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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01267825
Recruitment Status : Terminated (Study terminated early due to low enrollment. No data collected.)
First Posted : December 29, 2010
Results First Posted : June 1, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

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 Lumbosacral Radiculopathy Drug: CT-guided corticosteroid+ bupivicaine Drug: Standard medical care Phase 4

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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

Arm Intervention/treatment
Experimental: CT-guided intervention
CT guided perineural injection of corticosteroid+ bupivicaine 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




Primary Outcome Measures :
  1. Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire [ Time Frame: Baseline and one week after emergency department discharge ]
    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.


Secondary Outcome Measures :
  1. Functional Disability Assessed Using Roland-Morris Scale [ Time Frame: 1 month ]
    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, increasing functional disability.

  2. Adverse Events [ Time Frame: 1 week after discharge from emergency department ]
    Any adverse events since randomization. %s will be compared between groups



Information from the National Library of Medicine

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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

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
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Todd Miller, MD Montefiore Medical Center
Principal Investigator: Benjamin W. Friedman, MD, MS Montefiore Medical Center/Albert Einstein College of Medicine
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Responsible Party: Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01267825    
Other Study ID Numbers: 10-06-162
First Posted: December 29, 2010    Key Record Dates
Results First Posted: June 1, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Benjamin W. Friedman, MD, Montefiore Medical Center:
Disc herniation
Lumbosacral radiculopathy
Corticosteroids
Additional relevant MeSH terms:
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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