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

Completed · Early Phase 1

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT01382771

Run by

University of Florida

People needed

28

Starts

2010-10-01

Expected to finish

2012-09-01

Last updated by the study team

2013-10-14

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Low back pain episode greater than six months in duration
• NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
• Previous medial branch block providing >80% pain relief for current painful episode
• Subject must be scheduled to undergo a second medial branch block for their back pain

You may not qualify if…

• Litigation
• Those seeking new or increased long-term remuneration
• Leg pain greater than back pain
• Radicular pain or evidence of neurological compromise in the lower limbs
• Those unable to read English and complete the assessment instruments
• Systemic inflammatory arthritis (e.g. rheumatoid, lupus)
• Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
• Significant lower extremity pathology that affects gait
• Sustained cervical or thoracic pain that is present at a level >3/10 on NPR
• Possible pregnancy or other reason that precludes the use of fluoroscopy
• Significant scoliosis
• Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms
• Contra-indication to corticosteroid, including known allergies or sensitivities
• History of prior epidural spinal injections relieving their current pain, or prior lumbar surgery.

Where it is running

• UF & Shands Orthopaedics and Sports Medicine Institute — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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