Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection



Status:Not yet recruiting
Conditions:Neurology, Women's Studies
Therapuetic Areas:Neurology, Reproductive
Healthy:No
Age Range:18 - 99
Updated:9/16/2017
Start Date:January 2018
End Date:October 2019
Contact:Byron Schneider
Email:byron.j.schneider@vanderbilt.edu
Phone:6153220738

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Pragmatic Randomized Prospective Study of Cervical Interlaminar Epidural Injection of Particulate Steroid and Cervical Transforaminal Epidural Injection of Non-particulate Steroid in Patients With Cervical Radicular Pain

compare cervical interlaminar epidural injection of betamethasone (9mg) and cervical
transforaminal epidural injection of dexamethasone (15 mg) for cervical radicular pain

This study will compare one route of epidural steroid injection (interlaminar) using a
particulate steroid to another route of epidural steroid injection (transforaminal) using a
different non-particulate steroid dexamethasone. Repeat injections may be allowed.

All injections will be done with image guidance. Patients will be evaluated for improvements
in pain and function.

Inclusion Criteria:

- - aged >18, capable of understanding and providing consent in English, capable of
complying with the outcome instruments used, capable of attending all planned follow
up visits

- unilateral cervical radicular pain as defined by arm pain or shoulder girdle
pain/periscapular pain with or without neck pain of at least 2 weeks.

- 7 day average of numeric pain rating score (NPRS) for arm pain or shoulder
girdle/periscapular pain of at least 5/10 at baseline evaluation

- MRI (or CT if MRI not available) shows one or two level cervical disc herniation(s) or
disc osteophyte complex(es) between levels C4-T1, corresponding in location with
unilateral radicular pain, with or without neurological deficits. MRI or CT may show
degenerative changes at other levels.

- Patient consents to treatment with epidural injection in a shared decision-making
process with the treating physician.

- Pain duration of at least 2 weeks or more.

Exclusion Criteria:

- - Neck pain is greater than arm pain or shoulder girdle/periscapular pain based on 7
day average NPRS

- Those receiving remuneration for their pain treatment (e.g., disability, worker's
compensation).

- Those involved in active litigation relevant to their pain.

- Those unable to read English and complete the assessment instruments.

- Those unable to attend follow up appointments

- The patient is incarcerated.

- Spondylolisthesis at the involved or adjacent segments.

- History of prior cervical surgery

- Progressive motor deficit, and/or clinical signs of myelopathy.

- Prior cervical epidural steroid injections.

- Prior epidural steroid injection within the prior 12 months in any location within the
spine.

- Possible pregnancy or other reason that precludes the use of fluoroscopy.

- Allergy to contrast media or local anesthetics.

- BMI>35.

- Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis,
lupus).

- Active infection or treatment of infection with antibiotics within the past 7 days.

- Medical conditions causing significant functional disability (e.g., stroke, COPD)

- Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).

- Addictive behavior, severe clinical depression, or psychotic features.
We found this trial at
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Nashville, Tennessee 37067
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