Low Back Pain
Conditions
Brief summary
The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight. Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.
Detailed description
Participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure. Primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.
Interventions
PROCEDUREIntracept Procedure
radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain
Sponsors
M Squared Associates, Inc.
Relievant Medsystems, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients scheduled for the Intracept procedure and whose treating physician is referring to the registry
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) Reduction | 3 months post procedure | 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 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Score | 3, 12, 24, 36, 48 and 60 months post procedure | Mean reduction in patient reported low back pain from baseline (scale 0 no pain to 10 worst pain imaginable) |
| Combined Responder Rates (improvement thresholds of ODI ≥ 15 and NPS ≥ 2) | 3, 12, 24, 36, 48 and 60 months post procedure | Percent of responders meeting both thresholds |
| Oswestry Disability Index (ODI) improvement | 3, 12, 24, 36, 48 and 60 months post procedure | Mean improvement in ODI scores from baseline (scale 0 to 100) |
| Injections utilization compared to baseline | 3, 12, 24, 36, 48 and 60 months post procedure | Numbers of injections post procedure compared to baseline |
| Post ablation pain interventions/surgeries | 3, 12, 24, 36, 48 and 60 months post procedure | Numbers of pain interventions/surgeries post procedure compared to baseline |
| PROMIS 29 Change | 3, 12, 24, 36, 48 and 60 months post procedure | Mean change in PROMIS-29 from baseline |
Countries
United States
Outcome results
None listed