RFA Using Multi-Tined Electrodes Vs.Traditional Electrodes for Lumbar Spondylosis
NCT Number: NCT06477094
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lumbar Spondylosis
Sponsor: University of Arkansas
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2025-07-01

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, and 9. 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.

Primary Outcome Measures: PROMIS Outcomes, The PROMIS (Patient Reported Outcomes Measurement Information System) outcomes as reported by the PROMIS-29 questionnaire serve as an indicator for pain severity and impairment of activities of daily living. The PROMIS-29 questionnaire which assess 7 heath domains which include 4 survey items with scores ranging from 0 being no impairment and 5 being the most severe impairment. The questionnaire also assess the patient's pain on a numerical scale from 0 being no pain and 10 being the worst pain experienced by the patient. Both components are then used to assess impairment of daily activities using composite T-scores which are calculated from the raw data. T-Scores between 40-45 is considered mild impairment, 30-40 is considered moderate impairment, and less then 30 is considered severe impairment., 0, 1, 3, 6, and 9 months from procedure date