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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02095197
• Other study ID #: STU00089080
• Secondary ID: STU00089080
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 20, 2014
• Last updated: April 25, 2016
• Start date: March 2014

Study information

• Verified date: April 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain
• Radicular; Neuropathic, Cervical
• Radiculopathy

Intervention

Procedure:
• Interlaminar cervical epidural steroid injection
C7-T1 Cervical interlaminar epidural steroid injection
• Targeted cervical epidural steroid injections
Targeted cervical epidural steroid injections with an epidural catheter introduced at the C7-T1 level

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain medicine consumption	The difference in pain medication use between the two groups. The change in Medication Quantification Scale (MQS III) at one month following procedure.	1 month	Yes
Secondary	Numeric Rating Scale (NRS-11)	The Numeric Rating Scale (NRS-11)	2wk, 1 month, 3 months, 6 months	No
Secondary	McGill Pain Questionnaire		2wk, 1 month, 3 months, 6 months	No
Secondary	Pain Disability Index		2wks, 1 month, 3 months, 6 months	No
Secondary	Patient's Global Impression of Change		2wks, 1 month, 3 months, 6 months	No
Secondary	Neck Pain questionnaire		2wks, 1 month, 3 months, 6 months	No