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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.

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.

How is the Intracept Procedure treatment for lower back pain different from other treatments?

The Intracept Procedure is unique because it targets the basivertebral nerve, which is thought to be a source of chronic low back pain, using a minimally invasive approach. This is different from other treatments that may focus on disc issues or structural changes in the spine. ^{1 2 3 4 5}

Research Team

William Schnapp, PhD

Principal Investigator

Owner

Eligibility Criteria

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.

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

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

Exclusion Criteria

I do not have any active infections.

I have severe heart or lung disease.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Anterior lumbar interbody fusion for low back pain]. [2006]

2. China pubmed.ncbi.nlm.nih.gov

[Percutaneous endoscopic lumbar discectomy for treatment of chronic discogenic low back pain]. [2019]

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

Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results. [2023]

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

Intradiscal electrothermal therapy (IDET) for low back pain in worker's compensation patients: can it provide a potential answer? Long-term results. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous endoscopic lumbar herniectomy for high-grade down-migrated L4-L5 disc through an L5-S1 interlaminar approach: a technical note. [2022]