scholarly journals Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results

2021 ◽  
pp. rapm-2020-102259
Author(s):  
Matthew Smuck ◽  
Jad Khalil ◽  
Kevin Barrette ◽  
Joshua Adam Hirsch ◽  
Scott Kreiner ◽  
...  

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; p<0.001)), VAS pain improvement (difference of −2.5 cm between arms (CI −3.37 to −1.64, p<0.001)) and quality of life outcomes. At 12 months, basivertebral ablation demonstrated a 25.7±18.5 point reduction in mean ODI (p<0.001), and a 3.8±2.7 cm VAS reduction (p<0.001) from baseline, with 64% demonstrating ≥50% reduction and 29% pain free. Similarly, the former SC patients who elected BVN ablation (92%) demonstrated a 25.9±15.5 point mean ODI reduction (p<0.001) from baseline. The proportion of opioid use did not change in either group (p=0.56).Discussion/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.

2018 ◽  
Vol 11 (3) ◽  
pp. 208 ◽  
Author(s):  
NitinJ Patil ◽  
R Nagaratna ◽  
Padmini Tekur ◽  
PV Manohar ◽  
Hemant Bhargav ◽  
...  

2018 ◽  
Vol 4 (3) ◽  
pp. 153 ◽  
Author(s):  
Vinod K. Podichetty, MD, MS ◽  
Eric S. Varley, DO ◽  
Michelle Secic, MS

Objective: The aim of the study was to identify patient factors that correlate with a strong response to opioid pain medications in low back pain patients.Design: Prospective analysis.Setting: Tertiary Institutional Spine Care Center.Patients, Participants: All patients visiting a tertiary referral spine center with primary diagnosis of low back pain (n = 486) and minimum duration of 6 months.Interventions: Opioid medication.Main Outcome Measures: Analysis factors included visual analog pain scale (VAS), symptom relief scores, and results on 36-item Short Form Health Survey (SF-36). A longitudinal descriptive analysis and a multivariable logistic regression were performed on the results of the VAS and SF-36 scores.Results: The average age of opioid and nonopioid treated patients was 62 years versus 64 years, (p = 0.13) and gender distributions at 53 percent versus 50 percent female (p = 0.43). SF-36 scores were statistically significant and associated with the opioid categorization. For every unit increase in symptom relief score, the likelihood of opioid use is doubled (OR = 2.1, 95 percent CI = 1.5-2.8, p < 0.001); and increased by 25 percent with each 10-point decrease in the social functioning quality of life score (OR = 0.98, 95 percent CI = 0.96-0.99, p = 0.006).Conclusions: Social quality of life and symptom relief measurements comprise the optimal set of independent factors that correlate most strongly with a response to opioid use in low back pain patients.


2003 ◽  
Vol 11 (1) ◽  
pp. 31-38 ◽  
Author(s):  
Olle Hägg ◽  
Carol Burckhardt ◽  
Peter Fritzell ◽  
Anders Nordwall

2012 ◽  
Vol 153 (33) ◽  
pp. 1314-1319
Author(s):  
Julianna Rozália Sallai ◽  
Gábor Héjj ◽  
István †Ratkó ◽  
Aniella Hunka ◽  
Ilona Márkus ◽  
...  

There has been no report on demographic, social and quality of life data of osteoporotic patients attending rheumatology rehabilitation in-patient units in Hungary. Aim: The authors analyzed the data of osteoporotic patients treated in rheumatology rehabilitation departments as in-patients in four hospitals in Hungary. Methods: Demographic and social data were obtained by using a questionnaire developed by the authors, and quality of life was assessed with the use of the SF-36 questionnaire. The quality of life data of osteoporotic patients were compared to that obtained from patients with rheumatoid arthritis, osteoarthrosis and chronic low back pain who were treated in the same department at the same time. Results: Of the 253 patients who were asked to participate in the study, 211 patients filled out the questionnaires. 25.6% of the patients were male. 58% of the patients were younger than 60 years of age, and 40% of them were heavy physical workers earlier. More than 50% of the patients did not complete secondary school education, and only 6.7% of the patients had a per capita monthly income higher than 100 000 HUF. The quality of life of the osteoporotic patients assessed by SF-36 scored 34.7, which was significantly lower than that of the mean of the Hungarian population scoring 70–90. The SF-36 scores of osteoporotic patients were lower in all domains compared to the scores of patients with rheumatoid arthritis, osteoarthritis and low back pain, although the difference was significant only in the domain of physical activity. The affective role of patients with osteoporosis was significantly lower than those with rheumatoid arthritis and osteoarthritis. Conclusions: Osteoporotic patients attending in-patient rheumatology in-patient rehabilitation units in Hungary have poor quality of life comparable, even worse than that found in patients with rheumatoid arthritis, osteoarthritis and chronic low back pain. Orv. Hetil., 2012, 153, 1314–1319.


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