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1.
Pain Physician ; 27(3): 161-168, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38506683

ABSTRACT

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.


Subject(s)
Radiculopathy , Spinal Nerve Roots , Humans , Retrospective Studies , Spinal Nerve Roots/surgery , Spinal Cord , Radiculopathy/surgery , Pain
2.
Pain Physician ; 24(S1): S1-S26, 2021 01.
Article in English | MEDLINE | ID: mdl-33492917

ABSTRACT

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.


Subject(s)
Chronic Pain , Chronic Pain/diagnosis , Chronic Pain/therapy , Humans , Systematic Reviews as Topic
3.
Pain Physician ; 24(S1): S209-S232, 2021 01.
Article in English | MEDLINE | ID: mdl-33492919

ABSTRACT

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.


Subject(s)
COVID-19 , Dexmedetomidine , Bupivacaine , Humans , Injections, Epidural , Patient Protection and Affordable Care Act , SARS-CoV-2 , Steroids , Ultrasonography, Interventional , United States
4.
Pain Physician ; 24(S1): S27-S208, 2021 01.
Article in English | MEDLINE | ID: mdl-33492918

ABSTRACT

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.


Subject(s)
Chronic Pain , Physicians , Chronic Pain/drug therapy , Epidural Space , Humans , Injections, Epidural , Pain Management , United States
5.
Pain Physician ; 19(2): E245-82, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26815254

ABSTRACT

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.


Subject(s)
Analgesics/administration & dosage , Endoscopy/methods , Low Back Pain/drug therapy , Pain Management/methods , Catheterization/methods , Chronic Disease , Epidural Space , Humans , Lower Extremity , Lumbosacral Region/surgery
6.
Pain Pract ; 15(5): 414-22, 2015 Jun.
Article in English | MEDLINE | ID: mdl-24666747

ABSTRACT

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.


Subject(s)
Cost-Benefit Analysis , Low Back Pain/economics , Lumbar Vertebrae , Pain Management/economics , Pain, Postoperative/economics , Spinal Stenosis/economics , Adult , Aged , Cost-Benefit Analysis/methods , Female , Humans , Low Back Pain/diagnosis , Low Back Pain/surgery , Lumbar Vertebrae/surgery , Male , Middle Aged , Pain Management/methods , Pain, Postoperative/diagnosis , Quality of Life , Spinal Stenosis/diagnosis , Syndrome , United States
7.
Pain Physician ; 17(3): E263-90, 2014.
Article in English | MEDLINE | ID: mdl-24850111

ABSTRACT

BACKGROUND: A major component of a systematic review is an assessment of the methodological quality and bias of randomized trials. The most commonly utilized methodological quality assessment and bias assessment for randomized trials is by the Cochrane Review Group. While this is not a "gold standard," it is an indication of the current state-of-the-art review methodology. There is, however, no specific instrument to assess the methodological quality of manuscripts published for interventional techniques. OBJECTIVES: Our objective was to develop an instrument specifically for interventional pain management, to assess the methodological quality of randomized trials of interventional techniques. METHODS: Item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the trial. Applicability was defined as the extent to which the trial produced procedures could be applied with contemporary interventional pain management techniques. Multiple items based on Cochrane review criteria were utilized along with specific requirements for interventional techniques. RESULTS: A total of 22 items were developed which formed IPM-QRB or Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment tool. This included 9 of the 12 items from the Cochrane review criteria with definition of some items that were repetitive or duplicate, and the addition of 13 new items. The results were compared for inter-rater reliability of Cochrane review criteria and IPM-QRB, and inter-instrument reliability. The assessment was performed in multiple stages with an initial learning curve. The final assessment was for 4 randomized controlled trials (RCTs) utilizing both Cochrane review criteria and IPM-QRB criteria. The inter-rater agreement for Cochrane review criteria with overall intra-class correlation coefficient was 0.407 compared to an intra-class correlation coefficient of 0.833 for IPM-QRB criteria. The inter-rater agreement was superior for IPM-QRB criteria compared to Cochrane review criteria despite twice the items of Cochrane review criteria as IPM-QRB criteria with the detailed nature of assessment. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of randomized trials of interventional techniques. This instrument is superior to Cochrane review methodology criteria in that it provides more extensive and specific information for interventional techniques that will be useful in assessing the methodologic quality and bias of interventional techniques.


Subject(s)
Early Medical Intervention/methods , Early Medical Intervention/standards , Pain Management/methods , Pain Management/standards , Randomized Controlled Trials as Topic/methods , Randomized Controlled Trials as Topic/standards , Humans , Reproducibility of Results
8.
Pain Physician ; 17(3): E291-317, 2014.
Article in English | MEDLINE | ID: mdl-24850112

ABSTRACT

BACKGROUND: The major component of a systematic review is assessment of the methodologic quality and bias of randomized and nonrandomized trials. While there are multiple instruments available to assess the methodologic quality and bias for randomized controlled trials (RCTs), there is a lack of extensively utilized instruments for observational studies, specifically for interventional pain management (IPM) techniques. Even Cochrane review criteria for randomized trials is considered not to be a "gold standard," but merely an indication of the current state of the art review methodology. Recently a specific instrument to assess the methodologic quality of randomized trials has been developed for interventional techniques. OBJECTIVES: Our objective was to develop an IPM specific instrument to assess the methodological quality of nonrandomized trials or observational studies of interventional techniques. METHODS: The item generation for the instrument was based on a definition of quality, to the extent to which the design and conduct of the trial were congruent with the objectives of the study. Applicability was defined as the extent to which procedures produced by the study could be applied using contemporary IPM techniques. Multiple items based on Cochrane review criteria and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR) were utilized. RESULTS: A total of 16 items were developed which formed the IPM-QRBNR tool. The assessment was performed in multiple stages. The final assessment was 4 nonrandomized studies. The inter-rater agreement was moderate to good for IPM-QRBNR criteria. LIMITATIONS: Limited validity or accuracy assessment of the instrument and the large number of items to be scored were limitations. CONCLUSION: We have developed a new comprehensive instrument to assess the methodological quality of nonrandomized studies of interventional techniques. This instrument provides extensive information specific to interventional techniques is useful in assessing the methodological quality and bias of observational studies of interventional techniques.


Subject(s)
Early Medical Intervention/standards , Non-Randomized Controlled Trials as Topic/standards , Pain Management/standards , Quality Assurance, Health Care/methods , Quality Assurance, Health Care/standards , Early Medical Intervention/methods , Humans , Non-Randomized Controlled Trials as Topic/methods , Pain Management/methods , Reproducibility of Results
9.
Pain Physician ; 17(2): E129-39, 2014.
Article in English | MEDLINE | ID: mdl-24658484

ABSTRACT

BACKGROUND: Multiple reviews have shown that interventional techniques for chronic pain have increased dramatically over the years. Of these interventional techniques, both sacroiliac joint injections and facet joint interventions showed explosive growth, followed by epidural procedures. Percutaneous adhesiolysis procedures have not been assessed for their utilization patterns separately from epidural injections. STUDY DESIGN: An analysis of the utilization patterns of percutaneous adhesiolysis procedures in managing chronic low back pain in the Medicare population from 2000 to 2011. OBJECTIVE: To assess the utilization and growth patterns of percutaneous adhesiolysis in managing chronic low back pain. METHODS: The study was performed utilizing the Centers for Medicare and Medicaid Services (CMS) Physician Supplier Procedure Summary Master of Fee-For-Service (FFS) Data from 2000 to 2011. RESULTS: Percutaneous adhesiolysis procedures increased 47% with an annual growth rate of 3.6% in the FFS Medicare population from 2000 to 2011. These growth rates are significantly lower than the growth rates for sacroiliac joint injections (331%), facet joint interventions (308%), and epidural injections (130%), but substantially lower than lumbar transforaminal injections (665%) and lumbar facet joint neurolysis (544%). LIMITATIONS: Study limitations include lack of inclusion of Medicare Advantage patients. In addition, the statewide data is based on claims which may include the contiguous or other states. CONCLUSION: Percutaneous adhesiolysis utilization increased moderately in Medicare beneficiaries from 2000 to 2011. Overall, there was an increase of 47% in the utilization of adhesiolysis procedures per 100,000 Medicare beneficiaries, with an annual geometric average increase of 3.6%.


Subject(s)
Catheter Ablation , Chronic Pain/therapy , Injections, Epidural/statistics & numerical data , Medicare/statistics & numerical data , Age Distribution , Catheter Ablation/methods , Catheter Ablation/statistics & numerical data , Catheter Ablation/trends , Humans , Injections, Epidural/methods , Injections, Epidural/trends , Longitudinal Studies , Population Groups , Retrospective Studies , United States
11.
Pain Physician ; 16(2 Suppl): S1-48, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23615882

ABSTRACT

In 2011, the Institute of Medicine (IOM) re-engineered its definition of clinical guidelines as follows: "clinical practice guidelines are statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefit and harms of alternative care options." This new definition departs from a 2-decade old definition from a 1990 IOM report that defined guidelines as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." The revised definition clearly 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. The IOM committee acknowledged that for many clinical domains, high quality evidence was lacking or even nonexistent. Even though the guidelines are important decision-making tools, along with expert clinical judgment and patient preference, their value and impact remains variable due to numerous factors. Some of the many factors that impede the development of clinical practice guidelines include bias due to a variety of conflicts 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 elimination of clinician autonomy, and overzealous and inappropriate recommendations, either positive, negative, or non-committal. Consequently, a knowledgeable, multidisciplinary panel of experts must develop guidelines based on a systematic review of the existing evidence, as recently recommended by the IOM. Chronic pain is a complex and multifactorial phenomenon associated with significant economic, social, and health outcomes. Interventional pain management is an emerging specialty facing a disproportionate number of challenges compared to established medical specialties, including the inappropriate utilization of ineffective and unsafe techniques. In 2000, the American Society of Interventional Pain Physicians (ASIPP) created treatment guidelines to help practitioners. There have been 5 subsequent updates. These guidelines address the issues of systematic evaluation and ongoing care of chronic or persistent pain, and provide information about the scientific basis of recommended procedures. These guidelines are expected to increase patient compliance; dispel misconceptions among providers and patients, manage patient expectations reasonably; and form the basis of a therapeutic partnership between the patient, the provider, and payers.


Subject(s)
Chronic Pain , Evidence-Based Medicine/standards , Guidelines as Topic/standards , Pain Management/standards , Spinal Cord/pathology , Chronic Pain/diagnosis , Chronic Pain/therapy , Humans , Pain Management/methods , Societies, Medical/standards , United States
12.
Pain Physician ; 16(2 Suppl): S49-283, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23615883

ABSTRACT

OBJECTIVE: To develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. METHODOLOGY: Systematic assessment of the literature. EVIDENCE: I. Lumbar Spine • The evidence for accuracy of diagnostic selective nerve root blocks is limited; whereas for lumbar provocation discography, it is fair. • The evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. • The evidence is good in managing disc herniation or radiculitis for caudal, interlaminar, and transforaminal epidural injections; fair for axial or discogenic pain without disc herniation, radiculitis or facet joint pain with caudal, and interlaminar epidural injections, and limited for transforaminal epidural injections; fair for spinal stenosis with caudal, interlaminar, and transforaminal epidural injections; and fair for post surgery syndrome with caudal epidural injections and limited with transforaminal epidural injections. • The evidence for therapeutic facet joint interventions is good for conventional radiofrequency, limited for pulsed radiofrequency, fair to good for lumbar facet joint nerve blocks, and limited for intraarticular injections. • For sacroiliac joint interventions, the evidence for cooled radiofrequency neurotomy is fair; limited for intraarticular injections and periarticular injections; and limited for both pulsed radiofrequency and conventional radiofrequency neurotomy. • For lumbar percutaneous adhesiolysis, the evidence is fair in managing chronic low back and lower extremity pain secondary to post surgery syndrome and spinal stenosis. • For intradiscal procedures, the evidence for intradiscal electrothermal therapy (IDET) and biaculoplasty is limited to fair and is limited for discTRODE. • For percutaneous disc decompression, the evidence is limited for automated percutaneous lumbar discectomy (APLD), percutaneous lumbar laser disc decompression, and Dekompressor; and limited to fair for nucleoplasty for which the Centers for Medicare and Medicaid Services (CMS) has issued a noncoverage decision. II. Cervical Spine • The evidence for cervical provocation discography is limited; whereas the evidence for diagnostic cervical facet joint nerve blocks is good with a criterion standard of 75% or greater relief with controlled diagnostic blocks. • The evidence is good for cervical interlaminar epidural injections for cervical disc herniation or radiculitis; fair for axial or discogenic pain, spinal stenosis, and post cervical surgery syndrome. • The evidence for therapeutic cervical facet joint interventions is fair for conventional cervical radiofrequency neurotomy and cervical medial branch blocks, and limited for cervical intraarticular injections. III. Thoracic Spine • The evidence is limited for thoracic provocation discography and is good for diagnostic accuracy of thoracic facet joint nerve blocks with a criterion standard of at least 75% pain relief with controlled diagnostic blocks. • The evidence is fair for thoracic epidural injections in managing thoracic pain. • The evidence for therapeutic thoracic facet joint nerve blocks is fair, limited for radiofrequency neurotomy, and not available for thoracic intraarticular injections. IV. Implantables • The evidence is fair for spinal cord stimulation (SCS) in managing patients with failed back surgery syndrome (FBSS) and limited for implantable intrathecal drug administration systems. V. ANTICOAGULATION • There is good evidence for risk of thromboembolic phenomenon in patients with antithrombotic therapy if discontinued, spontaneous epidural hematomas with or without traumatic injury in patients with or without anticoagulant therapy to discontinue or normalize INR with warfarin therapy, and the lack of necessity of discontinuation of nonsteroidal anti-inflammatory drugs (NSAIDs), including low dose aspirin prior to performing interventional techniques. • There is fair evidence with excessive bleeding, including epidural hematoma formation with interventional techniques when antithrombotic therapy is continued, the risk of higher thromboembolic phenomenon than epidural hematomas with discontinuation of antiplatelet therapy prior to interventional techniques and to continue phosphodiesterase inhibitors (dipyridamole, cilostazol, and Aggrenox). • There is limited evidence to discontinue antiplatelet therapy with platelet aggregation inhibitors to avoid bleeding and epidural hematomas and/or to continue antiplatelet therapy (clopidogrel, ticlopidine, prasugrel) during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic fatalities. • There is limited evidence in reference to newer antithrombotic agents dabigatran (Pradaxa) and rivaroxan (Xarelto) to discontinue to avoid bleeding and epidural hematomas and are continued during interventional techniques to avoid cerebrovascular and cardiovascular thromboembolic events. CONCLUSIONS: Evidence is fair to good for 62% of diagnostic and 52% of therapeutic interventions assessed. DISCLAIMER: The authors are solely responsible for the content of this article. No statement on this article should be construed as an official position of ASIPP. The guidelines do not represent "standard of care."


Subject(s)
Chronic Pain/diagnosis , Chronic Pain/therapy , Evidence-Based Medicine/standards , Guidelines as Topic/standards , Pain Management , Spinal Cord/pathology , Evidence-Based Medicine/methods , Humans , Pain Management/instrumentation , Pain Management/methods , Pain Management/standards , United States
13.
Pain Pract ; 13(7): 594-6, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23517504

ABSTRACT

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.


Subject(s)
Decompression, Surgical/adverse effects , Ligamentum Flavum/surgery , Minimally Invasive Surgical Procedures/adverse effects , Spinal Stenosis/surgery , Humans , Hypertrophy/complications , Hypertrophy/surgery , Lumbar Vertebrae , Spinal Stenosis/etiology
17.
Pain Pract ; 8(4): 277-86, 2008.
Article in English | MEDLINE | ID: mdl-18503627

ABSTRACT

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.


Subject(s)
Catheter Ablation/adverse effects , Catheter Ablation/methods , Epidural Space/pathology , Tissue Adhesions/therapy , Analgesics/administration & dosage , Animals , Drug Delivery Systems/adverse effects , Drug Delivery Systems/methods , Epidural Space/drug effects , Humans , Low Back Pain/pathology , Low Back Pain/therapy , Lumbosacral Region/pathology , Radiculopathy/pathology , Radiculopathy/therapy , Randomized Controlled Trials as Topic/methods , Tissue Adhesions/pathology
18.
Pain Physician ; 9(2): 135-7, 2006 Apr.
Article in English | MEDLINE | ID: mdl-16703974

ABSTRACT

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.


Subject(s)
Egg White/radiation effects , Electrocoagulation , Pulse/methods , Radio Waves , Cardiac Catheterization/methods , In Vitro Techniques , Temperature
19.
Pain Pract ; 5(3): 223-7, 2005 Sep.
Article in English | MEDLINE | ID: mdl-17147584

ABSTRACT

This study evaluated the efficacy of sphenopalatine ganglion pulsed radiofrequency (SPG-PRF) treatment in patients suffering from chronic head and face pain. Thirty patients were observed from 4 to 52 months after PRF treatment. The primary efficacy measures were the reduction in oral medication use, including opioids, time-to-next-treatment modality for presenting symptoms, duration of pain relief, and the presence of residual symptoms. Secondary objectives included the evaluation of adverse effects and complications. All data were derived from patient charts, phone conversations, and clinical follow-up visits. Fourteen percent of respondents reported no pain relief, 21% had complete pain relief, and 65% of the patients reported mild to moderate pain relief from SPG-PRF treatment. Sixty-five percent of the respondents reported mild to moderate reduction in oral opioids. None of the patients developed significant infection, bleeding, hematoma formation, dysesthesia, or numbness of palate, maxilla, or posterior pharynx. A large-scale study of SPG-PRF for the treatment of face and head pain has not been previously reported. Our results suggest that a prospective, randomized, controlled trial study to confirm efficacy and safety of this novel treatment for chronic head and face pain is justified.

20.
Arch Phys Med Rehabil ; 85(6): 1013-6, 2004 Jun.
Article in English | MEDLINE | ID: mdl-15179659

ABSTRACT

Posttraumatic headache is a common and disabling pain syndrome in patients who sustain a head injury. Unfortunately, conventional treatments may fail or cause intolerable side effects. Because chronic headache may be mediated by central and peripheral neural processes, these structures may be therapeutic targets. One target, the sphenopalatine ganglion (SPG), is implicated in several headache disorders and has been lesioned for headache relief. Because of the risks of neurolytic procedures, nonablative procedures that provide pain relief would be useful. We present a case wherein a man in his late twenties with posttraumatic headache obtained more than 17 months of relief with SPG pulsed-mode radiofrequency lesioning. SPG pulsed-mode radiofrequency is a nonablative, neural lesioning method that may be useful in the treatment of posttraumatic headache.


Subject(s)
Catheter Ablation/methods , Craniocerebral Trauma/complications , Headache Disorders/surgery , Trigeminal Ganglion/surgery , Trigeminal Neuralgia/surgery , Adult , Headache Disorders/etiology , Humans , Male , Treatment Outcome
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