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
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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