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

NCT01267825 | Terminated Phase 4 Results

• 1 other identifier: 10-06-162
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Herniation; Lumbosacral Radiculopathy

Keywords

Disc herniation; Lumbosacral radiculopathy; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional Disability Assessed Using Roland-Morris Scale

  1 month

• Adverse Events

  1 week after discharge from emergency department

Study Arms (2)

CT-guided intervention

EXPERIMENTAL

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

Drug: CT-guided corticosteroid+ bupivicaine

Standard medical care

ACTIVE COMPARATOR

Drug: Standard medical care

Interventions

CT-guided corticosteroid+ bupivicaine DRUG

CT-guided corticosteroid+ bupivicaine Also get standard medical care

CT-guided intervention

Standard medical care DRUG

Naproxen + Oxycodone/ Acetaminophen

Standard medical care

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults \<60y
• \< 1m of symptoms
• Symptoms consistent with herniated disc
• MRI demonstrates corresponding disc
• Back pain resulting in functional disability

You may not qualify if:

• Chronic pain
• Daily pain medication
• Frequent back pain
• On the job injury

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Benjamin W. Friedman, MD, MS
• Organization: Montefiore Medical Center

befriedm@montefiore.org

718-920-6266

Study Officials

• Todd Miller, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Benjamin W. Friedman, MD, MS

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Emergency Medicine

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: December 29, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 31, 2018
• Results First Posted: June 1, 2018

Record last verified: 2018-08

Locations

US (1)