Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain (NCT04803149) | Clinical Trial Compass
UnknownNot Applicable
Cooled RFA vs Conventional RFA to Manage Chronic Facetogenic Low Back Pain
United States79 participantsStarted 2021-02-23
Plain-language summary
This study is being conducted to assess the relative effectiveness of radiofrequency neurotomy in subjects with chronic axial low back pain originating in the lumbar facet joints using the COOLIEF\* Cooled Radiofrequency Probe as compared to the same procedure conducted using a Standard Radiofrequency Probe.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Age ≥ 21 years
✓. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
✓. Subjects who have chronic axial (non-radicular) low back pain (at least 3 months) attributed to bilateral L4/L5, L5/S1 lumbar facet joint arthropathy based on clinical evaluation (paraspinal tenderness in the absence of signs and symptoms suggestive of focal neurological deficits) despite conservative treatments, including activity modification, home exercise, protective weight bearing, and/or analgesics (for example, acetaminophen or non-steroidal anti-inflammatory drugs \[NSAIDs\]).
✓. Positive response to dual diagnostic medial branch blocks (defined as a decrease in numeric pain scores of at least 80% for a min of 3 hours for bupivacaine and minimum of 2 hours for lidocaine) using 0.5mL or less of 0.5% bupivacaine and 2% lidocaine, on respective encounters on separate days, at each of the appropriate medial branches.
✓. Usual/Average Pain ≥ 6 on an 11-point NRS scale.
✓. Analgesics including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain, such as Cymbalta (duloxetine), must be clinically stable (defined as stable dosage for ≥ 6 weeks prior to the screening visit) and shall not change during the study without approval of the investigator.
✓. Agree to see one physician (study physician) for back pain during the study period.
✓. Subjects of child bearing potential must be willing to utilize double barrier contraceptive method for duration of participation.
Exclusion criteria
What they're measuring
1
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months
Timeframe: 6 months
2
Proportion of subjects experiencing adverse events through 6-months
. Evidence of inflammatory arthritis (example, rheumatoid arthritis) or other systemic condition (example; gout, fibromyalgia, MS, Lupus, etc.) that could cause pain.
✕. Focal neurologic signs or symptoms.
✕. Spinal pathology that may impede recovery such as spina bifida occulta, grade II or higher spondylolisthesis at an affected joint or adjacent level, or significant lumbar scoliosis (sagittal vertical axis angle \>5 degrees or Cobb Angle \>10 degrees).
✕. Suspected mechanical instability based on flexion/extension and/or films at the proposed treatment levels
✕. History of prior lumbar fusion or previous lumbar back surgery at the intended treatment levels.
✕. Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy.
✕. Radiologic evidence of a symptomatic herniated disc or nerve root impingement.
✕. Symptomatic moderate or severe foramina or central canal stenosis demonstrating radicular symptoms or neurogenic claudication.