Efficacy of Radiofrequency Ablation Using Multi-Tined Electrodes vs. Traditional Electrodes for Treatment of Lumbar Spondylosis
University of Arkansas
Summary
Spondylosis is an anatomical defect of the small facet joints between the spinal vertebrae often due to load bearing and mechanical wear. It is a major contributor to lower back pain. The current standard of care in patients diagnosed with spondylosis in the lower back is to perform a radiofrequency ablation (RFA) of the lumbar medial branch nerves which carry the pain signals from that region to the brain. RFA accomplishes this by using radio waves transmitted through inserted electrodes. This leads to a temporary lesion or "burn"; stopping the pain signals from being transmitted as as well as changing the pain signals themselves. The electrodes themselves do not heat up but instead cause ions in the surrounding tissue to vibrate and heat up. When performing the procedure at the UAMS pain clinic, one can use the Stryker system with a single electrode end which protrudes out of the cannula or the Stratus Nimbus electrode with two prongs which expand in a "V"; formation along the sides of the cannula. While testing in chicken tissue shows that the latter electrode type produces a larger lesion size, anecdotal evidence suggests that it may lead to longer term pain relief. As such, the choice is currently left up to physician preference as both are FDA approved for use in this condition. This study is trying to assess if the larger lesion size results in a reduction in impairment of activities of daily living due to pain measured by the patient-reported PROMIS (Patient Reported Measurement Information System)-29 questionnaire. The PROMIS-29 is given to all patients who are seen in the UAMS Pain Clinic at initial and follow-up visits. In this study we would like to randomize what electrode and cannula set is used in RFA for patient's who are already going to be receiving the procedure for treatment for their spondylosis. The study team would then compare the PROMIS outcomes between cases that used the Stryker and Stratus Nimbus electrodes at 1,3,6,9 and 12 months. It is hypothesized that the Nimbus electrode will result in a greater reduction and improvement in PROMIS scores for a longer duration than the Stryker electrode.
Description
This study is a single center double-blinded prospective randomized clinical trial. Patients will be recruited from the pool of patients seen by the Principal Investigators (PIs) and collaborating physicians in the UAMS pain management clinic through the Department of Anesthesiology. Candidacy for RFA is determined by the standard of care which includes diagnosis of axial low back pain without lower extremity radiation or other primary pain generators. These patients should not have had previous RFA's in the lumbar region before. These patients should receive greater than 80% pain relief follo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Greater than 18 years of age 2. Presenting with chronic non-radicular lower back pain 3. Failure of conservative treatment such as physical therapy or NSAID usage 4. Diagnosis of lumbar facet mediated lower back pain by a board-certified chronic pain physician via two sets of prognostic lumbar MBBs with 0.5cc of 0.5% bupivacaine with \>80% pain relief Exclusion Criteria: 1. History of known coagulopathy 2. \> 3 American Society of Anesthesiologists Classification 3. Pregnancy 4. Spinal hardware between L3 and S1 5. Allergies to injection medications 6. English illiter…
Interventions
- DeviceStratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode
Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stratus Nimbus Electrode
- DeviceStryker Venom Radiofrequency Cannula
Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stryker Venom Cannula
Location
- University of Arkansas for Medical SciencesLittle Rock, Arkansas