Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Intervention: Transforaminal ESI with dexamethasone; Transforaminal catheter-targeted ESI with triamcinolone; Dexamethasone Sodium Phosphate 10 MG/ML; Lidocaine; Triamcinolone Acetonide 40mg/mL
Intervention description: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).; Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).; Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1; 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2; Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Dexamethasone 21-phosphate; BB 1101; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, comparative trial
Masking: Single (Participant)
Masking description: Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cervical epidural steroid injection; transforaminal approach; epidural catheter targeted; interlaminar approach; cervical radicular pain

Summary:

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

Eligibility 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.