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

This study has been withdrawn prior to enrollment.
Information provided by:
Montefiore Medical Center Identifier:
First received: October 25, 2010
Last updated: July 13, 2011
Last verified: July 2011
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
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

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Roland Morris Scale [ Time Frame: 1 week ]
    Absolute change in Roland Morris score from baseline assessment

Secondary Outcome Measures:
  • 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

  • Adverse events [ Time Frame: 1 week ]
    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


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

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 identifier: NCT01267825

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
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 Identifier: NCT01267825     History of Changes
Other Study ID Numbers: Low Back Radiculopathy: CT
Study First Received: October 25, 2010
Last Updated: July 13, 2011

Keywords provided by Montefiore Medical Center:
Disc herniation
Lumbosacral radiculopathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 21, 2017