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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lumbosacral Radiculopathy; Disc Herniation
• Intervention / Treatment: Drug: CT-guided corticosteroid+ bupivicaine; Drug: Standard medical care

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire	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.	Baseline and one week after emergency department discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Disability Assessed Using Roland-Morris Scale	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.	1 month
Adverse Events	Any adverse events since randomization. %s will be compared between groups	1 week after discharge from emergency department

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: December 27, 2010
• First Posted (Estimate): December 29, 2010

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Disc herniation; Corticosteroids; Lumbosacral radiculopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 10-06-162