Intracept Procedure for Lower Back Pain

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Neuro Spine and Pain Center of Key West

Disqualifiers: Severe cardiac, Pulmonary, Infection, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of the Intracept Procedure for individuals with long-lasting lower back pain. The procedure targets nerves in the spine to reduce pain. It is intended for those who have experienced chronic back pain for at least six months without relief from other treatments. Participants should exhibit specific changes in their spine, known as Modic type 1 or 2 changes, visible on an MRI. The trial aims to gather feedback on pain relief and overall satisfaction after the treatment. As a Phase 4 trial, this research helps determine how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Intracept Procedure?

Research has shown that the Intracept Procedure, which targets a specific nerve in the spine, is generally safe. Several studies have found this treatment effective and well-tolerated. Specifically, a 5-year review of three different clinical trials confirmed its safety and long-lasting benefits. These studies revealed that many patients experienced significant pain relief, with some reporting up to a 50% reduction in pain. This treatment has been used for some time and is already approved for treating chronic back pain. Overall, existing evidence suggests that the Intracept Procedure is a safe option for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Intracept Procedure is unique because it targets the basivertebral nerve through intraosseous radiofrequency ablation, a novel approach for treating chronic lower back pain. Unlike traditional treatments like physical therapy, medications, or spinal fusion surgery, which address symptoms or structural issues, this procedure directly interrupts pain signals at their source within the vertebrae. Researchers are excited about this treatment because it offers a minimally invasive option with the potential for long-lasting pain relief, especially for patients who have not found success with other therapies.

What evidence suggests that the Intracept Procedure is effective for lower back pain?

Studies have shown that the Intracept Procedure, evaluated in this trial as Basivertebral Nerve Ablation, effectively treats chronic lower back pain. Research indicates significant improvements in pain and function, with 83% of patients experiencing a meaningful reduction in pain. Specifically, patients reported lasting relief for over six years. The procedure also reduced the need for other treatments, such as spinal injections and surgeries. These findings suggest that the Intracept Procedure can offer long-term relief for those suffering from persistent back pain. ^{6 7 8 9 10}

Who Is on the Research Team?

William Schnapp, PhD

Principal Investigator

Owner

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had chronic low back pain for at least 6 months and haven't improved after trying other treatments. It's specifically for those with certain types of spinal bone changes known as Modic type 1 or 2. People with severe heart or lung disease, or infections cannot participate.

Inclusion Criteria

I have not improved after 6 months of standard treatment.

I have had chronic low back pain for 6 months or more.

You have specific changes in your spine that can affect the study.

Exclusion Criteria

I do not have any active infections.

I have severe heart or lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants are consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit

1 day

1 visit (in-person)

Treatment

Participants undergo intraosseous basivertebral nerve ablation using the Intracept Procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness post-treatment at 1, 3, 6, 12, and 24 months

24 months

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intracept Procedure

Trial Overview The Intracept Procedure is being evaluated in this study. It involves a minimally invasive technique to stop specific nerves within the spine from transmitting pain signals, aiming to reduce chronic lower back pain.

How Is the Trial Designed?

Group I: Basivertebral Nerve Ablation Experimental Treatment 1 Intervention

Intraosseous radiofrequency basivertebral nerve ablation

Who Is Running the Clinical Trial?

Neuro Spine and Pain Center of Key West

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

In a study involving patients undergoing lumbar interlaminar decompression with interspinous fixation, 76% of patients reported significant improvements in pain and function at 6 months post-treatment, indicating the efficacy of this minimally invasive procedure for spinal stenosis.

The treatment demonstrated a good safety profile, with only two minor procedure-related adverse events that resolved without further surgical intervention, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results. Falowski, SM., Raso, LJ., Mangal, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10075185/

The Effectiveness of Intraosseous Basivertebral Nerve ... Intraosseous basivertebral nerve ablation has shown sustained efficacy in treating chronic axial low back pain (LBP) in patients with type 1 or 2 Modic changes.

2. relievant.com relievant.com/proof/clinical-evidence/

Clinical Evidence - The Intracept Procedure by Boston Scientific Demonstrate clinically and statistically significant improvement in both pain and function · 83% of patients reported a ≥ 2-point reduction in VAS from baseline ...

3. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf122/8245836

1-year results of a prospective real-world cohort study | Pain ... The procedure was associated with substantial reductions in spinal injections and radiofrequency ablations, and a very low rate of lumbar fusion ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772594424000670

Prospective cohort study of basivertebral nerve ablation for ... BVNA demonstrates potential as an effective and minimally invasive treatment for chronic low back pain in a real-world patient cohort where substantial ...

5. utswmed.org utswmed.org/medblog/lower-back-pain-intracept/

New Intracept procedure provides lasting relief for chronic ... In clinical studies, patients reported continued pain relief and functional improvement for longer than six years after treatment. A previous ...

6. relievant.com relievant.com/intracept/

The Intracept Procedure by Boston Scientific The Intracept Procedure is the only procedure specifically designed to target the basivertebral nerve for the relief of chronic vertebrogenic low back pain.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9246496/

Basivertebral Nerve Ablation - PMC - PubMed Central - NIH Overall, several studies have demonstrated the safety and effectiveness of BVA in treating chronic LBP, specifically patients with MC I and II involving L3–S1.

8. bostonscientific.com bostonscientific.com/en-US/medical-specialties/pain-management/intracept.html

The Intracept™ Procedure by Boston Scientific The procedure targets a specific nerve within the vertebra called the basivertebral nerve and has been shown to improve function and relieve pain long-term.

9. sciencedirect.com sciencedirect.com/science/article/pii/S277259442400150X

A 5-year pooled analysis from three prospective clinical trials Results demonstrate that intraosseous BVNA treatment for patients with vertebrogenic pain is safe, effective, and durable through five years.

10. hss.edu hss.edu/health-library/conditions-and-treatments/intracept-procedure-basivertebral-nerve-ablation

Basivertebral Nerve Ablation (Intracept Procedure) Roughly two-thirds of patients said their pain was reduced by 50% and roughly one-third of patients were 100% pain free. In addition, 70% of ...