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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT01267825

First received: October 25, 2010

Last updated: July 13, 2011

Last verified: July 2011

History of Changes

Purpose

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	Intervention	Phase
Disc Herniation Lumosacral Radiculopathy	Drug: CT-guided corticosteroid+ bupivicaine Drug: Standard medical care	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Hernia Steroids

Drug Information available for: Bupivacaine

U.S. FDA Resources

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:

Roland Morris Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Absolute change in Roland Morris score from baseline assessment

Secondary Outcome Measures:

Pain and functional disability [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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
Adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Any adverse events since randomization. %s will be compared between groups


Estimated Enrollment:	72
Study Start Date:	September 2010
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	21 Years to 50 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267825

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


Responsible Party:	Benjamin Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT01267825 History of Changes
Other Study ID Numbers:	Low Back Radiculopathy: CT
Study First Received:	October 25, 2010
Last Updated:	July 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016

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