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Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03165825
Enrollment
0
Registered
2017-05-24
Start date
2018-01-31
Completion date
2019-10-31
Last updated
2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Radiculopathy

Brief summary

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

Detailed description

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.

Interventions

DRUGTransforaminal Epidural Steroid Injection with Dexamethasone

Transforaminal Epidural Steroid Injection with Dexamethasone

DRUGInterlaminar Epidural Steroid Injection with Betamethasone

Interlaminar Epidural Steroid Injection with Betamethasone

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain12 monthsNumeric rating pain score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026