ORIGINAL ARTICLE Page | 51

A comparison of the analgesic efficacy of

transforaminal methylprednisolone alone and
with low doses of clonidine in lumbo-sacral
radiculopathy
Nazia Tauheed, A B S T R A C T
Hammad Usmani,
Background: Although transforaminal epidural steroid injections under fluoroscopic
Anwar Hasan Siddiqui1 guidance have become a common mode of treatment of lumbosacral radiculopathy
Departments of Anaesthesiology due to herniated disc, the efficacy of steroid with low doses of clonidine has not been
and Critical Care and 1Physiology, compared yet. Objectives: Comparison of the analgesic efficacy of methylprednisolone
Jawaharlal Nehru Medical alone and with low doses of clonidine for transforaminal injection in lumbosacral
College, Aligarh Muslim University, radiculopathy. Study Design: A randomized, double-blind trial. Setting: This study was
Aligarh, Uttar Pradesh, India performed at the Pain Clinic under the Department of Anaesthesiology, Jawaharlal
Nehru Medical College Hospital, Aligarh Muslim University, Aligarh, India. Methods: One
hundred and eighty ASA grade I and II patients aged between 18 and 55 years
were allocated into groups I, II and III to receive methylprednisolone 60 mg alone or
methylprednisolone 60 mg with or without low doses of clonidine (0.5 mcg/kg or
1 mcg/kg) as transforaminal epidural injection. Pain relief and patient’s satisfaction
were evaluated with the global pain scale. Follow-up visits were advised at 1, 2, 4, 6
and 12 weeks and then at 6 months after injection. Associated complications were
recorded. Results: Maximum pain relief was observed at 2 weeks after injection in all
the three groups, with no difference in complication rate among the three groups. The
most common complication observed was paresthesia in the nerve distribution. Greater
than 60% improvement in pain scores was seen in 40% of the patients in group I,
50% of the patients in group II and 75% of the patients in group III. Limitations: This
study is limited by the lack of a placebo group. Conclusion: Adding 1 mcg/kg clonidine
to 60 mg methylprednisolone in transforaminal epidural injections provided better
Address for correspondence: pain relief than 60 mg methylprednisolone with 0.5 mcg/kg clonidine or 60 mg
Dr. Nazia Tauheed, methylprednisolone alone in patients suffering from lumbosacral radiculopathy, with
Flat-24 Ahmad Apartments, practically no significant side-effects.
Jamia Urdu Road, Aligarh - 202 002,
Uttar Pradesh, India. Key words: Epidural, lumbosacral radiculopathy, sciatica, transforaminal
E-mail: [email protected]

more than 4-6 weeks in most patients. In about 10% of

INTRODUCTION
the patients, surgery is considered after 6 weeks because of
Sciatica is defined as pain in the distribution of a lumbar persistent pain or progressive neurologic deficit. Although
nerve root accompanied by neurosensory and motor discectomy at the short term produces better pain relief
deficits[1] when, due to a herniated disc, it tends to have a than conventional therapy, its advantage for pain relief
more protracted course, with persistence of symptoms for after 10 years is not evident.[2]

Access this article online

Epidural steroid injection has been one of the “gold
Quick Response Code:
standards” in the management of chronic low back pain and
Website: sciatica for over 40 years. Controversy, however, continues
www.saudija.org regarding its efficacy, with conflicting conclusions found in
two systematic reviews.[3,4] A small but definite beneficial
DOI: effect in chronic sciatica can be noted,[5] believed to derive
10.4103/1658-354X.125937 mainly from a reduction in inflammation and edema of
injured and irritated spinal nerve roots.

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 Tauheed, et al.: Transforminal methylprednisolone alone or with clonidine for lumbosacral radiculopathy
Page | 52
A major problem with all those studies was that the received prior epidural steroid injection or lumbar surgery.
commonly used injection techniques did not guarantee that Apart from the magnetic resonance imaging (MRI) of the
medication actually reached the desired target nerve.[6] Many lumbosacral spine, all the patients were advised to get their
patients with chronic sciatica and low back pain showed complete hemogram, renal function tests, blood sugar and
filling defects on epidurography due to the presence of coagulation profile reported.
scar tissue, which “shields” the affected nerve from the
injectate. More direct application of medication, e.g., via a Randomization
catheter introduced 10 cm into the epidural space via the After taking a written informed consent, the patients
sacral hiatus has not resulted in a more favorable outcome were randomly allocated into one of the three groups of
in terms of pain relief.[7] Therefore, a transforaminal 60 patients each using a computer-generated randomization
targeted approach has been advocated for injection of the schedule. Patients belonging to group I received
medication to the affected nerve root.[8] methylprednisolone 60 mg as transforaminal injection,
while those of group II received methylprednisolone 60 mg
Clonidine, an α-2 adrenergic agonist, has been traditionally and clonidine 0.5 mcg/kg and those of group III received
used as an antihypertensive agent. The large expression methylprednisolone 60 mg and clonidine 1 mcg/kg. The
of α-2 receptors in the central ner vous system, total volume of injected medication in each group was
i.e., loecuscoeruleus and dorsal horn of the spinal cord, kept constant at 1.5 mL with the addition of normal saline.
has eventually focused the interest of this drug on centrally
mediated sedation and analgesia.[9] It, however, has its own Pre-procedure assessment
set of side-effects, i.e., hypotension, bradycardia, sedation, All the patients were assessed at least 1 week prior to
etc.[10] Recently, there is more emphasis on the use of low the procedure and a standard treatment protocol was
doses of clonidine due to a remarkable decrease in the advised to them, i.e., combination of oral tramadol
incidence of these side-effects.[11,12] 37.5 mg + paracetamol 325 mg and gabapentin 300 mg
three times a day. The patients were given a pain diary
The present study was designed to compare the analgesic to note down the global pain scale scores twice a
efficacy of methylprednisolone (a long-acting steroid week (Monday and Thursday) beginning 7 days before the
compound) with or without low doses of clonidine for day of treatment up to 6 weeks after treatment.
the treatment of sciatica via transforaminal sleeve root
injection. Technique
The procedure was performed with the patient in the prone
METHODS position on an X-ray translucent table. Fluoroscopy was
used to identify and mark the essential bony landmarks.
After obtaining approval from the institutional ethics No sedation was given. Baseline pulse rate, blood pressure
committee, this prospective, randomized, double-blinded and respiratory rate were recorded before undertaking the
study was conducted at the Pain Clinic under the procedure.
Department of Anaesthesiology, Jawaharlal Nehru Medical
College Hospital, Aligarh Muslim University, Aligarh, Lumbar transforaminal approach was performed by placing
India, over a period of 2 years, i.e., from April 2010 to the needle in the neural foramen, ventral to the nerve root.
March 2012. The needle was directed in an oblique approach toward a
target point on the upper margin of an imaginary triangle,
Participants the “safe triangle,”[13] with the three sides corresponding
The study was conducted on 180 patients of either sex, to the horizontal base or the pedicle, the outer vertical
with age ranging from 18 years to 55 years, with body border of the intervertebral foramen and the connecting
weight between 40 and 70kg, ASA grade I or II, suffering diagonal nerve root and dorsal ganglion. The image
from sciatica due to disc herniation [lumbar spine magnetic was adjusted until the superior articulating process was
resonance imaging scan documenting a herniated nucleus visualized between the anterior and the posterior edge of
pulposus (HNP) at not more than two levels, i.e., L3-L4, the vertebral body and the base of the articulating process
L4-L5 or L5-S1] and symptomatic for more than 6 weeks. was in line with the pedicle above.
The exclusion criteria were a large HNP with severe central
or foraminal stenosis on magnetic resonance imaging, After sterile preparation, draping and anesthetising the skin
progressive neurologic deficits, cauda-equina syndrome, and the overlying tissues with 2% lidocaine, a 12-cm-long,
blood coagulation disorder, valvular heart diseases, 22-gauge spinal needle was inserted just above the superior
hypotension, emotional instability, known history of articulating process and directed toward the base of the
allergy to local anesthetics, corticosteroids or clonidine or pedicle, and advanced slowly until the bone was contacted

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 Tauheed, et al.: Transforminal methylprednisolone alone or with clonidine for lumbosacral radiculopathy
Page | 53
just below the pedicle. The needle was then slightly Sample size and statistical analysis
withdrawn and redirected inferiorly into the targeted spinal Sample size was calculated based on a pilot study conducted
nerve canal. Advancement was made under lateral and on 15 patients for an improvement of at least 60% in visual
anteroposterior (AP) views to provide a 3-dimensional analogue scale (VAS). The minimum sample size turned
spatial representation. The AP view was taken to verify that out to be 48 for α = 0.05 with power of 80%. Considering
the needle was not medial to the 6-o clock position of the any loss of subjects during follow-up, 60 patients were
pedicle; on the lateral view, the needle was positioned just enrolled in each group. Data from subjects of the pilot
below the pedicle in the ventral aspect of the intervertebral study were also included in the study. Demographic data
foramen.[14] and side-effects were analyzed using Fisher’s exact test.
Pain relief and other parameters on the global pain scale
The first sacral (S1) foramen was best seen by directing were assessed using the Analysis of Variance (ANOVA)
the X-ray beam in a cephalocaudad direction so that
test. Results were considered statistically significant if the
the anterior and posterior foramina align, appearing as a
P value was less than 0.05.
small radioluscent circle just below the oval S1 pedicle.[15]
The needle was inserted slightly lateral and inferior to the
S1 pedicle and advanced slowly through the posterior RESULTS
foramen to the medial edge of the pedicle and the
appropriate depth was gauged by first striking the posterior Study design and participant flowchart [Figure 1].
sacral bone just above the posterior S1 foramen before
directing the needle tip into the S1 neural canal. Baseline characteristics
The three study groups were similar in terms of their age,
Non-ionic contrast dye (iohexol) 0.5-1 mL was injected gender, weight and duration of pain [Table 1].
very slowly (at about 1 mL in 20 s) and the dye pattern
was assessed. If leg paraethesias were noted as the needle The baseline hemodynamic and respiratory parameters,
approached the neural foramen, the needle was withdrawn i.e., pulse rate, mean arterial pressure (MAP), respiratory
slightly and the dye was injected. A positive image of the rate and oxygen saturation, were also compared among
nerve root on fluoroscopy indicated that the needle had the three study groups. Although small differences
penetrated the epiradicular membrane. After an adequate were observed, they were found to be statistically
dye pattern was observed, 1.5 mL of the mixture prepared insignificant (P > 0.05).
was injected (maximum volume of 2 mL of injectate is
necessary to preserve selectivity of single nerve block).
The injection was given at two levels depending upon the
level of disc herniation.

All patients were observed for any change in pulse rate,

blood pressure and respiratory depression throughout
the procedure. The level of sedation was assessed using a
four-point scale;[16] 1 = responds readily to name spoken in
a normal tone, 2 = lethargic response to a name spoken in a
normal tone, 3 = responds only after name is called loudly
and 4 = responds only after mild prodding or shaking.

The patients were discharged from the recovery room after

they were fully awake and oriented (sedation scale = 1) and
no adverse effects noted for 6 h after the injection of the
drugs under study. The subjects were allowed to take oral
tramadol 37.5 mg and paracetamol 325 mg combination
as and when required during the study period with a
minimum interval of 6 h between two doses. Gabapentin
300 mg three times a day, however, continued as in the
pre-treatment period. An overall improvement in the
patients’ condition was assessed in the follow-up visits at
1, 2, 4, 6 and 12 weeks after injection, the basis being a
reduction of scores on global pain scale. Figure 1: Study design and participant flowchart

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 Tauheed, et al.: Transforminal methylprednisolone alone or with clonidine for lumbosacral radiculopathy
Page | 54
Efficacy of treatment study groups had significant relief of symptoms after
Visual analogue scale treatment in all the follow-up visits. At the same time,
The extent of pain was evaluated in terms of VAS relief observed in group III patients was significantly
scores, a component of the global pain scale. As better than that seen in the patients of groups I and
observed, the baseline pain scores were similar in II [Figure 4].
the three study groups (P > 0.05). Significant pain
relief was observed after treatment in all three study Complications
groups, with maximum relief 2 weeks after treatment. None of the patients developed any serious complication.
However, post-treatment pain scores showed a The only complication observed in the study was transient
significant difference among the three groups at all paresthesia in the nerve distribution, which began during
the follow-up visits. Statistical analyses depicted that the procedure and resolved within 24 h without any
the extent of pain relief among the three study groups sequelae. There was no difference in complication rate
after the same duration of treatment was significantly among the three study groups [Table 4].
different, the best relief being in patients belonging to
group III [Table 2 and Figure 2].
Table 3: Changes in quality of sleep
Analgesic requirement Very poor Poor Satisfactory Well Very well P value
The analgesic requirement (mean ± SD) of patients in QS p
all the three treatment groups decreased significantly Group I 15 15 25 5 0 >0.05
Group II 18 13 24 2 0
after the treatment as compared with the pre-treatment
Group III 17 15 23 4 0
requirements. At the same time, the difference in analgesic
QS 1
requirement among the three study groups was also Group I 0 0 20 18 22 >0.05
significant in all follow-up visits, with a maximum reduction Group II 0 0 18 17 23
in analgesic requirement seen in patients belonging to Group III 0 1 21 17 20
group III [Figure 3]. QS 2
Group I 0 0 16 26 18 <0.05
Quality of sleep Group II 0 0 10 19 29
The changes observed in the quality of sleep after treatment Group III 0 0 6 14 39
showed a significant improvement from the baseline values. QS 4
On statistical analysis, the inter-group difference after Group I 0 0 18 20 22 <0.05
treatment was also significant [Table 3]. Group II 0 0 11 22 25
Group III 0 0 6 15 38
Global pain scale scores QS 6
Group I 0 0 18 20 22 <0.05
Patient’s overall comfort was evaluated in terms of
Group II 0 0 8 24 26
global pain scale score. Analysis showed that the three
Group III 0 0 4 14 41
QS 12
Table 1: Baseline characteristics Group I 0 0 18 20 22 <0.05
Parameters Group I Group II Group III P value Group II 0 0 8 24 26
(n=60) (n=58) (n=59) Group III 0 0 4 14 41
Age (years) 39.33±11.57 42.30±9.55 41.31±10.35 0.283 QS P – Quality of sleep at presentation; QS 1 – Quality of sleep 1 week after
treatment; QS 2 – Quality of sleep 2 weeks after treatmen; QS 4 – Quality of
Weight (kg) 57.90±10.39 60.57±9.64 59.82±8.66 0.307 sleep 4 weeks after treatment; QS 6 – Quality of sleep 6 weeks after treatment,
Male:Female 38:22 43:15 40:19 0.445 QS 12 – Quality of sleep 12 weeks after treatment
Duration of pain (days) 128±20 130±18 127±22 0.52

Table 4: Complications
Table 2: Changes in VAS Complications Group I Group II Group III
(n=60) (n=58) (n=59)
VAS Group I Group II Group III P value
Bradycardia 0 0 0
At presentation 7.83±0.65 7.60±0.71 7.72±0.47 0.133
Hypotension/fainting 0 0 0
1 week after treatment 5.41±1.03 4.62±1.13 4.41±1.13 0.000
Sedation 0 0 0
2 weeks after treatment 3.97±0.63 3.61±0.87 2.02±0.76 0.000
Respiratory depression 0 0 0
4 weeks after treatment 4.37±0.93 3.91±0.87 2.23±0.91 0.000
Nausea/vomiting 0 0 0
6 weeks after treatment 4.46±0.77 4.11±0.83 2.41±0.69 0.000
Paresthesia 3 5 4
12 weeks after treatment 4.66±0.71 4.24±0.79 2.65±0.62 0.000
VAS – Visual analogue scale Others 0 0 0

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 Tauheed, et al.: Transforminal methylprednisolone alone or with clonidine for lumbosacral radiculopathy
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DISCUSSION

In modern times, lumbosacral radiculopathy has become

one of the most costly and ubiquitous medical problems,
especially in Western Europe and North America.[17]
However, the exact data on incidence and prevalence of
sciatica are lacking and the annual prevalence of disc-related
sciatica in the general population is estimated to be roughly
at 2.2%.[18]

MRI, introduced in the early 1970s, stands today as an

excellent tool for the screening of patients with radicular pain.

In the present study, diagnosis of sciatica was primarily made

on the basis of history taking and physical examination. The
level of disc herniation was, however, reconfirmed before
Figure 2: Visual analog scale score for pain intensity in the study
groups transforaminal block with the help of an MRI. MRI was also
performed to exclude severe canal stenosis, infective cause
of radicular pain and massive disc protrusion, wherein the
patients were excluded from the study.

The modern era of treatment of sciatica initially focused

primarily on surgery. However, in recent years, numerous
studies have shown that a disc herniation may decrease in
size or disappear in the course of a few months, no matter
whether it is contained, extruded or migrated or of a small
or large size.[19-21]

Saal and Saal[22] also emphasized the effectiveness of

conservative management of disc herniation. Fifty-eight
patients on treatment with analgesics, anti-inflammatory
medication (NSAIDs), epidural injection of steroids, at a low
back school or by exercises were followed for a mean period
of 31 months. Only 10% of the patients required surgery due
Figure 3: Analgesic requirement (tablets/day) to failure of resolution of symptoms. Majority of patients
with lumbar radicular pain who avoid an operation for at
least 1 year after receiving a nerve root injection will continue
to avoid operative intervention for a minimum of 5 years.[23]

The lumbar transforaminal injection technique using

fluoroscopic control ensures the corticosteroid preparation
to be delivered precisely to the target site, i.e., the
ventral aspect of the lumbar nerve root as well as the
dorsal root ganglion, and the efficacy of radio-guided
transforaminal epidural corticosteroid injections is higher
than that obtained with blindly performed interspinous
injections.[8,24] Furman et al.[25] emphasized the need for
contrast injection apart from flouroscopic guidance in
lumbosacral transforaminal epidural steroid injection
(TFESI). They observed that a flash or blood aspiration
to predict an intravascular injection is not sensitive and,
therefore, a negative flash or aspiration is not reliable.
Figure 4: Scores on the global pain scale – pre- and post-treatment Thus, procedures without contrast confirmation may

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 Tauheed, et al.: Transforminal methylprednisolone alone or with clonidine for lumbosacral radiculopathy
Page | 56
instill medications intravascularly and therefore not into Burgher et al.[35] have used clonidine in transforaminal
the desired epidural location. injections along with lidocaine and compared its efficacy
with lidocaine and steroid group in their study on 26 patients
The efficacy of transforaminal steroid injection has been who underwent up to three lumbar transforaminal epidural
emphasized in a number of studies, clearly proving the steroid injection (TFESIs) with 2% lidocaine and either
adequacy of this method. One of the earliest studies triamcinolone (40 mg) or clonidine (200 or 400 μg) for acute
comparing the efficacy of epidural, perineural, single lumbar radicular pain treatment. Their prime objective was
shot steroid injection with the conventional interlaminar to find an effective alternative to steroids for transforaminal
epidural steroid injection in patients with lumbar radicular injections. Both groups showed statistically significant
pain syndromes was performed by Kraemer et al.,[26] who improvements at 2 weeks and 1 month post-enrollment,
found that patients with perineural selective nerve root but the steroid group noted greater improvement.
steroid injections showed significantly better results than
conventional epidural steroid injections. A deduction can thus be made from these studies that
clonidine as an adjuvant to steroid would provide better
TFESI is a relatively simple, effective and low-risk pain relief than steroid alone.
alternative to surgical decompression for the treatment of
lumbar disc herniation in selected cases. The procedure An analysis of complications associated with fluoroscopically
significantly alleviates the severity of sciatica due to a guided lumbar transforaminal epidural steroid injections
herniated disc and improves the patient’s daily activity, shows that there are no major complications reported and
reducing the need for surgical decompression.[27] that the minor complications found also resolve without
sequalae.[36-39]
The steroid used in this study, methylprednisolone
Injury to the nerve root with the sharp tip of the spinal
acetate (MPA), is a long-acting steroid compound
needle is a potential complication of TFESI.[40] Huston
manufactured as an injectable preparation. MPA temporarily
et al.[38] reported increased radicular pain in 8.8% of the
blocks nociceptive C-fiber transmission.[28] Also, ectopic
patients while Manchikanti et al.[41] reported increased
discharge from injured nerves appears to be suppressed
radicular pain in 1% and Botwin et al.[37] in 0.6% of the
by stabilization of axonal membranes by steroids, and this
patients after TFESI. Some authors have proposed a
has been shown to correlate with their local anesthetic
retrodiscal[42] or retroneural[43] approach as an alternative
effect. [29,30] Epidural injection of MPA seems to be
to the conventional sub-pedicular safe triangle approach
associated with little risk of serious neurological damage.
to minimize the risk of this complication.
Even after a single accidental subarachnoid injection,
the possibility of a serious complication is probably very The question regarding use of corticosteroids is due to
low.[31] Epidural administration of clonidine was shown the potential for their adverse/side-effects. These may
to produce post-operative analgesia as early as 1989 by be due to their local action or systemic effects. Although
Eisenach et al.,[32] the mechanism being activation of alfa-2 the different preparations of steroids used for epidural
adrenoceptors found concentrated near sites of peripheral injections, e.g. methylprednisolone acetate (used in this
nerve injury or inflammation. Clonidine has been shown study), triamcinolone acetonide, betamethasone acetate
to produce analgesia when given as perineural injection. and phosphate, have not been found to cause any serious
This analgesia is further enhanced in cases of persistent complications after TFESI, accidental injections of
neuritis.[33] particulate matter of steroids into the artery of Adamkeiwicz,
the major supplier of the anterior spinal artery in the
One of the inclusion criteria of patients in this study was thoracolumbar region of the spinal cord[44] that may arise
that they were suffering from the radicular pain for at least in a minority of patients near the lower lumbar vertebrae,[45]
6 weeks, making the condition persistent in nature. Hence, can lead to a catastrophic outcome, i.e., paraplegia resulting
anticipation of efficacy of clonidine in our patients can be from profound spinal cord infarction as a result of
further justified. interruption of blood flow.[46] A non-particulate preparation
of steroid, i.e., dexamethasone sodium phosphate, was
Clonidine has been used as targeted injection in sciatica found to be safer as compared with other steroids,[47] but
with methylprednisolone and hyaluronidase after this preparation is not available in the Indian market yet.
diagnostic epiduroscopy. Adhesions unreported in MRI
were mechanically mobilized under direct vision, and this Systemic side-effects of corticosteroids were extremely
targeted medication resulted in substantial and prolonged rare after TFESI as the doses of steroids used was
pain relief.[34] very small (20-40 mg) compared with conventional

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 Tauheed, et al.: Transforminal methylprednisolone alone or with clonidine for lumbosacral radiculopathy
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interlaminar epidural injections. A temporary elevation and 1 mcg/kg, showed a dose-dependent increase in the
of blood sugar levels in an insulin-dependent diabetic quality of analgesia. No side-effect could be attributed to
has been reported by Botwin et al.[37] A small number transforaminal clonidine in a dose of up to 1 mcg/kg.
of patients have also complained of flushing of
face after TFESI,[37,39] which was presumed to be an CONCLUSION
IgE-mediated reaction in response to steroids. Patients
with congestive heart failure should be aware of possible The results of this randomized, double-blind trial of
fluid retention.[48] Studies with other agents, which can fluoroscopy-guided transforaminal methylprednisolone
be used as alternatives to steroids in transforaminal alone and with low doses of clonidine (0.5 mcg/kg and
injections, are hence being conducted,[35,49] and it is likely 1 mcg/kg) in persistent pain of lumbosacral radiculopathy
that drugs blocking tumour necrosis factor (TNF)-α due to herniated intervertebral disc have demonstrated pain
and other similar candidate compounds could emerge relief in 75% of the patients receiving methylprednisolone
as potential treatments for sciatica. with 1 mcg/kg clonidine over the course of 6 months, with
superior results compared with the methylprednisolone
The primary concerns with the use of clonidine are alone and with 0.5 mcg/kg clonidine.
regarding its adverse effects and possible neurotoxicity.
Bradycardia and hypotension associated with epidural Thus, it can be said that transforaminal injection of
clonidine have been reported, but the doses used in clonidine as an adjuvant to steroid, methylprednisolone
this study are significantly lower than those found to be acetate, may be an effective treatment for sciatica due
associated with these complications. Moreover, the use to disc herniation. Clonidine is found to be a more
of clonidine as an adjuvant to steroids in transforaminal effective adjuvant at doses of 1 mcg/kg as compared
injections has not been reported till date. Burgher et al. with 0.5 mcg/kg with practically no significant side-effect
have used clonidine as an alternative to steroids in TFESI or complication. A longer duration of follow-up may be
giving 2% lidocaine and either clonidine (200 or 400 mcg) necessary to assess whether there is a difference in the
or triamcinolone (40 mg). A rapid improvement in radicular duration of analgesia between the study groups.
pain was observed in both treatment groups, but with
greater functional improvement in those patients receiving
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