Radiofrequency Neurotomy for Facetogenic Headache

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Allevio Pain Management Clinic

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Coagulation issues, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial compares two treatments, PRF and CRF, which use electrical currents to reduce chronic neck pain by numbing the nerves. It targets patients with conditions like cervicogenic headache or occipital neuralgia who may not respond well to other treatments. Pulsed radiofrequency (PRF) was introduced as a non-destructive alternative to continuous radiofrequency (CRF) energy for treating chronic pain.

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.

What data supports the effectiveness of the treatment Pulsed Radiofrequency Ablation for Facetogenic Headache?

Research shows that pulsed radiofrequency is effective in treating various types of facial and head pain, such as supraorbital neuralgia and trigeminal neuralgia, providing pain relief without nerve damage. This suggests it could be promising for treating facetogenic headache as well. ^{1 2 3 4 5}

Is radiofrequency neurotomy safe for treating headaches?

Radiofrequency neurotomy, including pulsed radiofrequency, is generally considered safe for treating various types of pain, with severe complications being extremely rare when proper techniques are used. In a case of supraorbital neuralgia, pulsed radiofrequency was used without any nerve damage or side effects reported over a year of follow-up. ^{2 3 5 6 7}

How is pulsed radiofrequency ablation different from other treatments for facetogenic headache?

Pulsed radiofrequency ablation is unique because it uses electrical energy to create heat that targets specific nerves, potentially reducing pain without the need for continuous sedation or invasive surgery. This treatment is distinct from others as it can be precisely guided using imaging equipment, making it a minimally invasive option for managing pain. ^{2 5 8 9 10}

Research Team

Eligibility Criteria

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 am between 18 and 90 years old.

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.

Trial Timeline

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)

Treatment Details

Interventions

• Pulsed Radiofrequency Ablation (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

[Sphenopalatine ganglion pulsed radiofrequency treatment in patients suffering from chronic face and head pain]. [2016]

2. United States 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. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Treatment of post-craniotomy acute severe supraorbital neuralgia using ultrasound-guided pulsed radiofrequency: a case report. [2020]

4. Brazil pubmed.ncbi.nlm.nih.gov

Sphenopalatine ganglion pulsed radiofrequency treatment in patients suffering from chronic face and head pain. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous radiofrequency rhizotomy and neurovascular decompression of the trigeminal nerve for the treatment of facial pain. [2022]

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

Dropped head syndrome: report of a rare complication after multilevel bilateral cervical radiofrequency neurotomy. [2022]

7. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Percutaneous trigeminal nerve radiofrequency rhizotomy guided by computerized tomography with three-dimensional image reconstruction. [2016]

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

Effect of lesion temperature on the durability of percutaneous radiofrequency rhizotomies to treat trigeminal neuralgia. [2023]

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

Technical limitations to the efficacy of radiofrequency neurotomy for spinal pain. [2022]

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

Facet nerve blockade and radiofrequency neurotomy. [2013]