Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional
Phase: Phase 4

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 interlaminar interlaminar access at the C7-T1 level with subsequent advancement
      of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary
      in order to achieve a targeted injection via an interlaminar approach in order to prevent
      dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between
      the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or
      smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural
      puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar
      technique directly at the level where pathology is located (C4-C5, or C5-C6, for example).
      Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly
      discouraged.

      Both the transforaminal injection approach and the targeted catheter approach demonstrate
      effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid
      injection for the treatment of cervical radicular pain. Our own recent work demonstrates the
      clinical effectiveness of the catheter-based targeted approach. However, these two approaches
      have never been directly compared. Thus, we aim to compare the differences in pain reduction,
      medication utilization, functional outcomes, patient satisfaction, and surgical rate
      reduction between these two approaches to the treatment of cervical radicular pain.

      Cervical radicular pain is a common syndrome, often treated with epidural steroid injection
      (ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal
      pathology can be performed via a transforaminal approach or via a interlaminar approach at
      C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no
      universal guidelines that recommend the use of one technique over the other. We will directly
      compare the clinical effectiveness of these two approaches as measured by pain reduction,
      medication utilization, functional outcomes, patient satisfaction, and surgical rate
      reduction. The results of this study will potentially influence clinical practice
      recommendations regarding the treatment of cervical radicular pain. If one technique proves
      superior, instating this technique will have implications potentially for reducing opioid
      use, surgery and other healthcare utilization, and general healthcare cost related to the
      treatment of cervical radicular pain.
    

Intervention name(s): Transforaminal ESI with dexamethasone; Transforaminal catheter-targeted ESI with triamcinolone; Dexamethasone Sodium Phosphate 10 MG/ML; Lidocaine; Triamcinolone Acetonide 40mg/mL
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Xylocaine; Kenalog
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Dexamethasone 21-phosphate; BB 1101; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, comparative trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: cervical epidural steroid injection; transforaminal approach; epidural catheter targeted; interlaminar approach; cervical radicular pain