Status:
COMPLETED
Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Epimed
Conditions:
Cervical Radiculopathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
Detailed Description
Two distinct techniques used to administer epidural steroids specifically to the nerve root affected in a radicular pain syndrome, which include transforaminal access at the level of pathology and int...
Eligibility Criteria
Inclusion
- Age 18-80.
- Clinical diagnosis of unilateral C4-C8 radicular pain.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- Numerical Rating Scale (NRS) pain score of 4 or higher.
- Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
Exclusion
- Refusal to participate, provide consent, or provide follow-up information for the 6-month duration of the study.
- Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for Cervical epidural steroid injection (CESI), and pregnancy).
- Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
- Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.
- Prior cervical spine surgery.
- Patient request for or requirement of conscious sedation for the injection procedure.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03382821
Start Date
September 15 2017
End Date
August 19 2020
Last Update
November 25 2022
Active Locations (1)
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1
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108