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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for radiofrequency ablation, a treatment aimed at reducing pain from lumbar spondylosis (a type of arthritis in the lower back). Researchers aim to determine if a new procedure, the parasagittal approach, is more effective than the traditional method. Participants will receive the traditional approach on one side of the back and the new approach on the other to compare results. The trial seeks individuals who have experienced low back pain for at least six months and have not found relief from standard treatments like medication and physical therapy. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that could potentially provide pain relief where other treatments have failed.

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

Research has shown that radiofrequency ablation (RFA) is generally safe for treating chronic low back pain, including lumbar spondylosis. The traditional RFA method for lumbar medial branch nerves effectively reduces pain with minimal risks, often providing relief without major side effects.

The new parasagittal approach, though less studied, aims to achieve the same pain reduction by heating specific nerves. While both treatments are similar, the parasagittal approach might better target the nerves. Its safety is expected to match the traditional method due to the similarity in procedures and goals.

Both RFA methods have been used without major safety concerns, making them promising options for managing chronic back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring two different techniques for radiofrequency ablation (RFA) in treating lumbar spondylosis, a common cause of back pain. Unlike traditional RFA, which targets nerves at a specific angle to avoid certain ligaments, the new parasagittal approach aims to place the electrode more parallel to the nerve, potentially improving nerve coagulation. This could enhance the effectiveness of RFA by ensuring better nerve targeting, offering a promising alternative to existing pain management options like medications or physical therapy. This trial could help refine RFA to provide more consistent pain relief for patients suffering from chronic back issues.

What evidence suggests that this trial's approaches to radiofrequency ablation could be effective for lumbar spondylosis?

Research has shown that radiofrequency ablation (RFA) effectively treats lower back arthritis, providing long-lasting pain relief and improving quality of life for many with persistent lower back pain. One study found that RFA targeting the nerves in the lower back offers significant and lasting pain relief. Another study reported improvements in daily activities and patient satisfaction after the procedure. In this trial, participants will receive RFA using both traditional and new parasagittal methods. The traditional method effectively targets the nerves, while the parasagittal method aims to enhance treatment by positioning the electrode more precisely. ^{6 7 8 9 10}

Who Is on the Research Team?

Yakov Vorobeychik, MD PhD

Principal Investigator

Professor, Department of Anesthesiology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000378

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31609391/

The Effectiveness of Radiofrequency Ablation of Medial ... Lumbar medial branch RFA is an effective, durable treatment for a significant proportion of patients with recalcitrant lumbar z-joint pain.

3. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf131/8268580?searchresult=1

Impact of prior lumbar medial branch radiofrequency ablation ... Impact of prior lumbar medial branch radiofrequency ablation on surgical outcomes following single-level posterior lumbar fusion: a propensity ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07214844

A Prospective Study to Evaluate the Efficacy of Iovera ... Radiofrequency ablation (RFA). Subjects will receive radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine.

5. nejm.org nejm.org/doi/full/10.1056/NEJMvcm2211108

Medial Branch Blocks and Radiofrequency Ablation for ... Medial branch blocks and radiofrequency ablation are procedures used in the diagnosis and treatment of low back pain from facet joints.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772594424001547

Targeting the lateral neck of superior articular process and ... Lumbar medial branch (MB) radiofrequency ablation (RFA) is a common image-guided procedure to treat facetogenic low back pain [1]. Detailed anatomical knowledge ...

7. withpower.com withpower.com/trial/phase-spondylosis-lumbar-3-2024-f0dbb

Radiofrequency Ablation for Lumbar Spondylosis ... The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8436449/

Latest Evidence-Based Application for Radiofrequency ... Radiofrequency neurotomy (RFN), also known as radiofrequency ablation (RFA), is a common interventional procedure used to treat pain from an ...

9. ctv.veeva.com ctv.veeva.com/study/comparative-effectiveness-of-two-different-approaches-to-radiofrequency-ablation-of-lumbar-medial-br

Comparative Effectiveness of Two Different Approaches to ... The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation ...

10. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/17411-radiofrequency-ablation

Radiofrequency Ablation (RFA): What It Is & Procedure Radiofrequency ablation (RFA) is a procedure that uses heat to destroy tissue. For pain management involving joints, RFA heats a nerve, which stops or ...