Radiofrequency Ablation Techniques for Neck Pain

Recruiting at 2 trial locations

Overseen By PMR Research Group

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Chronic opiates

Disqualifiers: Fibromyalgia, Severe depression, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two tools for a heat-based treatment that deactivates pain-causing nerves in the neck. It targets patients with chronic neck pain who have shown significant improvement in preliminary tests. The goal is to see if the newer tool is as effective and safer than the older one.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using daily chronic opiates over 50 morphine equivalents, you may not be eligible to participate.

Is radiofrequency ablation for neck pain safe?

Radiofrequency ablation for neck pain is generally considered safe, but there are risks, such as the potential for spinal cord injury, especially when performed at certain levels like C7. It's important to ensure the procedure is done accurately to minimize these risks. ^{1 2 3 4 5}

How is the treatment Cervical Medial Branch Radiofrequency Ablation (CMBRFA) unique for neck pain?

Cervical Medial Branch Radiofrequency Ablation (CMBRFA) is unique because it uses radiofrequency energy to target specific nerves in the neck that are responsible for pain, providing a minimally invasive option for patients whose pain does not respond to other treatments. This technique is guided by precise diagnostic blocks to ensure the correct nerves are treated, and a new end-on approach with multi-tined cannulae may offer a simpler and quicker procedure with less discomfort compared to traditional methods. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Cervical Medial Branch Radiofrequency Ablation for neck pain?

Research shows that Cervical Medial Branch Radiofrequency Ablation (CMBRFA) is effective for treating neck pain caused by facet joint issues, especially when patients are carefully selected based on specific guidelines. Studies indicate that this treatment can provide significant pain relief for those with chronic neck pain related to cervical facet joint disease. ^{1 2 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with neck pain lasting at least 3 months, who can understand and consent in English. They must have a pain score of at least 4/10 and have shown ≥80% symptom reduction after dual medial branch blocks. Excluded are those with conflicts like litigation or disability claims, allergies to certain medications, chronic widespread pain disorders, prior similar treatments, severe depression or psychosis, possible pregnancy, high daily opiate use, pacemakers or infections.

Inclusion Criteria

My average neck pain score is 4 or more out of 10.

I have had neck pain for at least 3 months that does not spread to my arms.

The doctor will decide the appropriate tests based on your symptoms, physical exam, and imaging results.

Exclusion Criteria

Those unable to read English and complete the assessment instruments

I have been diagnosed with chronic widespread pain or a condition like fibromyalgia.

You have a pacemaker or neurostimulator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cervical medial branch radiofrequency ablation using either the Trident or conventional cannula

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain response, functional response, and perception of improvement at 3, 6, and 12 months

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Medial Branch Radiofrequency Ablation

Trial Overview The study compares the Trident multi-tined cannula (a new tool that requires fewer lesions) to the conventional cannula used in cervical medial branch radiofrequency ablation for neck pain relief. It aims to see if Trident is just as effective while reducing procedure discomfort and time as well as radiation exposure.

How Is the Trial Designed?

Group I: Trident Cervical Medial Branch Radiofrequency Ablation Active Control 1 Intervention

During this procedure a 50 mm or 100 mm long (dependent on body habitus), 18-gauge insulated cannula with a 5 mm active tip will be placed perpendicularly at targeted medial branches (the nerves carrying pain signals from the facet joints).

Group II: Conventional Cervical Medial Branch Radiofrequency Ablation Active Control 1 Intervention

During this procedure a 50 mm or 100 mm long (dependent on body habitus), 18-gauge conventional cannula with a straight 5 mm active tip will be placed parallel and oblique to the targeted medial branch branches (the nerves carrying pain signals from the facet joints). At each location, one lesion will be made to accommodate anatomic variation.

Cervical Medial Branch Radiofrequency Ablation is already approved in United States, Canada, Switzerland for the following indications:

Approved in United States as Cervical Medial Branch Radiofrequency Ablation for:

• Cervical facet pain

Approved in Canada as Cervical Medial Branch Radiofrequency Ablation for:

• Cervical facet pain

Approved in Switzerland as Cervical Medial Branch Radiofrequency Ablation for:

• Cervical facet pain

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

The study analyzed 20 cervical specimens from adult cadavers to clarify the anatomy of cervical medial branches, revealing that while most branches have one medial branch, 27% of C4, 15% of C5, and 2% of C6 branches have two, which is crucial for accurate treatment planning.

The findings provide important anatomical details, such as the average distance of medial branches from the inferior articular process and their location relative to the transverse process, which can enhance the safety and effectiveness of radiofrequency denervation procedures for chronic neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical analysis of medial branches of dorsal rami of cervical nerves for radiofrequency thermocoagulation. Kweon, TD., Kim, JY., Lee, HY., et al.[2022]

In a study of 120 patients with chronic neck pain from cervical facet joints, both groups receiving cervical medial branch blocks (with or without steroids) showed significant pain relief, with 85% in the bupivacaine-only group and 93% in the bupivacaine plus steroid group achieving at least 50% pain reduction over 2 years.

The average duration of pain relief from each injection was about 17-19 weeks, and significant improvements in pain and function were maintained for 83 to 89 weeks, indicating that these treatments can provide long-term benefits for managing chronic neck pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial. Manchikanti, L., Singh, V., Falco, FJ., et al.[2022]

This study will compare a new end-on approach for cervical medial branch nerve radiofrequency neurotomy (RFN) against the conventional parallel technique in 72 adults with chronic neck pain due to cervical facet joint disease, aiming to determine if the new method is equally effective while being technically easier and causing less discomfort.

The trial will assess pain intensity and related factors over 12 months, providing valuable insights into the safety and efficacy of the end-on approach, which could improve treatment options for patients suffering from this common condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. Alomari, A., Ferreira-Dos-Santos, G., Singh, M., et al.[2023]

In a study of 65 patients with chronic neck pain due to facet joint degeneration, 55.4% reported pain relief at 2 months after receiving radiofrequency treatment, indicating its short-term efficacy.

At a 3-year follow-up, 30% of patients still experienced pain reduction, suggesting that while the treatment has lasting effects for some, further research is needed to fully understand its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of cervical facet medial branch radiofrequency treatment with the single posterior-lateral approach: an exploratory study. van Eerd, M., de Meij, N., Dortangs, E., et al.[2014]

Cervical medial branch radiofrequency ablation (CMBRFA) is effective for treating facetogenic pain, showing a 54% rate of patients achieving at least a 50% reduction in pain after the procedure, regardless of whether they had 80-99% or 100% symptom improvement from dual medial branch blocks (MBBs).

The study indicates that selecting patients for CMBRFA based on ≥80% symptom relief is valid, as there was no significant difference in outcomes between those with 80-99% and 100% symptom improvement, suggesting that both groups can benefit similarly from the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Cervical Medial Branch Radiofrequency Ablation for Chronic Facet Joint Syndrome in Patients Selected by a Practical Medial Branch Block Paradigm. Burnham, T., Conger, A., Salazar, F., et al.[2021]

Ultrasound-guided cervical medial branch block (CMBB) at the C7 level has been shown to be less accurate, which can increase the risk of serious complications, including spinal cord injury, as demonstrated in a reported case.

The case involved a patient who experienced an iatrogenic spinal cord injury after the procedure, highlighting the need for caution and improved techniques when performing CMBB at this specific cervical level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Injury During Ultrasound-Guided C7 Cervical Medial Branch Block. Park, D., Seong, MY., Kim, HY., et al.[2022]

In a study of 62 patients with chronic cervical facet syndrome, both lidocaine and bupivacaine provided significant pain relief and improved neck function, but lidocaine showed superior results, lasting up to 16 weeks for pain reduction and 8 weeks for functional improvement.

There was no significant difference in the overall duration of pain relief between the two anesthetics, but lidocaine was more effective for longer-lasting pain control, making it a preferred choice for cervical medial branch blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Outcome of Lidocaine Versus Bupivacaine for Cervical Medial Branch Block in Chronic Cervical Facet Arthropathy: A Randomized Double-Blind Study. Pasuhirunnikorn, P., Tanasansomboon, T., Singhatanadgige, W., et al.[2023]

The study compared two methods of radiofrequency neurotomy for treating cervical facet joint pain in 71 patients, finding that both the single entry posterior parasagittal approach and the conventional posterolateral approach significantly reduced pain levels, as measured by the numerical rating scale (NRS).

The posterior parasagittal approach was notably quicker, taking an average of 44.13 minutes compared to 54.68 minutes for the posterolateral approach, while both methods had no serious complications, indicating that the new approach is both safe and efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Entry Posterior Parasagittal Approach Radiofrequency Neurotomy of Cervical Medial Branch: A Feasible Alternative to Conventional Approaches in the Treatment of Cervical Facet Pain. Chen, CK., Wong, CC., Teo, YY., et al.[2022]

Using a smaller volume of 0.25 mL for cervical medial branch blocks (MBBs) results in more targeted delivery of anesthetic to the intended nerves, reducing the risk of affecting nearby structures and improving diagnostic accuracy.

In contrast, the larger 0.50 mL volume spreads more widely, potentially leading to false positives in identifying the source of neck pain, which could compromise the effectiveness of subsequent therapeutic radiofrequency ablation (RFA).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical Medial Branch Block Volume Dependent Dispersion Patterns as a Predictor for Ablation Success: A Cadaveric Study. Wahezi, SE., Molina, JJ., Alexeev, E., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Anatomical analysis of medial branches of dorsal rami of cervical nerves for radiofrequency thermocoagulation. [2022]

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

Comparative outcomes of a 2-year follow-up of cervical medial branch blocks in management of chronic neck pain: a randomized, double-blind controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. [2023]

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

Long-term follow-up of cervical facet medial branch radiofrequency treatment with the single posterior-lateral approach: an exploratory study. [2014]

5. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Cervical Medial Branch Radiofrequency Ablation for Chronic Facet Joint Syndrome in Patients Selected by a Practical Medial Branch Block Paradigm. [2021]

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

Spinal Cord Injury During Ultrasound-Guided C7 Cervical Medial Branch Block. [2022]

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

Comparative Outcome of Lidocaine Versus Bupivacaine for Cervical Medial Branch Block in Chronic Cervical Facet Arthropathy: A Randomized Double-Blind Study. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Single Entry Posterior Parasagittal Approach Radiofrequency Neurotomy of Cervical Medial Branch: A Feasible Alternative to Conventional Approaches in the Treatment of Cervical Facet Pain. [2022]

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

Cervical Medial Branch Block Volume Dependent Dispersion Patterns as a Predictor for Ablation Success: A Cadaveric Study. [2020]