The Chiropractic Hospital-based Interventions Research
Outcomes (CHIRO) study: A Randomized Controlled Trial
on the Effectiveness of Clinical Practice Guidelines
in the Medical and Chiropractic Management of Patients
with Acute Mechanical Low Back PainThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: Spine J. 2010 (Dec); 10 (12): 1055−1064 ~ FULL TEXT
Paul B. Bishop, DC, MD, PhD, Jeffrey A. Quon, DC, PhD, FCCSC,
Charles G. Fisher, MD, MHS, FRCSC, Marcel F.S. Dvorak, MD, FRCSC
International Collaboration on Repair Discoveries (ICORD),
University of British Columbia,
Vancouver, British Columbia, Canada.
paul.bishop@vch.ca
Paul Bishop, DC, MD, PhD, is a Clinical Associate Professor in the Department of Orthopaedics at the University of British Columbia. He has completed training as both a chiropractor and a physician and holds a PhD degree in pathology for which he studied the origins of human lumbar spine disc degeneration. His clinical practice is focused on the treatment of acute spinal pain. Dr. Bishop’s main research interests include the standardization of treatment for acute spinal pain, the value of spinal injections in the treatment of acute sciatica and the relationship between biochemical composition of extruded disc and severity of acute sciatica. He is the Director of the Outpatient Clinic in the Combined Neurosurgical and Orthopaedic Spine Program (CNOSP).
In a Health Insights Today interview, Dr. Bishop discusses the research project − winner of the North American Spine Society’s 2010 Award for Outstanding Paper in Medical and Interventional Science − where his team compared guidelines-based care (including chiropractic spinal manipulation) for low back pain of less than 16 weeks versus usual care administered by primary care medical physicians. Among the key findings were that(1) guidelines-based care including chiropractic spinal manipulation is significantly more effective than usual (medical) care and
(2) usual care by primary care MDs is highly guideline-discordant.Dr. Bishop’s team at the University of British Columbia is currently engaged in an ongoing series of studies to further illuminate these issues.
Thanks to Daniel Redwood, DC for access to his review.BACKGROUND CONTEXT: Evidence-based clinical practice guidelines (CPGs) for the management of patients with acute mechanical low back pain (AM-LBP) have been defined on an international scale. Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments. To date, the value of implementing full and exclusively CPG-based treatment remains unclear.
PURPOSE: To determine if full CPGs-based study care (SC) results in greater improvement in functional outcomes than family physician-directed usual care (UC) in the treatment of AM-LBP.
STUDY DESIGN/SETTING: A two-arm, parallel design, prospective, randomized controlled clinical trial using blinded outcome assessment. Treatment was administered in a hospital-based spine program outpatient clinic.
PATIENT SAMPLE: Inclusion criteria included patients aged 19 to 59 years with Quebec Task Force Categories 1 and 2 AM-LBP of 2 to 4 weeks' duration. Exclusion criteria included "red flag" conditions and comorbidities contraindicating chiropractic spinal manipulative therapy (CSMT).
OUTCOME MEASURES:PRIMARY OUTCOME: improvement from baseline in Roland-Morris Disability Questionnaire (RDQ) scores at 16 weeks.
SECONDARY OUTCOMES: improvements in RDQ scores at 8 and 24 weeks; and in Short Form-36 (SF-36) bodily pain (BP) and physical functioning (PF) scale scores at 8, 16, and 24 weeks.METHODS: Patients were assessed by a spine physician, then randomized to SC (reassurance and avoidance of passive treatments, acetaminophen, 4 weeks of lumbar CSMT, and return to work within 8 weeks), or family physician-directed UC, the components of which were recorded.
RESULTS: Ninety-two patients were recruited, with 36 SC and 35 UC patients completing all follow-up visits. Baseline prognostic variables were evenly distributed between groups. The primary outcome, the unadjusted mean improvement in RDQ scores, was significantly greater in the SC group than in the UC group (p=.003). Regarding unadjusted mean changes in secondary outcomes, improvements in RDQ scores were also greater in the SC group at other time points, particularly at 24 weeks (p=.004). Similarly, improvements in SF-36 PF scores favored the SC group at all time points; however, these differences were not statistically significant. Improvements in SF-36 BP scores were similar between groups. In repeated-measures analyses, global adjusted mean improvement was significantly greater in the SC group in terms of RDQ (p=.0002), nearly significantly greater in terms of SF-36 PF (p=.08), but similar between groups in terms of SF-36 BP (p=.27).
CONCLUSIONS: This is the first reported randomized controlled trial comparing full CPG-based treatment, including spinal manipulative therapy administered by chiropractors, to family physician-directed UC in the treatment of patients with AM-LBP. Compared to family physician-directed UC, full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning.
Keywords: Clinical practice guidelines, Acute low back pain, Nonoperative treatment, Chiropractic, Spinal manipulation
From the FULL TEXT Article:
Introduction
Current clinical practice guidelines (CPGs) for the treatment of acute low back pain (AM-LBP) have been derived from independent systematic reviews carried out on an international scale. [1−12] Their recommendations have been shown to be highly consistent and based on sound scientific evidence rather than on consensus. [13] The knowledge translation of these guidelines to primary health-care providers has, to date, been unimpressive. [14−16] Multiple studies have demonstrated a poor correlation between what primary health-care providers think is an effective treatment and what has actually been shown to be an effective treatment. [17−20] Without widespread implementation of guideline-recommended treatments, the degree to which otherwise extensive scientific research (which the guidelines are based on) is actually helping this patient population remains to be determined.
The Chiropractic Hospital-based Interventions Research Outcome (CHIRO) initiative was designed to evaluate the outcomes of spinal pain patient management strategies that involve a component of chiropractic assessment and/or spinal manipulative therapy, administered in a hospital-based spine program outpatient clinic. This CHIRO framework was used in the present study to examine the effectiveness of current evidence-based CPG-recommended treatments for patients with AM-LBP pain.
The specific objective of the present study was to compare the short-term outcome of treatment comprised exclusively of guideline-recommended therapies on the one hand, with family physician−directed ‘‘usual care (UC)’’ on the other hand, for patients with AM-LBP. Our primary hypothesis was that guideline-concordant treatment would result in greater improvement in condition-specific quality of life than physician-directed UC at 16 weeks. One of our secondary goals was to advance the process of knowledge translation by directly involving community-based clinicians in research and thereby exposing this clinician population (and their patients) to a culture of evidence-based care.
Discussion
To our knowledge, this is the first randomized controlled clinical trial assessing the efficacy of full, multimodal, CPG-based therapy for patients with AM-LBP. In this respect, it is distinct from previous studies that have evaluated only individual components of guidelines-based therapies in isolation or combinations of relatively few selected guidelines-based treatment elements as a package. [24−26] This study also follows two previous studies conducted by our group that demonstrated that treatments commonly recommended by primary care physicians are often highly guideline discordant [14, 15], and other studies that have demonstrated that primary care physicians are highly resistant to changing their patterns of practice for managing patients with AM-LBP. [19, 20] An important, although not unique, feature of the design of the present study was that it successfully achieved the cooperation from a diverse group of physicians and chiropractors to modify their preexisting patterns of practice to conform to our specific guidelinesbased treatment protocol.
The results of this study demonstrated that in equivalent groups of patients with AM-LBP of less than 4 weeks’ duration, carefully controlled and comprehensive CPG-based care was associated with greater improvement in terms of condition-specific functioning (RDQ scores) at 16 weeks after treatment initiation. The study was primarily designed to evaluate treatment outcomes for the entire duration of the acute phase of the patient’s clinical course (ie, 16 weeks). The important issue of whether patients in either treatment group later experience reoccurrences of acute back pain or go on to develop chronic low back pain is the subject of a future study. However, the importance of improving patient outcomes within the acute phase of the patient’s clinical course is important because the development of chronic and often refractory low back pain is commonly preceded by a poor outcome from the management of the patient’s AM-LBP.
In regard to other secondary findings, a nonsignificant benefit of guidelines-based care over UC was observed at 8 weeks in both our unadjusted and adjusted analyses. Subsequently, the effect of guidelines-based care on back pain−specific functioning was significantly greater than guidelines-discordant care at 16 weeks, and this benefit was maintained at 24 weeks.
Regarding our SF-36 outcomes, the SF-36 BP subscale did not detect a significant difference between groups, which may reflect lower discriminative ability of the SF-36 BP subscale among some patients with low back pain. [27] On the other hand, 78% of patients in the UC group, compared with 0% of patients in the SC group, were also taking narcotic analgesic medications. This differential use of narcotic analgesics would normally bias the SF-36 BP score results in favor of the UC group; yet, SC patients showed comparable improvement in BP scores.
General PF, as assessed using the SF-36 PF scale, was generally greater in the guideline-concordant treatment group than in the guideline-discordant treatment group. In both adjusted and unadjusted analyses, the superiority of guideline-concordant treatment on general PF was greatest at 16 weeks, then less at 24 weeks’ follow-up. A trend toward a statistically significant difference in favor of SC was seen at 8 weeks in both our unadjusted and adjusted analysis and at 16 weeks in our adjusted analysis only.
Another interesting finding in this study is that although patients in both the SC and UC groups showed improvement in general BP scores and general PF scores over time, patients in the UC group uniquely showed no improvement whatsoever in back-specific functioning (RDQ scores) throughout the entire study period. The apparently poorer natural course of low back pain among UC patients is perhaps not surprising, given that patients with AM-LBP referred to a tertiary care hospital-based spine program are more likely to harbor underlying spine pathology (eg, spinal stenosis, disc degeneration, or facet joint arthropathy). A recent study has demonstrated that patients with some forms of underlying spine pathology have less favorable nonoperative treatment outcomes than patients with no identifiable underlying spine pathology. [28]
The design of this study carried out in the setting of the Canadian health-care system had some similarities but also some other important differences to other recent studies that have evaluated guideline-based treatment in this patient population in other National health-care environments. Using nonrandomized clinical trial methodology, McGuirk et al. [24] evaluated the use of ‘‘special clinics’’ established in a single state of Australia, which were staffed by physicians who agreed to ‘‘abide’’ by the guidelines to treat a cohort of patients with acute back pain. Although the treatments provided under the umbrella of ‘‘evidence-based care’’ did not include all of the current guidelinerecommended treatments (eg, chiropractic spinal manipulation), evidence-based care was shown to achieve greater rates of full recovery, result in reduced need for continuing care, and was less expensive. The United Kingdom BEAM [25] study used randomized control study design to evaluate spinal manipulative therapy administered by chiropractors, osteopaths, and physiotherapists as a component of a package of therapies in the treatment of patients with acute and chronic low back pain. The results showed that combined elements of guideline-based treatments resulted in better patient outcomes than treatment based on single guidelines-based elements. The findings of all of these studies are somewhat at odds with the findings of the recent study by Hancock et al. [26] that reported that some components of the current guideline-recommended treatment are superfluous. In particular, using this study design, the addition of NSAIDs and a form of spinal manipulative therapy or mobilization administered by a physiotherapist to the lumbar spine, thoracic spine, sacroiliac joint, pelvis, and hip (compared with a detuned ultrasound as placebo manipulative therapy), to family physician ‘‘advice’’ and acetaminophen were shown to have no clinically worthwhile benefit when compared with advice and acetaminophen alone.
Current CPG are derived exclusively from the best available scientific evidence. Research studies that evaluate the efficacy of these guidelines are a desirable and necessary step in the development of more refined guidelines, and it is through this process that optimum treatment strategies will be defined. When evaluating current guidelines, care must be taken to avoid making invalid comparisons. This is particularly the case when evaluating guideline-concordant forms of spinal manipulative therapy. Its inclusion as a component of current guideline-concordant treatment is based on the independent reviews carried out on an international scale of the published high-quality clinical trials that have evaluated spinal manipulative therapy administered virtually entirely by chiropractors. Although spinal manipulative therapy is currently administered by many different healthcare professionals, including chiropractors, osteopaths, orthopedic surgeons, family physicians, kinesiologists, naturopaths, and physiotherapists, the levels of training and clinical acumen vary widely. The study design used by Hancock et al., therefore, differs from our study because it did not use chiropractic spinal manipulation, and current guidelinebased care does not endorse any forms of spinal manipulation administered by any other practitioners. However, this is an issue that certainly requires further study. Similarly, the reported finding that addingNSAIDs to the treatment regimen produced no further benefit to patients is again not guideline discordant, as the guidelines recommend either acetaminophen or NSAID medications and not both.
Our study has several limitations beginning with the comparison of UC, directed by a family physician, to SC provided by medical spine specialists and chiropractors in a hospital-based spine program setting. It may be argued that highly standardized evidence-based care provided by spine specialists is likely to result in improved outcomes when compared with UC provided by a random group of practitioners (eg, family physicians, chiropractors, and physiotherapists) in private offices. Therefore, this study does not necessarily comment on the effectiveness of nonhospital or community-based guideline-concordant care. Furthermore, from the time that treatment actually commences within each study arm, the potential development of higher expectations of benefit (from specialized treatment) within the SC group cannot be ruled out. It should also be noted that neither patients nor health-care providers were blinded in this study. It was not possible to blind health-care providers from the interactive interventions they were administering, particularly in the case of hands-on interventions such as chiropractic manipulation and massage therapy. Furthermore, it was impracticable to blind patients to their respective interventions as this would have required the addition of simulated multidisciplinary health-care visits and corresponding interactive interventions in both study arms. This was deemed unworkable, as it would have required an impractical number of patients and clinician hours. Furthermore, the ethical standards that our institution defined required that the normal patterns of practice for the clinicians and patients in the UC group would not be disrupted in any way.
In the present study, the dropout rate was the same (20%) in each treatment arm. Furthermore, in terms of baseline variables, patients with missing responses were very similar to those with complete response information, and therefore dropouts did not appear to be associated with treatment or other measured confounders. Given the absence of differential dropouts between groups, we suspect that our intention-to-treat analysis — involving a last observation carried forward approach — underestimates the true benefit of CPG-based care. Under the last observation carried forward method, patients with missing responses are assumed not to improve at all after the time of their last follow-up visit. Yet, anecdotally, it is our experience that the few patients at our center who do miss or cancel their follow-up visits do so only in the event that they experience early recovery or some other level of improvement downgrading their need for attention from a spine physician.
It should be noted that although the hospital-based setting of our study intervention potentially limits the generalizability of these results to thecommunity practice setting, the fact that the family practitioners knew they were in a study and that their treatments and resultswould be reported, potentially makes the observed difference between the two groups even more robust as attending physicians would likely have been inclined to treat study patients more diligently. However, the degree to which the outcomes of this study can be applied to a similar treatment program administered in the community (outside of a hospital-based spine program) is not known. A study addressing this issue is now underway.
Finally, although these results are supportive ofCPG-based care, they should not in any way be interpreted as an endorsement or criticism of any one particular health-care profession. The results of this study clearly support the use of multimodal full guidelines-based treatment in this patient population and therefore validate the process of improving quality of care through the implementation of evidence-based care.
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