Chronic Low-back Pain, Vertebrogenic Pain Syndrome
Conditions
Keywords
Intraosseous basivertebral nerve ablation, Axial low back pain, Low Back Pain
Brief summary
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic 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.
Interventions
DEVICEIntracept™ Intraosseous Nerve Ablation
Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability (Oswestry Disability Index (ODI) from Baseline | 60-months post-procedure | 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. |
Countries
United States
Contacts
CONTACTAnn Yamano
CONTACTDiane Keesey
STUDY_DIRECTORNatalie Bloom Lyons, M.A.
Boston Scientific Corporation
Outcome results
None listed