Intracept Procedure for Lower Back Pain
What You Need to Know Before You Apply
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants are consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit
Treatment
Participants undergo intraosseous basivertebral nerve ablation using the Intracept Procedure
Follow-up
Participants are monitored for safety and effectiveness post-treatment at 1, 3, 6, 12, and 24 months
What Are the Treatments Tested in This Trial?
Interventions
- Intracept Procedure
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neuro Spine and Pain Center of Key West
Lead Sponsor