Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach



Status:Recruiting
Conditions:Neurology, Women's Studies
Therapuetic Areas:Neurology, Reproductive
Healthy:No
Age Range:18 - 80
Updated:10/14/2018
Start Date:January 3, 2018
End Date:January 14, 2021
Contact:Shellie S Cunningham, BS
Email:shellie.cunningham@hsc.utah.edu
Phone:801-587-5488

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A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain

Do cervical epidural steroid injections done by transforaminal catheter targeted approach
improve pain and function in patients with cervical radicular pain?

Two distinct techniques used to administer epidural steroids specifically to the nerve root
affected in a radicular pain syndrome, which include transforaminal access at the level of
pathology and interlaminar interlaminar access at the C7-T1 level with subsequent advancement
of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary
in order to achieve a targeted injection via an interlaminar approach in order to prevent
dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between
the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or
smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural
puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar
technique directly at the level where pathology is located (C4-C5, or C5-C6, for example).
Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly
discouraged.

Both the transforaminal injection approach and the targeted catheter approach demonstrate
effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid
injection for the treatment of cervical radicular pain. Our own recent work demonstrates the
clinical effectiveness of the catheter-based targeted approach. However, these two approaches
have never been directly compared. Thus, we aim to compare the differences in pain reduction,
medication utilization, functional outcomes, patient satisfaction, and surgical rate
reduction between these two approaches to the treatment of cervical radicular pain.

Cervical radicular pain is a common syndrome, often treated with epidural steroid injection
(ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal
pathology can be performed via a transforaminal approach or via a interlaminar approach at
C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no
universal guidelines that recommend the use of one technique over the other. We will directly
compare the clinical effectiveness of these two approaches as measured by pain reduction,
medication utilization, functional outcomes, patient satisfaction, and surgical rate
reduction. The results of this study will potentially influence clinical practice
recommendations regarding the treatment of cervical radicular pain. If one technique proves
superior, instating this technique will have implications potentially for reducing opioid
use, surgery and other healthcare utilization, and general healthcare cost related to the
treatment of cervical radicular pain.

Inclusion Criteria:

- Age 18-80.

- Clinical diagnosis of unilateral C4-C8 radicular pain.

- Magnetic resonance imaging pathology consistent with clinical symptoms/signs.

- Numerical Rating Scale (NRS) pain score of 4 or higher.

- Pain duration of more than 6 weeks despite trial of conservative therapy (medications,
physical therapy, or chiropractic care).

Exclusion Criteria:

- Refusal to participate, provide consent, or provide follow-up information for the
6-month duration of the study.

- Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection,
bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to
medications used for Cervical epidural steroid injection (CESI), and pregnancy).

- Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular
muscular disease.

- Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.

- Prior cervical spine surgery.

- Patient request for or requirement of conscious sedation for the injection procedure.
We found this trial at
1
site
Salt Lake City, Utah 84108
Phone: 801-587-5488
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Salt Lake City, UT
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