Radiofrequency Neurotomy for Facetogenic Headache

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allevio Pain Management Clinic

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Coagulation issues, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two types of radiofrequency ablation, a treatment using heat to interrupt pain signals, in relieving headaches believed to originate from neck issues. Participants will receive either continuous or pulsed radiofrequency ablation to determine which method more effectively reduces pain. The trial seeks individuals who have experienced neck, shoulder, or headache pain for over three months and have found little relief from treatments such as medications, massage, or acupuncture. As an unphased trial, this study offers participants the chance to explore innovative treatment options that might provide relief where other methods have not.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that there should be no change in your pain control medication dose for at least 4 weeks before the procedure. If you are on anticoagulants (blood thinners), you may need to stop them according to the clinic's policy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both pulsed and continuous radiofrequency ablation (RFA) are generally safe for treating certain types of pain, such as headaches or neck pain. Pulsed radiofrequency treatment provides long-lasting benefits without serious issues. However, some patients experience minor side effects, like post-procedure pain or numbness. Continuous radiofrequency ablation is also safe and effective, especially when other treatments have failed. Still, up to 40% of patients report side effects like dizziness or numbness after treatment. Overall, both treatments are usually well-tolerated and considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Pulsed Radiofrequency Ablation for facetogenic headaches because it offers a unique approach compared to standard pain management methods, like medications and physical therapy. Unlike typical treatments, which often involve drugs that may have systemic side effects, this technique targets the sensory nerves directly in the cervical spine. It uses controlled bursts of radiofrequency energy, providing precise nerve modulation with minimal heat, which could potentially reduce pain more effectively and with less risk. This localized treatment might offer better pain relief and improved function for patients with fewer side effects.

What evidence suggests that this trial's treatments could be effective for facetogenic headache?

This trial will compare two treatments for facetogenic headache: continuous radiofrequency ablation (C-RF) and pulsed radiofrequency ablation (P-RF). Research has shown that C-RF can effectively treat headaches originating from the neck. In one study, 95% of patients experienced significant pain relief for about 11.5 months with repeated treatments. Another study found an 88% success rate after the first treatment, with some individuals benefiting for up to 17 months. In contrast, P-RF has shown mixed results. One study reported a 61% pain relief rate within six weeks for certain nerve-related pains, but P-RF generally provides less consistent and shorter-lasting relief compared to C-RF. Overall, C-RF appears more reliable for long-term headache relief. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 with chronic neck, shoulder pain or cervicogenic headaches lasting over 3 months. Participants must have had some relief from two medial branch blocks and not responded well to other treatments like medications or physical therapies. Pregnant individuals, non-English speakers, those who refuse consent, allergy sufferers, patients with coagulation issues on anticoagulants that can't be stopped as per clinic policy are excluded.

Inclusion Criteria

I had two specific spine injections 30 days before a spine procedure.

I experience over 50% pain relief after each medial branch block.

I have tried various treatments for my condition without success or could not tolerate them.

Exclusion Criteria

I have blood clotting issues and haven't stopped my anticoagulants as per clinic policy.

You are allergic to a specific medication or the contrast dye used in radiology tests.

My pain medication dose has been stable for the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Pulsed or Continuous Radiofrequency Ablation

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits every 3 months (virtual)

Extended Follow-up

Participants complete additional questionnaires and assessments

6 months

Monthly questionnaires (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Pulsed Radiofrequency Ablation

Trial Overview The study compares Pulsed Radiofrequency Ablation (P-RF) against Continuous Radiofrequency Neurotomy (C-RF) in treating cervical facet joint-mediated pain. It aims to determine which method offers better pain control by reviewing previous studies where C-RF showed higher success rates than P-RF for conditions like trigeminal neuralgia and occipital neuralgia.

How Is the Trial Designed?

Group I: Continuous Radiofrequency Ablation Active Control 1 Intervention

Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds.

Group II: Pulsed Radiofrequency Ablation Active Control 1 Intervention

Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine with Maximum allowable temperature 50° rotation: 90.; Pulse rate: 3 Hz; pulse duration: 50 ms; 3 minutes

Pulsed Radiofrequency Ablation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pulsed Radiofrequency Neurotomy for:

• Cervical facet joint mediated pain
• Cervicogenic headache
• Occipital neuralgia
• Migraines

Approved in European Union as Pulsed Radiofrequency Neurotomy for:

• Chronic neck pain
• Cervicogenic headache
• Occipital neuralgia
• Facet joint syndrome

Approved in Canada as Pulsed Radiofrequency Neurotomy for:

• Cervical facet joint mediated pain
• Cervicogenic headache
• Occipital neuralgia

Who Is Running the Clinical Trial?

Allevio Pain Management Clinic

Lead Sponsor

Trials

4

Recruited

350+

Published Research Related to This Trial

CT-guided percutaneous radiofrequency trigeminal rhizotomy resulted in over 90% pain relief for 80% of the 79 patients studied, demonstrating its efficacy in treating trigeminal neuralgia.

This method significantly reduced the time for needle placement compared to fluoroscopy (14 minutes vs. 40 minutes), while also enhancing patient comfort and ensuring no intra-operative failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous trigeminal nerve radiofrequency rhizotomy guided by computerized tomography with three-dimensional image reconstruction. Yang, JT., Lin, M., Lee, MH., et al.[2016]

Pulsed radiofrequency treatment provided complete pain relief for a 52-year-old female patient suffering from acute severe supraorbital neuralgia after a craniotomy, allowing her to stop all analgesic medications.

The treatment was safe, with no observed side effects or nerve damage, and the patient reported no pain during a 1-year follow-up, indicating the potential effectiveness of pulsed radiofrequency for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of post-craniotomy acute severe supraorbital neuralgia using ultrasound-guided pulsed radiofrequency: a case report. Xiao, X., Ren, H., Ji, N., et al.[2020]

In a study of 367 facial pain patients, radiofrequency rhizotomy provided significant pain relief for 100% of idiopathic trigeminal neuralgia patients and 96.2% of those with symptomatic trigeminal neuralgia, demonstrating its efficacy as a treatment option.

Neurovascular decompression also showed effectiveness for idiopathic trigeminal neuralgia, but radiofrequency rhizotomy was not effective for atypical facial pain, indicating that treatment choice should be tailored to the specific type of facial pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous radiofrequency rhizotomy and neurovascular decompression of the trigeminal nerve for the treatment of facial pain. Teixeira, MJ., Siqueira, SR., Almeida, GM.[2022]

Lesions created by radiofrequency electrodes for pain treatment only extend radially around the electrode tip in an oblate spheroid shape, with a maximum effective radius of just 2 mm, meaning they may not adequately encompass nearby nerves.

The study suggests that clinical failures in treating back and neck pain with percutaneous neurotomy may be due to the limited reach of these lesions, and recommends modifying techniques to position electrodes parallel to target nerves for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical limitations to the efficacy of radiofrequency neurotomy for spinal pain. Bogduk, N., Macintosh, J., Marsland, A.[2022]

Pulsed radiofrequency treatment of the sphenopalatine ganglion showed that 35% of patients experienced complete pain relief, while 42% had mild to moderate relief, indicating it can be an effective option for chronic facial and head pain.

However, 23% of patients did not achieve any pain relief, highlighting the need for further research through prospective, randomized controlled trials to better understand the efficacy and safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sphenopalatine ganglion pulsed radiofrequency treatment in patients suffering from chronic face and head pain]. Akbas, M., Gunduz, E., Sanli, S., et al.[2016]

Pulsed radiofrequency treatment of the sphenopalatine ganglion showed that 35% of patients experienced complete pain relief, while 42% had mild to moderate relief, indicating its potential effectiveness for chronic facial and head pain.

However, 23% of patients did not achieve any pain relief, highlighting the need for further research, including prospective randomized controlled trials, to better understand the efficacy and safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion pulsed radiofrequency treatment in patients suffering from chronic face and head pain. Akbas, M., Gunduz, E., Sanli, S., et al.[2017]

In a study of patients undergoing radiofrequency rhizotomy for trigeminal neuralgia under continuous sedation, 90.8% experienced significant pain relief at 1 month, indicating that this sedation method is effective for pain management.

Patients with multiple sclerosis showed particularly high success rates, with 100% relief at 1 month and 87.5% at 1 year, suggesting that continuous sedation does not compromise the efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Review of the Outcomes and Utility of Percutaneous Radiofrequency Rhizotomy for Trigeminal Neuralgia Using Anatomic Landmark Guidance in Asleep Patients. Stone, LE., Falowski, SM.[2021]

Facet nerve blockade and radiofrequency (RF) neurotomy are effective techniques for diagnosing and managing spinal pain associated with facet joints, highlighting their clinical importance.

These procedures are evolving with advancements in patient selection and technique, and they can be performed safely using imaging equipment by trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facet nerve blockade and radiofrequency neurotomy. Schellhas, KP.[2013]

Cervical radiofrequency neurotomy is generally a safe procedure for treating neck pain, but it can lead to rare complications such as dropped head syndrome, as seen in a case involving a 77-year-old man who developed this condition six weeks post-procedure.

Management of dropped head syndrome can be effective with conservative treatments like physical therapy and the use of a cervical collar, but it highlights the need for discussing this potential complication during the consent process for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dropped head syndrome: report of a rare complication after multilevel bilateral cervical radiofrequency neurotomy. Bajaj, HS., Chapman, AW.[2022]

In a study of 280 patients who underwent percutaneous radiofrequency rhizotomy for trigeminal neuralgia, lower lesion temperatures were associated with longer periods without pain recurrence, indicating that temperature plays a crucial role in the procedure's long-term effectiveness.

Postoperative numbness and the absence of multiple sclerosis were identified as significant protective factors for improved outcomes, suggesting that these variables should be considered when planning treatment for trigeminal neuralgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of lesion temperature on the durability of percutaneous radiofrequency rhizotomies to treat trigeminal neuralgia. Mulford, KL., Darrow, DP., Dharnipragada, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12398795/

Assessment of real-world, prospective outcomes in patients ... Cervical facet joint pain and cervicogenic headache treated with radiofrequency ablation: a systematic review. Pain Physician. 2022 May;25(3): ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000378

Assessment of real-world, prospective outcomes in patients ... Following RFA treatment at 1-month and out to 24-months, 77.0% and 79.0% of patients were observed to be treatment responders (i.e., ≥50% pain relief), ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40896553/

Assessment of real-world, prospective outcomes in patients ... Conclusions: The cervical RFA cohort in the RAPID study demonstrated consistent, clinically meaningful improvements in pain, function, quality- ...

4. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NzQ2NA%3D%3D&journal=143

Cervical Facet Joint Pain and Cervicogenic Headache ... Conclusions: Based on this systematic review, efficacy of cervical facet RFA in treatment of chronic neck pain has Level II evidence. Key words: Cervicalgia, ...

5. apm.amegroups.org apm.amegroups.org/article/view/125367/html

Radiofrequency ablation for the cervical spine - Engle Radiofrequency ablation (RFA), a minimally invasive procedure for pain reduction, is increasingly used for managing chronic neck pain and headaches.

6. jtss.org jtss.org/articles/the-efficacy-and-safety-of-radiofrequency-neurotomy-in-the-treatment-of-chronic-cervical-facet-zygapophyseal-joint-pain-a-retrospective-study/jtss.galenos.2024.04274

THE EFFICACY AND SAFETY OF RADIOFREQUENCY ... Our data indicates that TRFA is a safe and effective treatment for cervical facet joint-related pain lasting for at least six months. Partial recurrence of pain ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9686245/

A Systematic Review and Meta-analysis of the Effectiveness of ... The objective of this systematic review and meta-analysis is to evaluate the effectiveness of radiofrequency neurotomy as a therapeutic cervical facet joint ...

8. apm.amegroups.org apm.amegroups.org/article/view/126268/html

Radiofrequency ablation for headache pain Conclusions: Overall, RFA shows favorable outcomes in the management of chronic headache pain. Therefore, RFA can serve as an alternative treatment option for ...