Trial Summary
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 have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, it does require that your low back pain has not responded to at least 6 weeks of physical therapy and oral pain medication. It's best to discuss your current medications with the trial team.
Is the treatment 'Parallel placement of 16 gauge electrodes, Perpendicular placement with 22 gauge electrodes' promising for low back pain?Yes, this treatment, also known as lumbar medial branch radiofrequency neurotomy, shows promise for treating low back pain. It is considered accurate and effective for targeting specific nerves that cause pain, potentially providing relief for people with chronic low back pain.13456
What safety data exists for radiofrequency neurotomy for low back pain?The available research does not directly address safety data for radiofrequency neurotomy techniques. However, studies have explored the accuracy and effectiveness of different techniques, such as parallel and perpendicular electrode placements, and the impact on lumbar spine structures. These studies suggest that the technique's accuracy may influence its efficacy, but specific safety outcomes are not detailed.12347
What data supports the idea that Radiofrequency Neurotomy Techniques for Low Back Pain is an effective treatment?The available research shows that Radiofrequency Neurotomy Techniques for Low Back Pain, such as lumbar medial branch radiofrequency neurotomy, are considered effective because they target specific nerves responsible for pain. One study suggests that this method is more accurate than previous techniques, which could lead to better outcomes. Another study from New Zealand indicates that when performed by trained practitioners, this treatment can be effective. However, some studies also highlight that the long-term effects on the spine's structure are not fully understood, suggesting that more research is needed to confirm its overall effectiveness.12346
Eligibility Criteria
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
I experienced significant pain relief from two back nerve block procedures.
I have had lower back pain for 2 months, not better after 6 weeks of physical therapy and pain meds.
Exclusion Criteria
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.
My BMI is over 40.
I can attend all required follow-up appointments.
I am experiencing worsening muscle weakness or signs of nerve issues in my lower back.
I have an active inflammatory arthritis condition.
My main issue is sciatica.
I receive payment for my pain treatment, like disability benefits.
I have had surgery to join two or more spine bones in my lower back.
Treatment Details
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.
2Treatment groups
Active Control
Group I: Parallel placement of 16 gauge electrodesActive Control1 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 electrodesActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Vanderbilt University Medical CenterNashville, TN
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
Spine Intervention SocietyCollaborator
References
Percutaneous lumbar medial branch neurotomy: a modification of facet denervation. [2022]Percutaneous lumbar medial branch neurotomy is a technique for facet denervation in which the target is specifically the medial branch of the dorsal ramus. The radiology of the technique is illustrated, and the technical aspects of the procedure are described. The accuracy of previous techniques for facet denervation as compared with medial branch neurotomy is reviewed in a comparative analysis of radiographs illustrating the various techniques. It is suggested that the greater accuracy of medial branch neurotomy will permit a more adequate trial of the rationale and efficacy of facet denervation.
The surgical anatomy of lumbar medial branch neurotomy (facet denervation). [2019]To demonstrate the validity of placing electrodes parallel to the target nerve in lumbar radiofrequency neurotomy.
Lumbar medial branch radiofrequency neurotomy in New Zealand. [2022]This study aims to determine the effectiveness of lumbar medial branch radiofrequency neurotomy (RFN) performed by two practitioners trained according to rigorous guidelines.
Morphologic changes in the lumbar spine after lumbar medial branch radiofrequency neurotomy: a quantitative radiological study. [2018]Medial branch radiofrequency neurotomy (RFN) is a common treatment for zygapophyseal joint pain. The lumbar medial branch innervates these joints and adjacent structures. The impact of the intended neurotomy on these structures remains unclear. No studies have yet verified quantitatively the effect of medial branch RFN on intervertebral discs, facet joints, and multifidus cross-sectional area.
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]To compare the effectiveness of radiofrequency neurotomy (RN) and endoscopic neurotomy (EN) of lumbar medial branch (MB) for facetogenic chronic low back pain (FCLBP).
Systematic Review of the Effectiveness of Lumbar Medial Branch Thermal Radiofrequency Neurotomy, Stratified for Diagnostic Methods and Procedural Technique. [2022]To determine the effectiveness of lumbar medial branch thermal radiofrequency neurotomy based on different selection criteria and procedural techniques.
Randomized Pragmatic Pilot Trial Comparing Perpendicular Thin Electrode Versus Parallel Thick Electrode Approaches for Lumbar Medial Branch Neurotomy in Facetogenic Low Back Pain. [2021]Although there are different ways of performing medial branch neurotomy on facetogenic low back pain, few studies have compared clinical outcomes of a parallel technique over the medial branch vs. a perpendicular technique. We investigated differences in pain outcome with both techniques.