Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.

Study Overview
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Brief Summary
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Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. The interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). However, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.

Official Title
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Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial

Conditions
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Cervicobrachial Neuralgia

Intervention / Treatment
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* Other: Ultrasound-guided transforaminal epidural steroid injection
* Other: Interlaminar epidural steroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status (ASA) I-III Chronic unilateral cervicobrachial pain Allowed Steroid infiltration Exclusion Criteria: Pregnancy Lactation Allergy or intolerance to any of the drugs/materials used in this study, Participation in another interventional study Systemic anticoagulation, Infection at the puncture site Patient refusal.

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided transforaminal epidural steroid injection<br> | Other: Ultrasound-guided transforaminal epidural steroid injection<br>* Ultrasound identification of the nerve root, fluoroscopic control of the position and injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.<br>|
| Experimental: Interlaminar epidural steroid injection<br> | Other: Interlaminar epidural steroid injection<br>* Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score change at 30 minutes post infiltration when compared to baseline | Pain will be evaluated by Visual Analog Scale (VAS) before and 30 minutes after corticosteroid infiltration. Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable) | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score change at 1 month post infiltration when compared to baseline | Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after corticosteroid infiltration. Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable) | up to 1 month | 
| Patient satisfaction during procedure | Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied) | at the end of infiltration | 
| Neck disability index (NDI) score (questionnaire) | Neck disability index (NDI) score will be calculated before, 30 minutes and 1 month after corticosteroid infiltration The NDI is a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, Interpretation for scoring intervals : 0 - 4 = no disability; 5 - 14 = mild disability; 15 - 24 = moderate disability; 25 - 34 = severe disability, above 34 = complete disability. | up to 1 month | 
| Rate of Procedure failure | The procedure will be considered as a failure if the infiltration is not performed. | up to 30 minutes | 
| Incidence of Adverse effects (lipothymia, nausea, vomiting) |  | up to 1 month | 
| Incidence of complications (stroke, hematoma, paralysis) |  | up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropathic Cervicobrachial, Ultrasound-guided transforaminal infiltration, Cervical Interlaminar epidural infiltration, Cervical Chronic Pain