Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain
Status: | Recruiting |
---|---|
Conditions: | Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/25/2018 |
Start Date: | August 2014 |
End Date: | December 2019 |
Contact: | Susan M Odum, PhD |
Email: | susan.odum@orthocarolina.com |
Phone: | 704-323-2265 |
Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial
Cervical radicular pain is a common cause of disability and pain in the upper extremity and
neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and
includes relative rest, use of anti-inflammatory and analgesic medication, as well as
physical therapy and home exercise. For patients who have persistent and significant
symptoms, interventional pain management and surgical management are considered. Cervical
epidural injections are the mainstay of the interventional, non-surgical modalities. They can
be considered to provide short and long-term relief when disc herniation, foraminal stenosis
or central canal stenosis pathology is identified. We are not aware of any published
prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of
cervical transforaminal epidural steroid injections. However, the North American Spine
Society (NASS) Review and Recommendation Statement states that based on the literature and
expert opinion, a minimum of one or two cervical epidural steroid injections would be very
appropriate in the treatment of a specific episode of cervical radicular pain.
The purpose of this study is to determine the effectiveness of cervical transforaminal
epidural steroid injections in decreasing the need for an operation in patients with cervical
radicular pain, otherwise considered to be operative candidates.
neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and
includes relative rest, use of anti-inflammatory and analgesic medication, as well as
physical therapy and home exercise. For patients who have persistent and significant
symptoms, interventional pain management and surgical management are considered. Cervical
epidural injections are the mainstay of the interventional, non-surgical modalities. They can
be considered to provide short and long-term relief when disc herniation, foraminal stenosis
or central canal stenosis pathology is identified. We are not aware of any published
prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of
cervical transforaminal epidural steroid injections. However, the North American Spine
Society (NASS) Review and Recommendation Statement states that based on the literature and
expert opinion, a minimum of one or two cervical epidural steroid injections would be very
appropriate in the treatment of a specific episode of cervical radicular pain.
The purpose of this study is to determine the effectiveness of cervical transforaminal
epidural steroid injections in decreasing the need for an operation in patients with cervical
radicular pain, otherwise considered to be operative candidates.
Cervical radicular pain is a common cause of disability and pain in the upper extremity and
neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and
includes relative rest, use of anti-inflammatory and analgesic medication, as well as
physical therapy and home exercise. For patients who have persistent and significant
symptoms, interventional pain management and surgical management are considered. Cervical
epidural injections are the mainstay of the interventional, non-surgical modalities. They can
be considered to provide short and long-term relief when disc herniation, foraminal stenosis
or central canal stenosis pathology is identified.
Cervical epidural injections can be performed by two different approaches, transforaminal and
interlaminar. Transforaminal epidural injections allow delivery of medication to the ventral
epidural space, while the interlaminar approach reaches the ventral epidural space in only
28% of injections (2-4). The results of cervical epidural injections remain controversial and
their efficacy in decreasing the need for surgery in patients who would otherwise be
operative candidates has not been thoroughly investigated. Studies have been limited by small
sample sizes, lack of control groups, and lack of randomization. Kolstad et al reported that
23% (5/21) of patients waiting for cervical disc surgery cancelled surgery when assessed at
four months after having a series of two cervical epidural injections (6). Lin et al reported
that 63% (44/70) of patients who were deemed to be surgical candidates were able to avoid
surgery with an average of 13-month follow up (7). Lee et al reported that over 80% of 98
patients evaluated with cervical radiculopathy were able to avoid surgery with a 2-year
follow-up (8). Anderberg et al reported that there was no short-term difference in symptoms
of cervical radiculopathy between patients who received transforaminal injections of steroid
with local anesthetic versus saline with local anesthetic. However, this study did not
evaluate whether the injections were successful in the patients avoiding surgery (11).
In terms of lumbar transforaminal epidural injections, Riew et al demonstrated that steroid
injections obviated the need for surgery in patients with lumbar radiculopathy. Moreover,
Reiw et al showed that steroid combined with local anesthetic was more effective than local
anesthetic alone in a prospective, randomized, controlled, double-blinded study (9). Riew et
al later studied the efficacy of cervical transforaminal epidural injections in the same
fashion, but the findings were not statistically significant (p<0.35) and not published (10).
We are not aware of any published prospective, randomized, controlled, double-blinded studies
demonstrating the efficacy of cervical transforaminal epidural steroid injections. However,
the North American Spine Society (NASS) Review and Recommendation Statement states that based
on the literature and expert opinion, a minimum of one or two cervical epidural steroid
injections would be very appropriate in the treatment of a specific episode of cervical
radicular pain. This literature also suggests that a maximum of four injections can be used
within six months, assuming there was a positive response and improvement seen with the
previous injections.
neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and
includes relative rest, use of anti-inflammatory and analgesic medication, as well as
physical therapy and home exercise. For patients who have persistent and significant
symptoms, interventional pain management and surgical management are considered. Cervical
epidural injections are the mainstay of the interventional, non-surgical modalities. They can
be considered to provide short and long-term relief when disc herniation, foraminal stenosis
or central canal stenosis pathology is identified.
Cervical epidural injections can be performed by two different approaches, transforaminal and
interlaminar. Transforaminal epidural injections allow delivery of medication to the ventral
epidural space, while the interlaminar approach reaches the ventral epidural space in only
28% of injections (2-4). The results of cervical epidural injections remain controversial and
their efficacy in decreasing the need for surgery in patients who would otherwise be
operative candidates has not been thoroughly investigated. Studies have been limited by small
sample sizes, lack of control groups, and lack of randomization. Kolstad et al reported that
23% (5/21) of patients waiting for cervical disc surgery cancelled surgery when assessed at
four months after having a series of two cervical epidural injections (6). Lin et al reported
that 63% (44/70) of patients who were deemed to be surgical candidates were able to avoid
surgery with an average of 13-month follow up (7). Lee et al reported that over 80% of 98
patients evaluated with cervical radiculopathy were able to avoid surgery with a 2-year
follow-up (8). Anderberg et al reported that there was no short-term difference in symptoms
of cervical radiculopathy between patients who received transforaminal injections of steroid
with local anesthetic versus saline with local anesthetic. However, this study did not
evaluate whether the injections were successful in the patients avoiding surgery (11).
In terms of lumbar transforaminal epidural injections, Riew et al demonstrated that steroid
injections obviated the need for surgery in patients with lumbar radiculopathy. Moreover,
Reiw et al showed that steroid combined with local anesthetic was more effective than local
anesthetic alone in a prospective, randomized, controlled, double-blinded study (9). Riew et
al later studied the efficacy of cervical transforaminal epidural injections in the same
fashion, but the findings were not statistically significant (p<0.35) and not published (10).
We are not aware of any published prospective, randomized, controlled, double-blinded studies
demonstrating the efficacy of cervical transforaminal epidural steroid injections. However,
the North American Spine Society (NASS) Review and Recommendation Statement states that based
on the literature and expert opinion, a minimum of one or two cervical epidural steroid
injections would be very appropriate in the treatment of a specific episode of cervical
radicular pain. This literature also suggests that a maximum of four injections can be used
within six months, assuming there was a positive response and improvement seen with the
previous injections.
Inclusion Criteria:
- Subjects who have cervical radicular pain without significant neurologic deficit
(neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT
findings of neural compression (neural compression is defined as disc herniation or
central or foraminal spinal stenosis),
- Failed 6 weeks of conservative treatment (conservative treatment is defined as
relative rest, home exercise, physical therapy, and use of anti-inflammatory and/or
analgesic medications),
- Deemed to be good operative candidates by spine surgeons (patients with MRI/CT
findings of neural compression with concordant symptoms) and had agreed to possible
operative intervention
Exclusion Criteria:
- History of
1. acute trauma,
2. diabetes (type I or type II),
3. active infection
- Active progressive neurological deficit (neurologic is deficit defined as manual
muscle testing less than 3/5),
- Medical condition that may affect the cervical spine neurological exam and/or pain
assessment (e.g. peripheral neuropathy),
- Bilateral disease,
- More than one cervical level requiring injection,
- Bleeding disorders or other medical contraindications to the injection procedure,
- Absence of substantial radicular pain (radicular pain is defined as arm pain greater
than neck pain),
- Involvement in workers' compensation claim, or any litigation related to neck injury.
- Patients who are pregnant, or who plan to become pregnant in the next 12 months
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