CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
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ClinicalTrials.gov Identifier: NCT01267825 |
Recruitment Status
:
Terminated
(Slow enrollment)
First Posted
: December 29, 2010
Last Update Posted
: April 18, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Disc Herniation Lumosacral Radiculopathy | Drug: CT-guided corticosteroid+ bupivicaine Drug: Standard medical care | Phase 4 |
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 |

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

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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

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
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Todd Miller, MD | Montefiore Medical Center | |
Principal Investigator: | Benjamin W. Friedman, MD, MS | Montefiore Medical Center, Albert Einstein College of Medicine |
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 |
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 |