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

Phase 4TerminatedNCT01267825

Montefiore Medical Center1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Disc Herniation Lumbosacral Radiculopathy

Interventions

CT-guided corticosteroid+ bupivicaineDRUG

CT-guided corticosteroid+ bupivicaine Also get standard medical care

Standard medical careDRUG

Naproxen + Oxycodone/ Acetaminophen

Eligibility

Sex: ALLMin age: 21 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and one week after emergency department discharge

Secondary Outcomes

Functional Disability Assessed Using Roland-Morris Scale

Time frame: 1 month

Adverse Events

Any adverse events since randomization. %s will be compared between groups

Time frame: 1 week after discharge from emergency department

Data from ClinicalTrials.gov

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