Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

Phase 4

Withdrawn

• Conditions: Cervical Radiculopathy
• Interventions: Drug: Interlaminar Epidural Steroid Injection with Betamethasone; Drug: Transforaminal Epidural Steroid Injection with Dexamethasone

• Registration Number: NCT03165825
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Study Start: 2018-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-04
• Primary Completion: 2019-09
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interlaminar	Interlaminar Epidural Steroid Injection with Betamethasone	will receive cervical epidural injection via an interlaminar route with betamethasone steroid
Tranforaminal	Transforaminal Epidural Steroid Injection with Dexamethasone	will receive cervical epidural injection via a transforaminal route with dexamethasone steroid

Primary Outcome Measures

Name	Time	Method
Pain	12 months	Numeric rating pain score