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Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03165825
Collaborator
(none)
0
Enrollment
2
Arms
21
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Transforaminal Epidural Steroid Injection with Dexamethasone
  • Drug: Interlaminar Epidural Steroid Injection with Betamethasone
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tranforaminal

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

Drug: Transforaminal Epidural Steroid Injection with Dexamethasone
Transforaminal Epidural Steroid Injection with Dexamethasone
Other Names:
  • Decadron

    		•
    Active Comparator: Interlaminar

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

    Drug: Interlaminar Epidural Steroid Injection with Betamethasone
    Interlaminar Epidural Steroid Injection with Betamethasone

    Outcome Measures

    Primary Outcome Measures

    1. Pain [12 months]

      Numeric rating pain score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Vanderbilt University Medical Center

    Investigators

    • Principal Investigator: Byron Schneider, Assistant professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Byron Schneider, Assistant Professor, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03165825
    Other Study ID Numbers:
    • IRB #170187
    First Posted:
    May 24, 2017
    Last Update Posted:
    Oct 4, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Radiculopathy
    Dexamethasone
    Betamethasone

    Study Results

    No Results Posted as of Oct 4, 2018