Radiofrequency Ablation for Chronic Lower Back Pain

(MEE Trial)

Overseen By Angie Ballew, DC, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Morphine

Disqualifiers: Pregnancy, Infections, Psychiatric disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 20 minutes for RFA procedure; ongoing for CMM

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how people with chronic lower back pain respond to a treatment called radiofrequency ablation, which uses a special needle. The goal is to compare this new treatment, specifically the Multi-Tined Expandable Electrode (MEE), to usual care methods like medication and physical therapy. Radiofrequency ablation uses heat waves to stop nerves from sending pain signals. People who have experienced non-radiating lower back pain for at least six months and have shown improvement after specific pain-relief tests might be suitable candidates for this trial. As an unphased trial, this study offers patients the opportunity to explore innovative treatments beyond standard care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on a daily oral morphine equivalent of 50 or more, you may not be eligible to participate.

What prior data suggests that the Multi-Tined Expandable Electrode (MEE) is safe for radiofrequency ablation?

Research has shown that radiofrequency ablation (RFA) using a multi-tined expandable electrode (MEE) is generally well-tolerated. This technique uses heat to target and reduce pain by affecting the responsible nerves. Studies suggest it can effectively lessen pain without causing significant side effects.

Patients who undergo this procedure often report less pain and an improved quality of life. The MEE is designed to treat a larger area, potentially providing better and longer-lasting pain relief. While the safety data is encouraging, like any medical procedure, some risks may exist. However, current research does not indicate any major negative effects from this treatment.

As an improvement on traditional RFA methods, MEE builds on a well-known and established procedure, further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radiofrequency ablation (RFA) with a multi-tined expandable electrode (MEE) is unique because it uses radiofrequency waves to target and burn the nerve responsible for chronic lower back pain, preventing it from sending pain signals to the brain. This approach is different from conventional treatments like medication, physical therapy, and chiropractic care, which often focus on managing symptoms rather than addressing the source directly. The MEE technique allows for a larger treatment area, potentially offering greater and longer-lasting pain relief. Researchers are excited about this method because it provides a minimally invasive alternative that could lead to significant improvements in pain management for patients.

What evidence suggests that the Multi-Tined Expandable Electrode (MEE) is effective for chronic lower back pain?

This trial will compare two treatment options for chronic lower back pain: Conventional Medical Management (CMM) and radiofrequency ablation using a multi-tined expandable electrode (MEE). Studies have shown that radiofrequency ablation with MEE can alleviate chronic lower back pain. This technique uses radio waves to target and burn the nerve causing the pain, preventing it from sending pain signals to the brain. The MEE needle treats a larger area, potentially leading to better and longer-lasting pain relief compared to traditional methods. Research suggests this can also make the procedure quicker. Although the long-term benefits are still under investigation, early results indicate promising outcomes. ^{2 5 6 7 8}

Who Is on the Research Team?

Dawood Sayed

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-radiating low back pain lasting at least 6 months, who've had significant relief from two medial branch blocks. It's not for those with drug/alcohol abuse, certain psychiatric diseases, high daily morphine use, pregnancy, or involvement in litigation related to disability.

Inclusion Criteria

You have a past history of low back pain that does not radiate to other parts of your body.

Patient has signed study-specific informed consent.

Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.

Exclusion Criteria

Patient currently receiving or seeking workers compensation, disability remuneration, and/or involved in injury litigation.

You have a device implanted in your spine for pain management.

You have a history of drug or alcohol abuse or are currently using drugs or alcohol excessively.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either radiofrequency ablation with a multi-tined expandable electrode or conventional medical management

20 minutes for RFA procedure; ongoing for CMM

1 visit (in-person) for RFA; multiple visits for CMM

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Medical Management
• Multi-Tined Expandable Electrode (MEE)

Trial Overview

The study compares the effects of a radiofrequency ablation surgery using a multi-tined expandable electrode (MEE) against conventional medical management techniques in treating chronic lower back pain.

How Is the Trial Designed?

Group I: Conventional Medical Management (CMM) Treatment Only Active Control 1 Intervention

Your current standard of care treatment may already consist of some CMM therapies. Standard of care includes a variety of intervention types such as medication, physical therapy, home exercise programs, back brace, walking aid, and chiropractic care.

Group II: Radiofrequency ablation (RFA) with MEE Active Control 1 Intervention

Radiofrequency ablation involves a minimally invasive procedural technique. It uses radiofrequency waves to burn the nerve causing pain. This nerve will no longer be able to send pain signals to your brain. For this study, the multi-tined expandable electrode needle will be used. This needle will result in a larger treatment area. This may result in better pain relief and longer lasting pain relief. If you undergo the radiofrequency ablation procedure you will have pain medication injected where the ablation will be done. The procedure will take about 20 mins to complete. You will be allowed to go home afterward.

Multi-Tined Expandable Electrode (MEE) is already approved in United States for the following indications:

Approved in United States as Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode for:

• Lumbar facet arthropathy
• Spondylosis
• Chronic low back pain

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

Radiofrequency ablation (RFA) is a safe and effective treatment for chronic low back pain, as demonstrated in an 81-year-old patient who experienced a 75% reduction in pain for over eight months after a conventional RFA procedure.

The use of a combined technique involving bipolar-RFA and V-shaped cannulas resulted in sustained pain relief for over twelve months, suggesting that this method may enhance lesion size and effectiveness, warranting further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Bipolar and V-Shaped Lesions for Lumbar Facet Radiofrequency Ablation: A Technical Report. Sagir, A., Bolash, R.[2022]

Pulsed radiofrequency treatment using multifunctional epidural electrodes significantly reduces pain levels in patients with chronic low back pain, as evidenced by improved Visual Analogue Scale (VAS) scores at multiple follow-up points (10 days, 1, 3, and 6 months post-treatment).

The treatment also enhances physical function, demonstrated by significant improvements in the straight leg raising test (SLR), indicating its efficacy in addressing various underlying causes of low back pain with a low complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of Effectiveness of Pulsed Radiofrequency With Multifunctional Epidural Electrode for Low Back Pain. Gulduren Aydın, LG., Akesen, S., Turker, YG., et al.[2022]

In a study involving 51 patients, both the conventional monopolar (CM) and multi-tined (MT) cannulas for radiofrequency ablation (RFA) showed similar effectiveness in reducing chronic low back pain, with no significant differences in pain relief or quality of life outcomes after 3 months.

The MT cannula procedure was completed significantly faster and required less local anesthetic and radiation exposure compared to the CM cannula, indicating it may be a more efficient option for patients undergoing RFA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Within Subject Comparison of Fluoroscopically Guided Lumbosacral Facet Joint Radiofrequency Ablation Using a Multi-Tined (Trident) Versus Conventional Monopolar Cannula. Deng, G., Smith, A., Burnham, R.[2022]

A study involving 43 subjects with chronic low back pain showed that both conventional paresthesia mapping and anatomic landmark-based approaches for spinal cord stimulation (SCS) lead placement resulted in significant pain relief and improved quality of life over a one-year follow-up period.

There were no significant differences in pain relief between the two lead placement methods, suggesting that the anatomic approach could simplify the implantation process without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Paresthesia Mapping With Anatomic Placement in Burst Spinal Cord Stimulation: Long-Term Results of the Prospective, Multicenter, Randomized, Double-Blind, Crossover CRISP Study. Al-Kaisy, A., Baranidharan, G., Sharon, H., et al.[2023]

Implanted multiple thoracolumbar lead spinal cord stimulation (SCS) significantly reduced pain in patients with mechanical back pain, with median pain scores decreasing from 9.0 to 6.5 (p < 0.01).

Intrathecal opioid drug delivery (ITDD) not only reduced pain from 8.5 to 5.5 (p < 0.01) but also led to significantly greater improvements in psychosocial quality of life measures compared to SCS (p < 0.05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple lead spinal cord stimulation for chronic mechanical low back pain: a comparative study with intrathecal opioid drug delivery. Raphael, JH., Southall, JL., Gnanadurai, TV., et al.[2022]

Out of 509 plate electrodes implanted in 350 patients, 70% are still in use, indicating a high rate of efficacy for chronic pain and motor disorder management.

The procedure had a low complication rate, with only 3.7% of electrodes becoming infected and 1.1% experiencing migration, suggesting that implantation is generally safe when performed by an experienced neurosurgeon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with 509 plate electrodes implanted epidurally from C1 to L1. Barolat, G.[2019]

In a study of 93 patients with failed back surgery syndrome, the use of percutaneous octapolar spinal cord stimulation (SCS) leads resulted in significant long-term pain relief, with average leg pain scores dropping from 72 to 32 after 12 months (P < 0.001).

The octapolar SCS leads also improved quality of life and sleep, with 63% of patients experiencing at least a 50% reduction in leg pain, indicating that advancements in SCS technology have led to better therapeutic outcomes compared to older 4-contact leads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1-Year Follow-Up: A Prospective Multicenter International Study. Gatzinsky, K., Baardsen, R., Buschman, HP.[2018]

Percutaneous CT-guided radiofrequency ablation using a targeted navigational bipolar electrode system is a safe and effective method for treating spinal osteoid osteomas.

The use of articulating bipolar electrodes with built-in thermocouples allows for precise monitoring and control during the procedure, reducing the risk of thermal injury and ensuring optimal access to the tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Radiofrequency Ablation of Spinal Osteoid Osteomas Using a Targeted Navigational Bipolar Electrode System. Tomasian, A., Jennings, JW.[2020]

In a study of 79 patients with postsurgical lumbar pain, 46% experienced discomfort from spinal cord stimulation due to the recruitment of small fibers in the ligamentum flavum when using percutaneous electrodes, particularly at T-8 and T-9 levels.

Switching to insulated plate electrodes eliminated this discomfort and improved pain coverage with lower stimulation power, highlighting a simple solution to a common side effect in spinal cord stimulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation with percutaneous and plate electrodes: side effects and quantitative comparisons. North, RB., Lanning, A., Hessels, R., et al.[2004]

In a study of 554 chronic low back pain (CLBP) patients using transcutaneous electrical nerve stimulation (TENS) over 10 weeks, those who reported improvement in pain interference with sleep experienced an increase in total sleep time by 29 minutes compared to those who did not improve.

The improved group also showed a lower periodic leg movement index, suggesting that TENS not only helps with pain but may also enhance sleep quality, highlighting the importance of sleep as an outcome measure in TENS effectiveness for CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study. Gozani, SN., Ferree, TC., Moynihan, M., et al.[2022]

Pulsed radiofrequency (RF) treatment has been shown to be a safe and effective method for managing severe radicular pain, with significant reductions in pain levels observed over a 12-month follow-up period in 28 patients.

After 3 months, patients reported an average pain reduction from 8.8 to 4.2 on the Visual Analog Scale, indicating that pulsed RF can provide meaningful pain relief, although some patients did not respond to treatment after 6 and 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulsed radiofrequency treatment of severe radicular pain]. Pevzner, E., David, R., Leitner, Y., et al.[2019]

Citations

1.

stratusmedical.com

stratusmedical.com/us/nimbus-overview/

NIMBUS Overview

NIMBUS has been shown to significantly decrease procedural time2, which opens up procedure rooms for additional patient treatments and provides improved revenue ...

2.

ctv.veeva.com

ctv.veeva.com/study/rfa-using-multi-tined-electrodes-vstraditional-electrodes-for-lumbar-spondylosis

RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for ...

Description: Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stratus Nimbus Electrode.

3.

withpower.com

withpower.com/trial/radiofrequency-ablation-for-chronic-lower-back-pain-374e5

Radiofrequency Ablation for Chronic Lower Back Pain

The purpose of this study is to better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle ...

4.

go2strategy.com

go2strategy.com/uploads/1/9/9/4/19948553/rs_medical_-_nimbus_electrosurgical_rf_multi-tined_expandable_electrode_-_clinical_white_paper_-robert_e_wright_md_dabpm_jan_2013.pdf

Nimbus Electrosurgical RF Multi-tined Expandable Electrode

The Nimbus radiofrequency multi-tined expandable electrode aims to improve radiofrequency neurotomy outcomes. Radiofrequency thermal neurotomy (RTN).

5.

semanticscholar.org

semanticscholar.org/paper/Nimbus-Electrosurgical-RF-Multi-tined-Expandable-Wright/a0dca7d91f9dea2bf14c3ce2dcb121387d7d31df

Nimbus Electrosurgical RF Multi-tined Expandable Electrode

The evidence was fair in favor of cooled radio frequencies neurotomy and poor for short-term and long-term relief from intraarticular steroid injections, ...

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06477094/rfa-using-multi-tined-electrodes-vstraditional-electrodes-for-lumbar-spondylosis

RFA Using Multi-Tined Electrodes vs.Traditional ...

It is hypothesized that the Nimbus electrode will result in a greater reduction and improvement in PROMIS scores for a longer duration than the Stryker ...

7.

marmaratibbiurunler.com.tr

marmaratibbiurunler.com.tr/wp-content/uploads/2016/01/338-0009-00-Rev-A-Nimbus-Technique-Guide.pdf

Multi-Tined Expandable Electrode for Radiofrequency ...

Nimbus Concepts was founded to advance RF electrode technology with the goal of broadly improving patient outcomes. The Nimbus Multi-Tined Expandable Electrode ...

8.

researchgate.net

researchgate.net/publication/265378661_Radiofrequency_Ablation_Using_a_Novel_Multitined_Expandable_Electrode_Device_Description_and_Research_Study

(PDF) Radiofrequency Ablation Using a Novel Multitined ...

Durable pain remission using radiofrequency thermal neurotomy (RTN) requires thoughtful patient selection and a lesion of optimal size and position.