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

Low Back Pain Clinical Trial

Official title: A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population

Status Completed

Clinical Trial 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.

Clinical Trial Description

Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.

Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

• NCT number: NCT01382771
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: Phase 0
• Start date: October 2010
• Completion date: September 2012