Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

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

Detailed Description
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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.

Official Title
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A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Procedure: Transforaminal ESI with dexamethasone
* Procedure: Transforaminal catheter-targeted ESI with triamcinolone
* Drug: Dexamethasone Sodium Phosphate 10 MG/ML
* Drug: Lidocaine
* Drug: Triamcinolone Acetonide 40mg/mL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, comparative trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transforaminal ESI with dexamethasone<br>Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate | Procedure: Transforaminal ESI with dexamethasone<br>* 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).<br>Drug: Dexamethasone Sodium Phosphate 10 MG/ML<br>* Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1<br>Drug: Lidocaine<br>* 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2<br>* Other names: Xylocaine;|
| Active Comparator: Transforaminal catheter-targeted ESI with triamcinolone<br>Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide | Procedure: Transforaminal catheter-targeted ESI with triamcinolone<br>* 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).<br>Drug: Lidocaine<br>* 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2<br>* Other names: Xylocaine;Drug: Triamcinolone Acetonide 40mg/mL<br>* Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2<br>* Other names: Kenalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score | The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score | 1 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index-5 | Percentage of patients with >30% improvement in Neck Disability Index-5 score. | 1 month, 3 month, 6 month, and 1 year follow up | 
| Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents. | 1 month, 3 month, 6 month, and 1 year follow up | 
| The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating much improved and very much improved) | 1 month, 3 month, 6 month, and 1 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical epidural steroid injection, transforaminal approach, epidural catheter targeted, interlaminar approach, cervical radicular pain