N/A
Completed N=117
Five-Plus Year Follow-Up of SMART Randomized Controlled Trial
Source: ClinicalTrials.gov NCT03997825 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline — 25.95 units on a scale of 0 to 100 points — p=0.001
Summary
The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline |
25.95 | 0.001 sig |
| SECONDARY LS Mean Reduction in VAS From Baseline |
4.38 | 0.001 sig |
| SECONDARY Responder Rates |
75 | — |
| SECONDARY Narcotics Use |
8 | — |
| SECONDARY Injections |
1 | — |
| SECONDARY Interventions |
11 | — |
Eligibility Criteria
Inclusion Criteria
- LBP at least 6 months from original SMART Trial
- RF Ablation Arm from SMART Trial
Exclusion Criteria
-Control Arm Subjects from SMART Trial
Data sourced from ClinicalTrials.gov (NCT03997825). 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. Informational only — not medical advice.