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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Disc Herniation; Lumosacral Radiculopathy	Drug: CT-guided corticosteroid+ bupivicaine; Drug: Standard medical care	Phase 4

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	September 1, 2010
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: CT-guided intervention; CT guided perineural injection of corticosteroid+ bupiviciane Also get typical medical care	Drug: CT-guided corticosteroid+ bupivicaine; CT-guided corticosteroid+ bupivicaine Also get standard medical care
Active Comparator: Standard medical care	Drug: Standard medical care; Naproxen + Oxycodone/ Acetaminophen

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Roland Morris Scale [ Time Frame: 1 week ]
   Absolute change in Roland Morris score from baseline assessment

Secondary Outcome Measures :

1. Pain and functional disability [ Time Frame: 1 month ]

   Disability to be assessed using Roland-Morris scale. %s reporting no disability will be compared.

   Worst pain over the previous 24 hours will be assessed using a 4 point descriptive scale: none, mild, moderate, or severe. %s reporting none will be compared

2. Adverse events [ Time Frame: 1 week ]
   Any adverse events since randomization. %s will be compared between groups

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467

Sponsors and Collaborators

Montefiore Medical Center

Investigators

Principal Investigator:	Todd Miller, MD	Montefiore Medical Center
Principal Investigator:	Benjamin W. Friedman, MD, MS	Montefiore Medical Center, Albert Einstein College of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT01267825 History of Changes
Other Study ID Numbers:	10-06-162
First Posted:	December 29, 2010
Last Update Posted:	April 18, 2018
Last Verified:	April 2018

Keywords provided by Benjamin W. Friedman, MD, Montefiore Medical Center:

Disc herniation; Lumbosacral radiculopathy; Corticosteroids

Additional relevant MeSH terms:

Radiculopathy; Hernia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Bupivacaine	Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents