Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382821
• Other study ID #: 105766
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2017
• Est. completion date: August 19, 2020

Study information

• Verified date: November 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 19, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Procedure:
• Transforaminal ESI with dexamethasone
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).
• Transforaminal catheter-targeted ESI with triamcinolone
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).

Drug:
• Dexamethasone Sodium Phosphate 10 MG/ML
Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
• Lidocaine
1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
• Triamcinolone Acetonide 40mg/mL
Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2

Locations

Country	Name	City	State
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Epimed

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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