Guide to Using This Textbook

CHAPTER 2 Guide to Using This Textbook





Chapter Format


The main goal of this book is to educate clinicians from a wide variety of health care disciplines about the relative merits of the many interventions currently offered for the management of LBP based on the best available supporting scientific evidence and expert opinion. To achieve this goal and facilitate comparing the information available for different treatments, each intervention uses a common chapter format. This format reflects the information that was thought to be most important for clinicians to understand and evaluate the many different interventions with which they may not be familiar. Each chapter contains five main sections: (1) description, (2) theory, (3) efficacy, (4) safety, and (5) costs. In addition, each chapter contains a summary section. A description of the information presented in each of these sections is provided below.



Section 1—Description


This section is intended to provide basic information about the interventions discussed so that a clinician who is not familiar with that particular approach may understand basic terminology, any relevant subtypes found within that intervention, a brief description of its history, an estimate of the frequency with which those with common LBP may use it, the type of health care practitioner who offers this intervention, in which settings and locations it is available, a description of how it is performed, and the regulatory status of any medication or medical device relevant to that intervention. Additional information on each segment in this section follows.




History and Frequency of Use


Some of the interventions used for LBP can trace their origins back to approaches used thousands of years ago (e.g., spinal manipulation), whereas others are based on relatively recent discoveries or inventions (e.g., X-STOP).1 Interventions that were once in favor may be discarded, only to be rediscovered decades later (e.g., manipulation under anesthesia).2 Understanding the genesis and evolution of interventions can be helpful to evaluating their role in the management of LBP. This segment is intended to briefly describe the origins and important milestones of an intervention. This segment is also intended to provide some estimate about the frequency of use for a particular intervention to give some idea of how commonly it is employed by those with LBP, often based on health care utilization surveys, if available.





Regulatory Status


Many of the interventions used for LBP are techniques or procedures practiced by licensed health care professionals (e.g., massage therapy given by massage therapists) that are not subject to specific regulatory approval by federal authorities, such as the US Food and Drug Administration (FDA). In the United States, only medications and medical devices used to address specific health conditions are subject to regulation and approval by the FDA.3 The regulatory approval process for medications in the United States is fairly rigorous. Manufacturers must first submit an investigational new drug application to the FDA summarizing the results of preclinical studies demonstrating safety and efficacy in different species of animals.4 They can then obtain permission to conduct progressively larger clinical studies in healthy humans or participants with the targeted disease using different medication doses and lengths of follow-up (e.g., phase 1, 2, and 3).4 Final approval is then sought from the FDA to market a medication for the defined indication studied in the clinical trials through a new drug application.4


The regulatory approval process for medical devices depends on the three classes recognized by the FDA (e.g., class I, II, and III).5 Class I medical devices generally pose a very low risk of harms when used correctly (e.g., bandages, thermometers).5 Class II medical devices are more complex and require greater training and prudence in their usage (e.g., x-ray machine, surgical sutures).5 Class III medical devices include implants (e.g., joint replacement) and equipment used to monitor life-preserving function (e.g., pacemaker).5 The supporting information required by the FDA increases substantially for each class. Medical devices may also be approved based on their similarity to previously approved medical devices, although greater latitude is used in the interpretation of this tenet for medical devices than medications.


Use of a medication for conditions other than its FDA approved indication is termed “off-label” and is generally left to the prescribing physician’s discretion.6 However, off-label use cannot be promoted by its manufacturer and supporting information must be provided to the FDA to formally expand the approved indication for a medication that is already on the market. Because manufacturers often pursue the indication most likely to be approved based on the supporting evidence provided, it can be revealing to discover that a medication often used for one purpose (e.g., sciatica) was in fact approved for another (e.g., postherpetic neuralgia).



Section 2—Theory


This section is intended to provide basic information about the scientific and clinical theories related to the interventions discussed, for clinicians who may not be familiar with that particular approach, including its proposed mechanism of action, indication, and any diagnostic testing required. Additional information on each segment in this section is provided below.






Section 3—Efficacy


This section is often the longest in a chapter and may be the one on which more attention is focused by clinicians evaluating various interventions. A distinction is often made by clinical researchers between efficacy, which is how well an intervention works in a controlled research setting such as a clinical trial, and effectiveness, which is how well an intervention works in the real world after the clinical trials are completed and it is more widely adopted by practicing clinicians. Not surprisingly, the effectiveness of interventions for common LBP is often less impressive than their preliminary efficacy as their use grows beyond simply the ideal patient.


Such differences are also noted in the efficacy reported by various study designs. Large improvements noted in prospective observational studies (OBSs) may diminish in randomized controlled trials (RCTs), or positive results noted in some RCTs may be offset by negative results in other RCTs when systematic reviews (SRs) are conducted. It is therefore important for clinicians to reconcile the evidence available from a variety of study designs. To facilitate this process, the evidence in this section is presented by study design according to the hierarchy suggested by the pyramid of evidence discussed in Chapter 1. Attempts were also made to standardize the sources of information summarized in this section, as described here.



Clinical Practice Guidelines


An SR was recently conducted to identify clinical practice guidelines (CPGs) related to the diagnosis and management of LBP, that had been sponsored by national organizations and for which English language reports had been published in the past decade; 10 such CPGs were found (Table 2-1).7 This segment of the section on efficacy is intended to provide a succinct summary of the conclusions from these CPGs on the interventions reviewed. Not all CPGs reviewed each of the interventions in this book, and not all interventions were in fact evaluated in any of these CPGs; some chapters also discussed conclusions from CPGs other than those listed in Table 2-1.


TABLE 2-1 Recent National Clinical Practice Guidelines















































Country Year Title
Australia 2003 Evidence-based management of acute musculoskeletal pain
Belgium 2006 Chronic low back pain. Good clinical practice
Europe 2006 European guidelines for the management of acute nonspecific low back pain in primary care
Europe 2005 European guidelines for the management of chronic nonspecific low back pain in primary care
Italy 2006 Diagnostic therapeutic flow charts for low back pain patients: the Italian clinical guidelines
New Zealand 2004 Acute low back pain guide
Norway 2002 Acute low back pain: interdisciplinary clinical guidelines
United Kingdom 2009 Low back pain: early management of persistent nonspecific low back pain
United States 2009 Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an evidence-based clinical practice guideline from the American Pain Society
United States 2007 Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society


Systematic Reviews


The Cochrane Back Review Group (CBRG) is one of 50 review groups focused on specific topics, which together form the Cochrane Collaboration.8 As of February 2010, the CBRG has conducted 45 SRs on a variety of topics related to spinal disorders, including 31 related to interventions for LBP. In addition, the two CPGs related to LBP that were sponsored by the American Pain Society (APS) and the American College of Physicians (ACP) were each accompanied by two SRs that evaluated and summarized the best available scientific evidence for many interventions.914 This segment of the section on efficacy is intended to briefly summarize the conclusions from these specific SRs, which are summarized in Table 2-2

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Jun 14, 2016 | Posted by in PAIN MEDICINE | Comments Off on Guide to Using This Textbook

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