Low Back Pain
Conditions
Keywords
Basivertebral nerve radiofrequency ablation, Chronic low back pain, Vertebrogenic pain
Brief summary
This is an independent prospective, noninterventional, single arm post market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site.
Detailed description
Participants in the study will have three study visits over a period of one-year (one prior to procedure and 2 post their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 1, 3, 6, and 12, and 24 months. Primary and secondary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index), low back pain reduction (Visual Analog Scale), and physical and mental health pre and post procedure (EQ-5D-5L and SF-36).
Interventions
DEVICEIntracept Procedure
Intraosseous radiofrequency ablation of the basivertebral nerve
Sponsors
Neuro Spine and Pain Center of Key West
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥18 years of age * Patients who have experienced chronic low back pain for ≥6 months. * Patients who have not responded to at least 6 months of conservative care. * Patients with Modic type 1 or 2 changes.
Exclusion criteria
* Patients with severe cardiac or pulmonary disease. * Patients with active systemic infection or localized infection in the treatment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) Change- 6 Months | 6 Months | Validated questionnaire of low back pain related disability. Compromised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a 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). Comparison of mean ODI baseline to 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS)- 6 Months | 6 Months | Change in the mean visual analog scale (VAS) low back pain score from baseline to 6-months post treatment. VAS in a 10-point numeric scale with a 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference is a 50% decrease in VAS from baseline. |
| Visual Analog Scale (VAS)- 12 Months | 12 Months | Change in the mean visual analog scale (VAS) low back pain score from baseline to 12-months post treatment. VAS is a 10-point numeric scale with 0 being no pain and 10 being worst imaginable pain. The minimally clinically important difference is a 50% decrease in VAS from baseline. |
| ODI Responder Rate- 6 Months | 6 Months | Number & percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 6 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally 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 is a 15-point reduction from baseline. |
| Oswestry Disability Index (ODI) Change-12 Months | 12 Months | Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored on a 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). Comparison of mean ODI baseline to 6 months. The minimally clinically important difference is a 15-point reduction from baseline. |
| VAS Responder Rate- 6 Months | 6 Months | Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain at 6 months post treatment. VAS is a patient-reported 10-point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimally clinically important difference in VAS from baseline is a 50% reduction. |
| VAS Responder Rate-12 Months | 12 Months | Number and percentage of participants with a greater than or equal to a 50% reduction from baseline in visual analog scale (VAS) for low back pain at 12 months post treatment. VAS is a patient-reported 10-point numeric pain scale with 0 being no pain and 10 being worst imaginable pain. The minimal clinically important difference in VAS from baseline is a 50% reduction. |
| ODI Responder Rate- 12 Months | 12 Months | Number & percent of patients with greater than or equal to 15-point reduction in Oswestry Disability Index (ODI) from baseline to 12 months post treatment. ODI is scored on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimally 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 is a 15-point reduction from baseline. |
Countries
United States
Outcome results
None listed