Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

NCT03382821 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 105766
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Radiculopathy

Keywords

cervical epidural steroid injection; transforaminal approach; epidural catheter targeted; interlaminar approach; cervical radicular pain

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score

  The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score

  1 month follow up

Secondary Outcomes (3)

• Neck Disability Index-5

  1 month, 3 month, 6 month, and 1 year follow up

• Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III

  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")

  1 month, 3 month, 6 month, and 1 year follow up

Study Arms (2)

Transforaminal ESI with dexamethasone

ACTIVE COMPARATOR

Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate

Procedure: Transforaminal ESI with dexamethasone; Drug: Dexamethasone Sodium Phosphate 10 MG/ML; Drug: Lidocaine

Transforaminal catheter-targeted ESI with triamcinolone

ACTIVE COMPARATOR

Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide

Procedure: Transforaminal catheter-targeted ESI with triamcinolone; Drug: Lidocaine; Drug: Triamcinolone Acetonide 40mg/mL

Interventions

Transforaminal ESI with dexamethasone PROCEDURE

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).

Transforaminal ESI with dexamethasone

Transforaminal catheter-targeted ESI with triamcinolone PROCEDURE

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).

Transforaminal catheter-targeted ESI with triamcinolone

Dexamethasone Sodium Phosphate 10 MG/ML DRUG

Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1

Transforaminal ESI with dexamethasone

Lidocaine DRUG

1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2

Also known as: Xylocaine

Transforaminal ESI with dexamethasone; Transforaminal catheter-targeted ESI with triamcinolone

Triamcinolone Acetonide 40mg/mL DRUG

Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2

Also known as: Kenalog

Transforaminal catheter-targeted ESI with triamcinolone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Epimed: collaborator

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (29)

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MeSH Terms

Conditions

Radiculopathy

Interventions

Dexamethasone; Triamcinolone; dexamethasone 21-phosphate; Lidocaine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Zachary McCormick
• Organization: University of Utah, Department of Physical Medicine and Rehabilitation

PMR.Research@hsc.utah.edu

801-587-5432

Study Officials

• Zachary L McCormick, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary L. McCormick, MD

Model Details: Prospective, randomized, comparative trial

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 26, 2017
• Study Start: September 15, 2017
• Primary Completion: April 15, 2020
• Study Completion: August 19, 2020
• Last Updated: November 25, 2022
• Results First Posted: March 22, 2021

Record last verified: 2022-11

Locations

US (1)