CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial

Study Overview
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Brief Summary
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Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.

Official Title
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A Randomized Trial of CT-guided Perineural Injection With a Corticosteroid Plus a Long Acting Local Anesthetic Versus Standard Medical Management in Patients With Acute Lumbar Radiculopathy and a Corresponding Disc Herniation

Conditions
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Disc Herniation, Lumbosacral Radiculopathy

Intervention / Treatment
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* Drug: CT-guided corticosteroid+ bupivicaine
* Drug: Standard medical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults <60y < 1m of symptoms Symptoms consistent with herniated disc MRI demonstrates corresponding disc Back pain resulting in functional disability Exclusion Criteria: Chronic pain Daily pain medication Frequent back pain On the job injury

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-guided intervention<br>CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care | Drug: CT-guided corticosteroid+ bupivicaine<br>* CT-guided corticosteroid+ bupivicaine Also get standard medical care<br>|
| Active Comparator: Standard medical care<br> | Drug: Standard medical care<br>* Naproxen + Oxycodone/ Acetaminophen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians. | Baseline and one week after emergency department discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Disability Assessed Using Roland-Morris Scale | The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, increasing functional disability. | 1 month | 
| Adverse Events | Any adverse events since randomization. %s will be compared between groups | 1 week after discharge from emergency department | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disc herniation, Lumbosacral radiculopathy, Corticosteroids