Radiofrequency Ablation for Lumbar Spondylosis

(LMB-RFA Trial)

Overseen By Nancy Ruth Jarbadan, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Radicular pain, Infection, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have failed conservative treatment, including nonsteroidal anti-inflammatory medications, which might imply that these medications are not effective for you.

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

Research shows that radiofrequency ablation (RFA) of the medial branch nerves can provide pain relief and improve function for 6-12 months, and possibly up to 2 years, in patients with lumbar facet syndrome, which is a similar condition to lumbar spondylosis. About 50% of patients experience long-term improvement, especially those who had pain relief after a preliminary test called a medial branch block. ^{1 2 3 4 5}

Is radiofrequency ablation for lumbar spondylosis safe?

Radiofrequency ablation (RFA) is generally considered a safe treatment for chronic low back pain, including conditions like lumbar spondylosis, as it has been shown to be effective and safe in various studies. ^{1 2 6 7 8}

How is radiofrequency ablation different from other treatments for lumbar spondylosis?

Radiofrequency ablation (RFA) is unique because it uses high-density electrical currents to target and disrupt the nerves that transmit pain signals from the affected facet joints in the spine, providing longer-lasting pain relief compared to other treatments. This procedure is guided by imaging techniques to ensure precise targeting of the nerves, which is not a feature of many other treatments for lumbar spondylosis. ^{2 7 8 9 10}

What is the purpose of this trial?

The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.

Research Team

Yakov Vorobeychik, MD PhD

Principal Investigator

Professor, Department of Anesthesiology

Eligibility Criteria

This trial is for individuals with lumbar spondylosis, a condition affecting the lower back. Participants should be candidates for radiofrequency ablation therapy, which is a treatment to reduce pain by heating nerve tissue. Specific eligibility details are not provided.

Inclusion Criteria

I am older than 18 years.

My average pain score is 3 or more out of 10 over the last three days.

I experienced significant pain relief from two back nerve block procedures.

Exclusion Criteria

Secondary gain identified due to ongoing legal proceedings or worker's compensation

I have a bleeding disorder.

Cognitive impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bilateral radiofrequency ablation (RFA) using both traditional and parasagittal approaches

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including self-reported analgesic consumption and pain intensity

6 months

Treatment Details

Interventions

• Radiofrequency Ablation of Lumbar Medial Branch Nerves

Trial Overview The study aims to compare two different methods of performing radiofrequency ablation on nerves in the lower back: the parasagittal approach and the traditional approach. It seeks to determine which method is more effective at reducing pain.

Participant Groups

Group I: Subjects with traditional approach on the right side and parasagittal approach on the left side. Active Control 1 Intervention

Patients will undergo bilateral RFA; the right side will be done following the traditional approach, and the left side will be done following the parasagittal approach. Traditional approach is done by placing the electrode at a 20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process and transverse process of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament that may be ossified in up to 10% of the normal spine and potentially prevent proper coagulation of the medial branch nerve during the RFA procedure. Parasagittal (new) approach: is performed by placing the RF cannula parasagittally and more dorsally. To achieve maximum nerve coagulation, the electrode should be placed as parallel to the nerve as possible, and placing it parasagittally helps achieve this goal. The remainder of the procedure does not differ from the traditional method.

Group II: Subjects with traditional approach on the left side and parasagittal approach on the right side. Active Control 1 Intervention

Patients will undergo bilateral RFA; the left side will be done following the traditional approach, and the right side will be done following the parasagittal approach. Traditional approach is done by placing the electrode at a 20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process and transverse process of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament that may be ossified in up to 10% of the normal spine and potentially prevent proper coagulation of the medial branch nerve during the RFA procedure. Parasagittal (new) approach: is performed by placing the RF cannula parasagittally and more dorsally. To achieve maximum nerve coagulation, the electrode should be placed as parallel to the nerve as possible, and placing it parasagittally helps achieve this goal. The remainder of the procedure does not differ from the traditional method.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Findings from Research

In a study of 27 patients undergoing lumbar medial branch radiofrequency neurotomy (RFN), significant disc degeneration was observed at treated levels compared to untreated levels, indicating a potential adverse effect of the procedure on intervertebral discs.

No changes were found in the cross-sectional area of the multifidus muscle or in the degeneration of facet joints, suggesting that while RFN may impact disc health, it does not appear to affect muscle size or joint deterioration in the same way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphologic changes in the lumbar spine after lumbar medial branch radiofrequency neurotomy: a quantitative radiological study. Smuck, M., Crisostomo, RA., Demirjian, R., et al.[2018]

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]

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]

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]

References

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

Long-Term Function, Pain and Medication Use Outcomes of Radiofrequency Ablation for Lumbar Facet Syndrome. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Predicting Treatment Success with Facet Syndrome: An Algorithm to Predict Lumbar Radiofrequency Ablation Responders in a Military Population. [2021]

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

The efficacy of repeated radiofrequency medial branch neurotomy for lumbar facet syndrome. [2021]

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

Morphologic changes in the lumbar spine after lumbar medial branch radiofrequency neurotomy: a quantitative radiological study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

A Review of Peripheral Nerve Stimulation Techniques Targeting the Medial Branches of the Lumbar Dorsal Rami in the Treatment of Chronic Low Back Pain. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Considerations for Lumbar Medial Branch Nerve Radiofrequency at Spinal Motion Segments Adjacent to a Fusion Construct. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Radiofrequency neurolysis. [2010]

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

Anatomical study of the medial branches of the lumbar dorsal rami: implications for image-guided intervention. [2022]