Conclusion

Conclusion



Scott Haldeman, Simon Dagenais


This textbook presents numerous approaches that are currently available for the management of low back pain, each of which could reasonably be considered a viable option to relieve this common and often debilitating symptom. An attempt was made to group similar interventions into sections describing somewhat related approaches, each of which may have a number of variations. Collectively, the chapters in this textbook present data from hundreds of studies related to dozens of interventions, many of which evaluated very specific treatment protocols for a highly selected group of patients with low back pain. Our natural inclination as clinicians is to formulate broad, sweeping statements that could easily be remembered and applied in clinical settings, whereas our tendency as researchers is to emphasize that findings from individual studies may not be reproducible when the setting, population, or clinical protocol is changed. The main challenge in presenting the information in this textbook was to generalize findings to facilitate their interpretation while maintaining the details necessary to ensure their accuracy; achieving such a perfect balance can often be elusive.


We have previously described the current management of low back pain as the “supermarket approach,” whereby the many approaches available are grouped into aisles (categories), within which products (treatments) differentiated by brands (clinicians) attempt to gain market share through advertising. This scenario has resulted in the seemingly haphazard heterogeneity observed in the management of low back pain, which has led to increases in the utilization and costs of all interventions without a corresponding improvement in outcomes. When considering that patients confronted with the vast array of available interventions often have chronic pain and other comorbidities influencing their psychological well-being, the previous analogy can be extended to shopping in a foreign supermarket while hungry and tired. This is clearly not an ideal vantage point from which to make an important medical decision such as choosing a treatment for low back pain.


When we elected to develop the January/February 2008 special focus issue of The Spine Journal on this topic into a textbook, we attempted to level the playing field by ensuring that each chapter would provide clinicians, patients, third-party payers, and other stakeholders with the information each required to make a more informed decision. This necessitated that all chapters follow the prescribed format, methods, content, and writing style to facilitate comparison of different interventions. Because this textbook is based on scientific evidence, it was also necessary for each chapter to review the best available literature in a similar fashion, highlighting the same important concepts for the studies uncovered. Our goal was to provide decision makers with a trustworthy source of information to educate them about the most common treatment options for low back pain using a standardized framework blending scientific evidence and clinical experience.


Although authors who had contributed review articles to the special focus issue in 2008 had received similar instructions at that time, this standardized approach was not strictly enforced because each manuscript also had to serve as a standalone journal article independently of the others. That limitation was not necessary when developing this textbook, in which we were able to edit the chapters in a much stricter fashion to ensure uniformity. We have attempted to create a reference source where it is possible for a reader to look at any treatment listed in this textbook and compare the information under any given section with similar information for alternative treatments they may also be considering in other chapters. Each chapter therefore focused mostly on those points that we believed were most likely to provide the information necessary for decision makers to choose among these many interventions.


The rationale for this approach should be intuitive to readers who are familiar with the types of buying guides we often turn to when making important or large purchases for any product or service. When applying the comparison shopping framework to selecting an intervention for low back pain, there are five basic questions that must be answered:


1 Exactly what is the intervention and what can I expect to happen if I decide to purchase it?

2 Is there a reasonable explanation as to how the intervention is likely to achieve the desired result and is there a body of research to support that theory?

3 What are the expected benefits of this intervention and how certain is it that I will experience these benefits?

4 What are the potential or known safety issues associated with this intervention and what is the likelihood that I may experience a harmful effect?

5 What is this intervention likely to cost and how does its cost compare to other available alternatives?

To answer these questions, each chapter is divided into five sections: (1) description, (2) theory, (3) efficacy, (4) safety, and (5) costs. Each of those sections is based on scientific evidence, supplemented by the authors’ professional judgment and clinical expertise when necessary to address gaps in the literature.


In this final chapter, we have elected to review all the treatment approaches explored in this textbook, propose a simplified framework to evaluate each one, and present our personal conclusions about how we would formulate a recommendation for a patient with low back pain. Our careful and repeated review of the material presented in this textbook allows us to arrive at what we now consider a reasonable approach to the management of low back pain. Although this represents merely our opinions as clinicians and researchers, we describe how the process of editing this textbook has influenced our thinking on this matter.



Basic Assumptions


There are a few points that became obvious to us after reading and editing the chapters in this textbook and the scientific literature related to low back pain on which they are based. Although these statements may not be universally accepted by all spine clinicians, researchers, or those with low back pain, and will no doubt be investigated for many years to come, they offer a perspective from which to evaluate the interventions presented in this textbook, as well as those yet to be discovered that will be added to this array of options in future years:


1 The most conservative interventions are generally preferred as the starting point when seeking care for low back pain.

2 It may be necessary to gradually progress from more conservative to less conservative interventions if prior approaches have failed to produce the intended results and patients are appropriate candidates for those interventions.

3 Most clinicians and patients will prefer interventions with a clearly understood mechanism of action, strong evidence supporting their efficacy, a low incidence of reported harms, and favorable cost effectiveness.

4 When two or more interventions are similar with respect to theory, efficacy, safety, and costs, issues such as convenience, availability, and personal preference may also guide decision making.

5 Not all patients will respond to interventions in a similar manner, and a certain degree of trial and error is unavoidable when selecting interventions for low back pain.

6 All interventions for low back pain generally have diminishing returns, and persistent, severe low back pain is the least likely to completely resolve.

7 Patients and clinicians should focus more on physical function and activities of daily living rather than pain severity alone when monitoring progress.

8 Many factors (whether known, suspected, or unknown), contribute to the chronicity and disability that can be associated with low back pain.

9 A multidisciplinary management approach addressing biopsychosocial and pathoanatomic factors may be necessary when single interventions are unable to improve symptoms, physical function, and overall health.

Having identified these basic assumptions, it is now possible to discuss conclusions about each of the important aspects of evaluating the interventions presented in the preceding chapters (i.e., efficacy, safety, cost effectiveness).



Evidence of Efficacy


The first and probably the most important thing to determine before a treatment is selected is whether that treatment is likely to be of any benefit in relieving symptoms and improving function. As noted in Chapter 1, there are a number of criteria that can be used to assess the strength and quality of the scientific evidence supporting the efficacy of a specific intervention. If one understands these criteria, it is possible to list and compare the best available evidence supporting the efficacy of the different interventions. To facilitate this process, a framework such as the hierarchy of evidence may be used to interpret findings from different study designs.



Expert Opinion


There was a time when expert opinion was the only basis necessary to consider a particular treatment approach. The opinions of clinicians are often based on their education, including the textbooks, mentors, and faculty members who influenced their opinions, as well their personal clinical experience with an intervention. Unfortunately, each of these criteria has been demonstrated to be flawed as vantage points for evaluating a treatment for low back pain. Few clinicians today receive training in more than a few of the multiple treatment approaches discussed in the text, leading to personal biases in favor of familiar interventions and against those which are unknown. Educational materials and academic experts rarely agree about which treatment is best. The natural tendency of patients with low back pain to recover with time and the strong placebo effect of any treatment for these symptoms make the personal experience of a clinician very unreliable as a predictor of the likelihood that an outcome, whether positive or negative, truly occurred as a result of a treatment offered a patient or simply occurred by chance.



Case Reports/Case Series


Reporting on the results of a small group of patients who undergo innovative treatments can be useful to alert others about new interventions or new uses of existing interventions, but offers very little information beyond the opinion and experience of a clinician using that approach. The biases that have the potential to render such observations invalid have been widely documented. They include the failure to determine and measure important outcomes, often retrospective assessment of records, failure to consider the natural history of low back pain, and the strong placebo effect of many treatments. Many case reports also lack adequate follow-up of patients, and large dropout rates are common in many of these studies. Case reports and case series are important in providing questions about the possibility that a treatment may be of value, but do not provide any definitive answers about effectiveness themselves.



Cohort Studies


Considerable information can be obtained by studying a large cohort of patients undergoing a specific treatment approach using a well-designed study protocol. This study design should include a predetermined research question, a prospective enrollment, assessment and interpretation of results by a person who is not the clinician offering the treatment, a well-defined follow-up procedure that includes multiple periods of outcomes assessment, and efforts to minimize dropout rates of subjects included in the study. These studies provide information on what we can expect to occur in a group of patients undergoing a specific treatment, which gives us good insight into prognosis, frequency of harms, and potential costs. These studies, however, cannot tell us whether a treatment is in fact responsible for the outcomes observed and generally do not compare the treatment with alternative approaches or no treatment at all.



Randomized Controlled Clinical Trials

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Jun 14, 2016 | Posted by in PAIN MEDICINE | Comments Off on Conclusion

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