What side effects are associated with this type of intervention?

Common treatments for lower back pain, such as radiofrequency ablation and steroid injections, have known side effects. Radiofrequency ablation can cause temporary pain at the injection site, numbness, and, rarely, infection or nerve damage. Steroid injections may lead to increased pain post-injection, infection, bleeding, and potential weakening of bones and tendons with repeated use. These treatments are generally safe when performed by experienced practitioners.

What prior FDA approvals exist?

The FDA has approved various treatments for lower back pain, including radiofrequency ablation (RFA) techniques similar to the Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA). Conventional RFA, which targets the medial branches of the dorsal rami nerves, has been used to treat facet joint pain. Additionally, epidural corticosteroid injections and pharmacologic treatments such as NSAIDs, muscle relaxants, and opioids have been approved for managing lower back pain. However, specific FDA approvals for large bipolar lesion RFA techniques like N-SIJRFA are not explicitly detailed in the available data.

What other types of research exist?

Promising alternatives to Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) for lower back pain include: 1) Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA), which uses a monopolar technique; 2) Genicular nerve block, which involves the ablation of specific knee nerves and has shown efficacy in pain relief; 3) Epidural corticosteroid injections, which are used for radiculopathy and spinal stenosis; 4) Lumbar facet joint blocks followed by radiofrequency denervation, which target facet joint pain. These alternatives offer different approaches to pain management and may be considered based on individual patient needs and responses.

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Radiofrequency Ablation

Radiofrequency Ablation for Lower Back Pain

Phase 4

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult participants aged 18-90 years old with at least 3 months of low back pain who have not responded to at least 3 months of conservative treatment

Pain relieved by at least 50% by either a fluoroscopically-guided intraarticular sacroiliac joint injection including a local anesthetic and a fluoroscopically-guided PSN block or dual fluoroscopically-guided PSN blocks.

Must not have

Evidence of hardware loosening (in participants with history lumbar or lumbosacral fusion)

Medical conditions causing significant functional disability (e.g., stroke, COPD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month

Awards & highlights

Summary

This trial tests two methods of using heat to destroy nerve tissue in patients with lower back pain from the sacroiliac joint. The goal is to see which method is better at reducing pain by stopping pain signals from reaching the brain.

Who is the study for?

Adults aged 18-90 with lower back pain for at least 3 months, unresponsive to conservative treatments, and a pain level of at least 4/10. Participants must have experienced a minimum of 50% pain relief from specific diagnostic injections and be able to follow the study procedures in English.

What is being tested?

The trial is testing two types of radiofrequency ablation (RFA) techniques for sacroiliac joint pain: Conventional RFA (C-SIJRFA) and Nimbus RFA (N-SIJRFA). It aims to determine which method is more effective in reducing pain and improving function over periods up to two years.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, temporary increase in nerve pain, bleeding or bruising where the needle was inserted, infection risk, and unintended damage to surrounding nerves or tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18-90 years old and have had low back pain for over 3 months without relief from conservative treatments.

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My pain was reduced by half after specific spine injections.

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My joint pain was halved by a specific guided injection.

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My average back pain score is 4 or more out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My spinal fusion hardware is loose.

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

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

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I have pain in my hip due to arthritis.

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I have had a radiofrequency ablation procedure on my sacroiliac joint.

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I have ongoing lower back pain that spreads down my leg.

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I use more than 50 mg of morphine-equivalent opioids daily.

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I have had surgery to fuse my sacroiliac joint.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Percent in NPRS Pain Score

Secondary study objectives

EQ-5D Improvement

ODI Reduction

PGIC Improvement

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)Active Control1 Intervention

N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.

Group II: Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)Active Control1 Intervention

C-SIJRFA - using conventional monopolar periforaminal technique

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radiofrequency ablation (RFA), such as Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA), works by using heat generated from radio waves to target and disrupt nerve function, specifically the posterior sacral network, which is responsible for transmitting pain signals from the sacroiliac joint. This large bipolar lesion technique aims to achieve more effective and comprehensive neural ablation, potentially leading to significant pain relief and improved function. This is crucial for lower back pain patients as it directly addresses the nerve pathways responsible for chronic pain, offering a targeted and minimally invasive treatment option. Other common treatments like NSAIDs and acetaminophen work by reducing inflammation and blocking pain signals, while physical therapy focuses on strengthening muscles and improving flexibility to alleviate pain and prevent further injury.

Developments in Minimally Invasive Surgical Options for Vertebral Pain: Basivertebral Nerve Ablation - A Narrative Review.