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

Trial Summary

What is the purpose of this trial?

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 (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques.

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 data supports the effectiveness of this treatment for chronic lower back pain?

Radiofrequency ablation (RFA) is shown to be a safe and effective treatment for chronic low back pain, as it uses electrical currents to target nerves causing pain. A study also highlights that pulsed radiofrequency with multifunctional electrodes can effectively manage chronic low back pain with minimal side effects. ^{1 2 3 4 5}

Is radiofrequency ablation generally safe for treating chronic lower back pain?

Radiofrequency ablation has been shown to be safe for treating spinal conditions, as it allows precise monitoring and minimizes the risk of unwanted thermal injury. ^{4 6 7 8 9}

How does the Multi-Tined Expandable Electrode treatment differ from other treatments for chronic lower back pain?

The Multi-Tined Expandable Electrode (MEE) treatment is unique because it uses a multi-tined cannula that targets the nerve perpendicularly, potentially creating a more effective lesion for pain relief compared to the traditional monopolar approach, which targets the nerve parallelly. ^{2 3 4 10 11}

Research Team

Dawood Sayed

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

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

Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study. [2022]

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

Investigation of Effectiveness of Pulsed Radiofrequency With Multifunctional Epidural Electrode for Low Back Pain. [2022]

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

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

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

Percutaneous Radiofrequency Ablation of Spinal Osteoid Osteomas Using a Targeted Navigational Bipolar Electrode System. [2020]

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

Multiple lead spinal cord stimulation for chronic mechanical low back pain: a comparative study with intrathecal opioid drug delivery. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2018]

8. United States 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. [2023]

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

Spinal cord stimulation with percutaneous and plate electrodes: side effects and quantitative comparisons. [2004]

10. Israel pubmed.ncbi.nlm.nih.gov

[Pulsed radiofrequency treatment of severe radicular pain]. [2019]

11. United States 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. [2022]