N/A
N=50
Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain
Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03266107 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Oswestry Disability Index (ODI) - 3 Months — -30.33 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intracept (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Relievant Medsystems, Inc.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oswestry Disability Index (ODI) - 3 Months |
-30.33 | <0.001 sig |
| SECONDARY Visual Analog Scale (VAS) - 3 Months |
-3.79 | <0.001 sig |
| SECONDARY ODI Responder Rate - 3-Month |
42 | — |
| SECONDARY VAS Responder Rate - 3 Month |
36 | — |
| SECONDARY ODI -12 Months |
-32.31 | <0.001 sig |
| SECONDARY VAS - 12 Month |
-4.31 | — |
| SECONDARY ODI Responder Rate - 12-Month |
40 | — |
| SECONDARY VAS Responder Rate - 12 Months |
36 | — |
| SECONDARY VAS Reduction 50% or More - 12 Month |
31 | — |
Summary
Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03266107). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.