Clinical trial NCT02095197: C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radicular; Neuropathic, Cervical
Neck Pain
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-03-24
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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

Primary outcomes:
measure: Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain
timeFrame: 1 month
Secondary outcomes:
measure: Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)
timeFrame: 1 month
measure: Patient Global Impression of Change Score (PGIC) Less Than 3
timeFrame: 1 month
measure: Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score
timeFrame: 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: David R Walega, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.