A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Relievant Medsystems, Inc.
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- Oswestry Disability Index (ODI) - 3 Months
Study Overview
Brief Summary
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
Detailed Description
This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Skeletally mature subjects at least 25 years of age
- •Chronic low back pain for at least 6 months
- •Failure to respond to at least 6 months of non-operative conservative management
- •Oswestry Disability Index (ODI) at least 30 points
- •Modic changes Type 1 or 2
Exclusion Criteria
- •Current or history of vertebral cancer or spinal metastasis
- •History of a fragility fracture
- •Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- •Disc extrusion or protrusion
Outcomes
Primary Outcomes
Oswestry Disability Index (ODI) - 3 Months
Time Frame: 3 months
Change in mean Oswestry Disability Index (ODI) total score from baseline to 3 months post-treatment. ODI total score scale of 0 (no disability) to 100 (complete disability), with categories of 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 minimally clinically important difference in ODI from baseline is considered to be a 10 points reduction from baseline.
Secondary Outcomes
- VAS - 12 Month(12 Months)
- ODI Responder Rate - 12-Month(12 Months)
- ODI Responder Rate - 3-Month(3 Months)
- VAS Responder Rate - 12 Months(12 Months)
- Visual Analog Scale (VAS) - 3 Months(3 Months)
- VAS Reduction 50% or More - 12 Month(12 Months)
- VAS Responder Rate - 3 Month(3 Months)
- ODI -12 Months(12 Months)