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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have not improved after 6 months of standard treatment.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oswestry Disability Index (ODI) Change- 6 Months

Secondary outcome measures

ODI Responder Rate- 12 Months

ODI Responder Rate- 6 Months

Oswestry Disability Index (ODI) Change-12 Months

+4 more

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

0 / 2Eligibility criteria met

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

Lower Back Pain Research Study Groups: Basivertebral Nerve Ablation

Lower 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be the ideal candidates for this research project?

"For this clinical trial, 50 participants who have experienced chronic low back pain for a minimum duration of 6 months and have not benefitted from conservative treatments are needed. The age range should be between 18 to 84 years old."

Answered by AI

Is there an opportunity for enrolment in this clinical experiment at the present time?

"Data published on clinicaltrials.gov indicates that this trial is not currently recruiting participants, as it was first announced in May 2021 and updated most recently in February 2023. Nevertheless, there are 343 other studies actively looking for patients at the moment."

Answered by AI

Does this medical experiment allow for those over 25 to participate?

"This clinical trial is seeking patients aged between 18 and 84. There are 9 trials targeting individuals below the age of majority, while 259 studies target those over 65 years old."

Answered by AI