Basivertebral nerve ablation for the treatment of chronic low back pain in a community practice setting: 6 Months follow-up.

Background: Strong innervation of the vertebral endplates by the basivertebral nerve makes it an ideal target for ablation in the treatment of vertebrogenic low back pain with Modic changes. This data represents the clinical outcomes for 16 consecutively treated patients in a community practice setting. Methods: Basivertebral nerve ablations were performed on 16 consecutive patients by a single surgeon (WS) utilizing the INTRACEPT® device (Relievant Medsystems, Inc.). Evaluations were performed at baseline, 1 month, 3 months, and 6 months. The Oswestry Disability Index (ODI), Visual Analog Scale (VAS), and SF-36 were recorded in Medrio electronic data capture software. All patients (n = 16) completed the baseline, 1 month, 3 months, and 6 months follow-up. Results: The ODI, VAS, and SF-36 Pain Component Summary showed statistically significant improvements above minimal clinically important differences at 1 month, 3 months, and 6 months (all p values <0.05). Change in ODI pain impact declined 13.1 points [95% CI: 0.01,27.2] at one month from baseline, 16.5 points [95% CI: 2.5,30.6] at three months from baseline, and 21.1 points [95% CI: 7.0,35.2] six-months from baseline. SF-36 Mental Component Summary also showed some improvements, but with significance only at 3 months (p = 0.0091). Conclusions: Basivertebral nerve ablation appears to be a durable, minimally invasive treatment for the relief of chronic low back pain that can be successfully implemented in a community practice setting. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation.

Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: A Scoping Review of the Literature.

BACKGROUND: Chronic low back pain is a leading cause of disability worldwide and its pathophysiology remains poorly understood, a problem exacerbated by the heterogeneity of the patient population with chronic low back pain. Although the intervertebral discs are often implicated in chronic low back pain, studies have demonstrated strong innervation of the vertebral endplates by the basivertebral nerve, therefore making it a possible target for ablation in the treatment of vertebrogenic chronic low back pain. OBJECTIVES: This work reviews the current evidence for the efficacy and safety of basivertebral nerve ablation as a treatment modality for chronic low back pain, and discusses the possible study biases and gaps in the current knowledge to provide insight on future research. STUDY DESIGN: The authors registered with the Center for Open Sciences and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews  (PRISMA-ScR). SETTING: A private clinic. METHODS: This study was performed in accordance with the following 5-stage methodological framework for scoping reviews: (i) identifying the research question; (ii) identifying relevant studies; (iii) selecting studies; (iv) charting the data; and (v) collating, summarizing and reporting the results. Three databases (PubMed, Web of Science, Embase) were searched using the keywords "basivertebral", "nerve", and "ablation". RESULTS: From March 2002 to March 2022, a total of 47 articles were identified, of which 12 were included in this scoping review, based on the exclusion criteria described in Table 1. LIMITATIONS: The limitations found were: • A very specific chronic pain population is typically utilized for this intervention. The inclusion criteria leave many who experience chronic low back pain ineligible for the procedure. • Study demographics need to be more diversified to truly represent the chronic low back pain population.• There is a lack of true control groups due to high crossover rates in published studies.• Very few high-level or long-term studies have been published.• Funding for many of the studies published on the subject is industry-led (Table 6). With an already limited amount of published research, a need for out-of-industry funding is required to avoid any possibility of bias. CONCLUSIONS: Current research has shown that basivertebral nerve ablation might be a promising treatment for chronic low back pain in patients exhibiting Modic type 1 or 2 endplate changes, while additional research on the association between Modic changes and low back pain is still needed to gain widespread use and acceptance of this new treatment modality. The introduction of new devices and a larger number of independent studies would greatly enhance the confidence in the outcomes reported with this treatment modality in order to ultimately benefit patients, clinicians, and society.

Improved Sensation Resulting From Spinal Cord Stimulation for the Treatment of Painful Diabetic Neuropathy: The Possible Role of Stochastic Resonance.

BACKGROUND: Painful diabetic neuropathy (PDN) is a progressive chronic pain condition that significantly affects the quality of life of patients with long-standing diabetes mellitus. Sensory deficits may result in falls, foot ulceration, and lower limb amputations. Recently, spinal cord stimulation (SCS) was studied for treatment of painful diabetic neuropathy. In addition to pain relief, we were surprised to discover that sensory improvements were also demonstrated. No mechanistic explanation has yet been offered to explain these findings. OBJECTIVES: Sensory improvements were observed in patients during the Senza-PDN clinical trial. Our objective was to offer a hypothesis to explain these results. STUDY DESIGN: The randomized, prospective, multicenter, open-label Senza-PDN clinical trial was aimed at documenting the value of 10 kHz SCS in addition to conventional medical management alone. We formulated an hypothesis to explain the neurologic improvement observed while using SCS in these study patients. SETTING: This work was conducted in a private clinical practice. RESULTS: SCS resulted in an overall decrease in pain for the enrolled PDN patients. An unexpected improvement in neurologic outcomes was also noticed at up to 12 months, which had never been reported before. We hypothesized that stochastic resonance mechanism could explain these sensory improvements. We believe that waveforms delivered to the spinal cord may have had the unexpected effect of creating noise-enhanced signal processing. LIMITATIONS: Further research will have to be performed to confirm the plausibility of the stochastic resonance hypothesis formulated. CONCLUSIONS: SCS might have unexpected benefits in patients with PDN beyond pain reduction. The Senza-PDN trial is the first to describe improved sensation in association with SCS. While the mechanism of action are still unknown, we hypothesize that noise-enhanced signal processing via stochastic resonance may explain these results. Stochastic resonance, or the benefit of additional randomness, should be further studied in the context of spinal cord stimulation. Further, SCS programming that optimizes for stochastic resonance should also be investigated for restoration of sensory and possibly even motor function.

Prevalence of bipolar disorder and schizophrenia in Houston Outreach Medicine, Education, and Social Services (HOMES) Clinic patients: implications for student-managed clinics for underserved populations.

PURPOSE: Psychiatric conditions require aggressive management that is challenging to provide in free clinics. The purpose of this study was to determine the prevalence of certain mental illnesses and comorbid conditions among the patients of a student-managed free clinic for the homeless. METHOD: The authors conducted a retrospective analysis of the records of patients who visited the student-run Houston Outreach Medicine, Education, and Social Services (HOMES) Clinic from May 2007 through May 2008. They assessed the prevalence of bipolar disorder and schizophrenia among patients. They compared demographics, health insurance status, comorbid medical conditions, and social habit data of patients with these mental illnesses with those of other clinic patients. RESULTS: Of 286 patients (74.5% male, mean age 45.8 years), 25 (8.7%) had a diagnosis of schizophrenia and 45 (15.7%) had bipolar disorder. Compared with other clinic patients, patients with bipolar disorder or schizophrenia were less likely to be male (P < .0001) and were more likely to have publicly funded insurance (P = .024). They were also more likely to have certain comorbid conditions, including asthma (P = .0004), seizures (P = .0007), kidney disease (P = .01), and heart disease (P = .02). CONCLUSIONS: The high prevalence of these mental illnesses combined with the increased burden of medical comorbidity among HOMES Clinic patients has implications for student-managed free clinics, which often operate on limited budgets. Strategies for providing care for these patients in this setting include integrated care, street medicine, and case management.

The Mental Health Needs Council of Harris County: a case report on community collaboration and adult mental illness prevalence assessment and service need analysis.

Accurate mental illness prevalence and service needs assessment are critical to the development and delivery of effective mental health programs. Assessment precision and efficient service development and delivery are best facilitated by a close collaboration of all relevant major stakeholders. This report examines the history, mission, and composition of the Mental Health Needs Council of Harris County, Texas. This Council, located in Houston, has for the past 25 years investigated mental health service problems and recommended strategies for their solution. This Council consists of all of Harris County's major public service providers, professional groups and advocacy organizations. This report traces the evolution of the Council's prevalence and needs assessment methodologies. Its current methodologies are examined. These assessment strategies are applicable to other metropolitan areas. The Mental Health Needs Council is a model for effective community collaboration on the needs and problems of persons with mental illness.

Overview of publicly funded managed behavioral health care.

Using MEDLINE and other Internet sources, the authors perform a systematic review of published literature. A total of 109 articles and reports are identified and reviewed that address the development, implementation, outcomes, and trends related to Managed behavioral health care (MBHC). MBHC remains a work in progress. States have implemented their MBHC programs in a number of ways, making interstate comparisons challenging. While managed behavioral health care can lower costs and increase access, ongoing concerns about MBHC include potential incentives to under-treat those with more severe conditions due to the nature of risk-based contracting, the tendency to focus on acute care, difficulties assuring quality and outcomes consistently across regions, and a potential cost-shift to other public agencies or systems. Success factors for MBHC programs appear to include stakeholder involvement in program and policy development, effective contract development and management, and rate adequacy.