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Procedure

BVN Ablation for Chronic Lower Back Pain (CLBP Trial)

N/A
Waitlist Available
Led By Steven R Garfin, MD
Research Sponsored by Relievant Medsystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Skeletally mature subjects at least 25 years of age
Chronic lower back pain for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

CLBP Trial Summary

This trial is comparing a new treatment for back pain (BVN ablation) to standard care. If the new treatment is better, participants in the control group will be offered it after 12 months.

Who is the study for?
This trial is for adults at least 25 years old who have had chronic lower back pain for over six months and haven't improved with non-surgical treatments. It's not suitable for pregnant individuals, those with certain types of back conditions, or anyone expecting to become pregnant within a year.Check my eligibility
What is being tested?
The INTRACEPT study is testing the Intracept System, which uses radiofrequency to target a nerve in the spine thought to cause chronic low back pain. Participants are randomly chosen to either receive this new treatment or continue standard care without surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, procedures like the Intracept System can potentially cause discomfort at the treatment site, infection risk, and temporary increase in back pain.

CLBP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 25 years old and my bones have stopped growing.
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I have had lower back pain for at least 6 months.
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My condition did not improve after 6 months of non-surgical treatment.

CLBP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
Secondary outcome measures
Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)

CLBP Trial Design

2Treatment groups
Active Control
Group I: Standard Care ControlActive Control1 Intervention
Continue with non-surgical standard care
Group II: BVN AblationActive Control1 Intervention
BVN ablation with continued standard care

Find a Location

Who is running the clinical trial?

Relievant Medsystems, Inc.Lead Sponsor
7 Previous Clinical Trials
464 Total Patients Enrolled
Steven R Garfin, MDPrincipal InvestigatorIndependent

Media Library

Intracept System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03246061 — N/A
Chronic Lower Back Pain Research Study Groups: Standard Care Control, BVN Ablation
Chronic Lower Back Pain Clinical Trial 2023: Intracept System Highlights & Side Effects. Trial Name: NCT03246061 — N/A
Intracept System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03246061 — N/A
Chronic Lower Back Pain Patient Testimony for trial: Trial Name: NCT03246061 — N/A

Frequently Asked Questions

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

In what capacity is this trial being conducted across various sites?

"18 sites are currently recruiting participants for this medical study. Notable clinics include St Luke's Hospital in Kansas City, Clinical Investigations in Edmond and Temple University of Philadelphia with other 15 locations also available."

Answered by AI

Is this trial open to individuals below the age of 45?

"This medical trial is only recruiting participants aged 25 to 70. However, prospective patients who are younger than that can find 11 other clinical trials for their age group and those older than the upper limit have access to 264 different studies."

Answered by AI

Does my health profile meet the criteria for inclusion in this experiment?

"A cohort of 140 individuals, aged 25 to 70 and experiencing chronic back pain lasting more than 6 months, will be enrolled in this medical trial. Additionally, these patients must have failed non-operative conservative management for a minimum period of half a year."

Answered by AI

Is the trial currently open to enrollment?

"As per the information found on clinicaltrials.gov, this trial is not currently enrolling participants. Initially posted in August 2017 and last updated in August 2022, no new patients are being admitted at present; however, 333 other trials remain actively recruiting for volunteers to join their medical study."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
Colorado
Other
California
How old are they?
18 - 65
65+
What site did they apply to?
Keck Medicine of USC
Denver Back Specialists
Other
Rush University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

40 years of chronic back pain. I'll do anything to help with my back pain and whoever may benefit from it.
PatientReceived 2+ prior treatments
I have tried several drugs and treatments. They helped yet, the pain is back I was advised to have a gel inserted.
PatientReceived 1 prior treatment
Treatments for chronic pain caused by degenerative discs in L4-L5 and L5-S1 have included PT, pain meds, epidurals, RFA and others, none of which have provided relief. Because I’m approaching the cutoff age of 80 for most investigational studies, yours may be my last hope for a novel solution.
PatientReceived 1 prior treatment
I’ve tried a number of drugs, including Morphine, other opiates, and muscle relaxers. I’ve tried deep steroid shots to no avail. We tried ablation a few years ago with no results. Tylenol takes a little bit of edge off, not much, though, than all the heavy meds. My back pain stops me from doing much with my family, or even taking walks.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
2017. "INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03246061.
~18 spots leftby Apr 2025
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