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

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Radicular; Neuropathic, Cervical; Neck Pain

Treatments: Drug: Triamcinolone 80mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02095197

STU00089080 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Cervical radicular pain is a common, painful, disabling problem, often treated by epidural steroid injection (ESI). Two techniques of steroid delivery into the cervical epidural space include the transforaminal and interlaminar approaches. We aimed to determine if the CIESI with versus without a catheter is associated with superior clinical outcomes at follow-up. We hypothesized that the use of a targeted epidural catheter technique would result in superior pain control, function, decreased analgesic use, and lower surgical incidence as compared to standard CIESI at C7-T1.

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

No Catheter delivery

Other group

Description:

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.

Treatment:

Drug: Triamcinolone 80mg

Catheter targeted delivery

Active Comparator group

Description:

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.

Treatment:

Drug: Triamcinolone 80mg