Lumbar Spondylosis RFA Study: Stratus Nimbus vs. Stryker Venom
This study is comparing two different devices used in radiofrequency ablation (RFA) for chronic lower back pain caused by lumbar spondylosis (wear and tear of the small joints in your spine). RFA uses radio waves to create a small burn that stops pain signals from reaching your brain. We are comparing the Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode to the Stryker Venom Radiofrequency Cannula. You might be able to join if you are over 18, have chronic lower back pain not helped by other treatments like physical therapy, and have been diagnosed with lumbar facet pain by a doctor. Success in this study will be measured by changes in your pain, disability, and daily living as reported on questionnaires over 12 months. The current recruitment status is unclear.
- Study design
- This is a double-blinded, randomized study involving about 25 participants. This means neither you nor your doctor will know which device you receive.
- What's involved
- You will undergo two diagnostic nerve blocks, and if successful, you will have an RFA procedure. You will complete questionnaires at 0, 1, 3, 6, 9, and 12 months after the procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the RFA procedure to assess their outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Aparna Jindal, MD · PRINCIPAL_INVESTIGATOR · University of Arkansas
Who to contact
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What this trial measures
- PROMIS Outcomes0, 1, 3, 6, 9, and 12 months from procedure date
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.