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
Overview
- Phase
- Phase 4
- Intervention
- Triamcinolone 80mg
- Conditions
- Radicular; Neuropathic, Cervical
- Sponsor
- Northwestern University
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Detailed 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.
Investigators
David Walega
Associate Professor of Anesthesiology
Northwestern University
Eligibility Criteria
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.
Arms & Interventions
No Catheter delivery
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.
Intervention: Triamcinolone 80mg
Catheter targeted delivery
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.
Intervention: Triamcinolone 80mg
Outcomes
Primary Outcomes
Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
Time Frame: 1 month
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)
Secondary Outcomes
- 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)