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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2013-08-31

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.

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Detailed Description

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Conditions

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Disc Herniation Lumbosacral Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CT-guided intervention

CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care

Group Type EXPERIMENTAL

CT-guided corticosteroid+ bupivicaine

Intervention Type DRUG

CT-guided corticosteroid+ bupivicaine Also get standard medical care

Standard medical care

Group Type ACTIVE_COMPARATOR

Standard medical care

Intervention Type DRUG

Naproxen + Oxycodone/ Acetaminophen

Interventions

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CT-guided corticosteroid+ bupivicaine

CT-guided corticosteroid+ bupivicaine Also get standard medical care

Intervention Type DRUG

Standard medical care

Naproxen + Oxycodone/ Acetaminophen

Intervention Type DRUG

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