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RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 31, 2026 → Jul 31, 2027
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Record History

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  1. Notable Primary completion pushed from Jul 31, 2026 to Jul 31, 2027
    • Site contact updated
    v9
  2. Minor Primary completion date: Jul 1, 2026 to Jul 31, 2026
    • Study completion date: Jul 1, 2026 to Sep 30, 2027
    • Site contact updated
    v8
  3. Notable Primary completion date: Jul 1, 2025 to Jul 1, 2026v7
  4. Minor Study completion date: Jul 1, 2025 to Jul 1, 2026
    • Site contact updated
    • Study description expanded, about 1 word
    v6
  5. Minor Site contact updatedv5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2024 to Aug 9, 2024
    • Site details revised
    v4
  2. Notable Start date: Jul 1, 2024 to Aug 1, 2024v3
  3. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06477094
Lead Sponsor University of Arkansas
Conditions
(from sponsor)
Lumbar Spondylosis
Related terms Low Back Pain, Spondylosis
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov