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

NCT06477094 | Recruiting FDA Device

• 1 other identifier: 297420
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 hypothesized that the Nimbus electrode will result in a greater reduction and improvement in PROMIS scores for a longer duration than the Stryker electrode.

Conditions

Lumbar Spondylosis

Keywords

Radiofrequency Ablation; Lower Back Pain; Lumbar Spondylosis

Outcome Measures

Primary Outcomes (1)

• 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, 9, and 12 months from procedure date

Study Arms (2)

Stratus Nimbus

ACTIVE COMPARATOR

Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stratus Nimbus Electrode.

Device: Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode

Stryker Venom

ACTIVE COMPARATOR

Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stryker Venom Cannula.

Device: Stryker Venom Radiofrequency Cannula

Interventions

Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode DEVICE

Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stratus Nimbus Electrode

Stratus Nimbus

Stryker Venom Radiofrequency Cannula DEVICE

Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stryker Venom Cannula

Stryker Venom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years of age
• Presenting with chronic non-radicular lower back pain
• Failure of conservative treatment such as physical therapy or NSAID usage
• Diagnosis of lumbar facet mediated lower back pain by a board-certified chronic pain physician via two sets of prognostic lumbar MBBs with 0.5cc of 0.5% bupivacaine with \>80% pain relief

You may not qualify if:

• History of known coagulopathy
• \> 3 American Society of Anesthesiologists Classification
• Pregnancy
• Spinal hardware between L3 and S1
• Allergies to injection medications
• English illiteracy
• Pain improvement following physical therapy or NSAID usage
• Previous history of attempted lumbar RFA

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Related Publications (10)

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  PMID: 8059268 BACKGROUND

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  PMID: 38512629 BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Spondylosis; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jarna Shah, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarna Shah, MD

CONTACT

6308648577; jshah2@uams.edu

Edward E Denton, BS

CONTACT

9018323377; edenton@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Blinded Randomized Control Trial

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 27, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

US (1)