Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

• Status: Completed
• Trial end date: 2020-08-19
• Target enrollment: 0
• Participant gender: All

Summary

Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Epimed
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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.