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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-articular corticosteroid injection | Active Comparator | Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks |
|
| Intra-articular saline injection | Placebo Comparator | Intra-articular saline injections with confirmatory anesthetic medial branch blocks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular corticosteroid injection | Drug | Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction | 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. | Hourly for 6 hours post injections |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating (NPR) Daily diary | The patient will be instructed to maintain a pain diary that records the degree and duration of any relief. | reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up |
| Oswestry Disability Index (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. J. Kennedy, M.D. | UF Department of Orthopaedics and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF & Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida | 32607 | United States |
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| Intra-articular saline injection | Drug | Intra-articular injection of 0.5 cc normal saline in each joint |
|
Patient will complete ODI at the follow-up intervals.
| 6 weeks, 3 months, 6 months, 12 months |
| Standard Form 36 (SF-36), General Health Survey | 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. | 6 weeks, 3 months, 6 months, 12 months |
| Daily Work History Log | Patient will keep a Work History Log during participation. The Log should indicate the daily work activities of the subject. | reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up |
| Daily Analgesic Use Log | Patient will keep a Daily Analgesic Use Log during participation. | reviewed at 6 weeks, 3 months, 6 months, 12 months |
| Ancillary Treatment Log | 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. | reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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