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Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

Primary Purpose

Cervical Radiculopathy

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Transforaminal Epidural Steroid Injection with Dexamethasone
Interlaminar Epidural Steroid Injection with Betamethasone
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tranforaminal

    Interlaminar

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Pain
    Numeric rating pain score

    Secondary Outcome Measures

    Full Information

    First Posted
    May 16, 2017
    Last Updated
    October 2, 2018
    Sponsor
    Vanderbilt University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03165825
    Brief Title
    Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    funding
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    October 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University Medical Center

    4. Oversight

    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

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Radiculopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranforaminal
    Arm Type
    Experimental
    Arm Description
    will receive cervical epidural injection via a transforaminal route with dexamethasone steroid
    Arm Title
    Interlaminar
    Arm Type
    Active Comparator
    Arm Description
    will receive cervical epidural injection via an interlaminar route with betamethasone steroid
    Intervention Type
    Drug
    Intervention Name(s)
    Transforaminal Epidural Steroid Injection with Dexamethasone
    Other Intervention Name(s)
    Decadron
    Intervention Description
    Transforaminal Epidural Steroid Injection with Dexamethasone
    Intervention Type
    Drug
    Intervention Name(s)
    Interlaminar Epidural Steroid Injection with Betamethasone
    Intervention Description
    Interlaminar Epidural Steroid Injection with Betamethasone
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    Numeric rating pain score
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Byron Schneider
    Organizational Affiliation
    Assistant professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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