Radiofrequency Neurotomy Techniques for Low Back Pain

Overseen By Blake Fechtel, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Lumbar radiculopathy, Active litigation, Prior lumbar fusion, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Observational studies have shown that lumbar medial branch radiofrequency neurotomy (LMBRFN) can be an effective treatment for z-joint low back pain. Nonetheless, other publications such as the Cochrane collaboration systematic review and the "Minimal Interventional Treatments for Participants with Chronic Low Back Pain" or "MINT" randomized controlled trial conclude that LMBRFN is not efficacious. These discrepancies in the literature may be due to differences in patient selection and procedural technique. This study aims to employ patient selection via dual medial branch block resulting in at least 80% relief on both occasions. Using this rather strict enrollment criteria, the aim of the study is to then compare LMBRFN utilizing 16 gauge needles via the "parallel" approach as endorsed by Spine Intervention Society guidelines to LMBRFN performed with 22 gauge needles and another commonly employed "perpendicular" technique similar to that approach used for medial branch blocks. The primary outcome of the study will be to determine if there is a difference in the percentage of patients with lumbar facet pain who achieve moderate or good response (improvement of Numeric Pain Rating Scale of at least 50% or 80%) or in the duration of effect (median duration of moderate or good response in those with positive outcome) between these two groups.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have low back pain that hasn't responded to at least 6 weeks of physical therapy and oral pain medication, suggesting that some medications might be continued.

Is lumbar medial branch radiofrequency neurotomy generally safe for humans?

The available research does not provide specific safety data for lumbar medial branch radiofrequency neurotomy, focusing instead on technical aspects and effectiveness. ^{1 2 3 4 5}

How does the treatment of lumbar medial branch radiofrequency neurotomy differ from other treatments for low back pain?

Lumbar medial branch radiofrequency neurotomy (RFA) is unique because it specifically targets the medial branch nerves that supply the facet joints in the spine, using radio waves to disrupt pain signals. This precision may offer more accurate pain relief compared to other treatments that do not focus on these specific nerves. ^{1 2 4 6 7}

What data supports the effectiveness of this treatment for low back pain?

The research suggests that lumbar medial branch radiofrequency neurotomy (a treatment that uses heat to target specific nerves) is more accurate than previous techniques for facet denervation, which may lead to better outcomes for patients with low back pain. ^{1 2 3 4 6}

Who Is on the Research Team?

Byron Schneider, MD

Principal Investigator

Vanderbilt University Medical Center

Blake Fechtel, MD MSc

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for people over 40 with low back pain that hasn't improved after physical therapy and pain meds. They must have had significant relief from two lumbar medial branch blocks, be able to understand English, consent to treatment, and attend follow-ups. It's not for those with certain conditions like lumbar radiculopathy, litigation or compensation cases related to their pain, severe mental health issues, recent infections or injections in the lower back area.

Inclusion Criteria

The doctor will decide if you need a first medial branch block based on your medical condition.

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

I agree to discuss and decide on my treatment with my doctor.

Exclusion Criteria

You are currently in a legal case related to your pain.

I have a medical condition like stroke or severe lung disease that greatly limits my daily activities.

I have been diagnosed with chronic widespread pain or a condition like fibromyalgia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar medial branch radiofrequency neurotomy using either the parallel or perpendicular technique

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Parallel placement of 16 gauge electrodes
• Perpendicular placement with 22 gauge electrodes

Trial Overview The study compares two techniques of radiofrequency neurotomy—a procedure used to reduce chronic low back pain—by using different needle sizes (16 gauge parallel vs. 22 gauge perpendicular) on patients who've responded well to preliminary treatments. The goal is to see which method gives better or longer-lasting pain relief.

How Is the Trial Designed?

Group I: Parallel placement of 16 gauge electrodes Active Control 1 Intervention

Parallel Group will undergo radiofrequency ablation via the approach described in Spine Intervention Practice Guidelines via 16 gauge electrodes. Specifically, the target nerve will be targeted with a parallel approach so as the electrode lay parallel to the nerves location within the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.

Group II: Perpendicular placement with 22 gauge electrodes Active Control 1 Intervention

Perpendicular Group will undergo radiofrequency ablation via the approach described in Spine Intervention Society Practice Guidelines for medial branch blocks, using a 22 gauge electrode. Specifically, the target nerve will be targeted with a perpendicular approach so as the tip of electrode contact the nerve at some point of it course along the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.

Parallel placement of 16 gauge electrodes is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lumbar Medial Branch Radiofrequency Neurotomy for:

• Chronic low back pain due to facet arthritis
• Arthritis-related pain in the lower back
• Lumbar spondylosis
• Degenerative changes in the spine
• Prior back surgery
• Neuropathic pain conditions

Approved in European Union as Lumbar Medial Branch Radiofrequency Neurotomy for:

• Chronic low back pain due to facet arthritis
• Arthritis-related pain in the lower back
• Lumbar spondylosis
• Degenerative changes in the spine

Approved in Canada as Lumbar Medial Branch Radiofrequency Neurotomy for:

• Chronic low back pain due to facet arthritis
• Arthritis-related pain in the lower back
• Lumbar spondylosis
• Degenerative changes in the spine

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Spine Intervention Society

Collaborator

Trials

2

Recruited

180+

Published Research Related to This Trial

Percutaneous lumbar medial branch neurotomy is a precise technique for denervating the medial branch of the dorsal ramus, which may improve outcomes for patients with facet joint pain.

The study suggests that this technique offers greater accuracy compared to previous methods, potentially leading to better evaluation of the effectiveness of facet denervation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous lumbar medial branch neurotomy: a modification of facet denervation. Bogduk, N., Long, DM.[2022]

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]

A systematic review of lumbar medial branch thermal radiofrequency neurotomy showed that patient selection and procedural techniques significantly affect outcomes, with 56% of patients achieving complete pain relief when selected based on high pain relief from dual medial branch blocks and using parallel electrode placement.

At six months, only 26% of patients selected via a single medial branch block achieved at least 50% pain relief, compared to 49% for those selected with dual blocks, highlighting the importance of rigorous selection criteria for better efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of the Effectiveness of Lumbar Medial Branch Thermal Radiofrequency Neurotomy, Stratified for Diagnostic Methods and Procedural Technique. Schneider, BJ., Doan, L., Maes, MK., et al.[2022]

Placing electrodes parallel to the target nerve during lumbar radiofrequency neurotomy is crucial for ensuring effective coagulation of the nerve, as improper placement can lead to incomplete treatment.

The study provides anatomical evidence and clinical validation for this technique, suggesting that suboptimal electrode placement may contribute to less effective outcomes in lumbar medial branch neurotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The surgical anatomy of lumbar medial branch neurotomy (facet denervation). Lau, P., Mercer, S., Govind, J., et al.[2019]

In a study of 106 patients with chronic back pain, lumbar medial branch radiofrequency neurotomy (RFN) resulted in successful outcomes for 58% and 53% of patients in two different practices, demonstrating its effectiveness when performed according to strict guidelines.

Patients experienced significant pain relief lasting an average of 15 months after the first RFN treatment, with some maintaining relief for up to 33 months, indicating that RFN can restore normal activities and quality of life for many individuals suffering from chronic back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar medial branch radiofrequency neurotomy in New Zealand. MacVicar, J., Borowczyk, JM., MacVicar, AM., et al.[2022]

In a pilot study involving 43 patients with severe lumbar pain, both parallel and perpendicular techniques for medial branch neurotomy showed no significant differences in pain relief or disability scores at 1, 3, or 6 months.

However, at the 6-month mark, the parallel technique demonstrated statistically significant improvements in pain evolution and disability measures compared to the perpendicular technique, suggesting it may be a more effective approach for treating facetogenic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Pragmatic Pilot Trial Comparing Perpendicular Thin Electrode Versus Parallel Thick Electrode Approaches for Lumbar Medial Branch Neurotomy in Facetogenic Low Back Pain. De Andrés Ares, J., Gilsanz, F.[2021]

In a study of 40 patients with chronic low back pain, both radiofrequency neurotomy (RN) and endoscopic neurotomy (EN) were effective treatments, but EN showed longer-lasting results.

While RN provided significant pain relief at 3 weeks, 6 months, and 1 year, by 2 years, its effectiveness diminished, whereas EN continued to show significant improvements in pain and disability scores even at the 2-year mark.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effectiveness of Radiofrequency Neurotomy and Endoscopic Neurotomy of Lumbar Medial Branch for Facetogenic Chronic Low Back Pain: A Randomized Controlled Trial. Song, K., Li, Z., Shuang, F., et al.[2020]

Citations

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

Percutaneous lumbar medial branch neurotomy: a modification of facet denervation. [2022]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Systematic Review of the Effectiveness of Lumbar Medial Branch Thermal Radiofrequency Neurotomy, Stratified for Diagnostic Methods and Procedural Technique. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The surgical anatomy of lumbar medial branch neurotomy (facet denervation). [2019]

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

Lumbar medial branch radiofrequency neurotomy in New Zealand. [2022]

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

Randomized Pragmatic Pilot Trial Comparing Perpendicular Thin Electrode Versus Parallel Thick Electrode Approaches for Lumbar Medial Branch Neurotomy in Facetogenic Low Back Pain. [2021]

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

Comparison of the Effectiveness of Radiofrequency Neurotomy and Endoscopic Neurotomy of Lumbar Medial Branch for Facetogenic Chronic Low Back Pain: A Randomized Controlled Trial. [2020]