Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach (NCT03382821) | Clinical Trial Compass
CompletedPhase 4
Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach
United States120 participantsStarted 2017-09-15
Plain-language summary
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score