Radiofrequency Ablation for Lower Back Pain
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.12345Why 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.13567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) or Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) to treat sacroiliac joint pain
Follow-up
Participants are monitored for pain relief and functional improvement at 3, 6, 12, 18, and 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)
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Stratus Medical, INC
Collaborator