Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

November 22, 2022 updated by: Zack McCormick, University of Utah

A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain

Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two distinct techniques used to administer epidural steroids specifically to the nerve root affected in a radicular pain syndrome, which include transforaminal access at the level of pathology and interlaminar interlaminar access at the C7-T1 level with subsequent advancement of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary in order to achieve a targeted injection via an interlaminar approach in order to prevent dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar technique directly at the level where pathology is located (C4-C5, or C5-C6, for example). Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly discouraged.

Both the transforaminal injection approach and the targeted catheter approach demonstrate effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid injection for the treatment of cervical radicular pain. Our own recent work demonstrates the clinical effectiveness of the catheter-based targeted approach. However, these two approaches have never been directly compared. Thus, we aim to compare the differences in pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction between these two approaches to the treatment of cervical radicular pain.

Cervical radicular pain is a common syndrome, often treated with epidural steroid injection (ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal pathology can be performed via a transforaminal approach or via a interlaminar approach at C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no universal guidelines that recommend the use of one technique over the other. We will directly compare the clinical effectiveness of these two approaches as measured by pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction. The results of this study will potentially influence clinical practice recommendations regarding the treatment of cervical radicular pain. If one technique proves superior, instating this technique will have implications potentially for reducing opioid use, surgery and other healthcare utilization, and general healthcare cost related to the treatment of cervical radicular pain.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopaedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-80.
  • Clinical diagnosis of unilateral C4-C8 radicular pain.
  • Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
  • Numerical Rating Scale (NRS) pain score of 4 or higher.
  • Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).

Exclusion Criteria:

  • Refusal to participate, provide consent, or provide follow-up information for the 6-month duration of the study.
  • Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for Cervical epidural steroid injection (CESI), and pregnancy).
  • Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
  • Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.
  • Prior cervical spine surgery.
  • Patient request for or requirement of conscious sedation for the injection procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transforaminal ESI with dexamethasone
Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Procedure: Transforaminal ESI with dexamethasone
Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Drug: Dexamethasone Sodium Phosphate 10 MG/ML
Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Drug: Lidocaine
1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Other Names:
  • Xylocaine
Active Comparator: Transforaminal catheter-targeted ESI with triamcinolone
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Drug: Lidocaine
1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Other Names:
  • Xylocaine
Procedure: Transforaminal catheter-targeted ESI with triamcinolone
Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Drug: Triamcinolone Acetonide 40mg/mL
Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
Other Names:
  • Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
Time Frame: 1 month follow up
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score
1 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index-5
Time Frame: 1 month, 3 month, 6 month, and 1 year follow up
Percentage of patients with >30% improvement in Neck Disability Index-5 score.
1 month, 3 month, 6 month, and 1 year follow up
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
Time Frame: 1 month, 3 month, 6 month, and 1 year follow up
The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents.
1 month, 3 month, 6 month, and 1 year follow up
The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")
Time Frame: 1 month, 3 month, 6 month, and 1 year follow up
Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved")
1 month, 3 month, 6 month, and 1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Epimed

Investigators

  • Principal Investigator: Zachary L McCormick, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Actual)

April 15, 2020

Study Completion (Actual)

August 19, 2020

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Radiculopathy

Clinical Trials on Transforaminal ESI with dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe