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

Primary Purpose

Disc Herniation, Lumbosacral Radiculopathy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CT-guided corticosteroid+ bupivicaine
Standard medical care
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disc Herniation focused on measuring Disc herniation, Lumbosacral radiculopathy, Corticosteroids

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT-guided intervention

Standard medical care

Arm Description

CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Adverse Events
Any adverse events since randomization. %s will be compared between groups

Full Information

First Posted
October 25, 2010
Last Updated
August 1, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01267825
Brief Title
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early due to low enrollment. No data collected.
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Herniation, Lumbosacral Radiculopathy
Keywords
Disc herniation, Lumbosacral radiculopathy, Corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-guided intervention
Arm Type
Experimental
Arm Description
CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care
Arm Title
Standard medical care
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CT-guided corticosteroid+ bupivicaine
Intervention Description
CT-guided corticosteroid+ bupivicaine Also get standard medical care
Intervention Type
Drug
Intervention Name(s)
Standard medical care
Intervention Description
Naproxen + Oxycodone/ Acetaminophen
Primary Outcome Measure Information:
Title
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
Description
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.
Time Frame
Baseline and one week after emergency department discharge
Secondary Outcome Measure Information:
Title
Functional Disability Assessed Using Roland-Morris Scale
Description
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.
Time Frame
1 month
Title
Adverse Events
Description
Any adverse events since randomization. %s will be compared between groups
Time Frame
1 week after discharge from emergency department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Miller, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin W. Friedman, MD, MS
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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