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WithdrawnNCT03165825Updated Oct 4, 2018

Cervical Interlaminar Versus Transforaminal Epidural Steroid Injection

A Phase 4 interventional study of Transforaminal Epidural Steroid Injection with Dexamethasone and Interlaminar Epidural Steroid Injection with Betamethasone in Cervical Radiculopathy, sponsored by Vanderbilt University Medical Center. Withdrawn. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-10-04.

Sponsored by Vanderbilt University Medical Center · Phase 4, Interventional, and Treatment

Why this study was withdrawn
funding
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cervical Radiculopathy

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03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

Browse Radiculopathy studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Tranforaminal

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

    Drug: Transforaminal Epidural Steroid Injection with Dexamethasone

  • Active comparator
    Interlaminar

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

    Drug: Interlaminar Epidural Steroid Injection with Betamethasone

Interventions

  • DrugTransforaminal Epidural Steroid Injection with Dexamethasone

    Transforaminal Epidural Steroid Injection with Dexamethasone

    Also known as: Decadron

  • DrugInterlaminar Epidural Steroid Injection with Betamethasone

    Interlaminar Epidural Steroid Injection with Betamethasone

06

What researchers measure

Primary outcomes

  1. Pain

    Numeric rating pain score

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03165825
Lead sponsor
Vanderbilt University Medical Center
Responsible party
Byron Schneider (Assistant Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
May 24, 2017
Start date
Jan 2018 (estimated)
Primary completion
Sep 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Oct 4, 2018

Study contacts

Byron Schneider
principal investigator · Assistant professor

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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