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

Lumbosacral Radiculopathy 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01267825
• Other study ID #: 10-06-162
• Status: Terminated
• Phase: Phase 4
• Start date: September 1, 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Disc Herniation
• Hernia
• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

Drug:
• CT-guided corticosteroid+ bupivicaine
CT-guided corticosteroid+ bupivicaine Also get standard medical care
• Standard medical care
Naproxen + Oxycodone/ Acetaminophen

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse Events	Any adverse events since randomization. %s will be compared between groups	1 week after discharge from emergency department