UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607, United States
NCT Number: NCT01382771
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.
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Notify Me45 year–90 year
All sexes
Interventional
Early Phase 1
Gainesville, Florida, 32607, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
Intra-articular injection of 0.5 cc normal saline in each joint
Time frame: Hourly for 6 hours post injections
A positive response is defined as are ≥ 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.
Time frame: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
Time frame: 6 weeks, 3 months, 6 months, 12 months
Patient will complete ODI at the follow-up intervals.
Time frame: 6 weeks, 3 months, 6 months, 12 months
Patient will complete the SF-36 at the follow-up intervals. The SF-36 is a self-administered, generic, general health survey consisting of 36 questions. The questions focus on the functional health and well being of the subject completing the form.
Time frame: reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
Patient will keep a Work History Log during participation. The Log should indicate the daily work activities of the subject.
Time frame: reviewed at 6 weeks, 3 months, 6 months, 12 months
Patient will keep a Daily Analgesic Use Log during participation.
Time frame: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
Patient will keep an Ancillary Treatment Log during participation. This log will indicate any outside medical care, additional medial branch blocks or radiofrequency neurotomy treatments.
University of Florida
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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