotic lesion involving the cervical and lumbar spine
(11,12). Historically, TSS accounts for between 5% and
25% of all cases of stenosis (11,12). However, cervical
spinal stenosis is less common than lumbar spinal ste-
nosis. With increasing age, a large proportion of the
population exhibit radiological signs of discopathy or
spondylosis, leading to constriction of the spinal canal
(9). Thus, cervical spinal stenosis has been detected in
26% of asymptomatic group of older individuals (13)
Despite multiple modalities of treatments, includ-
ing surgical interventions and various other modalities
for diagnosis and treatment of spinal pain, with ex-
ploding health care costs, the treatment modalities for
cervical spinal stenosis have not been well described
(1,3-6,11,12,14-40). Apart from surgical interventions,
epidural steroid injections are one of the most com-
mon interventions in the non-surgical management
of neck and upper extremity pain secondary to disc
herniation and radiculitis, spinal stenosis, post surgery
syndrome, and discogenic pain (1,14-20,25,41-43).
Benyamin et al (1) in a systematic review of cer-
vical interlaminar epidural injections determined that
the evidence was moderate in managing chronic neck
and upper extremity pain; however, this evidence has
been related to mostly disc herniation and radiculi-
tis even though some studies have included patients
with different etiologies. Further, Manchikanti et al in
2 studies, in their preliminary reports (14,25) showed
the effectiveness of cervical interlaminar epidural in-
jections with or without steroids in over 75% of the
patients with axial neck pain or disc herniation and ra-
diculitis. Even then, the evidence has been questioned
and continues to be debated similar to lumbar epi-
dural injections due to the design of the studies, fluo-
roscopic utilization, study size, outcome parameters,
duration of follow-up, and bias exerted peer reviews,
www.painphysicianjournal.com E61
Fluoroscopic Epidural Injections in Cervical Spinal Stenosis
Inclusion and Exclusion Criteria
Inclusion criteria were a diagnosis of cervical central
spinal stenosis with or without foraminal stenosis, patients
over 30 years old and with a history of chronic function-
limiting neck pain and upper extremity pain of at least 6
on a scale of 0-10, pain for at least 6 months in duration,
and patients who were competent to understand the
study protocol and provide voluntary, written informed
consent, and participate in outcome measurements.
Further inclusion criteria included patients who failed
to improve substantially with conservative management
including, but not limited to, physical therapy, chiropractic
manipulation, exercises, drug therapy, and bed rest.
Exclusion criteria were a history of cervical spinal
surgery, foraminal stenosis without central stenosis, un-
controllable or unstable opioid use, uncontrolled psy-
chiatric disorders, uncontrolled medical illness (either
acute or chronic), any conditions that could interfere
with the interpretation of the outcome assessments,
pregnant or lactating women, and patients with a his-
tory or potential for adverse reaction(s) to local anes-
thetics or steroids.
Description of Interventions
A single physician performed all procedures in an
ambulatory surgery’s sterile operating room. Patients
were prone, appropriately monitored, and sedated
with midazolam and fentanyl. Under fluoroscopy, the
epidural space between C7 and T1 to C5 and C6 was
entered, using the loss of resistance technique and con-
firmed with nonionic contrast medium. Then, the ap-
propriate injection, based on the group the patient was
assigned, was made.
Additional Interventions
Patients remained blinded unless they requested
unblinding or if an emergency arose. Treatments were
performed as assigned. Additional cervical epidural in-
jections were given depending on a patient’s response.
Nonresponsive patients continued conservative man-
agement without further injections, unless they re-
quested unblinding.
If physical and functional status improved, then re-
peat injections were given. Also, only when there was
increased pain and deteriorating relief below 50% were
repeat injections given.
Co-Interventions
Patients did not receive bracing, specific physical
or occupational therapy, or any intervention other than
the assigned study intervention. However, patients did
continue exercise programs already started as well as
their occupation. Most were already taking adjuvant
analgesics, both opioid and nonopioid. If they im-
proved enough, these adjuvants were either stopped or
dosages decreased. For some, dosages were increased.
Objectives
This study seeks to evaluate whether cervical epi-
dural injections, with or without steroids, are effective
for managing pain caused by chronic neck and upper ex-
tremity pain secondary to cervical central spinal stenosis.
Outcomes
The following outcomes were measured at base-
line and at 3, 6, and 12 months post-treatment: opioid
intake measured in morphine equivalent; work status;
NDI; and NRS.
Pain relief of 50% associated with a 50% improve-
ment in NDI was considered significant. The NRS and
NDI have been shown to be valid and reliable in pa-
tients with mechanical neck pain (45-47).
Morphine equivalents were used to measure opi-
oid intake (48).
Patients unemployed due to pain and those em-
ployed only part-time due to pain were considered
employable. Those not working, but not due to pain,
including those retired or who chose not to work and
homemakers were not considered employable.
Sample Size
The sample size needed for each group was deter-
mined to be 60 patients. This is based on a 10% attri-
tion/noncompliance rate, as well as a 0.05 two-sided
significance level, a power of 80%, and a 1:1 allocation
ratio (49). Fifty to 60 patients in a group is considered
appropriate (50-61).
Randomization
Sixty patients are expected to be randomly as-
signed to each group.
Sequence Generation
A computer-generated random allocation se-
quence performed the randomization.
Allocation Concealment
Patient randomizing and appropriate drug prepar-
ing were done by an operating room nurse who as-
sisted with the procedure.
Pain Physician: January/February 2012; 15:E59-E70
E62 www.painphysicianjournal.com
Implementation
If they met inclusion criteria, patients were invited
to become study participants. A nurse assigned as one
of the study’s 3 coordinators enrolled them and gave
them their group assignment.
Blinding (Masking)
Group assignments were blinded to the partici-
pants and the physicians performing the interventions.
The injectates were clear; it was impossible to tell if it
contained steroid. Also, participants were mixed with
patients not enrolled in the study who were presenting
for routine treatment. The physician was not informed
who was and who was not a study participant. A statis-
tician not involved with patient care selected those cho-
sen for one-year follow-up. If unblinding did occur, the
physician and other patients were not informed, thus
preserving the integrity of the blinding.
Statistical Methods
Four statistical analyses were performed: for dif-
ferences in proportions, Chi-squared statistic; if the ex-
pected value was less than 5, Fisher’s exact test; t test for
comparing mean scores between groups; paired t test for
comparing pre- and post-treatment average pain scores
and NDI measurements at baseline against scores at 3, 6,
and 12 months. Statistical significance was P < 0.05.
Intent-to-Treat-Analysis
The last follow-up data or initial patient data from
study dropouts was used for the intent-to-treat analy-
sis. A sensitivity analysis used best and worst case sce-
narios and last follow-up scores.
Results
Participant Flow
Figure 1 illustrates the participant flow.
Fig. 1. Schematic presentation of patient flow.
Patients Excluded
• Patients Not Meeting Inclusion Criteria = 22
• Patients Refusing to Participate = 16
Patients randomized
98
Patients included in this
evaluation = 60
Group II
30
Cervical epidural with local anesthetics
Participants included in analysis = 30
12 months
♦ 93% (28) participants available for follow-up
♦ 100% (30) participants included in analysis
Cervical epidural with local anesthetics
and one of the steroids
Participants included in analysis = 30
Eligible Patients Assessed
136
Group I
30
12 months
♦ 90% (27) participants available for follow-up
♦ 100% (30) participants included in analysis
www.painphysicianjournal.com E63
Fluoroscopic Epidural Injections in Cervical Spinal Stenosis
Recruitment
Enrollment period started in August 2007 and
continues.
Baseline Data
Table 1 shows baseline characteristics. There were
no significant differences observed in any of the aspects
except mean weight which was higher in Group I com-
pared to Group II.
Tables 2 and 3 illustrate severity and levels of spinal
stenosis.
Analysis of Data
Intention-to-treat analysis was carried out by last
follow-up data, as there were no significant differences
noted with sensitivity analysis.
Outcomes
Pain Relief
NRS scores are shown in Table 4. At 12 months, 73%
of Group I participants and 70% of Group II participant
showed significant pain relief. However, the proportion
Table 1. Baseline demographic characteristics.
Group 1
(30)
Group II
(30) P value
Gender Male 30% (9) 43% (13) 0.284
Female 70% (21) 57% (17)
Age Mean ± SD 49.9 ± 8.5 49.7 ± 8.9 0.918
Weight Mean ± SD 196.0 ± 54.2 170.7 ± 32.7 0.032
Height Mean ± SD 66.5 ± 4.5 65.9 ± 3.7 0.617
Duration of pain (months) Mean ± SD 115.2 ± 89.9 94.3 ± 77.4 0.338
Onset of the pain Gradual 60% (18) 53% (16) 0.602
Injury 40% (12) 47% (14)
Pain ratio
Neck Pain only 18% (5) 11% (3)
0.531
Neck worse than Upper extremity 68% (19) 54% (15)
Upper extremity worse than Neck 7% (2) 3% (1)
Both equal 7% (2) 32% (9)
Neck Pain Distribution
Right 10% (3) 17% (5)
0.467Left 20% (6) 10% (3)
Bilateral 70% (21) 73% (22)
Numeric rating score Mean ± SD 7.9 ± 0.8 8.0 ± 0.9 0.762
Neck Disability Index Mean ± SD 29.2 ± 5.2 29.2 ± 5.8 0.981
Table 2. Spinal stenosis: Severity and involved level(s) as classified by radiologist(s) (MRI or CT scan).
Group Severe Moderate Mild
C3/4 C4/5 C5/6 C6/7 C7/T1 C3/4 C4/5 C5/6 C6/7 C7/T1 C3/4 C4/5 C5/6 C6/7 C7/T1
Primary*
I 0 1 3 1 0 2 3 7 6 0 1 6 7 6 0
II 1 2 4 1 0 1 2 8 4 0 1 3 7 4 0
Tot a l 1 3 7 2 0 3 5 15 10 0 2 9 14 10 0
Secondar y
I 0 0 0 0 0 0 0 0 1 0 2 2 1 0 0
II 0 0 0 0 0 0 0 0 0 0 1 0 1 1 0
Tot a l 0 0 0 0 0 0 0 0 1 0 3 2 2 1 0
*Primary: Indicates worst level of stenosis or same type stenosis at multiple levels in participants with multiple level stenosis and all participants
with single level stenosis.
Pain Physician: January/February 2012; 15:E59-E70
E64 www.painphysicianjournal.com
of participants in the successful categories reporting
significant pain relief was 76% in Group I and 77% in
Group II.
Functional Assessment
Table 5 shows functional assessment evaluated
by NDI. Significant improvement was shown in both
groups at 12 months: 77% in Group I and 70% in
Group II. When further separated into failed and suc-
cessful categories, the successful categories showed
improvement in 79% of Group I and 77% of Group II.
Pain Relief and Functional Improvement
The proportion of participants with significant
changes in pain and function are shown in Fig. 2. At
12 months, the changes are 73% in Group I and 70%
in Group II. When successful categories are examined,
there was improvement of 76% in Group I and 77%
in Group II.
Employment Characteristics
Table 6 demonstrates employment characteristics
in both groups.
Opioid Intake
Table 7 illustrates opioid intake characteristics.
Therapeutic Procedural Characteristics
Therapeutic procedural characteristics are illus-
trated in Table 8. Epidural entry was as follows: 10%
between C5 and C6, 52% between C6 and C7, and
38% between C7 and T1 vertebral interspaces.
Average relief per year was 40.8 ± 16.3 weeks in
Group I and 30.4 ± 16.1 weeks in Group II. The average
number of injections per year was 3.7 ± 1.2 in Group
I and 3.6 ± 1.2 in Group II. However, when patients
were separated into successful and failed groups, the
average number of injections per year was 3.8 ± 1.1
in Group I and 3.6 ± 1.2 in Group II in the successful
group, with total relief of 42.2 ± 14.7 weeks in Group
I and 34.3 ± 13.4 weeks in Group II with significant
difference.
If a patient’s relief lasted at least 3 weeks with 2
initial injections, then it was considered successful; if
not, then it was considered a failure.
Table 3. Number of stenosis levels involved in the study
population.
Group I (30) Group II (30) Total
One Level 16 19 35
Two Levels 11 11 22
Three Levels 1 0 1
Four Levels 2 0 2
Table 4. Mean pain relief of NRS scores and proportion of
patients with significant pain relief (≥ 50%).
Numeric
Rating Score
Group I (30) Group II (30) P value
Mean ± SD Mean ± SD
Baseline 7.9 ± 0.8 8.0 ± 0.9 0.862
3 months 3.7* ± 1.2
(87%)
3.5* ± 0.9
(87%) 0.625
6 months 3.4 * ± 0.9
(90%)
3.7* ± 1.0
(80%) 0.353
12 months 3.6* ± 1.1
(73%)
3.8* ± 1.2
(70%) 0.434
Percentages in parentheses indicate proportion of participants with
significant relief (≥ 50% reduction in Numeric Rating Score from
baseline)
* indicates significant difference with baseline values (P < 0.001)
Table 5. Illustration of functional assessment scores by Neck
Disability Index and proportion of patients with significant
improvement (≥ 50%).
Neck Disability
Index
Group I
(30)
Group II
(30) P value
Mean ± SD Mean ± SD
Baseline 29.2 ± 5.2 29.2 ± 5.8 0.981
3 months 15.1* ± 5.8
(77%)
13.6* ± 3.8
(87%) 0.219
6 months 13.2* ± 4.8
(87%)
13.5* ± 4.6
(83%) 0.826
12 months 13.2* ± 5.4
(77%)
13.9* ± 4.5
(70%) 0.824
Percentages in parenthesis indicate proportion of patients with signifi-
cant improvement with NDI scores from baseline (≥ 50%).
* indicates significant difference with baseline values (P < 0.001)
www.painphysicianjournal.com E65
Fluoroscopic Epidural Injections in Cervical Spinal Stenosis
Fig. 2. Illustration of reduction (at least 50%) in average pain and Neck Disability Index from baseline.
Successful groups Failed groups Overall results
Table 6. Employment characteristics.
Employment status Group I (30) Group II (30)
Baseline 12 months Baseline 12 months
Employed part-time 0 0 0 1
Employed full-time 2 2 6 6
Unemployed (due to pain) 1 1 4 3
Not working 1 1 0 0
Eligible for employment 4 4 10 10
Total Employed 2 2 6 7
Housewife 22 22 18 18
Disabled 3 3 0 0
Retired 1 1 2 2
Total Number of Patients 30 30 30
Table 7. Opioid intake (morphine equivalence mg)
characteristics.
Opioid Intake
(morphine
equivalence mg)
Group I (30) Group II (30) P
value
Mean ± SD Mean ± SD
Baseline 51.37 ± 31.30 66.07 ± 72.62 0.313
3 months 45.63 ± 38.29 49.03* ± 70.40 0.817
6 months 45.13 ± 38.40 48.70* ± 70.52 0.809
12 months 46.13 ± 37.56 48.70* ± 70.52 0.861
* indicates significant difference with baseline values (P < 0.001)
Changes in Weight
Even though the 2 groups had a significant weight
difference from each other at baseline, Table 9 illus-
trates that neither group showed a change in body
weight from baseline.
Adverse Events
Two subarachnoid punctures, one intravascular en-
try and one report of soreness lasting one week were
reported from the 214 procedures performed. No post-
operative headache was reported in both patients after
subarachnoid puncture.
79%
90%
76%
0%
0%
0%
77%
87%
73%
92%
89%
77%
50%
25%
25%
87%
80%
70%
0%
20%
40%
60%
80%
100%
3
months
6
months
12
months
3
months
6
months
12
months
3
months
6
months
12
months
Gro u p I Gro u p II
Pain Physician: January/February 2012; 15:E59-E70
E66 www.painphysicianjournal.com
discussion
The fluoroscopic epidural injections in cervical spi-
nal stenosis evaluated by randomized, double-blind,
controlled trial showed significant pain relief in 73%
in Group I and 70% in Group II with functional status
improvement in 77% in Group I and 70% in Group II.
The study also showed decrease in opioid usage. How-
ever, this study’s results show no significant differences
in pain relief or functional status whether patients re-
ceived injections with steroids or without steroids. Spe-
cific data are illustrated in the tables above.
Cervical epidural injections are quite common,
but systematic reviews are limited (14). There is one
Cochrane review of medicinal and injection therapies
for mechanical neck disorders (37). Benyamin et al (1)
looked at the randomized evaluations included in the
evidence synthesis (41-43). Their conclusions were that
that positive results were shown for short-term relief in
all 3 studies; positive results for long-term relief were
shown in 2 studies, and the results of long-term relief
were not available for one study (43). Short-term relief
was defined as 6 months and long-term relief was de-
fined as more than 6 months. Manchikanti et al, in 2
studies (51,52) evaluating the role of cervical epidural
injections with or without steroids in patients with ax-
ial neck pain or disc herniation, showed significant im-
provement in physical and functional status in approxi-
mately 70% to 80% of the patients. But interlaminar
epidural injections of local anesthetic with or without
steroids do not provide long-term relief for patients
with cervical spinal stenosis as shown in the present
study. However, if patient evaluation is done appropri-
ately and repeat injections are performed judiciously,
long term relief can be achieved. The study has illus-
trated an average of 9.6 to 13.8 weeks of relief. Similar
results have been shown for cervical epidurals using the
same methodology for disc herniation (14), axial pain
without disc herniation or facet joint pain (25), or cer-
Table 8. Therapeutic procedural characteristics with procedural frequency, average relief per procedure, and average total relief in
weeks over a period of one year.
Successful Patients Failed Patients Combined
Group I
(29)
Group II
(26)
Group I
(1)
Group II
(4)
Group I
(30)
Group II
(30)
1st procedure relief 7.1* ± 5.5
(29)
4.5 ± 3.8
(26)
0
(1)
1.6 ± 2.3
(4)
6.8* ± 5.6
(30)
4.1 ± 3.7
(30)
2nd procedure relief 11.6 ± 7.9
(28)
8.4 ± 2.9
(24) -1 ± 1.2
(4)
11.6* ± 7.9
(28)
7.4 ± 3.8
(28)
3rd procedure relief 13.6 ± 9.1
(25)
13.4 ± 5.1
(22) -10
(1)
13.6 ± 9.1
(25)
13.2 ± 5.1
(23)
4th procedure relief 12.9 ± 0.9
(20)
12.8 ± 1.8
(16) - - 12.9 ± 0.9
(20)
12.8 ± 1.8
(16)
5th procedure relief 12.4 ± 1.5
(7)
12.7 ± 0.8
(6) - - 12.4 ± 1.5
(7)
12.7 ± 0.8
(6)
Number of procedures per
year 3.8 ± 1.1 3.6 ± 1.2 1 2.2 ± 0.5 3.7 ± 1.2 3.6 ± 1.2
Average relief per procedure 11.7 ± 5.5 9.6 ± 2.6 0 2.0 ± 1.9 11.3* ± 5.8 8.6 ± 3.6
Average relief per procedure
after initial 2 procedures 13.7 ± 8.7 13.8 ± 4.7 - 10 13.7 ± 8.7 13.6 ± 4.7
Total relief per year (weeks) 42.2* ± 14.7 34.3 ± 13.4 0 5.0 ± 5.7 40.8* ± 16.3 30.4 ± 16.1
Table 9. Characteristics of changes in weight.
Weight (lbs) Group I (30) Group II (30) P
value
Mean ± SD Mean ± SD
Weight at beginning 196.0 ± 54.2 170.7 ± 32.7 0.032
Weight at one year 190.7 ± 54.3 169.8 ± 30.4 0.070
Change -5.3 ± 10.6 -0.9 ± 6.8 0.060
Lost weight 63% 47%
0.328No change 17% 17%
Gained weight 20% 36%
www.painphysicianjournal.com E67
Fluoroscopic Epidural Injections in Cervical Spinal Stenosis
vical post-surgery syndrome (55). The same is true for
caudal and lumbar interlaminar epidurals ifor disc her-
niation, discogenic pain without disc herniation, spinal
stenosis, and post surgery syndrome (51-54).
This study provides an understanding of the proce-
dure’s effectiveness for successful and failed categories
in the two groups. Our results are generalizable for in-
terventional pain management settings. It is also the
first such study performed in an American private prac-
tice and that used fluoroscopy. Active control studies,
such as the present one, measure effectiveness rather
than efficacy like an explanatory trial, thus providing
useful data (1,17-20,31,32,62-64). Such an active control
design compares 2 commonly used therapies, rather
than just an existence of effect or absolute effect size
(65). Another difference in this study are the repeat in-
jections given based on an increase in pain and func-
tional status decline, rather than the normal routine of
3 injections or limiting the number of procedures.
The lack of a placebo group is a limitation for this
study, but having a placebo group for interventional
procedures in studies done in the United States is dif-
ficult (43,66-71). Unless the same methodology is used,
along with fluoroscopic guidance, the results might not
apply to the general patient population. Despite these
caveats, this study does help shed light on whether ste-
roids should be used with local anesthetic in injections
.Corticosteroids appear to make no difference in a pa-
tient’s improvement for managing chronic neck pain of
spinal stenosis. There were differences in weight, but
failed to influence results.
The mechanism of the action of steroids and lo-
cal anesthetic has been described (43,72-92). There is
also emerging evidence that local anesthetics may be
equally as effective as steroids in managing low back
and neck pain without disc herniation and also pain of
facet joint origin (50-57,76-85).
Multiple complications also have been described
with cervical epidural injections, including infection,
bleeding, neural trauma, etc. (1,93-98); however, none
were observed in this evaluation except 2 cases of sub-
arachnoid puncture without further side effects.
conclusion
This randomized, double-blind, controlled trial of
cervical interlaminar epidural injections shows a 71.5%
rate of effectiveness in pain reduction and functional
status improvement for patients with chronic function-
limiting neck pain and upper extremity pain secondary
to central spinal stenosis.
AcknowledgMents
The authors wish to thank Sekar Edem for as-
sistance in search of literature, Tom Prigge, MA, for
manuscript review, and Tonie M. Hatton and Diane E.
Neihoff, transcriptionists, for their assistance in prepa-
ration of this manuscript. We would like to thank the
editorial board of Pain Physician for review and criti-
cism in improving the manuscript.
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