CHAPTER 2 Guide to Using This Textbook
Book Sections
This book is organized into 11 sections, including one section for introductory chapters and ten sections pertaining to broad categories of interventions for low back pain (LBP). Those ten categories include educational therapies, exercise therapies, medications, physical modalities, manual therapies, complementary and alternative medicine, behavioral therapies, injection therapies, minimally invasive therapies, and surgical therapies. These categories are not meant to be mutually exclusive, and it is recognized that the division between certain categories may be quite blurry. An attempt was also made to present these categories in the order in which a typical patient with common LBP may navigate through the maze of available therapies, from least to most invasive. This presentation is imperfect and does not apply to all (or even most) patients with common LBP, some of whom may need to proceed immediately to surgical therapies while others may only resort to medications. This ordering is simply offered as a method of organizing the contents of this book and should not be interpreted as ascribing any particular worth to the interventions discussed in each chapter.
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.
Terminology and Subtypes
Practitioners often use medical or technical jargon that can be misunderstood even by highly trained health providers from slightly different disciplines. This can create a barrier to effective communication and lead to misunderstandings about the concepts being discussed. This segment is intended to list and define any special terminology that may be important to understanding the interventions reviewed, including commonly used synonyms. This segment should also make readers aware of any subtypes that may be relevant to understanding how a particular intervention fits within the broader context of other similar approaches.
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.
Practitioner, Setting, and Availability
Numerous clinicians are involved in the management of LBP, few of whom know much about the specific interventions offered by those outside their specialty. Although some clinicians are primarily associated with one type of therapy (e.g., surgeons and surgery), others may in fact be trained to offer a multitude of therapies but do not routinely practice all of them (e.g., physiatrists and medication, injections, and minimally invasive interventions). Some interventions are widely offered by a variety of clinicians (e.g., spinal manipulation and chiropractors, physical therapists, and osteopaths), whereas others are fairly atypical with few qualified practitioners (e.g., prolotherapy). This segment is intended to describe the type of clinician most commonly associated with a particular intervention, as well as the clinical setting in which it is administered, and provide some estimate of its availability across the United States.
Procedure
Some of the interventions used for LBP have nomenclature that is fairly descriptive and provides a general idea about what is actually involved (e.g., artificial disc replacement), whereas others have names that may seem somewhat misleading when details are sought about the procedure (e.g., minimally invasive interventions). Others may have names that do not provide any information about the nature of the treatment (e.g., X-STOP). Clinicians may therefore be acquainted with the names of many interventions, but may not be familiar with their precise nature. This segment is intended to provide a broad description of how the intervention is actually performed, although it is not intended to be a teaching manual for those interested in learning new techniques.
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.
Mechanism of Action
Interventions are often developed in response to the specific etiology of a medical condition (e.g., antipyretic medication for acute fever). Understanding the disease process can therefore provide some insight into its appropriate management by matching the intervention to the observed pathophysiology. However, this process can be quite challenging for a condition such as common LBP whose etiology is so poorly understood. Numerous anatomic structures have been implicated in the development of LBP (e.g., intervertebral discs, vertebrae, nerve roots) with corresponding interventions aimed at their eradication (e.g., discectomy, laminectomy, rhizotomy). Similarly, many disease constructs have been proposed to explain the presence of LBP (e.g., poor motor control or strength, hypomobility, emotional distress), also with analogous interventions (e.g., exercise therapy, spinal manipulation, cognitive behavioral therapy). This segment is intended to discuss the proposed mechanism of action for various interventions, if known, and to discuss any basic science studies supporting that mechanism.
Indication
Although this book is focused on the management of LBP, not every treatment discussed is appropriate for each patient with LBP. It is reasonable to assume that interventions intended to alleviate instability (e.g., arthrodesis) should be targeting a different group of patients with LBP than those that aim to improve hypomobility (e.g., spinal manipulation under anesthesia). Expert clinicians who routinely manage LBP often develop specific indications for the interventions they offer. This segment is intended to highlight some of the specific indications (if any) for the interventions discussed beyond simply having LBP.
Assessment
Despite the difficulty faced by clinicians who attempt to pursue a specific anatomic source for common LBP, many interventions do in fact require some form of diagnostic testing before being implemented. It is assumed that all interventions discussed in this book require a clinician to first rule out the possibility that symptoms may be related to potentially serious spinal or other pathology. Rather than repeating the steps involved in the basic assessment of LBP for each intervention, that process is described in detail in one of the introductory chapters. This segment is intended to describe any specific diagnostic testing required before initiating a particular intervention once a basic assessment has been conducted to rule out serious or specific pathologies related to LBP.
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.9–14 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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