Ultrasound-Guided Ablation for Neuropathic Pain

Overseen By Manuel Clark

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Unstable condition, Pregnant, Pacemaker, Craniotomy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound-guided method to treat occipital neuralgia and migraines by targeting the occipital nerve with radiofrequency ablation, a minimally invasive procedure. The goal is to reduce pain more effectively by allowing doctors to see the needle during the procedure. It is intended for individuals who have tried medications like NSAIDs, opioids, or anticonvulsants without success and experience headaches at least 10 days a month. Those dealing with stabbing pain at the back of the head and ineffective medications may find this trial suitable. As an unphased trial, it offers an opportunity to explore innovative treatment options that could provide relief when other medications have failed.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have tried and not found relief from oral medications like NSAIDs, opioids, and anticonvulsants.

What prior data suggests that this ultrasound-guided approach is safe for treating neuropathic pain?

Research has shown that using ultrasound to guide radiofrequency ablation of the occipital nerve is generally well-tolerated. Studies have demonstrated that controlling the temperature allows this procedure to be performed safely. For instance, one study reported careful monitoring of the temperature, which reached a maximum of 42 degrees Celsius. Another study compared different methods of this treatment and found it safe for treating occipital neuralgia, a type of nerve pain.

While side effects can occur with any medical procedure, these studies provide reassuring evidence about the safety of using ultrasound to guide the treatment. Visualizing the needle during the procedure improves accuracy, potentially reducing the risk of complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ultrasound-guided radiofrequency ablation for neuropathic pain is unique because it uses a precise, image-guided approach to target the occipital nerve. This method offers a more focused and potentially less invasive option compared to traditional nerve block or surgical interventions. By using ultrasound guidance, it aims to improve accuracy and safety, reducing the risk of damaging surrounding tissues. Researchers are excited because this technique could lead to more effective pain relief with fewer side effects, offering a promising new avenue for patients suffering from chronic neuropathic pain.

What evidence suggests that this ultrasound-guided approach is effective for reducing neuropathic pain?

Research has shown that using ultrasound to guide a procedure called radiofrequency ablation on the occipital nerve can significantly reduce pain for individuals with nerve-related pain. In this trial, participants will receive the ultrasound-guided approach to occipital nerve radiofrequency ablation. Studies have found that patients experienced at least a 50% decrease in pain after six months, with about two-thirds maintaining this improvement for up to a year. Another study found that this treatment also reduced headache episodes and improved sleep. On average, patients reported a 63.5% improvement in their pain after the procedure. These findings suggest that this method could be a promising option for managing nerve-related pain. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with occipital neuralgia or migraines in the occipital region, experiencing headaches at least 10 days a month. They must have tried and not responded well to NSAIDs, opioids, and anticonvulsants. Diagnosis should meet ICHD criteria including specific pain patterns and temporary relief from local anesthetic blocks.

Inclusion Criteria

I have been diagnosed with occipital neuralgia as per ICHD guidelines.

I have tried and found no relief from pain with NSAIDs, opioids, and anticonvulsants.

I have migraines, mainly in the back of my head, that got better with a specific nerve treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultrasound-guided radiofrequency ablation of the occipital nerve

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve

Trial Overview The study tests an ultrasound-guided method for radiofrequency ablation on the occipital nerve, aiming to visualize the needle during treatment to potentially reduce post-procedure pain compared to standard care.

How Is the Trial Designed?

Group I: Ultrasound Guided Approach Experimental Treatment 1 Intervention

Ultrasound-guided approach to occipital nerve radiofrequency ablation

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

Occipital nerve block is generally considered a safe and effective treatment for occipital neuralgia and other headache types, but there is a risk of complications, as demonstrated by a case of epidural abscess occurring 16 days post-procedure.

This case highlights the critical need for strict aseptic techniques during the procedure to minimize infection risks, reminding clinicians to be vigilant about potential complications even in otherwise healthy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occipital osteomylelitis and epidural abscess after occipital nerve block: A case report. Christie, SD., Kureshi, N., Beauprie, I., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11964712/

Ultrasound-guided continuous radiofrequency ablation of ... Conclusion. Ultrasound-guided PGON CRFA in refractory ON significantly reduced pain for up to 1 year. The initial frequency of attacks, electric shock like pain ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40174877/

Ultrasound-guided continuous radiofrequency ablation of ... At least 50% of pain reduction was noted in all patients at 6 months, and in 66% patients at 12 months. The frequency of attacks was correlated to poor response ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405603025001128

Comparative Efficacy of Greater Occipital Nerve ... The proximal and distal approaches for GON radiofrequency ablation effectively reduced headache episodes, disability, and sleep disturbance.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06583122

Ultrasound Guided Radiofrequency Ablation of the ... The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/papr.13276

Radiofrequency ablation of the occipital nerves for ... The mean patient-reported percent improvement in pain following RFA therapy was 63.53% (SD = 36.37). The mean duration of pain improvement was ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04124458

Study Details | NCT04124458 | Occipital Nerve RF ... In radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6162129/

Treatment of Occipital Neuralgia by Thermal ... The aim of the present study was to examine the effects of thermal radiofrequency ablation (TRF) on occipital neuralgia.