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, 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).
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:
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.  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.
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
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
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.  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. 
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.  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  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.  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
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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