Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Regenerative medicine is a medical subspecialty that seeks to recruit and enhance the body's own inherent healing armamentarium in the treatment of patient pathology. This therapy's intention is to assist in the repair, and to potentially replace or restore damaged tissue through the use of autologous or allogenic biologics. This field is rising like a Phoenix from the ashes of underperforming conventional therapy midst the hopes and high expectations of patients and medical personnel alike. But, because this is a relatively new area of medicine that has yet to substantiate its outcomes, care must be taken in its public presentation and promises as well as in its use. OBJECTIVE: To provide guidance for the responsible, safe, and effective use of biologic therapy in the lumbar spine. To present a template on which to build standardized therapies using biologics. To ground potential administrators of biologics in the knowledge of the current outcome statistics and to stimulate those interested in providing biologic therapy to participate in high quality research that will ultimately promote and further advance this area of medicine. METHODS: The methodology used has included the development of objectives and key questions. A panel of experts from various medical specialties and subspecialties as well as differing regions collaborated in the formation of these guidelines and submitted (if any) their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these guidelines. The literature pertaining to regenerative medicine, its effectiveness, and adverse consequences was thoroughly reviewed using a best evidence synthesis of the available literature. The grading for recommendation was provided as described by the Agency for Healthcare Research and Quality (AHRQ). SUMMARY OF EVIDENCE: Lumbar Disc Injections: Based on the available evidence regarding the use of platelet-rich plasma (PRP), including one high-quality randomized controlled trial (RCT), multiple moderate-quality observational studies, a single-arm meta-analysis and evidence from a systematic review, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best-evidence synthesis. Based on the available evidence regarding the use of medicinal signaling/ mesenchymal stem cell (MSCs) with a high-quality RCT, multiple moderate-quality observational studies, a single-arm meta-analysis, and 2 systematic reviews, the qualitative evidence has been assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Epidural Injections Based on one high-quality RCT, multiple relevant moderate-quality observational studies and a single-arm meta-analysis, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Lumbar Facet Joint Injections Based on one high-quality RCT and 2 moderate-quality observational studies, the qualitative evidence for facet joint injections with PRP has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. Sacroiliac Joint Injection Based on one high-quality RCT, one moderate-quality observational study, and one low-quality case report, the qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis. CONCLUSION: Based on the evidence synthesis summarized above, there is Level III evidence for intradiscal injections of PRP and MSCs, whereas the evidence is considered Level IV for lumbar facet joint, lumbar epidural, and sacroiliac joint injections of PRP, (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis.Regenerative therapy should be provided to patients following diagnostic evidence of a need for biologic therapy, following a thorough discussion of the patient's needs and expectations, after properly educating the patient on the use and administration of biologics and in full light of the patient's medical history. Regenerative therapy may be provided independently or in conjunction with other modalities of treatment including a structured exercise program, physical therapy, behavioral therapy, and along with the appropriate conventional medical therapy as necessary. Appropriate precautions should be taken into consideration and followed prior to performing biologic therapy. Multiple guidelines from the Food and Drug Administration (FDA), potential limitations in the use of biologic therapy and the appropriate requirements for compliance with the FDA have been detailed in these guidelines. KEY WORDS: Regenerative medicine, platelet-rich plasma, medicinal signaling cells, mesenchymal stem cells, stromal vascular fraction, bone marrow concentrate, chronic low back pain, discogenic pain, facet joint pain, Food and Drug Administration, minimal manipulation, evidence synthesis.

Responsible, Safe, and Effective Use of Antithrombotics and Anticoagulants in Patients Undergoing Interventional Techniques: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Interventional pain management involves diagnosis and treatment of chronic pain. This specialty utilizes minimally invasive procedures to target therapeutics to the central nervous system and the spinal column. A subset of patients encountered in interventional pain are medicated using anticoagulant or antithrombotic drugs to mitigate thrombosis risk. Since these drugs target the clotting system, bleeding risk is a consideration accompanying interventional procedures. Importantly, discontinuation of anticoagulant or antithrombotic drugs exposes underlying thrombosis risk, which can lead to significant morbidity and mortality especially in those with coronary artery or cerebrovascular disease. This review summarizes the literature and provides guidelines based on best evidence for patients receiving anti-clotting therapy during interventional pain procedures. STUDY DESIGN: Best evidence synthesis. OBJECTIVE: To provide a current and concise appraisal of the literature regarding an assessment of the bleeding risk during interventional techniques for patients taking anticoagulant and/or antithrombotic medications. METHODS: A review of the available literature published on bleeding risk during interventional pain procedures, practice patterns and perioperative management of anticoagulant and antithrombotic therapy was conducted. Data sources included relevant literature identified through searches of EMBASE and PubMed from 1966 through August 2018 and manual searches of the bibliographies of known primary and review articles. RESULTS: 1. There is good evidence for risk stratification by categorizing multiple interventional techniques into low-risk, moderate-risk, and high-risk. Also, their risk should be upgraded based on other risk factors.2. There is good evidence for the risk of thromboembolic events in patients who interrupt antithrombotic therapy. 3. There is good evidence supporting discontinuation of low dose aspirin for high risk and moderate risk procedures for at least 3 days, and there is moderate evidence that these may be continued for low risk or some intermediate risk procedures.4. There is good evidence that discontinuation of anticoagulant therapy with warfarin, heparin, dabigatran (Pradaxa®), argatroban (Acova®), bivalirudin (Angiomax®), lepirudin (Refludan®), desirudin (Iprivask®), hirudin, apixaban (Eliquis®), rivaroxaban (Xarelto®), edoxaban (Savaysa®, Lixiana®), Betrixaban(Bevyxxa®), fondaparinux (Arixtra®) prior to interventional techniques with individual consideration of pharmacokinetics and pharmacodynamics of the drugs and individual risk factors increases safety.5. There is good evidence that diagnosis of epidural hematoma is based on severe pain at the site of the injection, rapid neurological deterioration, and MRI with surgical decompression with progressive neurological dysfunction to avoid neurological sequelae.6. There is good evidence that if thromboembolic risk is high, low molecular weight heparin bridge therapy can be instituted during cessation of the anticoagulant, and the low molecular weight heparin can be discontinued 24 hours before the pain procedure.7. There is fair evidence that the risk of thromboembolic events is higher than that of epidural hematoma formation with the interruption of antiplatelet therapy preceding interventional techniques, though both risks are significant.8. There is fair evidence that multiple variables including anatomic pathology with spinal stenosis and ankylosing spondylitis; high risk procedures and moderate risk procedures combined with anatomic risk factors; bleeding observed during the procedure, and multiple attempts during the procedures increase the risk for bleeding complications and epidural hematoma.9. There is fair evidence that discontinuation of phosphodiesterase inhibitors is optional (dipyridamole [Persantine], cilostazol [Pletal]. However, there is also fair evidence to discontinue Aggrenox [dipyridamole plus aspirin]) 3 days prior to undergoing interventional techniques of moderate and high risk. 10. There is fair evidence to make shared decision making between the patient and the treating physicians with the treating physician and to consider all the appropriate risks associated with continuation or discontinuation of antithrombotic or anticoagulant therapy.11. There is fair evidence that if thromboembolic risk is high antithrombotic therapy may be resumed 12 hours after the interventional procedure is performed.12. There is limited evidence that discontinuation of antiplatelet therapy (clopidogrel [Plavix®], ticlopidine [Ticlid®], Ticagrelor [Brilinta®] and prasugrel [Effient®]) avoids complications of significant bleeding and epidural hematomas.13. There is very limited evidence supporting the continuation or discontinuation of most NSAIDs, excluding aspirin, for 1 to 2 days and some 4 to 10 days, since these are utilized for pain management without cardiac or cerebral protective effect. LIMITATIONS: The continued paucity of the literature with discordant recommendations. CONCLUSION: Based on the survey of current literature, and published clinical guidelines, recommendations for patients presenting with ongoing antithrombotic therapy prior to interventional techniques are variable, and are based on comprehensive analysis of each patient and the risk-benefit analysis of intervention. KEY WORDS: Perioperative bleeding, bleeding risk, practice patterns, anticoagulant therapy, antithrombotic therapy, interventional techniques, safety precautions, pain.

Interspinous process decompression is associated with a reduction in opioid analgesia in patients with lumbar spinal stenosis.

BACKGROUND: Lumbar spinal stenosis (LSS) causes significant pain and functional impairment, and medical management has increasingly included the prescription of opioid-based analgesics. Interspinous process decompression (IPD) provides a minimally-invasive treatment option for LSS. METHODS: This study estimated the type, dosage, and duration of opioid medications through 5 years of follow-up after IPD with the Superion Indirect Decompression System (Vertiflex Inc., Carlsbad, CA USA). Data were obtained from the Superion-treatment arm of a randomized controlled noninferiority trial. The prevalence of subjects using opiates was determined at baseline through 60 months. Primary analysis included all 190 patients randomized to receive the Superion device. In a subgroup of 98 subjects, we determined opioid-medication prevalence among subjects with a history of opioid use. RESULTS: At baseline, almost 50% (94 of 190) of subjects were using opioid medication. Thereafter, there was a sharp decrease in opioid-medication prevalence from 25.2% (41 of 163) at 12 months to 13.3% (20 of 150) at 24 months to 7.5% (8 of 107) at 60 months. Between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids. A similar pattern was also observed among subjects with a history of opiates prior to entering the trial. CONCLUSION: Stand-alone IPD is associated with a marked decrease in the need for opioid medications to manage symptoms related to LSS. In light of the current opiate epidemic, such alternatives as IPD may provide effective pain relief in patients with LSS without the need for opioid therapy.

Reframing Medicare Physician Payment Policy for 2019: A Look at Proposed Policy.

On July 12, 2018, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2019 Medicare physician fee schedule and quality payment program, combining these 2 rules for the first time. This occurred in a milieu of changing regulations that have been challenging for interventional pain management specialists. The Affordable Care Act (ACA) continuous to be amended by multiple administrative changes. This July 12th rule proposes substantial payment changes for evaluation and management (E&M) services, with documentation requirements, and blending of Level II to V CPT codes for E&M into a single payment. In addition, various changes in the quality payment program with liberalization of some metrics have been published. Recognizing that there are differing impacts based on specialty and practice type, as a whole interventional pain management specialists would likely see favorable reimbursement trends for E&M services as a result of this proposal. Moreover, in comparison with recent CMS final ruling, this proposed rule has relatively limited changes in procedural reimbursement performed in a facility or in-office setting.CMS, in the new rule, has proposed an overhaul of the E&M documentation and coding system ostensibly to reduce the amount of time physicians are required to spend inputting information into patients' records. The new proposed rule blends Level II to V codes for E&M services into a single payment of $93 for office outpatient visits for established patients and $135 for new patient visits. This will also have an effect with blended payments for services provided in hospital outpatients. CMS also has provided additional codes to increase the reimbursement when prolonged services are provided with total reimbursement coming to Level V payments. Interventional pain management-centered care has been identified as a specialty with complexity inherent to E&M associated with these services. Among the procedural payments, there exist significant discrepancies for the services performed in hospitals, ambulatory surgery centers (ASCs), and offices. A particularly egregious example is peripheral neurolytic blocks, which is reimbursed at 1,800% higher in hospital outpatient department (HOPD) settings as compared with procedures done in the office. The majority of hospital based procedures have faced relatively small cuts as compared with office based practice. The only significant change noted is for spinal cord stimulator implant leads when performed in office setting with 19.2% increase. However, epidural codes, which have been initiated with a lower payment, continue to face small reductions for physician portion.This review describes the effects of the proposed policy on interventional pain management reimbursement for E&M services, procedural services by physicians and procedures performed in office settings. KEY WORDS: Physician payment policy, physician fee schedule, Medicare, Merit-Based Incentive Payment System, interventional pain management, regulatory tsunami, Medicare Access and CHIP Reauthorization Act of 2015.

Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE.

BACKGROUND AND OBJECTIVES: This study evaluated the long-term durability of the minimally invasive lumbar decompression (MILD) procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This is a report of 2-year follow-up for MILD study patients. METHODS: This prospective, multicenter, randomized controlled clinical study compared outcomes for 143 patients treated with MILD versus 131 treated with epidural steroid injections. Follow-up occurred at 6 months and at 1 year for the randomized phase and at 2 years for MILD subjects only. Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire were used to evaluate function and pain. Safety was evaluated by assessing incidence of device-/procedure-related adverse events. RESULTS: All outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through 6-month, 1-year, and 2-year follow-ups. At 2 years, Oswestry Disability Index improved by 22.7 points, Numeric Pain Rating Scale improved by 3.6 points, and Zurich Claudication Questionnaire symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. There were no serious device-/procedure-related adverse events, and 1.3% experienced a device-/procedure-related adverse event. CONCLUSIONS: MILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are lower, and safety is higher for MILD versus other lumbar spine interventions, including interspinous spacers, surgical decompression, and spinal fusion. Given the minimally invasive nature of this procedure, its robust success rate, and durability of outcomes, MILD is an excellent choice for first-line therapy for select patients with central spinal stenosis suffering from neurogenic claudication symptoms with hypertrophic ligamentum flavum. CLINICAL TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov, identifier NCT02093520.

Reframing the Prevention Strategies of the Opioid Crisis: Focusing on Prescription Opioids, Fentanyl, and Heroin Epidemic.

The opioid epidemic has been called the "most consequential preventable public health problem in the United States." Though there is wide recognition of the role of prescription opioids in the epidemic, evidence has shown that heroin and synthetic opioids contribute to the majority of opioid overdose deaths. It is essential to reframe the preventive strategies in place against the opioid crisis with attention to factors surrounding the illicit use of fentanyl and heroin. Data on opioid overdose deaths shows 42,000 deaths in 2016. Of these, synthetic opioids other than methadone were responsible for over 20,000, heroin for over 15,000, and natural and semi-synthetic opioids other than methadone responsible for over 14,000. Fentanyl deaths increased 520% from 2009 to 2016 (increased by 87.7% annually between 2013 and 2016), and heroin deaths increased 533% from 2000 to 2016. Prescription opioid deaths increased by 18% overall between 2009 and 2016. The Drug Enforcement Administration (DEA) mandated reductions in opioid production by 25% in 2017 and 20% in 2018. The number of prescriptions for opioids declined significantly from 252 million in 2013 to 196 million in 2017 (9% annual decline over this period), falling below the number of prescriptions in 2006. In addition, data from 2017 shows significant reductions in the milligram equivalence of morphine by 12.2% and in the number of patients receiving high dose opioids by 16.1%. This manuscript describes the escalation of opioid use in the United States, discussing the roles played by drug manufacturers and distributors, liberalization by the DEA, the Food and Drug Administration (FDA), licensure boards and legislatures, poor science, and misuse of evidence-based medicine. Moreover, we describe how the influence of pharma, improper advocacy by physician groups, and the promotion of literature considered peer-reviewed led to the explosive use of illicit drugs arising from the issues surrounding prescription opioids.This manuscript describes a 3-tier approach presented to Congress. Tier 1 includes an aggressive education campaign geared toward the public, physicians, and patients. Tier 2 includes facilitation of easier access to non-opioid techniques and the establishment of a National All Schedules Prescription Electronic Reporting Act (NASPER). Finally, Tier 3 focuses on making buprenorphine more available for chronic pain management as well as for medication-assisted treatment. KEY WORDS: Opioid epidemic, fentanyl and heroin epidemic, prescription opioids, National All Schedules Prescription Electronic Reporting Act (NASPER), Prescription Drug Monitoring Programs (PDMPs).

An Update of the Systematic Appraisal of the Accuracy and Utility of Discography in Chronic Spinal Pain.

BACKGROUND: The intervertebral disc has been implicated as a major cause of chronic spinal pain based on clinical, basic science, and epidemiological research. There is, however, a lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, lumbar intervertebral discs have been shown to be the source of chronic back pain without disc herniation in 26% to 39% of patients, and in 16% to 53% of patients with pain in the cervical spine. Lumbar, cervical, and thoracic provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature on point, intense debate continues about lumbar discography as a diagnostic tool. STUDY DESIGN: A systematic review of the diagnostic accuracy of lumbar, cervical, and thoracic provocation and analgesic discography literature. OBJECTIVE: To systematically assess and re-evaluate the diagnostic accuracy of lumbar, cervical, and thoracic discography. METHODS: The available literature on discography was reviewed. A methodological quality assessment of included studies was performed using the Quality Appraisal of Reliability Studies (QAREL) checklist. Only diagnostic accuracy studies meeting at least 50% of the designated inclusion criteria were included in the analysis. To assess the level of evidence, a modified grading of qualitative evidence criteria was utilized, with grading of evidence into 5 categories from Level I to Level V incorporating evidence obtained from multiple high quality diagnostic accuracy studies for Level I and opinion or consensus of a large group of clinicians and/or scientists for Level V. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to June 2017, and manual searches of the bibliographies of known primary and review articles. RESULTS: Over 100 manuscripts were considered for inclusion. Of these, 8 studies met inclusion criteria for diagnostic accuracy and prevalence with 5 studies assessing lumbar provocation discography and 3 studies assessing cervical discography. The results showed variable prevalence from 16.9% to 26% for discogenic pain and 16.9% to 42% for internal disc disruption. The cervical discogenic pain prevalence ranged from 16% to 53%. Based on methodological quality assessment criteria the strength of evidence for lumbar provocation discography is Level III and for cervical discogenic pain is Level IV. LIMITATIONS: Despite multiple publications in the lumbar spine, value and validity of discography continues to be debated. In reference to cervical and thoracic discography, the available literature and value and validity continues to be low. CONCLUSION: This systematic review illustrates that lumbar provocation discography performed according to the International Association for the Study of Pain (IASP) criteria may be a useful tool for evaluating chronic lumbar discogenic pain. The evidence is weaker for cervical and nonexistent for thoracic discography. KEY WORDS: Lumbar intervertebral disc, cervical intervertebral disc, thoracic intervertebral disc, discography, provocation discography, analgesic discography, diagnostic accuracy, prevalence.

Cost Utility Analysis of Lumbar Interlaminar Epidural Injections in the Treatment of Lumbar Disc Herniation, Central Spinal Stenosis, and Axial or Discogenic Low Back Pain.

BACKGROUND: Cost utility or cost effective analysis continues to take center stage in the United States for defining and measuring the value of treatments in interventional pain management. Appropriate cost utility analysis has been performed for caudal epidural injections, percutaneous adhesiolysis, and spinal cord stimulation. However, the literature pertaining to lumbar interlaminar epidural injections is lacking, specifically in reference to cost utility analysis derived from randomized controlled trials (RCTs) with a pragmatic approach in a practical setting. OBJECTIVES: To assess the cost utility of lumbar interlaminar epidural injections in managing chronic low back and/or lower extremity pain secondary to lumbar disc herniation, spinal stenosis, and axial or discogenic low back pain. STUDY DESIGN: Analysis based on 3 previously published randomized trials of effectiveness of lumbar interlaminar epidural injections assessing their role in disc herniation, spinal stenosis, and axial or discogenic pain. SETTING: A contemporary, private, specialty referral interventional pain management center in the United States. METHODS: Cost utility of lumbar interlaminar epidural injections with or without steroids in managing lumbar disc herniation, central spinal stenosis, and discogenic or axial low back pain was conducted with data derived from 3 RCTs that included a 2-year follow-up, with inclusion of 360 patients. The primary outcome was significant improvement defined as at least a 50% in pain reduction and disability status. Direct payment data from 2016 was utilized for assessment of procedural costs. Overall costs, including drug costs, were determined by multiplication of direct procedural payment data by a factor of 1.6 to accommodate for indirect payments respectively for disc herniation, spinal stenosis, discogenic pain. RESULTS: The results of 3 RCTs showed direct cost utility for one year of quality-adjusted life year (QALY) of $2,050.87 for disc herniation, $2,112.25 for axial or discogenic pain without disc herniation, and $1,773.28 for spinal stenosis, with an average cost per one year QALY of $1,976.58, with total estimated costs of $3,425, $3,527, $2,961, and $3,301 respectively. LIMITATIONS: The limitation of this cost utility analysis includes that it is a single center evaluation, even though 360 patients were included in this analysis. Further, only the costs of interventional procedures and physician visits were assessed based on the data, with extrapolation of indirect costs presenting the overall total costs. The benefits of returning to work were not assessed. CONCLUSION: This cost utility analysis of lumbar interlaminar epidural injections in patients nonresponsive to conservative management in the treatment of disc herniation, central spinal stenosis, and axial or discogenic low back pain in the lumbar spine shows the clinical effectiveness and cost utility of these injections of $1,976.58 for direct costs with a total cost of $3,301 per QALY.

Paresthesia-Independence: An Assessment of Technical Factors Related to 10 kHz Paresthesia-Free Spinal Cord Stimulation.

BACKGROUND: Spinal cord stimulation (SCS) has been successfully used to treat chronic intractable pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation. In a large, prospective, randomized controlled pivotal trial, HF10 therapy was demonstrated to be statistically and clinically superior to paresthesia-based SCS in the treatment of severe chronic low back and leg pain. HF10 therapy, unlike traditional paresthesia-based SCS, requires no paresthesia to be experienced by the patient, nor does it require paresthesia mapping at any point during lead implant or post-operative programming. OBJECTIVES: To determine if pain relief was related to technical factors of paresthesia, we measured and analyzed the paresthesia responses of patients successfully using HF10 therapy. STUDY DESIGN: Prospective, multicenter, non-randomized, non-controlled interventional study. SETTING: Outpatient pain clinic at 10 centers across the US and Italy. METHODS: Patients with both back and leg pain already implanted with an HF10 therapy device for up to 24 months were included in this multicenter study. Patients provided pain scores prior to and after using HF10 therapy. Each patient's most efficacious HF10 therapy stimulation program was temporarily modified to a low frequency (LF; 60 Hz), wide pulse width (~470 mus), paresthesia-generating program. On a human body diagram, patients drew the locations of their chronic intractable pain and, with the modified program activated, all regions where they experienced LF paresthesia. Paresthesia and pain drawings were then analyzed to estimate the correlation of pain relief outcomes to overlap of pain by paresthesia, and the mediolateral distribution of paresthesia (as a surrogate of physiologic midline lead positioning). RESULTS: A total of 61 patients participated across 11 centers. Twenty-eight men and 33 women with a mean age of 56 ± 12 years of age participated in the study. The average duration of implantable pulse generator (IPG) implant was 19 ± 9 months. The average predominant pain score, as measured on a 0 - 10 visual analog scale (VAS), prior to HF10 therapy was 7.8 ± 1.3 and at time of testing was 2.5 ± 2.1, yielding an average pain relief of 70 ± 24%. For all patients, the mean paresthesia coverage of pain was 21 ± 28%, with 43% of patients having zero paresthesia coverage of pain. Analysis revealed no correlation between percentage of LF paresthesia overlap of predominant pain and HF10 therapy efficacy (P = 0.56). Exact mediolateral positioning of the stimulation electrodes was not found to be a statistically significant predictor of pain relief outcomes. LIMITATIONS: Non-randomized/non-controlled study design; short-term evaluation; certain technical factors not investigated. CONCLUSION: Both paresthesia concordance with pain and precise midline positioning of the stimulation contacts appear to be inconsequential technical factors for successful HF10 therapy application. These results suggest that HF10 therapy is not only paresthesia-free, but may be paresthesia-independent.

Evolution of US Health Care Reform.

Major health policy creation or changes, including governmental and private policies affecting health care delivery are based on health care reform(s). Health care reform has been a global issue over the years and the United States has seen proposals for multiple reforms over the years. A successful, health care proposal in the United States with involvement of the federal government was the short-lived establishment of the first system of national medical care in the South. In the 20th century, the United States was influenced by progressivism leading to the initiation of efforts to achieve universal coverage, supported by a Republican presidential candidate, Theodore Roosevelt. In 1933, Franklin D. Roosevelt, a Democrat, included a publicly funded health care program while drafting provisions to Social Security legislation, which was eliminated from the final legislation. Subsequently, multiple proposals were introduced, starting in 1949 with President Harry S Truman who proposed universal health care; the proposal by Lyndon B. Johnson with Social Security Act in 1965 which created Medicare and Medicaid; proposals by Ted Kennedy and President Richard Nixon that promoted variations of universal health care. presidential candidate Jimmy Carter also proposed universal health care. This was followed by an effort by President Bill Clinton and headed by first lady Hillary Clinton in 1993, but was not enacted into law. Finally, the election of President Barack Obama and control of both houses of Congress by the Democrats led to the passage of the Affordable Care Act (ACA), often referred to as "ObamaCare" was signed into law in March 2010. Since then, the ACA, or Obamacare, has become a centerpiece of political campaigning. The Republicans now control the presidency and both houses of Congress and are attempting to repeal and replace the ACA. Key words: Health care reform, Affordable Care Act (ACA), Obamacare, Medicare, Medicaid, American Health Care Act.

A Critical Analysis of Obamacare: Affordable Care or Insurance for Many and Coverage for Few?

The Affordable Care Act (ACA), of 2010, or Obamacare, was the most monumental change in US health care policy since the passage of Medicaid and Medicare in 1965. Since its enactment, numerous claims have been made on both sides of the aisle regarding the ACA's success or failure; these views often colored by political persuasion. The ACA had 3 primary goals: increasing the number of the insured, improving the quality of care, and reducing the costs of health care. One point often lost in the discussion is the distinction between affordability and access. Health insurance is a financial mechanism for paying for health care, while access refers to the process of actually obtaining that health care. The ACA has widened the gap between providing patients the mechanism of paying for healthcare and actually receiving it. The ACA is applauded for increasing the number of insured, quite appropriately as that has occurred for over 20 million people. Less frequently mentioned are the 6 million who have lost their insurance. Further, in terms of how health insurance is been provided, the majority the expansion was based on Medicaid expansion, with an increase of 13 million. Consequently, the ACA hasn't worked well for the working and middle class who receive much less support, particularly those who earn more than 400% of the federal poverty level, who constitute 40% of the population and don't receive any help. As a result, exchange enrollment has been a disappointment and the percentage of workers obtaining their health benefits from their employer has decreased steadily. Access to health care has been uneven, with those on Medicaid hampered by narrow networks, while those on the exchanges or getting employer benefits have faced high out-of-pocket costs.The second category relates to cost containment. President Obama claimed that the ACA provided significant cost containment, in that costs would have been even much higher if the ACA was not enacted. Further, he attributed cost reductions generally to the ACA, not taking into account factors such as the recession, increased out-of-pocket costs, increasing drug prices, and reduced coverage by insurers.The final goal was improvement in quality. The effort to improve quality has led to the creation of dozens of new agencies, boards, commissions, and other government entities. In turn, practice management and regulatory compliance costs have increased. Structurally, solo and independent practices, which lack the capability to manage these new regulatory demands, have declined. Hospital employment, with its associated increased costs, has been soaring. Despite a focus on preventive services in the management of chronic disease, only 3% of health care expenditures have been spent on preventive services while the costs of managing chronic disease continue to escalate.The ACA is the most consequential and comprehensive health care reform enacted since Medicare. The ACA has gained a net increase in the number of individuals with insurance, primarily through Medicaid expansion. The reduction in costs is an arguable achievement, while quality of care has seemingly not improved. Finally, access seems to have diminished.This review attempts to bring clarity to the discussion by reviewing the ACA's impact on affordability, cost containment and quality of care. We will discuss these aspects of the ACA from the perspective of proponents, opponents, and a pragmatic point of view.Key words: Affordable Care Act (ACA), Obamacare, Medicare, Medicaid, Medicare Modernization Act (MMA), cost of health care, quality of health care, Merit-Based Incentive Payments System (MIPS).

Responsible, Safe, and Effective Prescription of Opioids for Chronic Non-Cancer Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines.

BACKGROUND: Opioid use, abuse, and adverse consequences, including death, have escalated at an alarming rate since the 1990s. In an attempt to control opioid abuse, numerous regulations and guidelines for responsible opioid prescribing have been developed by various organizations. However, the US opioid epidemic is continuing and drug dose deaths tripled during 1999 to 2015. Recent data show a continuing increase in deaths due to natural and semisynthetic opioids, a decline in methadone deaths, and an explosive increase in the rates of deaths involving other opioids, specifically heroin and illicit synthetic fentanyl. Contrary to scientific evidence of efficacy and negative recommendations, a significant proportion of physicians and patients (92%) believe that opioids reduce pain and a smaller proportion (57%) report better quality of life. In preparation of the current guidelines, we have focused on the means to reduce the abuse and diversion of opioids without jeopardizing access for those patients suffering from non-cancer pain who have an appropriate medical indication for opioid use. OBJECTIVES: To provide guidance for the prescription of opioids for the management of chronic non-cancer pain, to develop a consistent philosophy among the many diverse groups with an interest in opioid use as to how appropriately prescribe opioids, to improve the treatment of chronic non-cancer pain and to reduce the likelihood of drug abuse and diversion. These guidelines are intended to provide a systematic and standardized approach to this complex and difficult arena of practice, while recognizing that every clinical situation is unique. METHODS: The methodology utilized included the development of objectives and key questions. The methodology also utilized trustworthy standards, appropriate disclosures of conflicts of interest, as well as a panel of experts from various specialties and groups. The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed, with a best evidence synthesis of the available literature, and utilized grading for recommendation as described by the Agency for Healthcare Research and Quality (AHRQ).Summary of Recommendations:i. Initial Steps of Opioid Therapy 1. Comprehensive assessment and documentation. (Evidence: Level I; Strength of Recommendation: Strong) 2. Screening for opioid abuse to identify opioid abusers. (Evidence: Level II-III; Strength of Recommendation: Moderate) 3. Utilization of prescription drug monitoring programs (PDMPs). (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 4. Utilization of urine drug testing (UDT). (Evidence: Level II; Strength of Recommendation: Moderate) 5. Establish appropriate physical diagnosis and psychological diagnosis if available. (Evidence: Level I; Strength of Recommendation: Strong) 6. Consider appropriate imaging, physical diagnosis, and psychological status to collaborate with subjective complaints. (Evidence: Level III; Strength of Recommendation: Moderate) 7. Establish medical necessity based on average moderate to severe (≥ 4 on a scale of 0 - 10) pain and/or disability. (Evidence: Level II; Strength of Recommendation: Moderate) 8. Stratify patients based on risk. (Evidence: Level I-II; Strength of Recommendation: Moderate) 9. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: Level I-II; Strength of Recommendation: Moderate) 10. Obtain a robust opioid agreement, which is followed by all parties. (Evidence: Level III; Strength of Recommendation: Moderate)ii. Assessment of Effectiveness of Long-Term Opioid Therapy 11. Initiate opioid therapy with low dose, short-acting drugs, with appropriate monitoring. (Evidence: Level II; Strength of Recommendation: Moderate) 12. Consider up to 40 morphine milligram equivalent (MME) as low dose, 41 to 90 MME as a moderate dose, and greater than 91 MME as high dose. (Evidence: Level II; Strength of Recommendation: Moderate) 13. Avoid long-acting opioids for the initiation of opioid therapy. (Evidence: Level I; Strength of Recommendation: Strong) 14. Recommend methadone only for use after failure of other opioid therapy and only by clinicians with specific training in its risks and uses, within FDA recommended doses. (Evidence: Level I; Strength of Recommendation: Strong) 15. Understand and educate the patients of the effectiveness and adverse consequences. (Evidence: Level I; Strength of Recommendation: Strong) 16. Similar effectiveness for long-acting and short-acting opioids with increased adverse consequences of long-acting opioids. (Evidence: Level I-II; Strength of recommendation: Moderate to strong) 17. Periodically assess pain relief and/or functional status improvement of ≥ 30% without adverse consequences. (Evidence: Level II; Strength of recommendation: Moderate) 18. Recommend long-acting or high dose opioids only in specific circumstances with severe intractable pain. (Evidence: Level I; Strength of Recommendation: Strong)iii. Monitoring for Adherence and Side Effects 19. Monitor for adherence, abuse, and noncompliance by UDT and PDMPs. (Evidence: Level I-II; Strength of Recommendation: Moderate to strong) 20. Monitor patients on methadone with an electrocardiogram periodically. (Evidence: Level I; Strength of Recommendation: Strong). 21. Monitor for side effects including constipation and manage them appropriately, including discontinuation of opioids when indicated. (Evidence: Level I; Strength of Recommendation: Strong)iv. Final Phase 22. May continue with monitoring with continued medical necessity, with appropriate outcomes. (Evidence: Level I-II; Strength of Recommendation: Moderate) 23. Discontinue opioid therapy for lack of response, adverse consequences, and abuse with rehabilitation. (Evidence: Level III; Strength of Recommendation: Moderate) CONCLUSIONS: These guidelines were developed based on comprehensive review of the literature, consensus among the panelists, in consonance with patient preferences, shared decision-making, and practice patterns with limited evidence, based on randomized controlled trials (RCTs) to improve pain and function in chronic non-cancer pain on a long-term basis. Consequently, chronic opioid therapy should be provided only to patients with proven medical necessity and stability with improvement in pain and function, independently or in conjunction with other modalities of treatments in low doses with appropriate adherence monitoring and understanding of adverse events.Key words: Chronic pain, persistent pain, non-cancer pain, controlled substances, substance abuse, prescription drug abuse, dependency, opioids, prescription monitoring, drug testing, adherence monitoring, diversionDisclaimer: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a "standard of care."

Merit-Based Incentive Payment System (MIPS): Harsh Choices For Interventional Pain Management Physicians.

UNLABELLED: The Merit-based Incentive Payment System (MIPS) was created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to improve the health of all Americans by providing incentives and policies to improve patient health outcomes. MIPS combines 3 existing programs, Meaningful Use (MU), now called Advancing Care Information (ACI), contributing 25% of the composite score; Physician Quality Reporting System (PQRS), changed to Quality, contributing 50% of the composite score; and Value-based Payment (VBP) system to Resource Use or cost, contributing 10% of the composite score. Additionally, Clinical Practice Improvement Activities (CPIA), contributing 15% of the composite score, create multiple strategic goals to design incentives that drive movement toward delivery system reform principles with inclusion of Advanced Alternative Payment Models (APMs). Under the present proposal, the Centers for Medicare and Medicaid Services (CMS) has estimated approximately 30,000 to 90,000 providers from a total of over 761,000 providers will be exempt from MIPS. About 87% of solo practitioners and 70% of practitioners in groups of less than 10 will be subjected to negative payments or penalties ranging from 4% to 9%. In addition, MIPS also will affect a provider's reputation by making performance measures accessible to consumers and third-party physician rating Web sites.The MIPS composite performance scoring method, at least in theory, utilizes weights for each performance category, exceptional performance factors to earn bonuses, and incorporates the special circumstances of small practices.In conclusion, MIPS has the potential to affect practitioners negatively. Interventional Pain Medicine practitioners must understand the various MIPS measures and how they might participate in order to secure a brighter future. KEY WORDS: Medicare Access and CHIP Reauthorization Act of 2015, merit-based incentive payment system, quality performance measures, resource use, clinical practice improvement activities, advancing care information performance category.

MILD® Is an Effective Treatment for Lumbar Spinal Stenosis with Neurogenic Claudication: MiDAS ENCORE Randomized Controlled Trial.

BACKGROUND: Lumbar spinal stenosis (LSS) is a common degenerative condition of the spine, which is a major cause of pain and functional disability for the elderly. Neurogenic claudication symptoms are a hallmark of LSS, where patients develop low back or leg pain when walking or standing that is relieved by sitting or lumbar flexion. The treatment of LSS generally begins with conservative management such as physical therapy, home exercise programs, and oral analgesics. Once these therapies fail, patients commonly move forward with interventional pain treatment options such as epidural steroid injections (ESIs) or MILD® as the next step. OBJECTIVE: To assess improvement of function and reduction in pain for Medicare beneficiaries following treatment with MILD (treatment group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy and to compare to a control group receiving ESIs. STUDY DESIGN: Prospective, multi-center, randomized controlled clinical trial. SETTING: Twenty-six US interventional pain management centers. METHODS: Patients in this trial were randomized one to one into 2 study arms. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Outcomes are assessed using the Oswestry Disability Index (ODI), Numeric Pain Rating Scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the ESI group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of = 10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy is the proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device- or procedure-related adverse events in each group. This report presents safety and efficacy results at 1-year follow-up. Outcomes at 2 years will be collected and reported for patients in the MILD group only. RESULTS: At 1-year follow-up, ODI, NPRS, and all 3 ZCQ domains (Symptom Severity, Physical Function and Patient Satisfaction) demonstrated statistically significant superiority of MILD versus the active control. For primary efficacy, the 58.0% ODI responder rate in the MILD group was higher than the 27.1% responder rate in the epidural steroid group (P < 0.001). The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). LIMITATIONS: There was a lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to adjunctive pain therapy study restrictions. Study enrollment was not limited to patients that had never received ESI therapy. CONCLUSIONS: One-year results of this randomized controlled clinical trial demonstrate that MILD is statistically superior to ESIs in the treatment of LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. Primary and secondary efficacy outcome measures achieved statistical superiority in the MILD group compared to the control group. With 95% of patients in this study presenting with 5 or more LSS co-factors, it is important to note that patients with spinal co-morbidities also experienced statistically significant improved function that was durable through 1 year. KEY WORDS: MILD, minimally invasive lumbar decompression, interlaminar epidural steroid injections, ESI neurogenic claudication, ligamentum flavum, ENCORE, PILD, CED Study, LSS.

Acute Epidural Hematoma Formation in Cervical Spine After Interlaminar Epidural Steroid Injection Despite Discontinuation of Clopidogrel.

BACKGROUND: Perioperative management of patients on anticoagulant therapy prior to interventional pain procedures creates a challenge when balancing the risk of bleeding against thromboembolic events. CASE REPORT: We report a case of epidural hematoma formation in the cervical spine following interlaminar epidural steroid injection in an elderly woman with chronic neck and arm pain, who was on clopidogrel therapy. CONCLUSIONS: This is the first reported case of hematoma formation immediately following an epidural steroid injection possibly associated with clopidogrel, even though established guidelines on the timing of the discontinuation of clopidogrel prior to the procedure were exceeded. Severe pain appears to be the first symptom of hematoma formation, and therefore immediate diagnostic workup and evacuation of hematoma are essential in preventing neurological damage. It may be advisable to carry out a test specific for clopidogrel such as the P2Y12 to ensure that there is no residual action on platelet aggregation function, particularly in patients who may be slow metabolizers of clopidogrel. Caution is advised prior to administering analgesics with antiplatelet effects such as ketorolac.

Physician Quality Reporting System (PQRS) for Interventional Pain Management Practices: Challenges and Opportunities.

Basing their rationale on multiple publications from Institute of Medicine (IOM), specifically Crossing the Quality Chasm, policy makers have focused on a broad range of issues, including assessment of the influence of medical practice organization structures on quality performance and development of quality measures. The 2006 Tax Relief and Health Care Act established the Physician Quality Reporting System (PQRS), to enable eligible professionals to report health care quality and health outcome information that cannot be obtained from standard Medicare claims. However, the Patient Protection and Affordable Care Act (ACA) of 2010 required the Centers for Medicare and Medicaid Services (CMS) to incorporate a combination of cost and quality into the payment systems for health care as a precursor to value-based payments. The final change to PQRS pending initiation after 2018, is based on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) which has incorporated alternative payment models and merit-based payment systems. Recent publication of quality performance scores by CMS has been less than optimal. When voluntary participation began in July 2007, providers were paid a bonus for reporting quality measures from 2008 through 2014, ranging from 0.5% to 2% of the Medicare Part B allowed charges furnished during the reporting period. Starting in 2015, penalties started for nonparticipation. Eligible professionals and group practices that failed to satisfactorily report data on quality measures during 2014 are subject to a 2% reduction in Medicare fee-for-service amounts for services furnished by the eligible professional or group practice during 2016. The CMS proposed rule for 2016 physician payments contained a number of provisions with proposed updates to the PQRS and Physician Value-Based Payment Modifier among other changes. The proposed rule is the first release since MACRA repealed the sustainable growth rate formula. CMS proposed to continue many existing policies regarding PQRS from 2015 to 2016. In addition, 2016 will be the year that is utilized to determine the 2018 PQRS payment adjustment. However, after 2018 the PQRS payment adjustment will be transitioned to the Merit-Based Incentive Payment System (MIPS), as required by MACRA. Overall, there will be over 280 measures in the 2016 PQRS.Readers might be surprised to find out that despite the cost intensity including time requirements personnel, the negative payment adjustments, are only the tip of the iceberg of cost. Indeed, all of the above may only be one-third or one-fourth of the cost to completely implement the PQRS system. Thus far, data across all specialties shows participation to be around 50%. In addition, penalties for lack of reporting of PQRS measures stands to be controversial to the Supreme Court ruling that unfunded mandates must not be permitted and also lack of significant relationships with improvement in quality in the overall analysis in multiple publications.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

BACKGROUND: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. STUDY DESIGN: Prospective, multi-center, randomized controlled clinical trial. SETTING: Twenty-six US interventional pain management centers. OBJECTIVE: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. METHODS: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. OUTCOME MEASURES: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. RESULTS: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). LIMITATIONS: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. CONCLUSIONS: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. CLINICAL TRIAL REGISTRATION: NCT02093520.

MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

BACKGROUND: Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. STUDY DESIGN: Prospective, multi-center, randomized controlled, clinical study. SETTING: Twenty-six interventional pain management centers throughout the United States. OBJECTIVE: To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. METHODS: Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. OUTCOME MEASURES: The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary efficacy outcome measures include the proportion of Zurich Claudication Questionnaire (ZCQ) and Numeric Pain Rating Scale (NPRS) responders from baseline to follow-up using validated MIC thresholds. Improvement in ZCQ domains of ≥ 0.5 is considered significant, and a Patient Satisfaction score of at least 2.5 represents a satisfied patient. A reduction of ≥ 2 points in NPRS is considered significant pain relief. The primary safety outcome measure is the incidence of device- and/or procedure-related adverse events. RESULTS: Descriptive summaries will be presented by randomized group for all outcome measures at baseline and follow-up time points. Inferential statistical analysis will be conducted to determine significant differences related to functional improvement, pain relief, and safety outcomes. Primary study results will be presented based on one-year follow-up data, with an interim analysis report when 6-month follow-up data become available. LIMITATIONS: Patients are not blinded due to significant differences in treatment protocols between study groups. Also, since neither study arm is focused on treatment of radicular pain, there may be a higher non-responder rate for both groups versus standard of care due to study restrictions on adjunctive pain therapies. CONCLUSIONS: This prospective, multi-center, randomized controlled study will provide Level I evidence of the safety and effectiveness of mild versus ESIs in managing neurogenic claudication symptoms in LSS patients.