Radiofrequency Ablation for Lower Back Pain

Recruiting at 2 trial locations

Overseen By PMR Research Group

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Utah

Must not be taking: Opioids, Antibiotics

Disqualifiers: SIJ fusion, Hip osteoarthritis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two techniques of radiofrequency ablation, a procedure using heat to reduce nerve pain, to determine which is more effective for sacroiliac joint pain in the lower back. The Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) technique uses a tool called Nimbus to create a larger area of nerve disruption, while the Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) employs a more traditional approach. The trial aims to identify which method offers better pain relief and improves daily function for participants. Individuals with lower back pain lasting at least three months, who have not found relief with other treatments, might be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking more than 50 mg of morphine-equivalent opioids per day, you may not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that radiofrequency ablation (RFA) is generally safe and can effectively reduce pain in the sacroiliac joint, a common source of lower back pain. This treatment uses heat to target nerves and stop them from sending pain signals.

Studies have found that RFA, including both Nimbus and traditional methods, helps most patients feel less pain and move better. For example, one study noted that most people experienced significant pain relief three months after the procedure. Another review found that RFA effectively relieved sacroiliac joint pain at both three and six months.

The Nimbus technique targets a larger area of nerves, which might make it more effective in some cases compared to traditional methods. However, more research with large groups of patients is needed to compare them directly.

Safety remains a key focus in clinical trials, and both Nimbus and traditional RFA are considered safe. Most research does not report serious side effects, suggesting that the treatment is well-tolerated. However, as with any procedure, there is always some risk of discomfort or minor side effects.

Overall, both Nimbus and traditional RFA are promising options for treating lower back pain from the sacroiliac joint, with evidence supporting their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for lower back pain because they explore innovative radiofrequency ablation techniques to target the sacroiliac joint. The Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) uses a bipolar "palisade" technique, which aims to create a continuous strip lesion, potentially offering more comprehensive pain relief. On the other hand, the Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) employs a standard monopolar periforaminal technique. By comparing these approaches, researchers hope to identify which method provides better outcomes for patients, potentially improving current treatment standards.

What evidence suggests that this trial's treatments could be effective for lower back pain?

This trial will compare two methods of radiofrequency ablation (RFA) for sacroiliac joint (SIJ) pain. Studies have shown that RFA can effectively reduce pain and improve movement in people with SIJ pain. A previous review found that 32-89% of patients experienced at least 50% pain relief for six months after undergoing posterior sacral network (PSN) ablation. Participants in this trial may receive Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA), which uses a larger treatment area and targets over 95% of the PSN, possibly offering better results than traditional methods. Others will receive Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA), which has also been beneficial, with many patients experiencing significant pain relief and improved function. Both techniques interrupt nerve signals in the SIJ area to reduce pain. While both methods have proven effective, the Nimbus technique might offer more thorough nerve treatment due to its design. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Participants capable of understanding and providing consent in English and capable of complying with the outcome instruments used

My pain was reduced by half after specific spine injections.

Exclusion Criteria

You are getting paid for your pain treatment through disability or worker's compensation.

My spinal fusion hardware is loose.

You had a severe allergic reaction to any medication in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) or Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) to treat sacroiliac joint pain

6 months

Follow-up

Participants are monitored for pain relief and functional improvement at 3, 6, 12, 18, and 24 months

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
• Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)

Trial Overview

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.

How Is the Trial Designed?

Group I: Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) Active Control 1 Intervention

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

Group II: Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) Active Control 1 Intervention

C-SIJRFA - using conventional monopolar periforaminal technique

Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) is already approved in United States, European Union for the following indications:

Approved in United States as Radiofrequency Denervation for:

• Sacroiliac joint pain

Approved in European Union as Sacroiliac Joint Radiofrequency Ablation for:

• Chronic sacroiliac joint pain

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Stratus Medical, INC

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

In a study of 16 patients with sacroiliac joint pain, Simplicity radiofrequency neurotomy significantly reduced pain scores from an average of 8.8 to 4.3 after 12 months, indicating effective pain relief.

The procedure also led to notable improvements in overall health quality, as measured by the SF-12 questionnaire, although some psychological aspects did not show significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Simplicity' radiofrequency neurotomy of sacroiliac joint: a real life 1-year follow-up UK data. Anjana Reddy, VS., Sharma, C., Chang, KY., et al.[2020]

Current fluoroscopic needle placements for cooled radiofrequency treatment of the sacroiliac joint are inadequate, with 9.4% of S1, 35% of S3, and 0.99% of S2 lateral branches not being ablated, potentially limiting treatment effectiveness.

Alternative target locations could significantly improve lesion accuracy, potentially reducing the miss rate to 2.8% at S1 and achieving complete denervation of all lateral branches in 95% of sacroiliac joints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proposed Optimal Fluoroscopic Targets for Cooled Radiofrequency Neurotomy of the Sacral Lateral Branches to Improve Clinical Outcomes: An Anatomical Study. Stout, A., Dreyfuss, P., Swain, N., et al.[2019]

In a study of 88 patients with sacroiliac joint pain, cooled radiofrequency ablation (c-RFA) did not show a significant advantage over traditional radiofrequency ablation (t-RFA) in providing longer pain relief, with both methods achieving over 50% pain reduction for 3 to 6 months.

The analysis indicated that neither technique significantly affected the duration of pain relief, suggesting that both c-RFA and t-RFA are similarly effective for managing sacroiliac joint pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain. Cheng, J., Pope, JE., Dalton, JE., et al.[2022]

In a study of 126 patients with sacroiliac joint dysfunction, pulsed radiofrequency denervation (PRFD) provided significant pain relief, with 72.7% of patients reporting over 50% reduction in pain after treatment.

PRFD not only reduced pain but also improved quality of life scores across all measured categories, indicating its potential as an effective intervention for patients who did not respond to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed radiofrequency denervation for the treatment of sacroiliac joint syndrome. Vallejo, R., Benyamin, RM., Kramer, J., et al.[2022]

The study identified significant variability in the exit points of lateral branches from the dorsal sacral foramina, which are crucial landmarks for radiofrequency ablation (RFA) targeting in sacroiliac joint (SIJ) pain treatment.

It was found that many hemipelves showed connections between the L5 dorsal rami and the S1 lateral plexus, suggesting that RFA techniques should be adapted to account for this complex innervation of the SIJ.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation. Cox, RC., Fortin, JD.[2018]

Recent randomized controlled trials in the Netherlands showed that radiofrequency denervation was ineffective in treating low back pain from the sacroiliac joint, highlighting potential treatment failures.

As an alternative, intra-articular injections combining a local anesthetic and glucocorticoid may offer a more effective solution for managing pain from the SI joint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The crux of the sacroiliac joint]. Fleisch, J., Dahan, A.[2018]

In a study of 30 patients with sacroiliac joint pain, those who underwent RF denervation with the Simplicity probe experienced a significant reduction in pain levels, as measured by the numerical rating scale (NRS), six months after the procedure.

Patients also reported improved quality of life across all domains of the SF-36 health survey, indicating that RF denervation not only alleviates pain but also enhances overall patient satisfaction and comfort without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective evaluation of quality of life in patients undergoing sacroiliac joint denervation with simplicity. Yalçın, Ç., Şahin, A.[2023]

The Simplicity III RF probe treatment for sacroiliac joint syndrome resulted in a significant 61% reduction in pain intensity over 12 months, based on a study of 11 patients, indicating its efficacy for long-term pain management.

Patients also showed substantial improvements in functional outcomes, with high satisfaction rates (77.7%), suggesting that this novel RF denervation technique could be an effective early intervention for SIJ symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcome Following Radiofrequency Denervation for Refractory Sacroiliac Joint Dysfunction Using the Simplicity III Probe: A 12-Month Retrospective Evaluation. Hegarty, D.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11418679/

Radiofrequency Denervation of the Spine and the Sacroiliac ...

Radiofrequency (RF) denervation of the spine and the SI joint may provide benefit to well-selected individuals. The recommendations of this guideline are based ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772594423001036

The effectiveness and predictive factors of Sacroiliac Joint ...

SIJ RFN effectively reduces pain and improves function in most patients at three months. Quadripolar/perpendicular technique and younger age predict SIJ RFN ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10928047/

Sacroiliac Joint Denervation—A Novel Approach to Target ...

We introduce a cost and time efficient technique to perform radiofrequency ablation of the sacral lateral branches using a single RF needle.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03230279

NCT03230279 | Sacroiliac Joint Fusion Comparison Study

A retrospective study on 88 patients revealed comparable effectiveness between conventional and cool radio frequency ablation with > 50% pain reduction in the ...

5.

rapm.bmj.com

rapm.bmj.com/content/early/2025/03/14/rapm-2024-106315

Cooled radiofrequency ablation provides extended clinical ...

CRFA in patients with SIJ pain provided clinically significant and sustained improvements for 12 months following a single CRFA treatment, regardless of ...

6.

molinahealthcare.com

molinahealthcare.com/-/media/Molina/PublicWebsite/PDF/Providers/wa/Medicaid/resource/mcp/MCP-469-Radiofrequency-Nerve-Ablation-for-Neck-and-Back-Pain.ashx

Molina Clinical Policy Radiofrequency Nerve Ablation for ...

The overall body of evidence suggests that conventional RFA for SIJ denervation is presumably safe and may confer short-term benefits in ...

7.

cms.gov

cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39462

LCD - Sacroiliac Joint Injections and Procedures (L39462)

Ablation relies on radiofrequency-generated thermal energy to ablate the sensory nerve fibers of the sacroiliac joint, thereby interrupting nociceptive signals.