CHAPTER 2 Guide to Using This Textbook
Chapter Format
Section 1—Description
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 3—Efficacy
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.
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