Radiofrequency Ablation for Lumbar Spondylosis

Overseen By Edward E Denton, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Coagulopathy, Pregnancy, Spinal hardware, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using NSAIDs (non-steroidal anti-inflammatory drugs) and they have been effective, you may not be eligible for the trial.

What data supports the effectiveness of the treatment Radiofrequency Ablation for Lumbar Spondylosis?

Research shows that radiofrequency ablation (RFA) is effective in reducing chronic low back pain by targeting nerves near the spine. Studies have demonstrated that using multi-tined electrodes can enhance the effectiveness of RFA by better targeting the nerves responsible for pain. ^{1 2 3 4 5}

Is radiofrequency ablation safe for treating lumbar spondylosis?

Radiofrequency ablation (RFA) is generally considered safe for treating chronic low back pain, including conditions like lumbar spondylosis, as it has been used for over 50 years with various techniques to manage pain. ^{1 6 7 8 9}

How is the treatment Radiofrequency Ablation Using Multi-Tined Electrodes unique for lumbar spondylosis?

Radiofrequency Ablation (RFA) using multi-tined electrodes is unique because it targets the nerve causing pain with a perpendicular approach, potentially creating larger lesions for more effective pain relief compared to traditional methods. This technique is designed to improve the precision and effectiveness of the treatment for chronic low back pain associated with lumbar spondylosis. ^{1 3 4 8 10}

What is the purpose of this trial?

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.

Research Team

Jarna Shah, MD

Principal Investigator

University of Arkansas

Eligibility Criteria

This trial is for patients with lumbar spondylosis, a condition causing lower back pain due to spinal joint defects. Participants are those already scheduled for radiofrequency ablation (RFA) treatment at the UAMS Pain Clinic and will be assessed using the PROMIS-29 questionnaire.

Inclusion Criteria

I am over 18 years old.

I have ongoing lower back pain that doesn’t shoot down my leg.

I have lower back pain diagnosed by a specialist, confirmed with specific tests showing significant pain relief.

Exclusion Criteria

I have a known blood clotting disorder.

> 3 American Society of Anesthesiologists Classification

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo radiofrequency ablation (RFA) using either the Stratus Nimbus or Stryker Venom electrode

1 day

1 visit (in-person)

Follow-up

Participants are monitored for response to intervention using the PROMIS-29 questionnaire at 1, 3, 6, and 9 months

9 months

4 visits (virtual)

Treatment Details

Interventions

• RFA Using Multi-Tined Electrodes

Trial Overview The study compares two FDA-approved RFA electrodes: Stryker Venom with a single tip versus Stratus Nimbus with an expandable 'V' shaped tip. It aims to determine if lesion size from Nimbus leads to better long-term pain relief as measured by patient-reported outcomes.

Participant Groups

Group I: Stratus Nimbus Active Control 1 Intervention

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

Group II: Stryker Venom Active Control 1 Intervention

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

RFA Using Multi-Tined Electrodes is already approved in United States, European Union for the following indications:

Approved in United States as Radiofrequency Ablation for:

• Lumbar spondylosis
• Arthritis of the spine
• Joint pain involving the knees, sacroiliac joints, hips, or shoulders

Approved in European Union as Radiofrequency Ablation for:

• Chronic pain management
• Neck and back pain
• Whiplash
• Complex regional pain syndrome
• Nerve entrapment syndromes
• Spinal arthritis (spondylosis)
• Cervicogenic headache
• Occipital neuralgia

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Findings from Research

Radiofrequency ablation (RFA) is a safe and effective treatment for chronic low back pain, as demonstrated in an 81-year-old patient who experienced a 75% reduction in pain for over eight months after a conventional RFA procedure.

The use of a combined technique involving bipolar-RFA and V-shaped cannulas resulted in sustained pain relief for over twelve months, suggesting that this method may enhance lesion size and effectiveness, warranting further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Bipolar and V-Shaped Lesions for Lumbar Facet Radiofrequency Ablation: A Technical Report. Sagir, A., Bolash, R.[2022]

In a study of 15 participants with degenerative spondylolisthesis, radiofrequency ablation (RFA) for facet pain did not significantly advance the condition, showing a mean progression of only 1.30% per year, which is comparable to the estimated baseline advancement of 2%.

The results suggest that RFA does not have a destabilizing effect on the spine in patients with spondylolisthesis, indicating it can be a safe option for managing pain without worsening spinal instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Spondylolisthesis Progression: What is the Effect of Lumbar Medial Branch Nerve Radiofrequency Ablation on Lumbar Spondylolisthesis Progression? A Single-Center, Observational Study. Patel, T., Watterson, C., McKenzie-Brown, AM., et al.[2022]

Radiofrequency ablation is an effective treatment for chronic pain caused by spondylosis in the cervical, thoracic, lumbar, and sacroiliac regions, helping to provide longer-lasting pain relief.

The procedure involves confirming the diagnosis by blocking the median branch nerve, followed by the use of a specialized needle and imaging techniques to accurately target the pain source.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency neurolysis. Golovac, S.[2010]

In a study involving 51 patients, both the conventional monopolar (CM) and multi-tined (MT) cannulas for radiofrequency ablation (RFA) showed similar effectiveness in reducing chronic low back pain, with no significant differences in pain relief or quality of life outcomes after 3 months.

The MT cannula procedure was completed significantly faster and required less local anesthetic and radiation exposure compared to the CM cannula, indicating it may be a more efficient option for patients undergoing RFA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Within Subject Comparison of Fluoroscopically Guided Lumbosacral Facet Joint Radiofrequency Ablation Using a Multi-Tined (Trident) Versus Conventional Monopolar Cannula. Deng, G., Smith, A., Burnham, R.[2022]

In a study of 192 patients with low back pain, the only clinical factor associated with successful outcomes from radiofrequency denervation was the presence of paraspinal tenderness, indicating its importance in patient selection.

Factors linked to treatment failure included 'facet loading' during pain assessment, a long duration of pain, and a history of previous back surgery, suggesting that these should be carefully considered when determining eligibility for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical predictors of success and failure for lumbar facet radiofrequency denervation. Cohen, SP., Hurley, RW., Christo, PJ., et al.[2022]

Patients who underwent radiofrequency ablation (RFA) of lumbar facet medial branch nerves at 90°C reported significantly greater functional improvement (3.1 times more likely to report at least 50% improvement) compared to those treated at 80°C, based on a retrospective analysis.

The higher temperature of 90°C also led to sustained improvements, with a 2.8 times higher likelihood of patients reporting at least 75% functional improvement, without an increase in complications, suggesting that higher temperatures may enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Temperature for Radiofrequency Ablation of Lumbar Medial Branches for Treatment of Facet-Mediated Back Pain. Costandi, S., Garcia-Jacques, M., Dews, T., et al.[2019]

In a study of nine patients with thoracic facet disease, bipolar radiofrequency thermocoagulation resulted in a significant 47.6% reduction in pain, as measured by the Visual Analog Scale (VAS), one month after the procedure.

The treatment was found to be safe, with no serious complications reported, suggesting it could be a viable option for managing mid back pain originating from thoracic facet joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipolar Intra-articular Radiofrequency Thermocoagulation of the Thoracic Facet Joints: A Case Series of a New Technique. Kim, D.[2021]

Bipolar radiofrequency facet ablation (RFA) offers a new technique that targets the posterior capsule of the lumbar facet joint, potentially providing more effective pain relief compared to traditional methods that focus solely on the recurrent sensory branches.

Early studies suggest that this approach can lead to long-term pain relief for localized facet joint pain and may also help prevent the recurrence of lumbar facet cysts when combined with standard RFA techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipolar Radiofrequency Facet Ablation of the Lumbar Facet Capsule: An Adjunct to Conventional Radiofrequency Ablation for Pain Management. Jacobson, RE., Palea, O., Granville, M.[2022]

In a study of 223 patients undergoing lumbar medial branch blocks, a significant decrease in diastolic blood pressure (DBP) of more than 7.5 mm Hg after the block was associated with a high likelihood (85.7%) of positive outcomes from subsequent radiofrequency (RF) denervation.

An algorithm combining age, baseline pain scores, and a significant decrease in DBP could accurately predict 76.7% of RF denervation outcomes, suggesting that objective vital sign changes may help improve treatment outcome predictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can changes in vital signs be used to predict the response to lumbar facet blocks and radiofrequency denervation? A prospective, correlational study. Cohen, SP., Atanelov, L., Rammasubu, C., et al.[2019]

In a controlled study using chicken breast models, pre-injecting 2% lidocaine or iohexol 240 before radiofrequency ablation (RFA) significantly increased lesion size compared to no injectate, suggesting these agents can enhance the efficacy of RFA for chronic pain treatment.

The study found that while lidocaine 2% and iohexol 240 improved lesion characteristics, other agents like lidocaine 1%, iohexol 180, and gadodiamide did not show significant differences in lesion size, indicating that not all solutions are equally effective in modifying RFA outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Local Anesthetics and Contrast Agents on Radiofrequency Ablation Lesion Size. Ortiz, N., Shahgholi, L., Kohan, L., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Combined Bipolar and V-Shaped Lesions for Lumbar Facet Radiofrequency Ablation: A Technical Report. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Lumbar Spondylolisthesis Progression: What is the Effect of Lumbar Medial Branch Nerve Radiofrequency Ablation on Lumbar Spondylolisthesis Progression? A Single-Center, Observational Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Radiofrequency neurolysis. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Prospective Within Subject Comparison of Fluoroscopically Guided Lumbosacral Facet Joint Radiofrequency Ablation Using a Multi-Tined (Trident) Versus Conventional Monopolar Cannula. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical predictors of success and failure for lumbar facet radiofrequency denervation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Optimal Temperature for Radiofrequency Ablation of Lumbar Medial Branches for Treatment of Facet-Mediated Back Pain. [2019]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Bipolar Intra-articular Radiofrequency Thermocoagulation of the Thoracic Facet Joints: A Case Series of a New Technique. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Bipolar Radiofrequency Facet Ablation of the Lumbar Facet Capsule: An Adjunct to Conventional Radiofrequency Ablation for Pain Management. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Can changes in vital signs be used to predict the response to lumbar facet blocks and radiofrequency denervation? A prospective, correlational study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The Effect of Local Anesthetics and Contrast Agents on Radiofrequency Ablation Lesion Size. [2023]