Synthesis of Recommendations for the Assessment
and Management of Low Back Pain from
Recent Clinical Practice GuidelinesThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: Spine J. 2010 (Jun); 10 (6): 514–529 ~ FULL TEXT
Simon Dagenais, DC, PhD, AndreaC.Tricco, PhD, ScottHaldeman, DC, MD, PhD
Palladian Health,
2732 Transit Rd,
West Seneca, NY 14224, USA.
simon@spine-research.comBACKGROUND CONTEXT: Low back pain (LBP) is a prevalent, costly, and challenging condition to manage. Clinicians must choose among numerous assessment and management options. Several recent clinical practice guidelines (CPGs) on LBP have attempted to inform these decisions by evaluating and summarizing the best available supporting evidence. The quality and consistency of recommendations from these CPGs are currently unknown.
PURPOSE: To conduct a systematic review of recent CPGs and synthesize their recommendations on assessing and managing LBP for clinicians.
STUDY DESIGN/SETTING: Systematic review.
METHODS: Literature search using MEDLINE, National Guidelines Clearinghouse, National Institute for Clinical Excellence, Internet search engines, and references of known articles. Only CPGs related to both assessment and management of LBP written in English were eligible; CPGs that summarized evidence from before the year 2000 were excluded. Data related to methods and recommendations for assessment and management of LBP were abstracted independently by two reviewers. Methodological quality was assessed using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument by two reviewers.
RESULTS: The search uncovered 669 citations, of which 95 were potentially relevant and 10 were included in the review; 6 discussed acute LBP, 6 chronic LBP, and 6 LBP with neurologic involvement. Methods used to develop CPGs varied, but the overall methodological quality was high as defined by AGREE scores. Recommendations for assessment of LBP emphasized the importance of ruling out potentially serious spinal pathology, specific causes of LBP, and neurologic involvement, as well as identifying risk factors for chronicity and measuring the severity of symptoms and functional limitations, through the history, physical, and neurologic examination. Recommendations for management of acute LBP emphasized patient education, with short-term use of acetaminophen, nonsteroidal anti-inflammatory drugs, or spinal manipulation therapy. For chronic LBP, the addition of back exercises, behavioral therapy, and short-term opioid analgesics was suggested. Management of LBP with neurologic involvement was similar, with additional consideration given to magnetic resonance imaging or computed tomography to identify appropriate candidates willing to undergo epidural steroid injections or decompression surgery if more conservative approaches are not successful.
CONCLUSIONS: Recommendations from several recent CPGs regarding the assessment and management of LBP were similar. Clinicians who care for patients with LBP should endeavor to adopt these recommendations to improve patient care. Future CPGs may wish to invite coauthors from targeted clinician user groups, increase patient participation, update their literature searches before publication, conduct their own quality assessment of studies, and consider cost-effectiveness and other aspects in their recommendations more explicitly.
Keywords: Low back pain; Clinical practice guidelines; Systematic review; Evidence-based medicine
From the FULL TEXT Article:
Introduction
Low back pain (LBP) is a common musculoskeletal condition, with a lifetime prevalence of 84% in the general adult population. [1] The severity of LBP varies from patient to patient and episode to episode,with only 15% suffering from severe disability and 20% to 25% visiting a health provider. [1–4] However, the economic burden of LBP is very heavy because of direct health-care costs and indirect costs from lost productivity. Health-care costs associated with spine problems, including LBP and neck pain, were estimated at $102 billion in the United States in 2004. [5] Data from other countries suggest that indirect costs maybe five to six times higher than direct costs, bringing the total annual costs of LBP in the United States to $500 billion or more. [6]
Care for LBP is fragmented. Patients may first present to a primary care provider (PCP), where it ranks as one of the top five reasons for seeking care and accounts for 5% of all PCP visits; doctors of chiropractics (DCs)and physical therapists (PTs) are also frequently consulted for LBP. [3, 7–10] A sizable number of those with LBP also seek care in secondary care(2°) settings, including nonsurgical spine specialists, such as neurologists, physiatrists, and rheumatologists, and surgical spine specialists, such as orthopedic and neurologic surgeons. Allied healthproviders, such as acupuncturists, naturopaths, psychologists, and other healthproviders also play a role in managing LBP. Differences in the training, education, and scope of practice of these providers have lead to heterogeneity in the management of LBP. [11, 12]
Ideally, all providers involved in managing LBP should be guided by the best available scientific evidence to minimize the use of ineffective, excessively costly, or even harmful procedures. However, the volume of literature related to LBP precludes clinicians reading all studies in their fields. [4] Clinical practice guidelines (CPGs) endeavor to locate, evaluate, and summarize the scientific evidence on particular topics and are considered important tools in the implementation of evidence-based medicine. [8, 13–15] However, methods for developing CPGs are not yet standardized, which may impact the perceived validity of their recommendations. [15, 16] Previous reviews of CPGs for LBP reported that although many recommendations were similar, discrepancies were noted regarding the use of medication, spinal manipulation therapy (SMT), exercise, and patient education. [12, 17, 18] Conclusions from previous reviews on this topic may no longer be valid because newer CPGs were subsequently published.
Adherence to recommendations from CPGs on the management of LBP has been associated with both improved clinical outcomes and decreased costs. [19–22] However, compliance with such recommendations from CPGs has been consistently low in studies of physicians, chiropractors, PTs, and other clinicians involved in managing LBP. [20, 21, 23–37] Interventions aimed at increasing compliance with CPGs among health practitioners have reported mixed results. [19, 28, 38–40] Barriers noted to the adoption of CPGs have included lack of understanding about how they arrive at their recommendations,insufficient clarity to apply them, inconsistency among different CPGs, or disagreement with their recommendations. [41]
The primary objective of this study was to synthesize recommendations from recent CPGs to provide guidance to clinicians on evidence-based assessment and management of acute LBP, chronic LBP, and LBP with substantial neurologic involvement, which are defined below. Secondary objectives were to compare methods used in different CPGs, rate their methodological quality, and make suggestions for developing future CPGs related to LBP.
Methods
Information sources
Clinical practice guidelines were primarily identified through electronics earches in MEDLINE (OVID Interface, 1996 to August Week1, 2009). Searches of the Internet also were conducted as CPGs are rarely published in med ical journals. [42] The National Guideline Clearinghouse (www.guideline.gov), Clinical Evidence (clinicalevidence.bmj.com), Intute(www.intute.ac.uk), National Institute for Health and Clinical Excellence (www.nice.org.uk), and other Websites were searched. [43] Clinical practice guidelines were also identified by scanning the reference lists of previous reviews. [12, 18]
Search
MEDLINE was searched using an established method that involved combining the following terms: {guideline) (text word) OR recommendation) (text word) OR ‘‘practice guideline’’ (medical subheading)} AND ‘‘lowback pain’’ (medical subheading). [44] The Internet searches were conducted in a similar manner.
Study selection
Two reviewers (SD and ACT) independently screened the literature search results using predefined eligibility criteria. Conflicts were resolved by discussion until consensus was reached.
Eligibility criteria
Evidence-based CPGs providing information pertaining to the assessment and management of LBP were eligible for inclusion. The CPGs were not limited by country of origin or publication status. However, CPGs were not in cluded if they were not endorsed by a national government agency or professional health provider group, were written in a language other than English, did not include both assessment and management of LBP in their scope, or were focused on a single discipline or intervention. To include recent CPGs based on current evidence, those whose literature search did not extend beyond the year 1999 were also excluded.
Data collection process
A draft data abstraction form was developed, piloted, and modified as necessary. Data were subsequently ab stracted by one reviewer and verified independently by another reviewer.
Data items
Abstracted data included CPG characteristics, methods used to develop the CPGs, and scope of CPGs. Recommen dations for the assessment and management of LBP were also abstracted.
Risk of bias
The Appraisal of Guidelines Research and Evaluation (AGREE)tool was used to assess the risk of bias. [45] This validated tool consists of 23 items allocated to six domains:1) scope and purpose (three items),
2) stakeholder involvement (fouritems),
3) rigor of development (sevenitems),
4) clarity and presentation (fouritems),
5) applicability (three items), and
6) editorial independence (twoitems).Each item is rated from one (strongly disagree) to four (strongly agree). An additional item asks the rater if they would recommend use of the CPG in clinical practice. No summary score is derived for this tool. Two reviewers rated the CPGs independently; conflicts were resolved by discussion until consensus was reached.
Synthesis of results
Recommendations for the assessment of LBP were synthesized according to the main goals, whether they were mostly delivered in primary care(1°), 2°, or tertiary care (3°) settings and for acute LBP, chronic LBP, and LBP with substantial neurologic involvement. Acute LBP was generally defined as symptom duration of less than 3 months, whereas chronic LBP was greater than 3 months. Low back pain with substantial neurologic involvement was generally defined as LBP with moderate, severe, or progressive (collectively termed substantial) signs or symptoms of neurologic dysfunction in the lower extremities secondary to neural impingement from common causes, such as spinal stenosis or intervertebral foramen stenosis; mild radiculopathy, referred pain, and cauda equina syndrome were generally excluded from this category.
Recommendations from CPGs about the use of specific assessment or management options were dichotomized to‘‘rec ommended’’ if there was strong, moderate, or limited evidence of efficacy (or similar wording),or ‘‘not recommended’’ if there was insufficient, conflicting, or evidence against a particular intervention (or similar wording). A distinction was often made in CPGs with respect to weak opioid analgesics (eg, codeineandtramadol) and strong opioid analgesics (eg,oxycodoneandmorphine); recommendations were categorized accordingly. [46] When CPGs contained multiple recommendations about a particular form of assessment or management, the one contained in its summary was abstracted.
Discussion
Most CPGs originated in Europe, where some countries not only participated in multinational efforts but also developed their own national CPGs. Reasons for doing this were unclear but may be because of a perceived need to adapt ‘‘generic’’ recommendations to the particular societal, cultural, legal, or economic realities of their countries. An equal number of CPGs were related acute and chronic LBP, countering previous reports that relatively few CPGs existed for the management of chronic LBP. [46] It was unclear why two CPGs used much shorter thresholds of 4 to 6 weeks to distinguish acute from chronic LBP rather than the 12 weeks recommended by the Cochrane Back Review Group (CBRG). [53] Such temporal classifications are somewhat arbitrary, given that patients with LBP often have symptoms that fluctuate over time but facilitate comparison of recommendations when used consistently. [50] It was unclear why some CPGs excluded LBP with substantial neurologic involvement from their scope when this group is often targeted for advanced diagnostic imaging or invasive interventions.
The multidisciplinary nature of managing LBP was evident in the composition of CPG authors. It should be noted that professional associations for PCPs, DCs, PTs, nonsurgical spine specialists, and surgical spine specialists only endorsed CPGs on which they were represented by at least one author with that type of clinical training. If the goal of CPGs is to make recommendations that will be adhered to by practicing clinicians, representation among their authors seems worthwhile both to inform the content of the recommendations and to secure subsequent endorsement of CPGs by professional organizations. All future CPGs should endeavor to discuss potential conflicts of interest among its authors.
Most CPGs appeared to follow many CBRG recommendations in their literature search, but few included non- English language or unpublished studies. [53] The delay between completing the literature search and publication of the CPG report varied from 10 [50, 51] to 32 months [49], with a mean of 19 months. In some cases,recommendations could have become outdated by the time CPGs were published, if new studies appeared in the interim; updated literature searches should be conducted immediately before publication to avoid this scenario. Few CPGs specified the conditions under which they should be updated (eg, every 2 years, whenever new evidence is published that could change recommendations). Considering that CPGs are based on the best available evidence at the time of their literature search, their recommendations have a limited shelf life; the average CPG included in this review is now nearly 4 years old.
Many CPGs relied on previous SRs to identify relevant primary studies, which can be an efficient way to begin a literatures earch. However, some CPGs also relied on previous SRs for quality assessments, which may overstate the objective nature of that process. Researchers who conduct SRs must make numerous decisions regarding study eligibility, data extraction, and synthesis of results, all of which may impact their quality assessment. Although these criteria are intended to be absolute, the relative quality among the studies considered can also be considered. Because quality assessment is important when determining the level of evidence supporting a recommendation, future CPGs may wish to evaluate methodological quality independently. Future CPGs may also wish to reconsider the number of levels of evidence and qualifiers used in their recommendations because clinicians looking for clear guidance may prefer a simple yes or no.
A synthesis of recommendations regarding the assessment of acute LBP suggests that a history, physical exam ination, and neurologic examination should be sufficient in the vast majority of patients. Because there were more than 20 red flags proposed in these CPGs, an intake questionnaire could conceivably be devised to ask patients about each one, with clinicians asking appropriate follow-up questions based on those answers. A similar approach could also be taken to screening for specific causes of LBP, such as systemic inflammatory, abdominal, genitourinary, or cardiovascular disorders. A brief physical examination and a neurologic examination of the L5, L5,andS1 dermatomes, myotomes,and deep tendon reflexes should then be conducted. It was estimated that this approach would be sufficient to identify 99% of potentially serious spinal pathology. [46]
Should this assessment suggest that potentially serious spinal pathology or specific causes of LBP are present,diagnostic testing, such as X-rays and bloodtests, MRI/CT, or urgent surgical evaluation may be appropriate, although few details were provided about management of these disorders. It may be helpful for future CPGs to provide a synopsis of how serious spinal pathology may be managed (eg, decompression surgery for cauda equina syndrome and fusion surgery for spinal fracture with instability). For LBP with substantial neurologic involvement, CPGs generally did not recommend conducting any further assessment until appropriate conservative management(which was rarely defined) had failed, after which MRI or CT was generally recommended. Even in such cases, however, it was suggested that because the goal of advanced imaging was to identify candidates for surgical interventions, those who are not apriori interested in those options may not wish to undergo presurgical assessment.
Despite the widespread use of diagnostic tests for LBP, none of the CPGs reviewed recommended them without specific indications and numerous caveats. It should also be noted that none of the CPGs reported it was necessary, or even beneficial, for a clinician to attempt to identify the specific anatomical structures involved in LBP after having eliminated potentially serious spinal pathology, specific causes,and substantial neurologic involvement. [7] It was even suggested that needlessly ordering diagnostic testing could independently increase the risk of chronicity. [52] In the context of LBP, it may be preferable for both clinicians and patients to accept that assessment is a more feasible objective than diagnosis, which implies a specific pathoanatomic cause that simply cannot be established for the vast majority of LBP. [52]
Although most CPGs suggested identifying patients with risk factors for chronicity, only one made any recommendations about what to do when these patients were identified. [49] Because many of the risk factors for chronicity are related to inappropriate beliefs and behaviors about LBP, clinicians may wish to recommend a combination of education and focused cognitive behavioral therapy to overcome these barriers. [42, 49] Suggestions were also made to emphasize function over pain when measuring outcomes, to support patients remaining employed, and to schedule frequent reassessments to reinforce these messages. [49] It is unclear if implementing such an approach for patients deemed at high risk of developing chronic LBP would be feasible or cost-effective on a population level.
It was somewhat disappointing for CPGs to recommend that clinicians evaluate the severity of symptoms and functional limitations for LBP without offering some guidance on specific outcome measures. Numerous validated instruments are available to assess pain, including the visual analog scale (0–to 100–mm line), numerical rating scales (whole numbers from 0 to 10) among many others. [54] Several instruments are also available to measure physical function or disability specific to LBP, including the Roland-Morris disability questionnaire, Oswestry Disability Index,and others. [54] The MCID for many of those instruments has already been established for LBP and corresponds to an improvement of 25% to 35%. [54] Alternatively, a generic health instrument, such as the Short Form-12 can also be used to evaluate physical function, with the added benefits of measuring mental function and yielding utility scores that can be used in health economic evaluations that are currently lacking for LBP. [55, 56]
The scope of interventions discussed for the management of LBP in each CPG was slightly different, and it was unclear why certain interventions were included or excluded from their literature search and summary recommendations. A synthesis of recommendations for acute LBP suggests that clinicians should educate patients about its etiology (eg, unknown and nonspecific), prognosis(eg, likely to improve within weeks with or without care), recurrence (eg, future occurrences are common), recommend staying active despite discomfort associated with activities of daily living, whereas relying mostly on acetaminophen, NSAIDs, or SMT for short-term symptomatic relief.
Those recommendations also held true for the management of chronic LBP, with the judicious addition of one or more interventions, such as back exercises, behavioral therapy, acupuncture, multidisciplinary rehabilitation, and adjunctive or strong opioid analgesics. Management recommendations for LBP with substantial neurologic involvement were largely similar, although patients who did not improve following conservative management were generally considered appropriate candidates for ESIs or decompression surgery. Future CPGs may wish to provide additional guidance on what constitutes appropriate conservative management, acceptable improvement at various time intervals, and proper escalation of interventions to help both clinicians and patients to determine the next course of action. Such clarification may prevent the unintended interpretation of these recommendations as an endorsement of decompression surgery for patients whose symptoms do not disappear completely after only a few weeks of using commonan algesics. Recommendations generally did not support the use of injections, minimally invasive approaches, or surgical procedures for LBP. Although this does not eliminate the possibility that individual patients may benefit from these interventions, current adherence to these recommendations by clinicians appears minimal.
Given the apparent similarity in the recommendations for managing acute LBP, chronic LBP, and LBP with substantial neurologic involvement, it was unclear why some CPGs excluded one or more of these categories from their scope. Although it may be more feasible for sponsorsor authors of CPGs to prepare them on limited aspects of the assessment and management of LBP, this approach may not reflect the universe of possibilities routinely faced by stakeholders attempting to choose among the hundreds of available options for LBP. [11] Rather than excluding acute LBP, chronic LBP, or LBP with substantial neurologic involvement, or focusing exclusively on 1°, 2°, or even 3° interventions, future CPGs may simply wish to consider including all aspects of LBP and making simplified sequential sets of recommendations that can be applied to progressively narrower patient populations (eg, recommendations for acute LBP that can also be applied to chronic LBP and LBP with substantial neurologic involvement).
It was noted in some CPGs that trial and error would likely be required when managing LBP as not all patients will respond to the same interventions. [47] It was also reported that no single intervention is likely to completely eliminate symptoms, and that some form of multidisciplinary care may be necessary. [46] This should not be construed as an encouragement for clinicians to simultaneously institute all recommended interventions in a haphazard manner. Although the clinical effects of such an approach are currently unknown, its financial consequences can easily be imagined for all stakeholders. Rather, these observations suggest that limited trials of one or more recommended interventions guided by a clinician familiar with evidence-based assessment and management of LBP may be appropriate. Once initiated, the decision to continue these therapies should be made on the basis of documented improvement noted with periodic outcome measures that surpass the MCID.
Only one CPG suggested specific parameters for some of the recommended interventions for chronic LBP that were based on repeated visits to clinicians. For supervised exercise therapy, a maximum of eight sessions over 12 weeks in a group setting was suggested. For SMT, it was a maximum of nine sessions over 12weeks. For acupuncture, it was a maximum of 10 sessions over 12 weeks. [50] The evidence on which these parameters were based is unclear, but the concept of applying restrictions to potentially unlimited interventions for chronic LBP appears prudent, given that costs are rapidly escalating while outcomes are generally worsening. [57] This principle should likely apply to all interventions for LBP, modifying the clinical approach and/or patient expectations when measurable outcomes fail to improve.
For a costly, recurring, and non–life-threatening disorder, such as LBP for which there are many competing interventions, none of which can definitely offer a cure, the concept of relative cost-effectiveness should be an important factor when making CPG recommendations. Although six CPGs reported that costs were considered [7–9, 46–48, 50], only two explicitly included health technology assessments in their literature search [58, 50], and only one CPG explicitly summarized cost-effectiveness analyses (CEAs) and cost-utility analyses(CUAs). [50] Failure to incorporate this aspect more prominently in CPGs may be related to a paucity of high-quality clear studies related to cost-effectiveness analyses and cost-utility analyses of interventions for LBP. [56] As only one CPG included both a health economist and an information scientist among its authors, it is possible that other CPGs were simply not aware of the pertinent literature or were unable to incorporate its findings into their clinical recommendations. [4] It would also be interesting to compare the recommendations made in these CPGs about specific interventions with the current reimbursement policies of third-party insurers; their effects on clinician adoption of specific recommendations should not be understated.
Study limitations
The results of this review may have been limited by its searching methodology, which focused on English language CPGs indexed in major health databases. Bias may have been introduced by overlooking non-English or unpublished CPGs. [58, 59] However, the search methods used were consistent with the study objectives to uncover most relevant methodologically sound CPGs intended for distribution to clinicians. [16] It is also possible that broad recommendations made in CPGs were misunderstood or unintentionally modified when applied to the specific research questions in this review. Although this review attempted to provide a broad summary of high-level evidence, it cannot reflect all the details and nuances located in the CPGs, let alone account for uncertainty in the primary studies that were themselves summarized in those CPGs. Recommendations from evidence-based CPGs often ignore practical realities faced by clinicians, such as ordering diagnostic testing to practice defensive medicine and the reimbursement policies of third-party insurers dictating management recommendations.
Conclusion
A total of 10 CPGs related to the assessment and management of LBP have been published in the past 10 years. Methods for conducting these CPGs varied, but most were of high methodological quality and had generally similar recommendations. Although CPGs differed in their scope with respect to acute LBP, chronic LBP, and LBP with substantial neurologic involvement, recommendations were broadly similar and erecting such barriers when formulating recommendations for clinicians appears some what artificial. Recommendations from CPGs suggest that the assessment of patients with LBP should be centered on the history, physical and neurologic examination, and ordering diagnostic testing only when potentially serious spinal pathology or specific causes of LBP are suspected. Management of LBP should focus mostly on patient education, with short-term use of acetaminophen, NSAIDs, or SMT for symptomatic relief of acute LBP, with the judicious addition of opioid analgesics, back exercises, behavioral therapy, or acupuncture for additional symptomatic relief with chronic LBP. Adopting these recommendations should provide satisfactory care for the vast majority of patients with LBP within 1° settings and may decrease the number of patients who unnecessarily seek advanced diagnostic testing or interventions in 2° when not warranted.
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