Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

NCT ID: NCT03165825

Last Updated: 2018-10-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2019-10-31

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.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tranforaminal

will receive cervical epidural injection via a transforaminal route with dexamethasone steroid

Group Type: EXPERIMENTAL

Transforaminal Epidural Steroid Injection with Dexamethasone

Intervention Type: DRUG

Transforaminal Epidural Steroid Injection with Dexamethasone

Interlaminar

will receive cervical epidural injection via an interlaminar route with betamethasone steroid

Group Type: ACTIVE_COMPARATOR

Interlaminar Epidural Steroid Injection with Betamethasone

Intervention Type: DRUG

Interlaminar Epidural Steroid Injection with Betamethasone

Interventions

Transforaminal Epidural Steroid Injection with Dexamethasone

Transforaminal Epidural Steroid Injection with Dexamethasone

Intervention Type: DRUG

Interlaminar Epidural Steroid Injection with Betamethasone

Interlaminar Epidural Steroid Injection with Betamethasone

Intervention Type: DRUG

Other Intervention Names

Decadron

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Byron Schneider

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Byron Schneider

Role: PRINCIPAL_INVESTIGATOR

Assistant professor

Other Identifiers

IRB #170187

Identifier Type: -

Identifier Source: org_study_id