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NCT06477094 · ClinicalTrials.gov registry record · NA
RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis
A NA study of Lumbar Spondylosis, sponsored by University of Arkansas.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06477094 is a NA study of Lumbar Spondylosis that is actively recruiting participants, run by University of Arkansas. The registered enrollment target is 25 participants, below the 128-participant average among 4 other Lumbar Spondylosis trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06477094, a NA study of Lumbar Spondylosis, is actively recruiting participants, sponsored by University of Arkansas.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DEVICE Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode
- DEVICE Stryker Venom Radiofrequency Cannula
Study Locations (1)
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-08-09 |
| Est. Completion | 2026-07-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06477094
The ClinicalTrials.gov registry entry for NCT06477094 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 4 other Lumbar Spondylosis trials with a reported enrollment target (80% lower). The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lumbar Spondylosis appearing as the primary indexed condition, and to 2 interventions - of which Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode is the first listed.
NCT06477094 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT06477094 about?
NCT06477094 is a clinical study titled "RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis". 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...
What is the current status of trial NCT06477094?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2024-08-09. Estimated completion is 2026-07-01.
What conditions does trial NCT06477094 study?
This clinical trial studies the following conditions: Lumbar Spondylosis.
What interventions are being tested in trial NCT06477094?
The interventions under investigation include: Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode (DEVICE), Stryker Venom Radiofrequency Cannula (DEVICE).
Who is sponsoring clinical trial NCT06477094?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06477094 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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