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Occupational Medicine Practice Guidelines, 2nd Edition: Evaluation and Management of Common Health Problems and Functional Recovery in Workers, 2008 Revision
... RCTs are considered to provide the most internally valid evidence for medical decision-making. In the specialty of interventional pain management, results from clinical trials, both randomized and observational, with substantial impact on patient care, have been ruled ineffective based on flawed methodology of evidence synthesis (34, 50,52,404,[444][445][446][447][448][449][450][451][452][453][454][455][456][457][458][459][460]. Smith and Pell (461) in their famous metaanalysis, proved that the evidence from randomized trials may be inaccurate. ...
... The WHO defines a clinical trial as "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes (120)." Very few studies in interventional pain management are RCTs and treatments even in surgery are only half as likely to be based on RCTs as treatments in internal medicine (34,50,52,(445)(446)(447)(448)(449)(450)(451)(452)(453)(454)(455)(456)(457)(458)(459)(460)(462)(463)(464)(465). There are multiple studies and opinions for and against randomized trials and observational studies and their importance. ...
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.
... These recommendations are considered by some as biased considering the strong negative recommendations they have provided for other guidelines (8,(166)(167)(168)(169)(170)(171)(172)(173)(174)(175)(176). It appears that guideline preparers have a different mindset with a priori decisions in favor of opioids and rehabilitation techniques compared with interventional techniques in assessment of pain relief, validity criteria, and outcomes assessment (173)(174)(175)(176)(177)(178)(179)(180)(181)(182)(183). These recommendations by Chou et al (8,(166)(167)(168) and other guideline preparers, (177)(178)(179)(180)(181)(182)(183) are in contrast to evidence-based medicine (EBM) and comparative effectiveness research principles, guidelines, and applications (32)(33)(34)45,. ...
... It appears that guideline preparers have a different mindset with a priori decisions in favor of opioids and rehabilitation techniques compared with interventional techniques in assessment of pain relief, validity criteria, and outcomes assessment (173)(174)(175)(176)(177)(178)(179)(180)(181)(182)(183). These recommendations by Chou et al (8,(166)(167)(168) and other guideline preparers, (177)(178)(179)(180)(181)(182)(183) are in contrast to evidence-based medicine (EBM) and comparative effectiveness research principles, guidelines, and applications (32)(33)(34)45,. Further, there is evolving evidence for the effectiveness of interventional techniques in multiple areas which has been to some extent ignored by the guideline developers; they have a major focus on lack of evidence, overuse and abuse, even though additional evidence has been rapidly evolving (32)(33)(34). ...
Even though opioids have been used for pain for thousands of years, opioid therapy for chronic non-cancer pain is controversial due to concerns regarding the long-term effectiveness and safety, particularly the risk of tolerance, dependance, or abuse. While the debate continues, the use of chronic opioid therapy for chronic non-cancer pain has increased exponentially. Even though evidence is limited, multiple expert panels have concluded that chronic opioid therapy can be effective therapy for carefully selected and monitored patients with chronic non-cancer pain.
A systematic review of randomized trials of opioid management for chronic non-cancer pain.
The objective of this systematic review is to evaluate the clinical efficacy of opioids in the treatment of chronic non-cancer pain.
A comprehensive evaluation of the literature relating to opioids in chronic non-cancer pain was performed. The literature was evaluated according to Cochrane review criteria for randomized controlled trials (RCTs) and Jadad criteria. A literature search was conducted by using PubMed, EMBASE, Cochrane library, ECRI Institute Library, U.S. Food and Drug Administration (FDA) website, U.S. National Guideline Clearinghouse (NGC), Database of Abstracts of Reviews of Effectiveness (DARE), clinical trials, systematic reviews and cross references from systematic reviews. The level of evidence was classified as good, fair, or poor based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) and used by other systematic reviews and guidelines.
Pain relief was the primary outcome measure. Other outcome measures were functional improvement, withdrawals, and adverse effects.
Based on the USPSTF criteria, the indicated level of evidence was fair for Tramadol in managing osteoarthritis. For all the drugs assessed, including Tramadol, for all other conditions, the evidence was poor based on either weak positive evidence, indeterminate evidence, or negative evidence.
A paucity of literature, specifically with follow-up beyond 12 weeks for all types of opioids with controlled trials for various chronic non-cancer pain conditions.
This systematic review illustrated fair evidence for Tramadol in managing osteoarthritis with poor evidence for all other drugs and conditions. Thus, recommendations must be based on non-randomized studies.
... Interventional techniques for managing chronic low back pain are commonly performed; however, there has been significant criticism of most of these procedures (69)(70)(71)(72)(73). The purpose of percutaneous epidural lysis of adhesions is to eliminate the deleterious www.painphysicianjournal.com ...
Speculated causes of post lumbar surgery syndrome include epidural fibrosis, acquired stenosis, and facet joint pain among other causes. Even though fluoroscopically directed caudal epidural injections and facet joint interventions are effective in some patients, others continue to suffer with chronic persistent pain. Percutaneous adhesiolysis with target delivery of medications has been demonstrated to be effective in these patients. However, the evidence for percutaneous adhesiolysis in managing post surgery syndrome has been questioned, coupled with a paucity of controlled trials.
A randomized, equivalence, controlled trial.
An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain in post surgery syndrome and compare with fluoroscopically directed caudal epidural steroid injections.
Patients were randomly assigned to one of 2 groups: Group I (60 patients) receiving caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution serving as the control group, and Group II (60 patients) receiving percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate Betamethasone serving as the intervention group. Randomization was performed by computer-generated random allocation sequence by simple randomization.
Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months post treatment. Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more.
Significant pain relief (>or= 50%) and functional status improvement was recorded in 73% of patients in Group II versus 12% in Group I (P < 0.001). The average procedures per year were 3.5 with an average total relief of 42 out of 52 weeks in Group II and 2.2 procedures with total relief per year of 13 weeks in Group I (P < 0.001).
The results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group, and the preliminary report of one-year follow-up.
Percutaneous adhesiolysis in chronic function-limiting, recalcitrant low back pain in post lumbar surgery syndrome demonstrated effectiveness in 73% of the patients.
... Conflicts of interest in guideline development and inappropriate methodologies have been questioned. The impropriety is based on pharmaceutical and medical device company sponsorship, when members of the guidelines committees have a substantial financial association with an industry, when there is a relationship between the developing organization and industry, or, finally, when there is no relevant clinical relationship or expertise on the part of the developers of the guidelines (1,3,7,8,1011121330,61,62,106,144,148,179,182,187, 196,202203204205206207 ). The financial ties between guideline panels and industry appear to be extensive. ...
Practice guidelines are systematically developed statements to assist practitioners and patients in making decisions about appropriate health care for specific clinical circumstances. Clinical practice guidelines present statements of best practice based on a thorough evaluation of the evidence from published studies on the outcomes of treatment. In November 1989, Congress mandated the creation of the Agency for Healthcare Policy and Research (AHCPR). AHCPR was given broad responsibility for supporting research, data development, and related activities. Associated with this mandate, the National Academy of Sciences published a document indicating that guidelines are expected to enhance the quality, appropriateness, and effectiveness of health care services. Guidelines as a whole have been characterized by multiple conflicts in terminology and technique. These conflicts are notable for the confusion they create and for what they reflect about differences in values, experiences, and interest among different parties. Despite this confusion, public and private development of guidelines is growing exponentially. There are only limited means to coordinate these guidelines in order to resolve inconsistencies, fill in gaps, track applications and results, and assess the soundness of individual guidelines. Significant diversity exists in clinical practice guidelines. The inconsistency amongst guidelines arises from variations in values, tolerance for risks, preferences, expertise, and conflicts of interest. In 2000, the American Society of Interventional Pain Physicians (ASIPP) first created treatment guidelines to help practitioners. There have been 4 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 payors. The ASIPP guidelines are based on evidence-based medicine (EBM). EBM is in turn based on 4 basic contingencies: the recognition of the patient's problem and the construction of a structured clinical question; the ability to efficiently and effectively search the medical literature to retrieve the best available evidence to answer the clinical question; clinical appraisal of the evidence; and integration of the evidence with all aspects of the individual patient's decision-making to determine the best clinical care of the patient. Evidence synthesis for guidelines includes the review of all relevant systematic reviews and individual articles, grading them for relevance, methodologic quality, consistency, and recommendations.
The intradiscal electrothermal therapy (IDET) procedure is a minimally invasive technique designed to treat discogenic chronic low back pain. The debate surrounding IDET ranges from the concept of the procedure, the technique and patient selection, to its effectiveness. The procedure provides modest improvement; however, it is considered less invasive and destructive than other modalities of treatments available at the present time, and has lower cost. The effectiveness evidence is limited at the present time, but based on the results of six recently published positive single-arm studies, it appears that patients experienced a perceptible clinical benefit from the IDET procedure. Thus, IDET is recommended in patients with moderate functional impairment, relatively well-maintained disc heights and discogenic pain caused by annular tears or protrusions less than 3-4 mm after the failure of less invasive procedures.
Background: Neuromodulation is an effective and reversible treatment option for chronic intractable pain. Spinal cord stimulation (SCS) represents a field of application of neuromodulation and is known to be effective for several conditions including complex regional pain syndrome (CRPS), failed back surgery syndrome (FBSS), and chronic leg and back pain. SCS has some technical limitations that can be bypassed through retrograde neuromodulation.
Objective: To examine the safety and efficacy of retrograde neuromodulation in consecutive patients with neuropathic pain in the perineum or lower limb.
Study Design: Prospective chart review analyzing one year of retrograde stimulation in our department.
Methods: We present a series of 10 patients who underwent retrograde neuromodulation at the University General Hospital of Valencia (Spain). We analyzed the variables that can improve the outcome and help physicians choose retrograde neuromodulation.
Results: Seven of 10 patients had an effective treatment and 3 patients had an ineffective stimulation. In the group with the effective treatment the most represented type of pain was radiculopathy and perineal pain.
Limitations: This is a prospective, single-center study with a relatively small number of patients and no control group.
Conclusion: Retrograde neuromodulation seems to be effective in patients that present with a well localized pain with a clear dermatome distribution. We found retrograde neuromodulation to be effective in radiculopathy related to FBSS. We found it to be limited in the treatment of perineal pain probably due to technical limitations and anatomical reasons besides the lack of knowledge of the etiology of this pain model and the exact mechanisms of action of neuromodulation.
Key words: Chronic pain, spinal cord stimulation, retrograde neuromodulation, sacral root stimulation, perineal pain
Recently, multiple regulations and recommendations for safe infection control practices and safe injection and medication vial utilization have been implemented. These include single dose and multi-dose vials for a single patient and regulations. It is a well known fact that transmission of bloodborne pathogens during health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication administration. Multiple case reports have been published illustrating the occurrence of infections in interventional pain management and other minor techniques because of lack of safe injection practices, and noncompliance with other precautions. However, there are no studies or case reports illustrating the transmission of infection due to the use of single dose vials in multiple patients when appropriate precautions are observed. Similarly, the preparation standards for simple procedures such as medial branch blocks or transforaminal epidurals have not been proven to be essential. Further, the effectiveness or necessity of surgical face masks and hats, etc., for interventional techniques has not been proven.
To assess the rates of infection in patients undergoing interventional techniques.
A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009.
An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
All patients presenting for interventional techniques from May 2008 to December 2009 are included with documentation of various complications related to interventional techniques including infection.
May 2008 to December 2009 a total of 3,179 patients underwent 12,000 encounters with 18,472 procedures. A total of 12 patients reported suspicion of infection. All of them were evaluated by a physician and only one of them was a superficial infection due to the patient's poor hygienic practices which required no antibiotic therapy.
Limitations include the nonrandomized observational nature of the study.
There were no infections of any significance noted in approximately 3,200 patients with over 18,000 procedures performed during a 20-month period in an ambulatory surgery center utilizing simple precautions for clean procedures with the use of single dose vials for multiple patients and using safe injection practices.
The Independent Payment Advisory Board (IPAB) is a vastly powerful component of the president's health care reform law, with authority to issue recommendations to reduce the growth in Medicare spending, providing recommendations to be considered by Congress and implemented by the administration on a fast track basis. Ever since its inception, IPAB has been one of the most controversial issues of the Patient Protection and Affordable Care Act (ACA), even though the powers of IPAB are restricted and multiple sectors of health care have been protected in the law. IPAB works by recommending policies to Congress to help Medicare provide better care at a lower cost, which would include ideas on coordinating care, getting rid of waste in the system, providing incentives for best practices, and prioritizing primary care. Congress then has the power to accept or reject these recommendations. However, Congress faces extreme limitations, either to enact policies that achieve equivalent savings, or let the Secretary of Health and Human Services (HHS) follow IPAB's recommendations. IPAB has strong supporters and opponents, leading to arguments in favor of or against to the extreme of introducing legislation to repeal IPAB. The origins of IPAB are found in the ideology of the National Institute for Health and Clinical Excellence (NICE) and the impetus of exploring health care costs, even though IPAB's authority seems to be limited to Medicare only. The structure and operation of IPAB differs from Medicare and has been called the Medicare Payment Advisory Commission (MedPAC) on steroids. The board membership consists of 15 full-time members appointed by the president and confirmed by the Senate with options for recess appointments. The IPAB statute sets target growth rates for Medicare spending. The applicable percent for maximum savings appears to be 0.5% for year 2015, 1% for 2016, 1.25% for 2017, and 1.5% for 2018 and later. The IPAB Medicare proposal process involves mandatory recommendations and advisory recommendations with multiple reporting requirements. However, although IPAB has been described as having limited authority, some believe that it has unlimited authority due to the lack of judicial review and the requirement of two-thirds of the Congress to override any recommendations by IPAB.
Physicians in the United States have been affected by significant changes in the patterns of medical practice evolving over the last several decades. The recently passed affordable health care law, termed the Patient Protection and Affordable Care Act of 2010 (the ACA, for short) affects physicians more than any other law. Physician services are an integral part of health care. Physicians are paid in the United States for their personal services. This payment also includes the overhead expenses for maintaining an office and providing services. The payment system is highly variable in the private insurance market; however, governmental systems have a formula-based payment, mostly based on the Medicare payment system. Physician services are billed under Part B. Since the inception of the Medicare program in 1965, several methods have been used to determine the amounts paid to physicians for each covered service. Initially, the payment systems compensated physicians on the basis of their charges. In 1975, just over 10 years after the inception of the Medicare program, payments changed so as not to exceed the increase in the Medical Economic Index (MEI). Nevertheless, the policy failed to curb increases in costs, leading to the determination of a yearly change in fees by legislation from 1984 to 1991. In 1992, the fee schedule essentially replaced the prior payment system that was based on the physician's charges, which also failed to live up to expectations for operational success. Then, in 1998, the sustainable growth rate (SGR) system was introduced. In 2009, multiple attempts were made by Congress to repeal the formula - rather unsuccessfully. Consequently, the SGR formula continues to hamper physician payments. The mechanism of the SGR includes 3 components that are incorporated into a statutory formula: expenditure targets, growth rate period, and annual adjustments of payment rates for physician services. Further, the relative value of a physician fee schedule is based on 3 components: physician work, practice expense (PE), and malpractice expense that are used to determine a value ranking for each service to which it is applied. On average, the work component represents 53.5% of a service's relative value, the fee component represents 43.6%, and the malpractice component represents 3.9%. The final schedule for physician payment was issued on November 24, 2010. This was based on a total cut of 30.8% with 24.9% of the cut attributed to SGR. However, as usual, with patchwork efficiency, Congress passed a one-year extension of the 0% update, effective through December 2011. Consequently, CMS issued an emergency update of the 2011 Medicare fee schedule, with multiple revisions, resulting in a reduction of the conversion factor of $36.8729 from December 2010 to $33.9764 for 2011.
Clinical guidelines are a constructive response to the reality that practicing physicians require assistance in assimilating and applying the exponentially expanding, often contradictory, body of medical knowledge. They attempt to define practices that meet the needs of most patients under most circumstances. Ideally, specific clinical recommendations contained within practice guidelines are systematically developed by expert panels who have access to all the available evidence, have an understanding of the clinical problem, and have clinical experience with the procedure being assessed, as well as knowledge of relevant research methods. The recent development of American Pain Society (APS) guidelines has created substantial controversy because of their perceived lack of objective analysis and recommendations perceived to be biased due to conflicts of interest.
To formally and carefully assess the APS guidelines' evidence synthesis for low back pain for therapeutic interventions using the same methodology utilized by the APS authors. The interventions examined were therapeutic interventions for managing low back pain, including epidural injections, adhesiolysis, facet joint interventions, and spinal cord stimulation.
A literature search by 2 authors was carried out utilizing appropriate databases from 1966 through July 2008. Articles in which conflicts arose were reviewed and mediated by a third author to arrive at a consensus. Selections of manuscripts and methodologic quality assessment was also performed by at least 2 authors utilizing the same criteria applied in the APS guidelines. The guideline reassessment process included the evaluation of individual studies and systematic reviews and their translation into practice recommendations.
The conclusions of APS and our critical assessment based on grading of good, fair, and poor, agreed that there is fair evidence for spinal cord stimulation in post lumbar surgery syndrome, and poor evidence for lumbar intraarticular facet joint injections, lumbar interlaminar epidural injections, caudal epidural steroids for conditions other than disc herniation or radiculitis, sacroiliac joint injections, intradiscal electrothermal therapy, endoscopic adhesiolysis, and intrathecal therapy. However, our assessment of APS guidelines for other interventional techniques, utilizing their own criteria, showed fair evidence for therapeutic lumbar facet joint nerve blocks, caudal epidural injections in disc herniation or radiculitis, percutaneous adhesiolysis in post lumbar surgery syndrome, radiofrequency neurotomy, and transforaminal epidural injections in radiculitis. Also it is illustrated that inclusion of latest literature will change the conclusions, with improved grading - caudal epidural, adhesiolysis, and lumbar facet joint nerve blocks from fair to good or poor to fair. The present critical assessment review illustrates that APS guidelines have utilized multiple studies inappropriately and have excluded appropriate studies. Our integrity assessment shows deep concerns that the APS guidelines illustrating significant methodologic failures which raise concerns about transparency, accountability, consistency, and independence.
The current reassessment, using appropriate methodology, shows evidence similar to APS guidelines for several procedures, but differs extensively from published APS guidelines for multiple other procedures including caudal epidural injections, lumbar facet joint nerve blocks, lumbar radiofrequency neurotomy, and percutaneous adhesiolysis.
The intervertebral disc has been implicated as an etiology of chronic lumbar spine pain based on clinical, basic science, and epidemiological research. However, there is lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, the lumbar intervertebral discs have been shown to be sources of chronic back pain without disc herniation in 26% to 39%. Lumbar provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature, controversy continues about provocation lumbar discography.
A systematic review of the lumbar provocation discography literature.
To systematically assess the diagnostic accuracy of lumbar discography.
A systematic review of the literature was performed to assess the diagnostic accuracy of lumbar discography with respect to chronic low back pain. Study inclusion/exclusion criteria were based on International Association for the Study of Pain (IASP) standards with pain provocation and determination of controlled discs. Selected studies were then subjected to a rating instrument for diagnostic accuracy studies. Specific data were then culled from these studies and tabulated. Quality of evidence was assessed using modified Agency for Healthcare Research and Quality (AHRQ) diagnostic accuracy evaluation. Studies meeting methodologic quality criteria scores of 50 or higher were included in the assessment of the level of evidence. Qualitative analysis was conducted using 5 levels of evidence, ranging from Level I to III, with 3 subcategories in Level II. The rating scheme was modified to evaluate the diagnostic accuracy.
Based on a modified U.S. Preventive Services Task Force (USPSTF) level of evidence criteria, this systematic review indicates the strength of evidence as Level II-2 for the diagnostic accuracy of lumbar provocation discography utilizing IASP criteria.
Limitations include a paucity of literature, poor methodologic quality, and very few studies performed utilizing IASP criteria.
Based on the current systematic review, lumbar provocation discography performed according to the IASP criteria with control disc (s) with minimum pain intensity of 7 of 10, or at least 70% reproduction of worst pain (i.e. worst spontaneous pain of 7 = 7 x 70% = 5) may be a useful tool for evaluating chronic lumbar discogenic pain. Discography is an important imaging and pain evaluation tool in identifying a subset of patients with chronic low back pain secondary to intervertebral disc disorders.
Failed back surgery syndrome is common in the United States. Management of post lumbar surgery syndrome with multiple modalities includes interventional techniques, resulting in moderate improvement, leaving a proportion of patients in intractable pain. The systematic reviews of long-term benefits and risks of spinal cord stimulation (SCS) for patients with failed back surgery syndrome showed limited to moderate evidence and cost effectiveness. However, with the exponential increase in surgery in the United States, spinal cord implants are also increasing. Thus, the discussion continues with claims of lack of evidence on one hand and escalating increases in utilization on the other hand.
A systematic review of SCS in patients with failed back surgery syndrome.
This systematic review is undertaken to examine the evidence from randomized controlled trials (RCTs) and observational studies to evaluate the effectiveness of SCS in post lumbar surgery syndrome and to demonstrate clinical and cost effectiveness.
Review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The 5 levels of evidence were classified as Level I, II, or III with 3 subcategories in Level II based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to December 2008, and manual searches of bibliographies of known primary and review articles.
The primary outcome measure was pain relief (short-term relief < or = one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized.
The indicated evidence is Level II-1 or II-2 for long-term relief in managing patients with failed back surgery syndrome.
The limitations of this review included the paucity and heterogeneity of the literature.
This systematic review evaluating the effectiveness of SCS in relieving chronic intractable pain of failed back surgery syndrome indicated the evidence to be Level II-1 or II-2 for clinical use on a long-term basis.
Disability, societal, and health impact of chronic intractable pain secondary to various failed therapies is a major issue. As advanced therapy, implantable therapies, which include intrathecal devices and spinal cord stimulation systems, are frequently used in managing chronic intractable pain. Thus, continuous infusion of intrathecal medication is one of the methods used for the control of chronic, refractory, cancer, and non-cancer pain. However, despite the high costs of chronic non-cancer pain, it has been claimed that there is a lack of evidence for intrathecal infusion systems and the cost effectiveness of these systems has been questioned in improving pain and function.
A systematic review of intrathecal infusion devices for chronic non-cancer pain.
To determine the efficacy, utilization, safety, and complications associated with the use of intrathecal infusion devices for long-term management of chronic non-cancer pain.
Literature search was performed through EMBASE, Medline, Cochrane databases, and systematic reviews identified from 1966 to December 2008. Studies were then reviewed and assessed using the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies and the Cochrane Musculoskeletal Review Group criteria for randomized trials. The level of evidence was determined using 5 levels of evidence, ranging from Level I to III with 3 subcategories in Level II, based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).
The primary outcome measure was pain relief (short-term relief < or = one-year and long-term > one-year). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were also utilized.
The level of evidence for intrathecal infusion systems indicated either Level II-3 or Level III (limited) based on U.S. Preventive Services Task Force (USPSTF) criteria.
The limitations of this study include the paucity of literature, lack of quality evidence, and lack of randomized trials.
This systematic review illustrates Level II-3 or Level III (limited) evidence for intrathecal infusion systems for long-term relief in chronic non-cancer pain.
Chronic, recurrent neck pain is common and is associated with high pain intensity and disability, which is seen in 14% of the adult general population. Controlled studies have supported the existence of cervical facet or zygapophysial joint pain in 36% to 67% of these patients. However, these studies also have shown false-positive results in 27% to 63% of the patients with a single diagnostic block. There is also a paucity of literature investigating therapeutic interventions of cervical facet joint pain.
A systematic review of cervical facet joint interventions.
To evaluate the accuracy of diagnostic facet joint nerve blocks and the effectiveness of cervical facet joint interventions.
Medical databases and journals were searched to locate all relevant literature from 1966 through December 2008 in the English language. A review of the literature of the utility of facet joint interventions in diagnosing and managing facet joint pain was performed according to the Agency for Healthcare Research and Quality (AHRQ) criteria for diagnostic studies and observational studies and the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials.
The level of evidence was defined as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF).
For diagnostic interventions, studies must have been performed utilizing controlled local anesthetic blocks which achieve at minimum 80% relief of pain and the ability to perform previously painful movements. For therapeutic interventions, the primary outcome measure was pain relief (short-term relief up to 6 months and long-term relief greater than 6 months) with secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake.
Based on the utilization of controlled comparative local anesthetic blocks, the evidence for the diagnosis of cervical facet joint pain is Level I or II-1. The indicated evidence for therapeutic cervical medial branch blocks is Level II-1. The indicated evidence for radiofrequency neurotomy in the cervical spine is Level II-1 or II-2, whereas the evidence is lacking for intraarticular injections.
A systematic review of cervical facet joint interventions is hindered by the paucity of published literature and lack of literature for intraarticular cervical facet joint injections.
The evidence for diagnosis of cervical facet joint pain with controlled comparative local anesthetic blocks is Level I or II-1. The indicated evidence for therapeutic facet joint interventions is Level II-1 for medial branch blocks, and Level II-1 or II-2 for radiofrequency neurotomy.
Epidural injection of corticosteroids is one of the most commonly used interventions in managing chronic spinal pain. The transforaminal route to the lumbar epidural space for steroid injection has gained rapid and widespread acceptance for the treatment of lumbar and leg pain. However, there are few well-designed randomized, controlled studies to determine the effectiveness of epidural injections. The role and value of transforaminal lumbar epidural steroid injections is still questioned.
A systematic review of transforaminal epidural injection therapy for low back and lower extremity pain.
To evaluate the effect of transforaminal lumbar epidural steroid injections in managing lumbar (low-back) and sciatica (leg) pain.
The available literature of lumbar transforaminal epidural injections in managing chronic low back and lower extremity pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria as utilized for interventional techniques for randomized trials and the criteria developed by the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of the bibliographies of known primary and review articles.
The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake.
The indicated evidence is Level II-1 for short-term relief and Level II-2 for long-term relief in managing chronic low back and lower extremity pain.
The limitations of this systematic review include the paucity of literature.
The indicated evidence for transforaminal lumbar epidural steroid injections is Level II-1 for short-term relief and Level II-2 for long-term improvement in the management of lumbar nerve root and low back pain.
Low back pain with or without lower extremity pain is the most common problem among chronic pain disorders with significant economic, societal, and health impact. Epidural injections are one of the most commonly performed interventions in the United States in managing chronic low back pain. However the evidence is highly variable among different techniques utilized - namely interlaminar, caudal, transforaminal - and for various conditions, namely - intervertebral disc herniation, spinal stenosis, and discogenic pain without disc herniation or radiculitis.
A systematic review of lumbar interlaminar epidural injections with or without steroids.
To evaluate the effect of lumbar interlaminar epidural injections with or without steroids in managing various types of chronic low back and lower extremity pain emanating as a result of disc herniation or radiculitis, spinal stenosis, and chronic discogenic pain.
Review of the literature and methodologic quality assessment were performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions. Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of bibliographies of known primary and review articles. Results of analysis were performed for multiple conditions separately.
The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > 6 months). Secondary outcome measures were improvement in functional status, psychological status, return to work, and reduction in opioid intake.
The available literature included only blind epidural injections without fluoroscopy. The indicated evidence is positive (Level II-2) for short-term relief of pain of disc herniation or radiculitis utilizing blind interlaminar epidural steroid injections with lacking of evidence with Level III for long-term relief for disc herniation and radiculitis. The evidence is lacking with Level III for short and long-term relief for spinal stenosis and discogenic pain without radiculitis or disc herniation utilizing blind epidural injections.
The limitations of this study include paucity of literature, lack of quality evidence, lack of fluoroscopic procedures, and lack of applicable evidence in contemporary interventional pain management practices.
The evidence based on this systematic review is limited for blind interlaminar epidurals in managing all types of pain except for short-term relief of pain secondary to disc herniation and radiculitis. This evidence does not represent contemporary interventional pain management practices and also the evidence may not be extrapolated to fluoroscopically directed lumbar interlaminar epidural injections.
Caudal epidural injection of local anesthetics with or without steroids is one of the most commonly used interventions in managing chronic low back and lower extremity pain. However, there has been a lack of well-designed randomized, controlled studies to determine the effectiveness of caudal epidural injections in various conditions - disc herniation and radiculitis, post-lumbar laminectomy syndrome, spinal stenosis, and chronic low back pain of disc origin without disc herniation or radiculitis.
A systematic review of caudal epidural injections with or without steroids in managing chronic pain secondary to lumbar disc herniation or radiculitis, post lumbar laminectomy syndrome, spinal stenosis, and discogenic pain without disc herniation or radiculitis.
To evaluate the effect of caudal epidural injections with or without steroids in managing various types of chronic low back and lower extremity pain emanating as a result of disc herniation or radiculitis, post-lumbar laminectomy syndrome, spinal stenosis, and chronic discogenic pain.
A review of the literature was performed according to the Cochrane Musculoskeletal Review Group Criteria as utilized for interventional techniques for randomized trials and the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF). Data sources included relevant literature of the English language identified through searches of PubMed and EMBASE from 1966 to November 2008, and manual searches of bibliographies of known primary and review articles.
The primary outcome measure was pain relief (short-term relief = up to 6 months and long-term > or = 6 months). Secondary outcome measures of improvement in functional status, psychological status, return to work, and reduction in opioid intake were utilized.
The evidence showed Level I for short- and long-term relief in managing chronic low back and lower extremity pain secondary to lumbar disc herniation and/or radiculitis and discogenic pain without disc herniation or radiculitis. The indicated evidence is Level II-1 or II-2 for caudal epidural injections in managing low back pain of post-lumbar laminectomy syndrome and spinal stenosis.
The limitations of this study include the paucity of literature, specifically for chronic pain without disc herniation.
This systematic review shows Level I evidence for relief of chronic pain secondary to disc herniation or radiculitis and discogenic pain without disc herniation or radiculitis. Further, the indicated evidence is Level II-1 or II-2 for caudal epidural injections in managing chronic pain of post lumbar laminectomy syndrome and spinal stenosis.
Recent reports of the United States Government Accountability Office (GAO), the Medicare Payment Advisory Commission (MedPAC), and the Office of Inspector General (OIG) expressed significant concern with overall fiscal sustainability of Medicare and exponential increase in costs for interventional pain management techniques. Interventional pain management (IPM) is an evolving specialty amenable to multiple influences. Evaluation and isolation of appropriate factors for increasing growth patterns have not been performed.
Analysis of the growth of interventional techniques in managing chronic pain in Medicare beneficiaries from 1997 to 2006.
To evaluate the use of all interventional techniques.
The standard 5% national sample of the CMS carrier claim record data for 1997, 2002, and 2006 was utilized. This data set provides information on Medicare enrollees in the fee-for-service Medicare program. Current procedural technology (CPT) codes for 1997, 2002, and 2006 were used to identify the number of procedures performed each year, and trends in expenditures.
Interventional techniques increased significantly in Medicare beneficiaries from 1997 to 2006. Overall, there was an increase of 137% in patients utilizing IPM services with an increase of 197% in IPM services, per 100,000 Medicare beneficiaries. The majority of the increases were attributed to exponential growth in the performance of facet joint interventions. There was a 13.9-fold difference in the increase between the state with the lowest rate and the state with the highest rate in utilization patterns of interventional techniques (California 37% vs. Connecticut 514%), with an 11.6-fold difference between Florida and California (431% vs. 37% increase). In 2006, Florida showed a 12.7-fold difference compared to Hawaii with the lowest utilization rate. Hospital outpatient department (HOPD) expenses constituted the highest increase with fewer patients treated either in an ambulatory surgery center (ASC) or in-office setting. Overall HOPD payments constituted 5% of total 2006 Medicare payments, in contrast to 57% of total IPM payments, an 11.4-fold difference.
The limitations of this study include a lack of inclusion of Medicare participants in Medicare Advantage plans and potential documentation, coding, and billing errors.
This study shows an overall increase of IPM services of 197% compared to an increase of 137% in patients utilizing IPM services from 1997 to 2006.
The workers' compensation system in the United States, comprised of independent state based and national programs for federal workers, covers approximately 127 million workers and has evolved and grown since its inception in 1911. Coverage has significantly broadened in scope to allow for the inclusion of most occupational injuries and illnesses. The cost of workers' compensation care has also increased. Some of the cost drivers have been identified,and various approaches have been taken to address medical cost containment. There is a need to balance cost control with ensuring benefit adequacy and quality of medical care. It is likely that managing workers' compensation costs will continue to be a challenge in the foreseeable future. The cost of workers' compensation care affects all stakeholders including workers, employers,providers, state workers' compensation regulators, legislatures,and insurers. A continued commitment to quality, accessibility to care, and cost containment, and being alert to emerging issues that can affect these elements, will help ensure that workers are afforded accessible, high quality, and cost-effective care.
The ACOEM occupational medicine practice guidelines: biased against chiropractic care
- G Lewkovich
- M Haneline
- E Mumbauer
- M Sackett
Lewkovich G, Haneline M, Mumbauer E, Sackett M. The ACOEM occupational medicine practice guidelines: biased against chir-opractic care. Dyn Chiropr. 2005;23(issue 01).