Browsing by Subject "Chronic low back pain"

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    Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect
    (Oxford University Press, 2023) Wasan, Ajay D.; Edwards, Robert R.; Kraemer, Kevin L.; Jeong, Jong; Kenney, Megan; Luong, Kevin; Cornelius, Marise C.; Mickles, Caitlin; Dharmaraj, Bhagya; Sharif, Essa; Stoltenberg, Anita; Emerick, Trent; Karp, Jordan F.; Bair, Matt J.; George, Steven Z.; Hooten, William M.; Medicine, School of Medicine
    Objective: Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain). Design: A randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders. Setting: A multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers. Methods: Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial. Conclusions: SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone.
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    Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study
    (Springer, 2019-04-30) Fischgrund, Jeffrey S.; Rhyne, Alfred; Franke, Jörg; Sasso, Rick; Kitchel, Scott; Bae, Hyun; Yeung, Christopher; Truumees, Eeric; Schaufele, Michael; Yuan, Philip; Vajkoczy, Peter; DePalma, Michael; Anderson, David G.; Thibodeau, Lee; Meyer, Bernhard; Orthopaedic Surgery, School of Medicine
    PurposeTo evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP.MethodsA total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25–69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months.ResultsAt 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.ConclusionPatients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain.Graphical abstract These slides can be retrieved under Electronic Supplementary Material. Open image in new window
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    Intraosseous basivertebral nerve ablation: A 5-year pooled analysis from three prospective clinical trials
    (Elsevier, 2024-12-13) Khalil, Jad G.; Truumees, Eeric; Macadaeg, Kevin; Nguyen, Daniel T. D.; Moore, Gregory A.; Lukes, Dylan; Fischgrund, Jeffrey; Anesthesia, School of Medicine
    Background: Vertebrogenic pain is a documented source of anterior column chronic low back pain (CLBP) that stems from damaged vertebral endplates. Nociceptive signals are transmitted by the basivertebral nerve (BVN) and endplate damage is observed as Type 1 or Type 2 Modic changes (MC) on magnetic resonance imaging (MRI). The clinical impact and safety of intraosseous radiofrequency ablation of the BVN (BVNA) for the treatment of vertebrogenic pain has been demonstrated in three prospective clinical trials (two randomized and one single-arm study). Objective: Report aggregate long-term BVNA outcomes at five years from three studies. Methods: Pooled results at 5-years post-BVNA are reported for three clinical trials with similar inclusion/exclusion criteria and outcomes measurements: 1) a prospective, open label, single-arm follow-up of the treatment arm of a randomized controlled trial (RCT) comparing BVNA to sham ablation (SMART); 2) a prospective, open label, single-arm follow-up of the treatment arm of an RCT comparing BVNA to standard care (INTRACEPT); and 3) a prospective, open label, single-arm long-term follow-up study of BVNA-treated participants (CLBP Single-Arm). Paired datasets (baseline and 5-years) for mean changes in Oswestry disability index (ODI) and numeric pain scores (NPS) were analyzed using a two-sided paired t-test with a 0.05 level of significance. Secondary outcomes included responder rates, patient satisfaction, adverse events, and healthcare utilization. Results: Two hundred forty-nine (249) of 320 BVNA-treated participants (78 % participation rate) completed a five-year visit (mean of 5.6 years follow-up). At baseline, 71.9 % of these participants reported back pain for ≥5 years, 27.7 % were taking opioids, and 61.8 % had prior therapeutic lumbar spinal injections. Pain and functional improvements were significant at 5-years with a mean improvement in NPS of 4.32 ± 2.45 points (95 % CI 4.01, 4.63; p < 0.0001) from 6.79 ± 1.32 at baseline and a mean improvement in ODI of 28.0 ± 17.5 (95 % CI 25.8, 30.2; p < 0.0001) from 44.5 ± 11.0 at baseline. Nearly one-third (32.1 %) of patients reported being pain-free (NPS = 0) at five years, 72.7 % of patients indicated their condition improved and 68.7 % had resumed activity levels they had prior to onset of CLBP. In the sixty-nine participants taking opioids at baseline, 65.2 % were no longer taking them at 5-years, and spinal injections decreased by 58.1 %. The rate of lumbosacral treatment (therapeutic spinal injection, radiofrequency ablation, or surgery) for the same index pain source and vertebral level was 33/249 (13.2 %) at 5 years post BVNA; including a 6.0 % rate of lumbar fusion. There were no serious device or device-procedure related adverse events reported during the long-term follow-up. Conclusion: In this 5-year aggregate analysis, BVNA significantly improved pain and function scores compared to baseline. Similarly, there were significant reductions in opioid consumption and spinal injections post BVNA. Data demonstrate a strong safety profile with no serious device or device-related events and low healthcare utilization rate for the same index pain source through a mean of 5.6 years. Results demonstrate that intraosseous BVNA treatment for patients with vertebrogenic pain is safe, effective, and durable through five years.