C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain

NCT02095197 | Completed Phase 4 Results

• 1 other identifier: STU00089080
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck, scapula or arm. The diagnosis of radicular pain is made clinically by history and physical examination, supported by imaging studies and electrodiagnostic tests. No study has compared the differences in pain, medication utilization, functional outcomes, or patient satisfaction between interlaminar and targeted epidural injections in the cervical spine. In theory, the technique of targeted epidural steroid delivery with a catheter has a lower risk of accidental vascular trespass or disc penetration during the procedure, and far less risk of dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as compared with the interlaminar technique. The investigators hypothesize that this technique results in superior pain control, decreased medication use, improved function and fewer repeat injections. This data could improve patient safety and affect the evolving treatment guidelines for cervical epidural injections.

Conditions

Radicular; Neuropathic, Cervical; Neck Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain

  The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period. Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain). Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)

  1 month

Secondary Outcomes (3)

• Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)

  1 month

• Patient Global Impression of Change Score (PGIC) Less Than 3

  1 month

• Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score

  1 month

Study Arms (2)

No Catheter delivery

OTHER

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. No Catheter Delivery will be used to deliver the medication.

Drug: Triamcinolone 80mg

Catheter targeted delivery

ACTIVE COMPARATOR

Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc. Catheter targeted delivery will be used to deliver the medication.

Drug: Triamcinolone 80mg

Interventions

Triamcinolone 80mg DRUG

C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.

Also known as: Kenalog

Catheter targeted delivery; No Catheter delivery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ages 18-75 with C2-6 unilateral radicular pain who are scheduled to undergo cervical epidural steroid injection treatment.
• Pain lasting greater than 2 weeks.
• Pain resistant to a trial of conservative therapy (i.e. oral steroids,nonsteroidal anti-inflammatory drugs, opioids, muscle relaxants, physical therapy or chiropractic care)

You may not qualify if:

• Patient refusal.
• Lack of consent.
• Systemic infection or local infection over planned injection site in posterior cervical spine.
• Bleeding disorder, current use of anticoagulants or anti-platelet medications.
• Intrinsic spinal cord lesions in the cervical region.
• History of central neurologic, cerebrovascular, demyelinating or muscular disease.
• Concomitant use of oral or injected steroids.
• Allergy to medications being used for injection procedures.
• Inability to communicate with staff or to participate in follow up.
• Pregnancy.
• Inability to perform handgrip or arm strength testing.
• Cognitive deficit or motor neuron disease.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• McCormick ZL, Nelson A, Bhave M, Zhukalin M, Kendall M, McCarthy RJ, Khan D, Nagpal G, Walega DR. A Prospective Randomized Comparative Trial of Targeted Steroid Injection Via Epidural Catheter Versus Standard C7-T1 Interlaminar Approach for the Treatment of Unilateral Cervical Radicular Pain. Reg Anesth Pain Med. 2017 Jan-Feb;42(1):82-89. doi: 10.1097/AAP.0000000000000521.

  PMID: 27922950 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Triamcinolone; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: David Walega, MD
• Organization: Northwestern University, Feinberg School of Medicine

d-walega@northwestern.edu

312-695-2500

Study Officials

• David R Walega, M.D.

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)