Phase 4
N=79
C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain
Radicular; Neuropathic, Cervical · Neck Pain
Bottom Line
View on ClinicalTrials.gov: NCT02095197 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain — 60; 72 percentage of participants — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Triamcinolone 80mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain |
60; 72 | 0.23 |
| SECONDARY Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III) |
13; 9 | 0.47 |
| SECONDARY Patient Global Impression of Change Score (PGIC) Less Than 3 |
22; 24 | 0.30 |
| SECONDARY Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score |
23; 24 | 0.41 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02095197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.