Overview

This trial is active, not recruiting.

Conditions radicular; neuropathic, cervical, neck pain
Treatments interlaminar cervical epidural steroid injection, targeted cervical epidural steroid injections
Phase phase 4
Sponsor Northwestern University
Start date March 2014
End date August 2016
Trial size 140 participants
Trial identifier NCT02095197, STU00089080

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
interlaminar cervical epidural steroid injection
C7-T1 Cervical interlaminar epidural steroid injection
(Active Comparator)
Triamcinolone 80mg and 1 ml of 1% lidocaine. Total volume is 2 cc.
targeted cervical epidural steroid injections
Targeted cervical epidural steroid injections with an epidural catheter introduced at the C7-T1 level

Primary Outcomes

Measure
Pain medicine consumption
time frame: 1 month

Secondary Outcomes

Measure
Numeric Rating Scale (NRS-11)
time frame: 2wk, 1 month, 3 months, 6 months
McGill Pain Questionnaire
time frame: 2wk, 1 month, 3 months, 6 months
Pain Disability Index
time frame: 2wks, 1 month, 3 months, 6 months
Patient's Global Impression of Change
time frame: 2wks, 1 month, 3 months, 6 months
Neck Pain questionnaire
time frame: 2wks, 1 month, 3 months, 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - 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) Exclusion Criteria: - 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. - Daily opiate use that preceded the onset of cervical radicular symptoms or daily opiate use exceeding 3 months prior to study inclusion

Additional Information

Official title A Prospective Randomized Controlled Trial of Standardized C7-T1 Epidural Steroid Injections Versus Targeted Injection Via Cervical Epidural Catheter for the Treatment of Cervical Radicular Pain
Principal investigator David R Walega, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Northwestern University.