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 tests two methods for treating neck pain, often caused by joint issues in the neck. It compares a new tool, the Trident cannula, with the traditional Cervical Medial Branch Radiofrequency Ablation (CMBRFA) to determine which is more effective and safer. The researchers aim to assess whether the new tool can reduce pain and improve function as effectively as the traditional method while making the procedure quicker and more comfortable. The trial seeks participants who have experienced neck pain for at least three months and have shown significant symptom relief after specific diagnostic tests. As an unphased trial, it offers an opportunity to contribute to innovative research that could enhance neck pain treatments.

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.

What prior data suggests that these radiofrequency ablation techniques are safe for treating neck pain?

Research shows that cervical medial branch radiofrequency ablation (CMBRFA) is generally safe and effective for treating neck pain. Studies have found that the traditional method can provide 80%-100% pain relief for many patients, lasting up to a year. About 69% of people felt much better one month after the procedure, increasing to 77% at six months.

The Trident cannula, a newer tool for this procedure, appears safer, faster, and more comfortable than the traditional method. It simplifies the process with fewer steps, potentially reducing discomfort during the procedure. While its safety looks promising, direct comparisons with the traditional method remain under study.

Both methods aim to reduce neck pain by targeting the nerves that send pain signals from the facet joints. Overall, research supports the safety of both approaches, but discussing any concerns with a healthcare provider is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these radiofrequency ablation techniques for neck pain because they offer potentially more precise targeting of nerve pain pathways. The Trident Cervical Medial Branch Radiofrequency Ablation uses a perpendicular approach to target the medial branches, which may provide more consistent nerve contact and effective pain relief. Meanwhile, the Conventional Cervical Medial Branch Radiofrequency Ablation uses an oblique approach to accommodate anatomical variations, possibly improving personalization of treatment. Both techniques aim to enhance the accuracy and effectiveness of nerve ablation, potentially leading to longer-lasting relief compared to standard pain management options like medications and physical therapy.

What evidence suggests that this trial's treatments could be effective for neck pain?

Research shows that cervical medial branch radiofrequency ablation (CMBRFA) effectively treats neck pain caused by the joints in the neck. In this trial, participants will join one of two treatment arms. The conventional method, received by some participants, has reduced pain and disability in over 65% of patients, according to studies. The Trident multi-tined cannula, used by participants in another arm, is a newer tool that might offer similar pain relief but with greater speed and comfort. Although not yet directly compared to the traditional method in a randomized study, the Trident cannula is designed for safer and simpler use. Both methods target the nerves that send pain signals from the neck joints, potentially offering significant relief for patients. ^{1 2 3 5 6}

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000330

The effectiveness of cervical medial branch radiofrequency ... pCMBRFN demonstrated effectiveness by reducing pain and disability in over 65 % of patients with confirmed cervical zygapophyseal joint-mediated pain at 3 ...

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

A Systematic Review and Meta-analysis of the Effectiveness of ... They concluded that higher degrees of relief from cervical medial branch thermal radiofrequency neurotomy are more often achieved, to a ...

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

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

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05424198

Trident Multi-tined Cannula for Cervical MBRFA Compared ... Cervical medial branch radiofrequency ablation (CMBRFA) is an effective treatment for cervical facet pain. The efficacy of CMBRFA was proven by studies ...

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

Radiofrequency ablation for the cervical spine - Engle Although medial branch blocks are clinically considered positive if the patient reports greater than or equal to 50% pain relief for the ...

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 ... The majority of chronic neck pain patients can experience 80%-100% pain relief for up to a year after the application of TRFA(24, 28). A major source of failure ...