Brief Summary
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
Brief Title
Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
Detailed Description
The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
855-213-9890
Central Contact Email
BSNClinicalTrials@bsci.com
Central Contact Role
Contact
Central Contact Phone
855-213-9890
Central Contact Email
BSNClinicalTrials@bsci.com
Completion Date
Completion Date Type
Estimated
Conditions
CHRONIC LOW-BACK PAIN
VERTEBROGENIC PAIN SYNDROME
Eligibility Criteria
Inclusion Criteria:
* Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
* Signed a valid, IRB/EC-approved informed consent form.
Exclusion Criteria:
* Meets any contraindications per locally applicable Instructions for Use (IFU).
* Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
* Signed a valid, IRB/EC-approved informed consent form.
Exclusion Criteria:
* Meets any contraindications per locally applicable Instructions for Use (IFU).
Inclusion Criteria
Inclusion Criteria:
* Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
* Signed a valid, IRB/EC-approved informed consent form.
* Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
* Signed a valid, IRB/EC-approved informed consent form.
Gender
All
Gender Based
false
Keywords
Intraosseous basivertebral nerve ablation
Axial low back pain
Low Back Pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06827262
Org Class
Industry
Org Full Name
Boston Scientific Corporation
Org Study Id
REL025
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
Primary Outcomes
Outcome Description
The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points.
Outcome Measure
Change in Disability (Oswestry Disability Index (ODI) from Baseline
Outcome Time Frame
60-months post-procedure
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andrew Gitkind
Investigator Email
agitkind@montefiore.org
Investigator Department
Physical Medicine & Rehabilitation
Investigator Division
Pediatric Physical Medicine and Rehabilitation
Investigator Sponsor Organization
External
Study Department
Rehabilitation Medicine
Study Division
Pediatric Physical Medicine and Rehabilitation
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- BACK PAIN
Brain, Spinal Cord & Nervous System --- LOW BACK PAIN
Brain, Spinal Cord & Nervous System --- PAIN
Headaches & Migraine --- PAIN
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
BACK PAIN
LOW BACK PAIN
PAIN
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS