24 research outputs found
Comprehensive, Evidence-Based, Consensus Guidelines for Prescription of Opioids for Chronic Non-Cancer Pain from the American Society of Interventional Pain Physicians (ASIPP).
BACKGROUND: Opioid prescribing in the United States is decreasing, however, the opioid epidemic is continuing at an uncontrollable rate. Available data show a significant number of opioid deaths, primarily associated with illicit fentanyl use. It is interesting to also note that the data show no clear correlation between opioid prescribing (either number of prescriptions or morphine milligram equivalent [MME] per capita), opioid hospitalizations, and deaths. Furthermore, the data suggest that the 2016 guidelines from the Centers for Disease Control and Prevention (CDC) have resulted in notable problems including increased hospitalizations and mental health disorders due to the lack of appropriate opioid prescribing as well as inaptly rapid tapering or weaning processes. Consequently, when examined in light of other policies and complications caused by COVID-19, a fourth wave of the opioid epidemic has been emerging.
OBJECTIVES: In light of this, we herein seek to provide guidance for the prescription of opioids for the management of chronic non-cancer pain. These clinical practice guidelines are based upon a systematic review of both clinical and epidemiological evidence and have been developed by a panel of multidisciplinary experts assessing the quality of the evidence and the strength of recommendations and offer a clear explanation of logical relationships between various care options and health outcomes.
METHODS: The methods utilized included the development of objectives and key questions for the various facets of opioid prescribing practice. Also utilized were employment of trustworthy standards, and appropriate disclosures of conflicts of interest(s). The literature pertaining to opioid use, abuse, effectiveness, and adverse consequences was reviewed. The recommendations were developed after the appropriate review of text and questions by a panel of multidisciplinary subject matter experts, who tabulated comments, incorporated changes, and developed focal responses to questions posed. The multidisciplinary panel finalized 20 guideline recommendations for prescription of opioids for chronic non-cancer pain. Summary of the results showed over 90% agreement for the final 20 recommendations with strong consensus. The consensus guidelines included 4 sections specific to opioid therapy with 1) ten recommendations particular to initial steps of opioid therapy; 2) five recommendations for assessment of effectiveness of opioid therapy; 3) three recommendations regarding monitoring adherence and side effects; and 4) two general, final phase recommendations.
LIMITATIONS: There is a continued paucity of literature of long-term opioid therapy addressing chronic non-cancer pain. Further, significant biases exist in the preparation of guidelines, which has led to highly variable rules and regulations across various states.
CONCLUSION: These guidelines were developed based upon a comprehensive review of the literature, consensus among expert panelists, and in alignment with patient preferences, and shared decision-making so as to improve the long-term pain relief and function in patients with chronic non-cancer pain. Consequently, it was concluded - and herein recommended - that chronic opioid therapy should be provided in low doses with appropriate adherence monitoring and understanding of adverse events only to those patients with a proven medical necessity, and who exhibit stable improvement in both pain relief and activities of daily function, either independently or in conjunction with other modalities of treatments
Bone Marrow Concentrate (BMC) Therapy in Musculoskeletal Disorders: Evidence-Based Policy Position Statement of American Society of Interventional Pain Physicians (ASIPP)
BACKGROUND: The use of bone marrow concentrate (BMC) for treatment of musculoskeletal disorders has become increasingly popular over the last several years, as technology has improved along with the need for better solutions for these pathologies. The use of cellular tissue raises a number of issues regarding the US Food and Drug Administration\u27s (FDA) regulation in classifying these treatments as a drug versus just autologous tissue transplantation. In the case of BMC in musculoskeletal and spine care, this determination will likely hinge on whether BMC is homologous to the musculoskeletal system and spine.
OBJECTIVES: The aim of this review is to describe the current regulatory guidelines set in place by the FDA, specifically the terminology around minimal manipulation and homologous use within Regulation 21 CFR Part 1271, and specifically how this applies to the use of BMC in interventional musculoskeletal medicine.
METHODS: The methodology utilized here is similar to the methodology utilized in preparation of multiple guidelines employing the experience of a panel of experts from various medical specialties and subspecialties from differing regions of the world. The collaborators who developed these position statements have submitted their appropriate disclosures of conflicts of interest. Trustworthy standards were employed in the creation of these position statements. The literature pertaining to BMC, its effectiveness, adverse consequences, FDA regulations, criteria for meeting the standards of minimal manipulation, and homologous use were comprehensively reviewed using a best evidence synthesis of the available and relevant literature. RESULTS/Summary of Evidence: In conjunction with evidence-based medicine principles, the following position statements were developed: Statement 1: Based on a review of the literature in discussing the preparation of BMC using accepted methodologies, there is strong evidence of minimal manipulation in its preparation, and moderate evidence for homologous utility for various musculoskeletal and spinal conditions qualifies for the same surgical exemption. Statement 2: Assessment of clinical effectiveness based on extensive literature shows emerging evidence for multiple musculoskeletal and spinal conditions. • The evidence is highest for knee osteoarthritis with level II evidence based on relevant systematic reviews, randomized controlled trials and nonrandomized studies. There is level III evidence for knee cartilage conditions. • Based on the relevant systematic reviews, randomized trials, and nonrandomized studies, the evidence for disc injections is level III. • Based on the available literature without appropriate systematic reviews or randomized controlled trials, the evidence for all other conditions is level IV or limited for BMC injections. Statement 3: Based on an extensive review of the literature, there is strong evidence for the safety of BMC when performed by trained physicians with the appropriate precautions under image guidance utilizing a sterile technique. Statement 4: Musculoskeletal disorders and spinal disorders with related disability for economic and human toll, despite advancements with a wide array of treatment modalities. Statement 5: The 21st Century Cures Act was enacted in December 2016 with provisions to accelerate the development and translation of promising new therapies into clinical evaluation and use. Statement 6: Development of cell-based therapies is rapidly proliferating in a number of disease areas, including musculoskeletal disorders and spine. With mixed results, these therapies are greatly outpacing the evidence. The reckless publicity with unsubstantiated claims of beneficial outcomes having putative potential, and has led the FDA Federal Trade Commission (FTC) to issue multiple warnings. Thus the US FDA is considering the appropriateness of using various therapies, including BMC, for homologous use. Statement 7: Since the 1980\u27s and the description of mesenchymal stem cells by Caplan et al, (now called medicinal signaling cells), the use of BMC in musculoskeletal and spinal disorders has been increasing in the management of pain and promoting tissue healing. Statement 8: The Public Health Service Act (PHSA) of the FDA requires minimal manipulation under same surgical procedure exemption. Homologous use of BMC in musculoskeletal and spinal disorders is provided by preclinical and clinical evidence. Statement 9: If the FDA does not accept BMC as homologous, then it will require an Investigational New Drug (IND) classification with FDA (351) cellular drug approval for use. Statement 10: This literature review and these position statements establish compliance with the FDA\u27s intent and corroborates its present description of BMC as homologous with same surgical exemption, and exempt from IND, for use of BMC for treatment of musculoskeletal tissues, such as cartilage, bones, ligaments, muscles, tendons, and spinal discs.
CONCLUSIONS: Based on the review of all available and pertinent literature, multiple position statements have been developed showing that BMC in musculoskeletal disorders meets the criteria of minimal manipulation and homologous use.
KEY WORDS: Cell-based therapies, bone marrow concentrate, mesenchymal stem cells, medicinal signaling cells, Food and Drug Administration, human cells, tissues, and cellular tissue-based products, Public Health Service Act (PHSA), minimal manipulation, homologous use, same surgical procedure exemption
Epidural Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Comprehensive Evidence-Based Guidelines.
BACKGROUND: Chronic spinal pain is the most prevalent chronic disease with employment of multiple modes of interventional techniques including epidural interventions. Multiple randomized controlled trials (RCTs), observational studies, systematic reviews, and guidelines have been published. The recent review of the utilization patterns and expenditures show that there has been a decline in utilization of epidural injections with decrease in inflation adjusted costs from 2009 to 2018. The American Society of Interventional Pain Physicians (ASIPP) published guidelines for interventional techniques in 2013, and guidelines for facet joint interventions in 2020. Consequently, these guidelines have been prepared to update previously existing guidelines.
OBJECTIVE: To provide evidence-based guidance in performing therapeutic epidural procedures, including caudal, interlaminar in lumbar, cervical, and thoracic spinal regions, transforaminal in lumbar spine, and percutaneous adhesiolysis in the lumbar spine.
METHODS: The methodology utilized included the development of objective and key questions with utilization of trustworthy standards. The literature pertaining to all aspects of epidural interventions was viewed with best evidence synthesis of available literature and recommendations were provided.
RESULTS: In preparation of the guidelines, extensive literature review was performed. In addition to review of multiple manuscripts in reference to utilization, expenditures, anatomical and pathophysiological considerations, pharmacological and harmful effects of drugs and procedures, for evidence synthesis we have included 47 systematic reviews and 43 RCTs covering all epidural interventions to meet the objectives.The evidence recommendations are as follows: Disc herniation: Based on relevant, high-quality fluoroscopically guided epidural injections, with or without steroids, and results of previous systematic reviews, the evidence is Level I for caudal epidural injections, lumbar interlaminar epidural injections, lumbar transforaminal epidural injections, and cervical interlaminar epidural injections with strong recommendation for long-term effectiveness.The evidence for percutaneous adhesiolysis in managing disc herniation based on one high-quality, placebo-controlled RCT is Level II with moderate to strong recommendation for long-term improvement in patients nonresponsive to conservative management and fluoroscopically guided epidural injections. For thoracic disc herniation, based on one relevant, high-quality RCT of thoracic epidural with fluoroscopic guidance, with or without steroids, the evidence is Level II with moderate to strong recommendation for long-term effectiveness.Spinal stenosis: The evidence based on one high-quality RCT in each category the evidence is Level III to II for fluoroscopically guided caudal epidural injections with moderate to strong recommendation and Level II for fluoroscopically guided lumbar and cervical interlaminar epidural injections with moderate to strong recommendation for long-term effectiveness.The evidence for lumbar transforaminal epidural injections is Level IV to III with moderate recommendation with fluoroscopically guided lumbar transforaminal epidural injections for long-term improvement. The evidence for percutaneous adhesiolysis in lumbar stenosis based on relevant, moderate to high quality RCTs, observational studies, and systematic reviews is Level II with moderate to strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections. Axial discogenic pain: The evidence for axial discogenic pain without facet joint pain or sacroiliac joint pain in the lumbar and cervical spine with fluoroscopically guided caudal, lumbar and cervical interlaminar epidural injections, based on one relevant high quality RCT in each category is Level II with moderate to strong recommendation for long-term improvement, with or without steroids. Post-surgery syndrome: The evidence for lumbar and cervical post-surgery syndrome based on one relevant, high-quality RCT with fluoroscopic guidance for caudal and cervical interlaminar epidural injections, with or without steroids, is Level II with moderate to strong recommendation for long-term improvement. For percutaneous adhesiolysis, based on multiple moderate to high-quality RCTs and systematic reviews, the evidence is Level I with strong recommendation for long-term improvement after failure of conservative management and fluoroscopically guided epidural injections.
LIMITATIONS: The limitations of these guidelines include a continued paucity of high-quality studies for some techniques and various conditions including spinal stenosis, post-surgery syndrome, and discogenic pain.
CONCLUSIONS: These epidural intervention guidelines including percutaneous adhesiolysis were prepared with a comprehensive review of the literature with methodologic quality assessment and determination of level of evidence with strength of recommendations
Is epidural injection of sodium chloride solution a true placebo or an active control agent? A systematic review and meta-analysis
Background: Epidural injections have been extensively used since their description in 1901, and steroids since their first utilization in 1952. Multiple randomized controlled trials and systematic reviews have reached discordant conclusions regarding the effectiveness of sodium chloride solution and steroids in managing spinal pain. True placebo-controlled trials with the injection of an inactive substance to unrelated structures have been nonexistent. Consequently, the discussions continue to escalate, seemingly without proper discourse. In this review, we sought to assess the true placebo nature of saline and the effectiveness of steroids.
Objectives: This assessment of sodium chloride solution is undertaken to assess if it is a true placebo when injected into the epidural space, is effective alone, and whether steroids are effective when injected with sodium chloride solution rather than local anesthetic in managing spinal pain.
Study design: A systematic review of randomized controlled trials utilizing sodium chloride solution alone, steroids alone, or sodium chloride solution with steroids in managing spinal pain secondary to disc herniation or spinal stenosis.
Methods: The systematic review was performed utilizing Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Cochrane review criteria and Interventional Pain Management techniques--Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) was used to assess the methodological quality assessment. Qualitative analysis was performed by utilizing best evidence synthesis principles, and quantitative analysis was performed utilizing meta-analysis with conventional methodology and single-arm meta-analysis. PubMed, Cochrane Library, US National Guideline Clearinghouse, Google Scholar, and prior systematic reviews and reference lists were utilized in the literature search from 1966 through December 2018. The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. Outcome measures for the present analysis, 20% improvement from the baseline pain scores or disability scores was considered clinically significant. Effectiveness was determined short-term if it was less than 6 months, whereas longer than 6 months was considered to be long-term.
Results: Of the 8 trials meeting inclusion criteria, 2 trials utilized fluoroscopic imaging and one study utilized ultrasound. All other studies performed the procedure without fluoroscopy. With dual-arm meta-analysis, there was no significant difference between epidural sodium chloride solution and epidural steroids with sodium chloride solution. Utilizing single-arm analysis, both epidural saline and epidural steroids with saline were effective in reducing 20% of pain, however, only reducing disability scores by 10% to 12%. Based on the qualitative analysis, epidural saline and epidural steroids with saline showed effect beyond placebo and showed level I, or strong evidence, that neither epidural saline, nor epidural steroids with saline are placebo and that both are effective.
Limitations: Despite 8 randomized controlled trials, only 2 of them utilized fluoroscopy. Overall evidence is considered less than optimal and further studies elucidating these actions are strongly recommended.
Conclusions: The findings of this systematic review and meta-analysis show that epidurally administered sodium chloride solution and sodium chloride solution with steroids may be effective in managing low back and lower extremity pain. Consequently, the findings of this review provide information that epidurally administered sodium chloride solution is not a true placebo
Is percutaneous adhesiolysis effective in managing chronic low back and lower extremity pain in post-surgery syndrome: A systematic review and meta-analysis
Purpose of review: The growing prevalence of spinal pain in the USA continues to produce substantial economic impact and strain on health-related quality of life. Percutaneous adhesiolysis is utilized for recalcitrant, resistant conditions involving spinal pain when epidural injections have failed to provide adequate improvement, especially low back and lower extremity pain, specifically in post-lumbar surgery syndrome. Despite multiple publications and systematic reviews, the debate continues in reference to effectiveness, safety, appropriate utilization, and medical necessity of percutaneous adhesiolysis in chronic pain. This systematic review, therefore, was undertaken to evaluate and to update effectiveness of percutaneous adhesiolysis to treat chronic refractory low back and lower extremity pain, post-surgical patients of the lumbar spine.
Recent findings: From 2009 to 2016, there was a decline of 53.2% utilization of percutaneous adhesiolysis with an annual decline of 10.3% per 100,000 fee-for-service (FFS) Medicare population. Multiple insurers, including Medicare, with Medicare area contractors of Noridian and Palmetto have issued noncoverage policies for percutaneous adhesiolysis resulting in these steep declines and continued noncoverage by Medicare Advantage plans, Managed Care plans of Medicaid, and other insurers. Since 2005, 4 systematic reviews of percutaneous adhesiolysis were published with 3 of them showing proper methodology and appropriate results with effectiveness of adhesiolysis, whereas one poorly performed systematic review showed negative results. In addition, there were only 4 randomized controlled trials (RCTs) to be included in the previous systematic reviews of post-surgery syndrome, whereas now, the RCTs and other studies have increased. This systematic review shows level I or strong evidence for the effectiveness of percutaneous adhesiolysis in managing chronic low back and lower extremity pain related to post-lumbar surgery syndrome
Efficacy of Percutaneous Adhesiolysis in Managing Low Back and Lower Extremity Pain: A Systematic Review and Meta-analysis of Randomized Controlled Trials
Abstract Introduction Chronic refractory low back and lower extremity pain recalcitrant to conservative management and epidural injections secondary to postsurgery syndrome, spinal stenosis, and disc herniation are sometimes managed with percutaneous adhesiolysis. Consequently, this systematic review and meta-analysis was undertaken to assess the efficacy of percutaneous adhesiolysis in managing low back and lower extremity pain. Methods A systematic review and meta-analysis of randomized controlled trials (RCTs) utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was performed. A comprehensive literature search of multiple databases from 1966 to July 2022, including manual searches of the bibliography of known review articles was performed. Quality assessment of the included trials, meta-analysis, and best evidence synthesis was performed. The primary outcome measure was a significant reduction in pain (short term up to 6Â months and long term more than 6Â months). Results The search identified 26 publications, with 9 trials meeting the inclusion criteria. The results of dual-arm and single-arm analyses showed significant improvement in pain and function at 12Â months. Opioid consumption was also significantly reduced at 6Â months with dual-arm analysis, whereas single-arm analysis showed a significant decrease from baseline to treatment at the 3-, 6-, and 12-month analyses. At 1 year follow-up, seven of seven trials were positive for improvements in pain relief, function, and diminution of opioid use. Discussion Based on the present systematic review of nine RCTs, the evidence level is I to II, with moderate to strong recommendation for percutaneous adhesiolysis in managing low back and lower extremity pain. The limitations of the evidence include paucity of literature, lack of placebo-controlled trials, and the majority of the trials studying post lumbar surgery syndrome. Conclusion The evidence is level I to II or strong to moderate based on five high-quality and two moderate-quality RCTs, with 1Â year follow-up that percutaneous adhesiolysis is efficacious in the treatment of chronic refractory low back and lower extremity pain
Role of percutaneous neurolysis in lumbar disc herniation: systematic review and meta-analysis
Background: Recalcitrant disc herniation may result in chronic lumbar radiculopathy or sciatica. Fluoroscopically directed epidural injections and other conservative modalities may provide inadequate improvement in some patients. In these cases, percutaneous neurolysis with targeted delivery of medications is often the next step in pain management.
Methods: An evidence-based system of methodologic assessment, namely, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used. Multiple databases were searched from 1966 to January 2021. Principles of the best evidence synthesis were incorporated into qualitative evidence synthesis. The primary outcome measure was the proportion of patients with significant pain relief and functional improvement (≥ 50%). Duration of relief was categorized as short-term (\u3c 6 months) and long-term (≥ 6 months).
Results: This assessment identified one high-quality randomized controlled trial (RCT) and 5 moderate-quality non-randomized studies with an application of percutaneous neurolysis in disc herniation. Overall, the results were positive, with level II evidence.
Conclusions: Based on the present systematic review, with one RCT and 5 nonrandomized studies, the evidence level is II for percutaneous neurolysis in managing lumbar disc herniation
Epidural injections for lumbar radiculopathy or sciatica: a comparative systematic review and meta-analysis of cochrane review
BACKGROUND: Epidural injections are one of the commonly performed procedures in managing low back and lower extremity pain. In the past, Pinto et al and Chou et al performed systematic reviews and meta-analyses with a recent update from Oliveira et al showing lack of effectiveness of epidural steroid injections in managing lumbar radiculopathy. In contrast, multiple other systematic reviews and meta-analyses have supported the efficacy and use of epidural injections utilizing fluoroscopic guidance.
STUDY DESIGN: A systematic review and meta-analysis of randomized controlled trials (RCTs) of epidural injections in managing chronic low back and lower extremity pain with sciatica or lumbar radiculopathy.
OBJECTIVES: To assess the efficacy of 3 categories of epidural injections for lumbar radiculopathy or sciatica performed utilizing saline with steroids, local anesthetic alone, or steroids with local anesthetic.
METHODS: In this systematic review and meta-analysis, RCTs with a placebo control or an active control design, performed under fluoroscopic guidance, with at least 6 months of followed-up were included. The outcome measures were pain relief and functional status improvement. Significant improvement was defined as 50% or greater pain relief and functional status improvement. Literature search was performed through January 2021. Methodological quality assessments were performed. Evidence was summarized utilizing principles of best evidence synthesis.
RESULTS: In this analysis, a total of 21 RCTs were utilized with at least 6 months of follow-up and performed under fluoroscopic guidance. However, only 6 of 25 trials from Cochrane review met inclusion criteria for this review. Based on qualitative analysis, of the 21 trials included in the present analysis, there was only one placebo-controlled trial found to be negative. With conventional meta-analysis, there was no significant difference among the studies because all of the studies were active control with local anesthetic or local anesthetic and steroids. Further, with single-arm analysis, of the 5 trials included in that portion of the study, significant improvement was seen with local anesthetic alone compared to local anesthetic and steroids. There was a tendency for better improvement with steroids in terms of both pain relief and functional status. The level of evidence is Level I or strong for local anesthetic with steroids and Level I to II or moderate to strong for local anesthetic as a single agent based on multiple relevant high quality RCTs.
LIMITATIONS: Despite multiple trials available, there is a paucity of true RCTs performed under fluoroscopic guidance with any of the approaches.
CONCLUSION: Epidural injections with or without steroids for radiculopathy showed significant effectiveness with Level I or strong evidence for local anesthetic with steroids and Level II to I or moderate to strong evidence with local anesthetic alone
Medial branch blocks and the effectiveness of radiofrequency neurotomy in managing chronic thoracic pain: A systematic review and meta-analysis
Background:Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a potential source of pain confirmed by precise, diagnostic blocks.The objective of this systematic review and meta-analysis is to evaluate the effectiveness of medial branch blocks and radiofrequency neurotomy as a therapeutic thoracic facet joint intervention.
Methods:Systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies of medial branch blocks and the radiofrequency neurotomy in managing thoracic pain utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was performed. A comprehensive literature search of multiple databases of RCTs and observational studies of medial branch blocks and radiofrequency neurotomy in managing chronic thoracic pain were identified from 1996 to December 2022 with inclusion of manual searches of the bibliography of known review articles and multiple databases. Methodologic quality and risk of bias assessment was also conducted. Evidence was synthesized utilizing principles of quality assessment and best evidence synthesis, with conventional and single meta-analysis. The primary outcome measure of success was 3 months of pain reduction for medial branch blocks and 6 months for radiofrequency thermoneurolysis for a single treatment. Short-term success was defined as up to 6 months and long-term was more than 6 months.
Results:This literature search yielded 11 studies meeting the inclusion criteria, of which 3 were RCTs and 8 were observational studies. Of the 3 RCTs, 2 of them assessed medial branch blocks and one trial assessed radiofrequency for thoracic pain. The evidence for managing thoracic pain with qualitative analysis and single-arm meta-analysis and GRADE system of appraisal, with the inclusion of 2 RCTs and 3 observational studies for medial branch blocks was Level II. For radiofrequency neurotomy, with the inclusion of one RCT of 20 patients in the treatment group and 5 observational studies, the evidence was Level III in managing thoracic pain.
Limitations:There was a paucity of literature with RCTs and real-world pragmatic controlled trials. Even observational studies had small sample sizes providing inadequate clinically applicable results. In addition, there was heterogeneity of the available studies in terms of their inclusion and exclusion criteria, defining their endpoints and the effectiveness of the procedures.
Conclusion:This systematic review and meta-analysis show Level II evidence of medial branch blocks and Level III evidence for radiofrequency neurotomy on a long-term basis in managing chronic thoracic pain
Equivalent outcomes of lumbar therapeutic facet joint nerve blocks and radiofrequency neurotomy: Comparative evaluation of clinical outcomes and cost utility
Background: Chronic low back pain secondary to facet joint pathology is prevalent in 27% to 40% of selected populations using controlled comparative local anesthetic blocks. Lumbar facet joint nerve blocks and radiofrequency neurotomy are the most common interventional procedures for lower back pain. Nonetheless, questions remain regarding the effectiveness of each modality. Moreover, there is no agreement in reference to superiority or inferiority of lumbar facet joint nerve blocks when compared with radiofrequency neurotomy. Centers for Medicare and Medicaid Services (CMS) and almost all payers prefer radiofrequency ablation. Both procedures have been extensively studied with randomized controlled trials, systematic reviews, and cost utility analysis.
Objective: To assess the clinical outcomes and cost utility of therapeutic lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) compared with radiofrequency neurotomy in managing chronic low back pain of facet joint origin.
Study design: A retrospective, case-control, comparative evaluation of outcomes and cost utility.
Setting: The study was conducted in an interventional pain management practice, a specialty referral center, a private practice setting in the United States.
Methods: The study was performed utilizing the Strengthening the Reporting of Observational Studies in Epidemiology Analysis (STROBE) criteria. Only the patients meeting the diagnostic criteria of facet joint pain by means of comparative, controlled diagnostic local anesthetic blocks were included.The main outcome measure was pain relief measured by the Numeric Rating Scale (NRS) evaluated at 3, 6, and 12 months. Significant improvement was defined as at least 50% improvement in pain relief. Cost utility was calculated utilizing direct payment data for the procedures with the addition of estimated indirect costs over a period of one year based on highly regarded surgical literature and previously published interventional pain management literature.
Results: A total of 326 patients met the inclusion criteria with 99 patients receiving lumbar facet joint nerve blocks (lumbar facet joint nerve blocks with L5 dorsal ramus block) and 227 receiving lumbar radiofrequency neurotomy. Forty-eight patients in the facet joint nerve block group and 148 patients in the radiofrequency group completed one-year follow-up. Patients experienced significant improvement in both groups from baseline to 12 months with significant pain relief (≥ 50%) Significant pain relief was recorded in 100%, 99%, and 79% of the patients in the facet joint nerve block group, whereas, it was 100%, 74%, and 65% in the radiofrequency neurotomy group at the 3, 6, and 12 month follow-up, with a significant difference at 6 months. Cost utility analysis showed average costs for quality-adjusted life year (QALY) of 5,446 for lumbar radiofrequency neurotomy. Twelve patients (12%) in the lumbar facet joint nerve block group and 79 patients (35%) in the lumbar radiofrequency group were converted to other treatments, either due to side effects or inadequate relief.
Conclusion: This study shows similar outcomes of therapeutic lumbar facet joint nerve blocks when compared with radiofrequency neurotomy as indicated by significant pain relief and cost utility