Cooled vs Conventional RFA for Chronic Lower Back Pain

(Lumbar CvS Trial)

Not currently recruiting at 10 trial locations

Overseen By William Keck

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Avanos Medical

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Arthritis, Neurologic signs, Scoliosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of radiofrequency treatments for managing chronic low back pain originating in the lumbar facet joints. The study will test a cooled radiofrequency probe (COOLIEF* Cooled Radiofrequency Probe) against a standard one to determine which more effectively reduces pain. It suits individuals who have experienced non-radiating low back pain for at least three months and have not found relief from treatments like exercise and pain relievers. Participants should also have experienced significant pain relief from specific diagnostic tests. As an unphased trial, this study provides an opportunity to explore innovative treatment options for chronic low back pain.

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

You may need to keep your current pain medications stable, as the trial requires that analgesics like Neurontin (gabapentin) and Cymbalta (duloxetine) remain at a stable dosage for at least 6 weeks before the trial and not change during the study without approval.

What prior data suggests that these radiofrequency probes are safe for treating chronic axial low back pain?

Research has shown that the COOLIEF Cooled Radiofrequency Probe is generally well-tolerated by patients. Studies have found it effectively reduces pain in individuals with long-term back pain from lumbar facet joints. Although these studies don't list specific side effects, the treatment is considered minimally invasive, typically resulting in fewer side effects.

Research also supports the safety and effectiveness of the Standard Radiofrequency Probe. Like the cooled version, it targets nerves in the lower back to help reduce pain. Various studies have tested both treatments, confirming their general safety for patients. However, as with any medical treatment, individual experiences may differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a new way to tackle chronic facetogenic low back pain by using radiofrequency energy to target medial branch nerves. The COOLIEF* Cooled Radiofrequency Probe is unique because it uses cooled radiofrequency energy, which may provide longer-lasting pain relief compared to heat alone, potentially offering a more effective and sustained option for patients. Unlike conventional radiofrequency treatments that use heat to reduce nerve pain, the cooled approach can treat a larger area with reduced risk of overheating tissues. This innovative method could mean more significant pain reduction and improved quality of life for patients struggling with chronic back pain.

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

Research has shown that the COOLIEF Cooled Radiofrequency Probe, a treatment in this trial, can reduce pain for many with long-term lower back pain. One study found that 85.92% of patients experienced improved pain levels after treatment, with 14.08% achieving complete pain relief. COOLIEF has also been proven to relieve pain for up to 24 months, enhance physical movement, and reduce the need for pain medications. This trial will compare the effectiveness of COOLIEF with the Standard Radiofrequency Probe, another treatment option being tested for lower back pain due to issues in the lumbar facet joints. ^{1 2 6 7 8}

Who Is on the Research Team?

David Provenzano

Principal Investigator

Pain Diagnostics and Interventional Care

Are You a Good Fit for This Trial?

Inclusion Criteria

You are experiencing moderate to severe pain, with a score of 6 or higher on a pain scale from 0 to 10.

You have chronic low back pain for at least 3 months that is caused by a specific condition in your lower back joints. You have tried different non-surgical treatments like exercise, pain relief medication, and activity modification but haven't gotten enough relief.

If you take certain types of pain medication, such as Neurontin or Cymbalta, you must have been taking the same amount for at least 6 weeks before the study. You cannot change your dosage during the study without permission from the study doctor.

Exclusion Criteria

Your body has physical differences that would make it difficult to follow the study's procedures.

You have a medical condition that weakens your immune system and it is not under control.

You have severe narrowing in your spine that is causing nerve-related pain or difficulty walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Cooled Radiofrequency Ablation (CRFA) or Conventional Radiofrequency Ablation (SRFA) to manage chronic facetogenic low back pain

Immediate procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary endpoint at 6 months and continued monitoring up to 12 months

12 months

What Are the Treatments Tested in This Trial?

Interventions

• COOLIEF* Cooled Radiofrequency Probe
• Standard Radiofrequency Probe

How Is the Trial Designed?

Group I: Cooled Radiofrequency Experimental Treatment 1 Intervention

Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Group II: Conventional Radiofrequency Active Control 1 Intervention

Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain

Who Is Running the Clinical Trial?

Avanos Medical

Lead Sponsor

Trials

9

Recruited

1,900+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40063221/

Outcomes of Cooled Radiofrequency Ablation of Lumbar ... Improvement of pain symptoms was reported in 85.92% (n = 1062), 14.08% (n = 174) reported complete pain remission, 7.61% (n = 94) reported no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7017749/

A Randomized Prospective Trial of Cooled Versus ... When using a single diagnostic block paradigm with a threshold of >75% pain reduction, C-RFA resulted in a treatment success rate greater than 50% when defined ...

3. mycoolief.com mycoolief.com/about/

About COOLIEF* Cooled Radiofrequency ablation for ... COOLIEF* Cooled RF is proven to provide up to 24 months of chronic pain relief, improved physical functionality and reduced analgesic utilization.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04145011

Coolief Cooled Radiofrequency vs. Conventional ... This study is being performed to assess the relative effectiveness of genicular nerve ablation with the COOLIEF* Cooled Radiofrequency probe to manage moderate ...

5. molinaclinicalpolicy.com molinaclinicalpolicy.com/molinaclinicalpolicy/-/media/Molina/PublicWebsite/PDF/Common/Molina-Clinical-Policy/Coolief-Cooled-Radiofrequency_R.pdf

Molina Clinical Policy COOLIEF Cooled Radiofrequency ... COOLIEF cooled radiofrequency ablation is considered experimental, investigational, and unproven for the relief of pain associated with the knee ...

6. academic.oup.com academic.oup.com/painmedicine/article/24/12/1318/7242328

A pragmatic randomized prospective trial of ... - Oxford Academic Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain.

7. molinahealthcare.com molinahealthcare.com/providers/oh/medicaid/policies/-/media/Molina/PublicWebsite/PDF/Providers/oh/medicaid/policies/MCP-386-Coolief-Cooled-Radiofrequency-0224.pdf

MCP 386 Coolief Cooled Radiofrequency McCormick et al. (2019) conducted a randomized, prospective trial of CRFA versus traditional RFA of the medial branch nerves for the treatment ...

8. journals.lww.com journals.lww.com/ijpn/fulltext/2024/38001/early_outcome_of_percutaneous_cooled.3.aspx

Early Outcome of Percutaneous Cooled Radiofrequency... Cooled radiofrequency significantly improves the pain associated with lumbar facet arthropathy with sacroiliac dysfunction with promising results.