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Device

Intracept Procedure for Lower Back Pain

Phase 4
Waitlist Available
Led By William Schnapp, PhD
Research Sponsored by Neuro Spine and Pain Center of Key West
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have not responded to at least 6 months of conservative care.
Patients who have experienced chronic low back pain for ≥6 months.
Must not have
Patients with active systemic infection or localized infection in the treatment area.
Patients with severe cardiac or pulmonary disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial studied the safety, effectiveness and satisfaction of a medical procedure for patients with chronic low-back pain.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not detailed here, side effects may include typical risks associated with minimally invasive spinal procedures such as discomfort at the treatment site, infection risk, and potential nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not improved after 6 months of standard treatment.
Select...
I have had chronic low back pain for 6 months or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any active infections.
Select...
I have severe heart or lung disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oswestry Disability Index (ODI) Change- 6 Months
Secondary study objectives
ODI Responder Rate- 12 Months
ODI Responder Rate- 6 Months
Oswestry Disability Index (ODI) Change-12 Months
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Basivertebral Nerve AblationExperimental Treatment1 Intervention
Intraosseous radiofrequency basivertebral nerve ablation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intracept Procedure
2022
N/A
~50

Find a Location

Who is running the clinical trial?

Neuro Spine and Pain Center of Key WestLead Sponsor
William Schnapp, PhDPrincipal InvestigatorOwner

Media Library

Intracept Procedure (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05692440 — Phase 4
Low Back Pain Research Study Groups: Basivertebral Nerve Ablation
Low Back Pain Clinical Trial 2023: Intracept Procedure Highlights & Side Effects. Trial Name: NCT05692440 — Phase 4
Intracept Procedure (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05692440 — Phase 4
~17 spots leftby Jan 2026
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