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

Phase 4

Terminated

• Conditions: Lumbosacral Radiculopathy; Disc Herniation
• Interventions: Drug: Standard medical care; Drug: CT-guided corticosteroid+ bupivicaine

• Registration Number: NCT01267825
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-01
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-29
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2018-05-04
• Results First Submitted QC: 2018-05-04
• Results First Posted: 2018-06-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard medical care	Standard medical care	-
CT-guided intervention	CT-guided corticosteroid+ bupivicaine	CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care

Primary Outcome Measures

Name	Time	Method
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire	Baseline and one week after emergency department discharge	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

Name	Time	Method
Functional Disability Assessed Using Roland-Morris Scale	1 month	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	1 week after discharge from emergency department	Any adverse events since randomization. %s will be compared between groups

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States