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

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ClinicalTrials.gov Identifier: NCT01267825
Recruitment Status : Terminated (Low enrollment)
First Posted : December 29, 2010
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Description
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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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Steroids
Drug Information available for: Bupivacaine

Arms and Interventions
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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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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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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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    Key Record Dates
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018
Last Verified: May 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