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

Conditions

• Lumbar Spondylosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode — DEVICE
  Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stratus Nimbus Electrode
• Stryker Venom Radiofrequency Cannula — DEVICE
  Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stryker Venom Cannula

Study Details

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.

Key Dates

Start date

Aug 9, 2024

Status verified

Jun 2026

Primary completion

Jul 31, 2026

Completion

Sep 30, 2027

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Stratus Nimbus
  Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stratus Nimbus Electrode.
• Active Comparator: Stryker Venom
  Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stryker Venom Cannula.

Primary Outcome Measure

PROMIS Outcomes [ Time Frame: 0, 1, 3, 6, 9, and 12 months from procedure date ]

Central Contacts

• Edward Denton, MD
  9018323377
  [email protected]
• Edward E Denton, BS
  9018323377
  [email protected]

Locations (1)

Find similar trials in Little Rock, AR

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