Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results
| Autor: | Jad G. Khalil, Theodore Koreckij, Matthew Smuck, Steven R. Garfin, Nagy Mekhail, Joshua A Hirsch, Kevin Barrette, Scott Kreiner |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Visual analogue scale medicine.medical_treatment back pain outcomes law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Clinical endpoint medicine Back pain Humans 030212 general & internal medicine Prospective Studies Original Research Pain Measurement business.industry Chronic pain General Medicine medicine.disease Ablation Interim analysis Oswestry Disability Index Surgery Anesthesiology and Pain Medicine Treatment Outcome Quality of Life medicine.symptom business chronic pain Low Back Pain 030217 neurology & neurosurgery |
| Zdroj: | Regional Anesthesia and Pain Medicine Regional Anesthesia and Pain Medicine, vol 46, iss 8 |
| ISSN: | 1532-8651 1098-7339 |
| Popis: | IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.MethodsProspective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of −20.3 (CI −25.9 to −14.7 points; pDiscussion/ConclusionBVN ablation demonstrates significant improvements in pain and function over SC, with treatment results sustained through 12 months in patients with chronic low back pain of vertebrogenic origin. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|