Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population

NCT01382771 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-10-14

No results posted yet for this study

Summary

Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial \>80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized. Both groups will receive the standard of care, a medial branch block. The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.

Conditions

  • Low Back Pain

Interventions

DRUG

Intra-articular corticosteroid injection

Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint

DRUG

Intra-articular saline injection

Intra-articular injection of 0.5 cc normal saline in each joint

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • D. J. Kennedy, M.D. · UF Department of Orthopaedics and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382771 on ClinicalTrials.gov