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Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

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Duke University

Status and phase

Completed
Phase 2

Conditions

Cervicogenic Upper Extremity Radiculopathy

Treatments

Drug: dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT03389620
Pro00083262

Details and patient eligibility

About

The purpose of this study is to compare two methods of giving epidural steroid injections for nerve pain in the arm that comes from the neck. An epidural steroid injection can be given in two different ways, either in the back of the spine within the neck or in the neck next to the nerve root going to the arm. Both are standard medical treatments. The investigators would like to see how effective these treatments are, and if there are any differences in effectiveness or safety between these two routes.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Unilateral cervicogenic upper extremity radiculopathy (with or without accompanying neck pain)
  • Baseline numerical pain scale (NRS) score > 4

Exclusion criteria

  • Recent (i.e., < 2 months) cervical spine surgery
  • Recent (i.e., < 1 month) cervical epidural or upper extremity corticosteroid injection
  • Contraindication or inability to the undergo procedure
  • Inability to provide informed consent
  • Expected inability to complete follow-up assessment
  • Contraindication to receiving contrast material (precluding an epidurogram)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

74 participants in 2 patient groups

Transforaminal Cervical Epidural Corticosteroid Injections
Active Comparator group
Treatment:
Drug: dexamethasone
Lateralized Interlaminar Epidural Corticosteroid Injections
Experimental group
Treatment:
Drug: dexamethasone

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Timothy Amrhein, MD

Data sourced from clinicaltrials.gov

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