Radiofrequency Ablation for Lower Back Pain

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Utah

Must not be taking: Opioids, Antibiotics

Disqualifiers: SIJ fusion, Hip osteoarthritis, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for lower back pain?

Some studies suggest that radiofrequency ablation (RFA) can improve quality of life and manage pain in patients with sacroiliac joint (SIJ) dysfunction, although results have been inconsistent. The Simplicity III RF probe has shown promise as a novel treatment option, and some patients report increased satisfaction and improved quality of life after undergoing RFA. ^{1 2 3 4 5}

Is radiofrequency ablation for lower back pain generally safe for humans?

The research articles provided do not contain specific safety data for radiofrequency ablation for lower back pain, focusing instead on anatomical considerations and treatment outcomes. ^{1 2 4 6 7}

How does radiofrequency ablation for lower back pain differ from other treatments?

Radiofrequency ablation (RFA) for lower back pain targets the lateral branches of the sacral nerves, which are variable in position, making it a unique approach compared to other treatments. The Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) uses a novel probe that may offer more consistent results than traditional methods, addressing the variability in nerve anatomy. ^{1 3 4 5 8}

Research Team

Eligibility Criteria

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 an adult aged 18-90 with low back pain for over 3 months, and conservative treatments haven't worked.

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

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Stratus Medical, INC

Collaborator

Trials

1

Recruited

120+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

The anatomy of the lateral branches of the sacral dorsal rami: implications for radiofrequency ablation. [2018]

2. Turkey pubmed.ncbi.nlm.nih.gov

Retrospective evaluation of quality of life in patients undergoing sacroiliac joint denervation with simplicity. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[The crux of the sacroiliac joint]. [2018]

4. United States 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. [2022]

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

Pulsed radiofrequency denervation for the treatment of sacroiliac joint syndrome. [2022]

6. England pubmed.ncbi.nlm.nih.gov

'Simplicity' radiofrequency neurotomy of sacroiliac joint: a real life 1-year follow-up UK data. [2020]

7. England 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. [2019]

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

Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain. [2022]