Back Pain Lower Back, Verteborgenic Low Back Pain
Conditions
Brief summary
The goal of this observational study is to evaluate patient outcomes following treatment of vertebrogenic low back pain using the Stryker OptaBlate BVN System. Patients treated in accordance with the device IFU as part of routine clinical care and who consent to participate will be followed for 12 months after the procedure to assess treatment outcomes.
Interventions
The basivertebral nerve ablation is a minimally invasive, image-guided procedure in which radiofrequency energy is used to ablate the basivertebral nerve within the vertebral body, interrupting pain signals associated with vertebrogenic low back pain.
Sponsors
Stryker Instruments
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for treatment with the OptaBlate BVN System in accordance with the device IFU and willing to participate in the clinical investigation, undergo study procedure, engage in follow-up, able to read, write, speak, and understand English, and able to provide written informed consent.
Exclusion criteria
* The patient meets one or more contraindications as defined in the locally applicable IFU * Spinal fracture or history of spinal trauma at index levels * Previous lumbar fusion at any level * Prior basivertebral nerve ablation at the target levels * Vertebral cancer, spinal metastasis or Tumor-related vertebral fractures * History of Osteoporotic vertebral fractures * Spine interventions, including epidural steroid injections within 30 days * BMI \> 40 kg/m² * Symptomatic spinal stenosis * Radicular pain or leg pain greater than back pain * Pregnancy or planning pregnancy during study period * Enrollment in another interventional clinical trial * Contraindication to MRI * Life expectancy of less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in functional disability, assessed by the mean improvement in Oswestry Disability Index (ODI) score | 3 months post-procedure |
| Incidence and severity of adverse events related to the procedure and/or device. | 12 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oswestry Disability Index (ODI) score | 6 and 12 months post-procedure | — |
| Change in Visual Analogue Score (VAS) | 3, 6 and 12 months post-procedure | — |
| Rate of patients achieving clinical success at 3 months, defined as Oswestry Disability Index (ODI) score improvement ≥10 points and VAS reduction ≥2 cm | 3 months post-procedure | — |
| Change in health-related quality of life (36-item Short Form Survey Instrument (SF-36)) | 3, 6, and 12 months post-procedure | — |
| Change in Pain Medication Dosage for Low Back Pain as Measured by Prescription Dosage Records | 3, 6 and 12 months post-procedure | — |
| Rate of additional procedures (lumbar transforaminal epidural steroid injections, lumbar interlaminar steroid injections, radiofrequency ablations etc.) | 12 months post-procedure | — |
| Imaging assessment - Magnetic Resonance Imaging (MRI) including Mean size of the lesion Rate of subjects with radiographic evidence of targeting success based on lesion location on MRI | 6 weeks post-procedure | — |
| Change in health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)) | 3, 6 and 12 months post-procedure | — |
| Assessment of global patient satisfaction through completion of a brief, non-validated, rating-scale questionnaire. | 3, 6 and 12 months post-procedure | Non-validated, rating-scale questionnaire to assess perceived satisfaction with the treatment received, willingness to undergo the same treatment again for a comparable outcome, and willingness to recommend the treatment to an individual with the same medical condition |
Countries
United States
Outcome results
None listed