CLBP Single-Arm Long-Term Follow-up Study
Study Details
Study Description
Brief Summary
This is a prospective, noninterventional, observational post market data collection of long-term effectiveness and satisfaction outcomes for "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Study)" population at three (3), four (4), and five (5) years post Intracept Procedure. The working hypothesis is that data collected in this study will demonstrate safety, efficacy, durability and reproducibility of BVN ablation treatment outcomes out to 3, 4, and 5-years post-procedure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Basivertebral nerve ablation treatment Patient-reported outcomes at three (3) follow-up visits for previously treated participants from the CLBP Single-Arm study. |
Device: Intracept Procedure
Intraosseous Basivertebral Nerve (BVN) Ablation
|
Outcome Measures
Primary Outcome Measures
- Mean improvement in Oswestry Disability Index (ODI) from baseline to 3 years post Intracept procedure [Difference between baseline and 3-year post treatment measurements.]
Oswestry Disability Index (100-point scale, "0" being the least disability and "100" being the worst degree of disability/function)
- Mean improvement in ODI from baseline to 4 years post Intracept procedure [Difference between baseline and 4-year post treatment measurements.]
- Mean improvement in ODI from baseline to 5 years post Intracept procedure [Difference between baseline and 5-year post treatment measurements.]
Secondary Outcome Measures
- Mean reduction in patient-reported numeric pain score from baseline for each timepoint. [3+ years, 4-years and 5-years post procedure]
10-point Numeric pain score (based on VAS): "0" representing no pain and "10" representing the worst pain imaginable.
- Responder rates for ODI: proportion of subjects who achieve ≥ 10-Point, ≥ 15-point and ≥ 20-point reduction in ODI from baseline for each timepoint [3+ years, 4-years and 5-years post procedure]
- Responder rates for Numeric Pain Score: proportion of subjects who achieve a ≥ 2.0-point reduction in NPS from baseline for each timepoint [3+ years, 4-years and 5-years post procedure]
- Number and proportion of subjects in each quartile (≤ 24%, 25-49%, 50-74%, 75-100%) for percent Numeric Pain Score reduction (in LBP) from baseline for each timepoint [3+ years, 4-years and 5-years post procedure]
- Composite responder rate at each timepoint defined as: 1) ODI decrease of ≥ 15 2) NPS decrease of ≥ 2 [3+ years, 4-years and 5-years post procedure]
- Composite responder rate at each timepoint defined as: 1) ODI decrease of ≥ 15 2) NPS decrease of greater than 50% [3+ years, 4-years and 5-years post procedure]
- Composite endpoint of long-term treatment success at each timepoint defined as: [3+ years, 4-years and 5-years post procedure]
ODI decrease of ≥15 NPS decrease of ≥2 No injections for the same low back pain etiology and location as treatment location No pain intervention or surgery for the same low back pain etiology and location as treatment location
- The number and proportion of subjects with surgical interventions for low back pain of the same treatment region post the Intracept procedure at each timepoint [3+ years, 4-years and 5-years post procedure]
- The number and proportion of subjects actively utilizing (defined as >25% of total dosage in 30 days prior to study visit) opioids for low back pain of the same treatment region at each timepoint [3+ years, 4-years and 5-years post procedure]
- The number and proportion of subjects utilizing injections since the last study visit for low back pain of the same treatment region at each timepoint [3+ years, 4-years and 5-years post procedure]
- Work impact: number of missed workdays in past 30 days at each timepoint [3+ years, 4-years and 5-years post procedure]
- Patient satisfaction with the Intracept Procedure at each timepoint [3+ years, 4-years and 5-years post procedure]
Non-validated questionnaire about degree of improvement (improved, no change, worsened), satisfaction with treatment (yes/no) and willingness to repeat the treatment (yes/no).
- Work impact: number of days in bed in past 30 days [3+ years, 4-years and 5-years post procedure]
Other Outcome Measures
- Ongoing safety [3+ years, 4-years and 5-years post procedure]
Serious adverse events potentially related to the procedure, device, or the spine will be reported and evaluated for relatedness
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient received the Intracept procedure while participating in "A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain (CLBP Single-Arm Long-Term Study)"
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana Spine Group | Carmel | Indiana | United States | 46032 |
| 2 | Seton Healthcare Family | Austin | Texas | United States | 78731 |
Sponsors and Collaborators
- Relievant Medsystems, Inc.
- M Squared Associates,Inc.
Investigators
- Principal Investigator: Kevin Macadaeg, MD, Indiana Spine Group
- Principal Investigator: Eeric Truumees, MD, Seton Spine and Scoliosis Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP0015