Cost Utility Analysis of Percutaneous Adhesiolysis in Managing Pain of Post-lumbar Surgery Syndrome and Lumbar Central Spinal Stenosis.

BACKGROUND: The increase in the number of interventions for the management of chronic pain and associated escalation of healthcare costs has captured the attention of health policymakers, in no small part due to the lack of documentation of efficacy, cost-effectiveness, or cost utility analysis. A recent cost utility analysis of caudal epidural injections in managing chronic low back pain of various pathologies showed a high cost utility with improvement in quality of life years, competitive with various other modalities of treatments. However, there are no analyses derived from high-quality controlled studies related to the cost utility of percutaneous adhesiolysis in the treatment of post-lumbar surgery syndrome or lumbar central spinal stenosis. STUDY DESIGN: This analysis is based on 2 previously published controlled studies. OBJECTIVE: To assess the cost utility of percutaneous adhesiolysis procedures in managing chronic low back and lower extremity pain secondary to post-lumbar surgery syndrome and lumbar central spinal stenosis. SETTING: A private, specialty referral interventional pain management center in the United States. METHODS: Two controlled studies were conducted assessing the clinical effectiveness of percutaneous adhesiolysis for post-lumbar surgery syndrome and lumbar central spinal stenosis in an interventional pain management setting utilizing contemporary interventional pain management practices. A cost utility analysis was performed with direct payment data for a total of 130 patients in treatment groups over a 2-year period. Various outcome measures were included with significant improvement, defined as at least 50% improvement with reduction in pain and disability status. RESULTS: The results of 2 controlled studies of low back pain with 60 and 70 patients and a 2-year follow-up with the actual reimbursement data showed cost utility for 1 year of quality-adjusted life year (QALY) of USD $2,652 for post-lumbar surgery syndrome and USD $2,649 for lumbar central spinal stenosis. The results of this assessment show that the cost utility of managing chronic, intractable low back pain with percutaneous adhesiolysis at a QALY that is similar or lower in price than medical therapy only, physical therapy, manipulation, spinal cord stimulation, and surgery. LIMITATIONS: The limitations of this cost utility analysis are that it is a single-center evaluation, with the inclusion of costs of adhesiolysis procedures in an ambulatory surgery center and physician visits, rather than all related costs including drug therapy and costs of disability in multiple settings. CONCLUSION: This cost utility analysis of percutaneous adhesiolysis in the treatment of post-lumbar surgery syndrome and lumbar central spinal stenosis shows the clinical effectiveness and cost utility of these procedures at USD $2,650 per one year of QALY when performed in an ambulatory surgery center.

Cervical Nerve Root Block Using a Curved Blunt Needle and Posterior Approach.

BACKGROUND: Cervical transforaminal epidural steroid injections have become less popular due to the risk of catastrophic complications they pose. However, cervical nerve root blocks are useful for surgical planning in patients with cervical radicular pain syndromes. OBJECTIVES: Our aim was to find a method of performing cervical selective nerve root blocks that removed the risk of catastrophic complications. STUDY DESIGN: Retrospective case review. SETTING: Academic multidisciplinary spine center. METHODS: Among patients, 50 consecutive cases were retrospectively reviewed for immediate pain scores and follow-up results. In the intervention, a posterior approach using a curved blunt needle was employed for cervical selective nerve root blocks to minimize the risk of arterial injection. To measure the outcomes, we used quantitative pain severity scores and qualitative responses. RESULTS: This technique detailed in this study has a high immediate analgesic effect that can be used for diagnostic purposes. It is not known if this technique has prognostic value with respect to surgery. The prolonged response rate is about 50%, which is in line with other techniques. LIMITATIONS: This study had no control group. CONCLUSION(S): Cervical selective nerve root blocks using a curved blunt needle and a posterior approach are effective in selectively identifying nerves that cause clinical symptoms. This technique minimizes the risk of arterial or spinal cord impingement and therefore may be safer than transforaminal selective nerve root blocks.

The MILD procedure.

We are following with great interest the increasing generally favorable impressions of the long-term results of the MILD (minimally invasive lumbar decompression) procedure for treating spinal stenosis due to hypertrophied ligamentum flavum (LF). We are also influenced by the cautionary surgical observations and opinions of Tumialan et al and publications about the lack of efficacy or placebo effect. The impression indeed has been virtual safety of the MILD procedure, but Tumialan et al describe some major complications resulting from the procedure. An algorithm for clinical use is needed.

Transforaminal Epidural Steroid Injections: A Systematic Review and Meta-Analysis of Efficacy and Safety.

BACKGROUND: Transforaminal epidural injections have been used since the late 1990s to treat lumbar radicular pain. They have been the subject of considerable attention, with varying conclusions from systematic reviews as to their efficacy. Transforaminal injections have been associated with rare but major complications. Further, the use of transforaminal injections has increased since the passage of the Affordable Care Act. Finally, with the SARS-CoV-2 pandemic, there has been heightened concern regarding the risk associated with steroid injections. OBJECTIVES: To evaluate and update the effectiveness of transforaminal injections for 4 indications: radicular pain; from spinal stenosis; from failed back surgery syndrome; and for axial low back pain; and to evaluate the safety of the procedure. STUDY DESIGN: A systematic review and meta-analysis of the efficacy of transforaminal injections. METHODS: The available literature on transforaminal injections was reviewed and the quality assessed. The level of evidence was classified on a 5-point scale based on the quality of evidence developed by the US Preventive Services Task Force (USPSTF) and modified by the American Society of Interventional Pain Physicians (ASIPP). Data sources included relevant literature from 1966 to April 2020, and manual searches of the bibliographies of known primary and review articles. Pain relief and functional improvement were the primary outcome measures. A minimum of 6 months pain relief follow-up was required. RESULTS: For this systematic review, 66 studies were identified. Eighteen randomized controlled trials met the inclusion criteria. No observational studies were included. Eleven randomized controlled trials dealt with various aspects of transforaminal injections for radicular pain owing to disc herniation. Based on these studies, there is Level 1 evidence supporting the use of transforaminal injections for radicular pain owing to disc herniation. A meta-analysis showed that at both 3 and 6 months, there was highly statistically significant improvement in both pain and function with both particulate and nonparticulate steroids. For radicular pain from central stenosis there is one moderate quality study, with Level IV evidence. For radicular pain caused by failed back surgery syndrome there is one moderate quality study, with Level IV evidence. For radicular pain from foraminal stenosis and for axial pain there is Level V evidence, opinion-based/consensus, supporting the use of transforaminal injections. Transforaminal injections are generally safe. However, they have been associated with major neurologic complications related to cord infarct. Causes other than intraluminal injection of particulates appear to be at play. The use of an infraneural approach and of blunt needles appear to offer the greatest patient safety. Because of concern over the role of particulate steroids, multiple other injectates have been evaluated, including nonparticulate steroids, tumor necrosis factor alpha (TNF-a) inhibitors, and local anesthetics without steroids. No injectate has been proven superior. If there is concern about immunosuppression because of risk of COVID-19 infection, either the lowest possible dose of steroid or no steroid should be used. LIMITATIONS: The study was limited by the paucity of literature for some indications. CONCLUSIONS: There is Level I evidence for the use of transforaminal injections for radicular pain from disc herniations.

Methodology for Evidence Synthesis and Development of Comprehensive Evidence-Based Guidelines for Interventional Techniques in Chronic Spinal Pain.

BACKGROUND: The re-engineered definition of clinical guidelines in 2011 from the IOM (Institute of Medicine) states, "clinical practice guidelines are statements that include recommendations intended to optimize patient care that is informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." The revised definition distinguishes between the term "clinical practice guideline" and other forms of clinical guidance derived from widely disparate development processes, such as consensus statements, expert advice, and appropriate use criteria. OBJECTIVE: To assess the literature and develop methodology for evidence synthesis and development of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. METHODS: A systematic review of the literature including methodology of guideline development encompassing GRADE approach for guidance on evidence synthesis with recommendations. RESULTS: Some of the many factors described in 2011 continue as of 2020 and impede the development of clinical practice guidelines. These impediments include biases due to a variety of conflicts and confluence of interest, inappropriate and poor methodological quality, poor writing and ambiguous presentation, projecting a view that these are not applicable to individual patients or too restrictive with the elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Thus, ideally, a knowledgeable, multidisciplinary panel of experts with true lack of bias and confluence of interest must develop guidelines based on a systematic review of the existing evidence. This manuscript describes evidence synthesis from observational studies, various types of randomized controlled trials (RCTs), and, finally, methodological and reporting quality of systematic reviews. The manuscript also describes various methods utilized in the assessment of the quality of observational studies, diagnostic accuracy studies, RCTs, and systematic reviews. LIMITATIONS: Paucity of publications with appropriate evidence synthesis methodology in reference to interventional techniques. CONCLUSION: This review described comprehensive evidence synthesis derived from systematic reviews, including methodologic quality and bias measurement. The manuscript described various methods utilized in the assessment of the quality of the systematic reviews, RCTs, diagnostic accuracy studies, and observational studies.

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.

Percutaneous lysis of epidural adhesions--evidence for safety and efficacy.

BACKGROUND: Percutaneous lysis of epidural adhesions is done worldwide. Over 1.7 million of these procedures were done in the U.S.A. by 2006. This interventional pain management technique is used to treat chronic low back pain (LBP) and/or radiculopathy. The primary object of the approach is to target drug delivery to areas of pathology in the spinal epidural space. The procedure involves removing barriers, such as epidural fibrosis, that prevent drug from reaching target sites. LITERATURE SEARCH: Primary sources of information for this manuscript include: (1) 2 systematic literature reviews that include literature published through September 2006; (2) expert opinions; and (3) peer reviewed publications from September 2006 to January 2008. The focus was on percutaneous entry using catheters via the sacral hiatus to treat pain in the lumbosacral region. RESULTS: The evidence is strong for short-term efficacy (3 months) and moderate for long-term efficacy (greater than 3 months). Complications do occur, but limited literature exists that documents incidence. CONCLUSION: The cumulative evidence through January 2008 show that percutaneous adhesiolysis with targeted drug delivery is an effective treatment for LBP and/or radiculopathy.

A comparison of pulsed radiofrequency and continuous radiofrequency on thermocoagulation of egg white in vitro.

BACKGROUND: Clinical studies have demonstrated the efficacy of pulsed radiofrequency (PRF). PRF energy is delivered to neural structures via specifically designed, percutaneously placed needles to treat some chronic pain states. PRF was introduced as a non-destructive alternative to destructive lesioning produced by continuous radiofrequency (CRF) energy. However, there is an ongoing controversy regarding the potential tissue-destructive effects of PRF used for pain management. OBJECTIVE: To evaluate the ability of PRF to coagulate egg white at various temperatures used clinically and to compare with CRF. METHODS: A commercially available (TYCO-Radionics Labs) 5 cm, 22G (0.7 mm) SMK needle with 5 mm active tip was inserted into a 10 mL test tube containing raw egg white at 37 degrees C and the tip was heated up to 80 degrees C. The photographic patterns of thermocoagulation of egg white in vitro produced by continuous and pulsed radiofrequency (RF) were compared and the lowest temperature at which PRF produced thermocoagulation was determined. RESULTS: Pulsed RF produced barely detectable thermocoagulation at 60 degrees C. Above 60 degrees C, the pattern of coagulation produced by PRF resembled that observed with CRF. However, the density and size of the coagulation ball appeared somewhat greater with CRF. CONCLUSION: PRF coagulated egg white at temperatures above 60degrees C in a manner similar to CRF. Monitoring needle tip temperature using the thermode supplied with the needle during PRF and keeping the recorded tip temperature below 60degrees C may minimize unwanted thermal destruction of tissue.

Percutaneous and Endoscopic Adhesiolysis in Managing Low Back and Lower Extremity Pain: A Systematic Review and Meta-analysis.

BACKGROUND: Chronic refractory low back and lower extremity pain is frustrating to treat. Percutaneous adhesiolysis and spinal endoscopy are techniques which can treat chronic refractory low back and lower extremity pain.Percutaneous adhesiolysis is performed by placing the catheter into the tissue plane at the ventrolateral aspect of the foramen so that medications can be injected. Adhesiolysis is used both for pain caused by scarring which is not resistant to catheter placement and other sources of pain, including inflammation in the absence of scarring.Mechanical lysis of scars with a catheter may or may not be necessary for percutaneous adhesiolysis to be effective. Spinal endoscopy allows direct visualization of the epidural space and has the possibility to use laser energy to treat pathology. STUDY DESIGN: A systematic review of the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis to treat chronic refractory low back and lower extremity pain. OBJECTIVE: To evaluate and update the effectiveness of percutaneous adhesiolysis and spinal endoscopic adhesiolysis to treat chronic refractory low back and lower extremity pain. METHODS: The available literature on percutaneous adhesiolysis and spinal endoscopic adhesiolysis in treating persistent low back and leg pain was reviewed. The quality of each article used in this analysis was assessed. The level of evidence was classified on a 5-point scale from strong, based upon multiple randomized controlled trials to weak, based upon consensus, as developed by the U.S. Preventive Services Task Force (USPSTF) and modified by ASIPP. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2015, and manual searches of the bibliographies of known primary and review articles. OUTCOME MEASURES: Pain relief of at least 50% and functional improvement of at least 40% were the primary outcome measures. Short-term efficacy was defined as improvement of 6 months or less; whereas, long-term efficacy was defined more than 6 months. RESULTS: For this systematic review, 45 studies were identified. Of these, for percutaneous adhesiolysis there were 7 randomized controlled trials and 3 observational studies which met the inclusion criteria. For spinal endoscopy, there was one randomized controlled trial and 3 observational studies. Based upon 7 randomized controlled trials showing efficacy, with no negative trials, there is Level I or strong evidence of the efficacy of percutaneous adhesiolysis in the treatment of chronic refractory low back and lower extremity pain. Based upon one high-quality randomized controlled trial, there is Level II to III evidence supporting the use of spinal endoscopy in treating chronic refractory low back and lower extremity pain. CONCLUSION: The evidence is Level I or strong that percutaneous adhesiolysis is efficacious in the treatment of chronic refractory low back and lower extremity pain. Percutaneous adhesiolysis may be considered as a first-line treatment for chronic refractory low back and lower extremity pain. The evidence is Level II to III that spinal endoscopy is effective in the treatment of chronic refractory low back and lower extremity pain. KEY WORDS: Spinal pain, chronic low back pain, post lumbar surgery syndrome, epidural scarring, adhesiolysis, endoscopy, radicular pain.