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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two different tools for performing radiofrequency ablation (RFA) to assist individuals with chronic lower back pain due to lumbar spondylosis. Spondylosis can lead to painful joints in the lower back, and RFA helps by interrupting pain signals. The trial compares two RFA tools to determine which provides longer-lasting pain relief and better quality of life. Individuals who have tried physical therapy or medications without relief and have been diagnosed with lower back pain from lumbar facet joints may be suitable for this study. As an unphased trial, this study offers an opportunity to explore innovative solutions for pain relief and improve quality of life.

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 prior data suggests that radiofrequency ablation for lumbar spondylosis is safe?

Research has shown that radiofrequency ablation (RFA) is a common treatment for lower back pain caused by lumbar spondylosis, which involves the wear and tear of the spine's joints. This procedure uses radio waves to create a small burn on the nerves, preventing pain signals from reaching the brain.

Studies have found that the Stratus Nimbus and Stryker Venom systems are both FDA-approved and frequently used in these treatments, indicating their safety. The Nimbus electrode creates a larger burn, and some believe it might provide longer-lasting relief. However, both treatments are generally well-tolerated by patients.

RFA is known for its safety, with few side effects. The most common issue is temporary discomfort at the treatment site, which is usually mild and short-lived. For both the Nimbus and Venom systems, no strong evidence of serious safety concerns exists, making them reliable options for reducing back pain from lumbar spondylosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radiofrequency ablation (RFA) for lumbar spondylosis is unique because it uses advanced multi-tined electrodes for precise targeting of nerve pain. Unlike traditional RFA methods that may use single-point electrodes, these multi-tined electrodes aim to provide broader and more consistent nerve coverage, potentially leading to more effective pain relief. Additionally, the use of different devices like the Stratus Nimbus and the Stryker Venom cannulas offers researchers the opportunity to compare outcomes and refine techniques, which could improve patient outcomes and reduce recovery times. Researchers are excited about these treatments because they could offer a more efficient and potentially faster way to alleviate back pain compared to current options.

What evidence suggests that this trial's treatments could be effective for lumbar spondylosis?

Studies have shown that radiofrequency ablation (RFA) effectively reduces chronic lower back pain by targeting nerves near the spine. In this trial, participants will receive RFA using either the Stratus Nimbus or Stryker Venom tools. Research indicates that both tools can provide significant pain relief. The Nimbus tool creates a larger treatment area, which may lead to longer-lasting pain relief, though this is based on personal reports. Clinical data for the Stryker Venom tool demonstrated significant pain reduction for up to a year. Both treatments are effective, but the Nimbus might offer longer relief due to its larger treatment area. ^{2 3 6 7 8}

Who Is on the Research Team?

Jarna Shah, MD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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

> 3 American Society of Anesthesiologists Classification

Pregnancy

Allergies to injection medications

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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 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]

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]

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 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]

Citations

1. amsvita.com amsvita.com/en/news/economic-impact-of-nimbus-stratus-radiofrequency-in-pain-management/

Economic Impact of Nimbus Stratus Radiofrequency in Pain ... Nimbus Stratus radiofrequency ablation (RFA) provides a minimally invasive option with significantly lower procedural costs. Compared to surgery ...

2. stratusmedical.com stratusmedical.com/us/clinical-compendium/

Clinical References, Evidence & Validation Radiofrequency (RF) ablation has been effectively used to interrupt nociception arising from various spinal pain generators1. Anatomic variation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060452/

Assessment of real-world, prospective outcomes in patients ... Clinically meaningful and durable improvements in pain relief, functional disability, quality-of-life and treatment satisfaction were observed across all RAPID ...

4. withpower.com withpower.com/trial/phase-spondylosis-7-2024-21bae

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 ...

5. mainstaymedical.com mainstaymedical.com/pros-and-cons-of-rfa/

Pros and Cons of RFA in Treating Chronic Low Back Pain Research shows that the pain relief from RFA often decreases over time, usually lasting between six months to a year.

6. trials.arthritis.org trials.arthritis.org/trials/NCT06477094

RFA Using Multi-Tined Electrodes vs ... - Clinical Trial Finder 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 ...

7. stratusmedical.com stratusmedical.com/2021/05/19/randomized-control-trial/

Stratus Medical This IRB-approved study will be the first level I, prospective, randomized control trial to compare Nimbus radiofrequency ablation to ...

8. orthospinenews.com orthospinenews.com/2023/03/09/stratus-medical-announces-first-patient-enrolled-in-important-double-blinded-randomized-comparative-trial-comparing-the-nimbus-radiofrequency-ablation-device-to-conventional-radiofrequen/

Stratus® Medical announces first patient enrolled in ... This IRB-approved study will be the first level I, double-blinded, randomized control trial to compare Nimbus bipolar radiofrequency ablation to conventional ...