FROM:
Lancet. 2018 (Jun 9); 391 (10137): 2368–2383 ~ FULL TEXT
Nadine E Foster, DPhil, Johannes R Anema, PhD, Dan Cherkin, PhD, Roger Chou, PhD, Steven P Cohen, MD, Douglas P Gross, PhDn Paulo H Ferreira, PhD, Julie M Fritz, PhD, Bart W Koes, PhD, Wilco Peul, PhD, Judith A Turner, PhD, Chris G Maher, PhD, on behalf of the Lancet Low Back Pain Series Working Group
Arthritis Research UK Primary Care Centre,
Research Institute for Primary Care and Health Sciences,
Keele University,
Staffordshire, UK.
Many clinical practice guidelines recommend similar approaches for the assessment and management of low back pain. Recommendations include use of a biopsychosocial framework to guide management with initial non-pharmacological treatment, including education that supports self-management and resumption of normal activities and exercise, and psychological programmes for those with persistent symptoms. Guidelines recommend prudent use of medication, imaging, and surgery. The recommendations are based on trials almost exclusively from high-income countries, focused mainly on treatments rather than on prevention, with limited data for cost-effectiveness. However, globally, gaps between evidence and practice exist, with limited use of recommended first-line treatments and inappropriately high use of imaging, rest, opioids, spinal injections, and surgery. Doing more of the same will not reduce back-related disability or its long-term consequences.
The advances with the greatest potential are arguably those that align practice with the evidence, reduce the focus on spinal abnormalities, and ensure promotion of activity and function, including work participation. We have identified effective, promising, or emerging solutions that could offer new directions, but that need greater attention and further research to determine if they are appropriate for large-scale implementation.
These potential solutions include focused strategies to implement best practice, the redesign of clinical pathways, integrated health and occupational interventions to reduce work disability, changes in compensation and disability claims policies, and public health and prevention strategies.
From the FULL TEXT Article:
Introduction
Despite the plethora of treatments and health-care
resources devoted to low back pain, back-related disability
and population burden have increased. [1, 2] The first paper [3]
in this Series describes the global burden and effect of
low back pain and provides an overview of the causes
and course of low back pain. In this Series paper, we
summarise the evidence for effectiveness of interventions
for the prevention and treatment of low back pain and the
recommendations from best practice guidelines. Despite
generally consistent guideline recommendations around
the world, clear evidence exists of substantial gaps
between evidence and practice that are pervasive in low-income,
middle-income, and high-income countries.
Different response strategies are needed that prevent and
minimise disability and promote participation in physical
and social activities. Here we highlight examples of
effective, promising, or emerging solutions from around
the world and make recommendations to strengthen the
evidence base for them.
Prevention
Table 1
|
By contrast with the large number of trials that assess
treatments for low back pain, evidence about prevention,
particularly primary prevention, is inadequate
(table 1). Most of the widely promoted interventions to
prevent low back pain (eg, work-place education, no-lift
policies, ergonomic furniture, mattresses, back belts,
lifting devices) do not have a firm evidence base. A 2016
systematic review [4] identified only 21 trials with 30,850 adults
(one in a low-middle-income country [Thailand]), and a
2014 systematic review [5] analysed only 11 randomised
controlled trials with 2,700 children (one in a low-middle income
country [Brazil]). The authors of the review in
adults concluded that moderate quality evidence existed
that exercise alone, or in combination with education, is
effective for prevention; and poor to very-poor quality
evidence existed that education alone, back belts, shoe
insoles, and ergonomic programmes might not be
effective. [4] The preventive effect of exercise and education
was large, with a pooled relative risk of 0.55 (95% CI
0.41–0.74); however, the trials were mainly of secondary
prevention and the effective programmes were quite
intensive (eg, 20 1-hour sessions of supervised exercise in
one trial). [4] The authors of the review in children concluded
that moderate quality evidence existed that education is
not effective and very low quality evidence existed that
ergonomically designed furniture could prevent low back
pain compared with conventional furniture. [5]
Key messages
Guidelines recommend self-management, physical and psychological therapies, and some forms of complementary medicine, and place less emphasis on pharmacological and surgical treatments; routine use of imaging and investigations is not recommended
Little prevention research exists, with the only known effective interventions for secondary prevention being exercise combined with education, and exercise alone
The evidence for prevention and treatment comes mainly from adults in high-income countries and whether the resulting recommendations are appropriate for children or those in low-income and middle-income countries is not known
Non-evidence-based practice is apparent across all income settings; common problems are presentations to emergency departments and liberal use of imaging, opioids, spinal injections, and surgery
Promising solutions include focused implementation of best practice, the redesign of clinical pathways, integrated health and occupational care, changes to payment systems and legislation, and public health and prevention strategies
The evidence underpinning these solutions is inadequate and whether they are appropriate for widespread implementation is not known
Further testing of these promising solutions, and development of new solutions, is needed, particularly in low-income and middle-income countries
|
Treatment
Low back pain without a known cause is referred to as
non-specific low back pain and guidelines [5–8] recommend
use of a biopsychosocial model to inform assessment
and management in view of associations between
behavioural, psychological, and social factors and the
future persistence of pain and disability. Guidelines also
recommend that laboratory tests and imaging should not
be routinely used as part of early management, but rather
reserved for patients for whom the result is likely to
change management (eg, if a serious condition, such as
infection, is suspected).
During the past three decades, changes have been made
to key recommendations in national clinical practice
guidelines. Greater emphasis is now placed on self-management,
physical and psychological therapies, and
some forms of complementary medicine, and less
emphasis on pharmacological and surgical treatments.
Guidelines encourage active treatments that address
psychosocial factors and focus on improvement in
function. The changed understanding of how best to
manage low back pain is shown in three current
guidelines, from Denmark, [6] the USA, [8] and the UK. [8]
The reduced emphasis on pharmacological care is
shown by the US guideline, [7] which recommends nonpharmacological
care as the first treatment option and
reserves pharmacological care for patients for whom nonpharmacological
care has not worked. These guidelines
endorse the use of exercise
(Danish, US, and UK
guidelines) and a range of other non-pharmacological
therapies, alone and in combination, such as massage
(US and UK), acupuncture (US), spinal manipulation
(Danish, US, and UK), Tai Chi (US), and yoga (US).
Table 2
|
Table 2 summarises the key recommendations of the
three clinical guidelines for the management of low
back pain and radicular pain, [6–8] separated by duration of
symptoms when information is available. Consistent
recommendations for early management are that
individuals should be provided with advice and
education about the nature of low back pain and
radicular pain; reassurance that they do not have a
serious disease and that symptoms will improve over
time; and encouragement to avoid bed rest, stay active,
and continue with usual activities, including work. [8]
Early supervised exercise therapy is typically unnecessary; [9] however, it can be considered if recovery is
slow or for patients with risk factors for persistent
disabling pain. [9] For acute radiculopathy without severe
or progressive motor weakness, data are insufficient to
suggest that initial management should differ from that
of acute non-specific low back pain. [8, 9]
Recommended physical treatments, particularly for
persistent low back pain (>12 weeks duration), include
a graded activity or exercise programme that targets
improvements in function and prevention of worsening
disability. Since evidence showing that one form of exercise
is better than another is not available, guidelines
recommend exercise programmes that take individual
needs, preferences, and capabilities into account in
deciding about the type of exercise. Some guidelines
do not recommend passive therapies, such as spinal
manipulation or mobilisation, massage, and acupuncture,
some consider them optional, and others suggest a short
course for patients who do not respond to other treatment. [10]
Other passive electrical or physical modalities, such as
ultrasound, transcutaneous electrical nerve stimulation,
traction, interferential therapy, short-wave diathermy,
and back supports are generally ineffective and not
recommended. [6–8]
Guidelines also recommend consideration of psychological
therapies — eg, cognitive behavioural therapy,
progressive relaxation, and mindfulness-based stress
reduction — and combined packages of physical and
psychological treatment, for those with persistent low back
pain or radicular pain who have not responded to previous
treatments. [6–8] For patients who have not responded to firstline
treatments, and who are substantially functionally
disabled by pain, multidisciplinary rehabilitation programmes
with coordinated delivery of supervised exercise
therapy, cognitive behavioural therapy, and medication are
more effective than standard treatments. [6–8, 11]
Guidelines now recommend pharmacological treatment
only following an inadequate response to first-line nonpharmacological
interventions. Paracetamol was once
the recommended first-line medicine for low back
pain; however, evidence [12] of absence of effectiveness in
acute low back pain and potential for harm has led to
recommendations against its use. [7, 8] Health professionals
are guided to consider oral non-steroidal anti-inflammatory
drugs (NSAIDs), taking into account risks, including
gastrointestinal, liver, and cardiorenal toxicity, and if
using, to prescribe the lowest effective dose for the
shortest possible time. [8] Routine use of opioids is not
recommended, since benefits are small and substantial
risks exist, including overdose and addiction potential,
and poorer long-term outcomes than without use. [9, 13]
Guidelines caution that opioid therapy should be used only
in carefully selected patients, for a short duration, [13] and
with appropriate monitoring. The role of gabaergic
drugs, such as pregabalin, is now being reconsidered
after a 2017 trial showed pregabalin to be ineffective for
radicular pain. [14] Guidelines generally suggest consideration
of muscle relaxants for short-term use, although further
research is recommended. [8]
The role of interventional therapies and surgery is
limited and recommendations in clinical guidelines
vary. Recent guidelines [6–8] do not recommend spinal
epidural injections or facet joint injections for low back
pain but do recommend consideration of epidural
injections of local anaesthetic and steroid for severe
radicular pain. [8] Epidural injections are associated with
small short-term (<4 weeks) reductions in pain, do not
seem to provide long-term benefits or reduce the longterm
risk of surgery, [6, 15] and have been associated with
rare but serious adverse events, including loss of vision,
stroke, paralysis, and death. [16] The UK guideline [8] suggests
consideration of radiofrequency denervation for chronic
low back pain that is unresponsive to non-surgical
treatments; however, the subsequently published MINT
trials [17] challenge this recommendation.
The benefits of spinal fusion surgery for non-radicular
low back pain thought to originate from degenerated
lumbar discs (known as discogenic) are similar to those
of intensive multidisciplinary rehabilitation and only
modestly greater than standard non-surgical management. [18] Surgery is also more costly and carries a greater
risk of adverse events than non-surgical management.
The UK guidelines recommend that patients are not
offered disc replacement or spinal fusion surgery for
low back pain, and instead recommend offering fusion
surgery only as part of a randomised trial. [8] Patients with
severe or progressive neurological deficits require surgical
referral. [19] Spinal decompression surgery can be considered
for radicular pain when non-surgical treatments have
been unsuccessful and clinical and imaging findings
indicate association of symptoms with herniated discs or
spinal stenosis. [8] For a herniated disc, early surgery is
associated with faster relief of radiculopathy than with
initial conservative treatment with the option of delayed
surgery, but benefits diminish with longer (>1 year)
follow-up. [19] For symptoms associated with lumbar spinal
stenosis, benefits of surgery over conservative care are
not clear but some beneficial effects have been shown. [20]
However, patients tend to improve with or without
surgery and, therefore, non-surgical management is an
appropriate option for patients who wish to defer or avoid
surgery. [20]
The evidence underpinning low back pain guidelines is
drawn almost exclusively from clinical trials of adults.
A 2014 systematic review found only four paediatric
trials, [5] so great uncertainty exists about the treatment
of back pain in children. The trial evidence is also
mainly from high-income countries and, therefore,
whether these guideline recommendations are appropriate
for low-income and middle-income countries is not
known. Guidelines developed in low-income and middle-income
countries (eg, Philippines, [21] Brazil [22]) provide
near identical recommendations to those in high-income
countries. Factors such as cultural acceptability
of treatments, patient attitudes towards and adherence
to treatment, and treatment providers could vary
systematically between countries and influence treatment
outcomes. Furthermore, in some countries access to
some treatments endorsed in guidelines is poor or
non-existent.
The global gap between evidence and practice
Despite multiple clinical guidelines providing similar
recommendations for managing low back pain, a
substantial gap between evidence and practice exists
worldwide in high-income as well as low-income and
middle-income countries. [23] Problems include both
overuse of low-value care and underuse of high-value care.
Panel 1 shows studies of clinical practice and highlights
the disparity between ten guideline recommendations
and the reality of current health care. Tremendous
opportunity exists to improve health-care outcomes and
potentially reduce costs by effectively implementing
known best practice recommendations.
Panel 1
Gaps between evidence and practice in the management of low back pain
Guideline message:
low back pain should be managed in primary care
Practice: in high-income, low-income, and middle-income settings, people with low back pain present to emergency departments or to a medical specialist
High-income settings
A 2003 study of an emergency department in Paris, France, found that the proportion of presentations in which low back pain was the primary complaint was 11.0% [24]
In Victoria, Australia, between 2009 and 2012, 14,568 calls were made to 000 for an emergency ambulance for low back pain; in 22.3% of these cases, an emergency ambulance was dispatched and in 38.8%, a non-emergency ambulance was dispatched [25]
In the 10 years from 2004–05 to 2013–14, the age-standardised rate of admissions to hospital for back problems in Australia increased by 20% [26]
Low back pain results in 2.6 million visits to emergency departments a year in the USA [27]
Of the 944 presentations for low back pain to an Italian emergency department in a year, six (0-6%) were diagnosed with a condition that was regarded as an emergency (defined as associated with high morbidity or mortality risk, requiring prompt assessment and hospital admission) [28]
Low-income or middle-income settings
A 2011 study showed no patient referral system existed in Iran: most patients with acute or chronic low back pain visit directly an orthopaedic surgeon, neurosurgeon, or rheumatologist, rather than visiting general practitioners [29]
A 2012 study of two emergency departments in Cambodia showed that the primary complaint was low back pain in 5-6% of the 1,295 presentations (11th most common complaint); 41% of patients with low back pain were admitted [30]
A 2009 study of an emergency department in Brazil showed that musculoskeletal conditions were the most common presentation, with low back pain the leading condition [31]
The 2011 National Health and Wellness Survey in Brazil estimated that 16.8 million Brazilians had had low back pain; of these, 16.7% had been admitted to hospital in the past 6 months and 36.5% had visited an emergency department (rates were 8.8% and 19.74%, respectively, for those not having low back pain) [32]
In Argentina, in 2006 to 2010, the most common reason for admission to hospital for a musculoskeletal condition was low back pain and the mean length of stay was 3–8 days [33]
Guideline message:
provide education and advice
Practice: in high-income, low-income, and middle-income settings, this aspect of care is rarely provided
High-income settings
Low-income or middle-income settings
Guideline message:
remain active and stay at work
Practice: in high-income, low-income, and middle-income settings, many clinicians and patients advocate rest and absence from work
High-income settings
Three surveys of Australian general practitioners in the period 1997–2004 revealed that 24.5% of them who had a special interest in low back pain, endorsed the incorrect view that “Patients should not return to work until they are almost pain free” compared with 15.8% of those who did not have a special interest [36]
A 2012 survey of primary care patients with low back pain in Qatar revealed that the most common treatment was bed rest (67.2% of 1,829 patients) [37]
Low-income or middle-income settings
A 2008 survey of all registered physiotherapists in the state of Maharashtra, India, (n = 186, 70% response rate) showed that 46% of physiotherapists advised patients with low back pain to rest [38]
63% of Indians believe that bed rest is the mainstay of therapy [39]
90% of Brazilian rheumatologists advised patients with acute low back pain to rest [40]
In Iran, “extended bed rest and reduction of physical activity are generally recommended by many clinicians, especially for patients with acute episodes of low back pain” [29]
Guideline message:
imaging should only occur if the clinician suspects
a specific condition that would require different management to
non-specific low back pain
Practice: although such specific causes of low back pain are rare, in high-income, low-income, and middle-income settings, imaging rates are high
High-income settings
Imaging was done for 56.4% of 746 patients who presented with low back pain to an emergency department of an Italian academic hospital in 2013 [41]
A 2011 Norwegian study showed that 38.9% of patients with low back pain were referred for imaging by their general practitioner [42]
In the USA, a study of insurer data revealed that the rate of imaging for low back pain without red flag conditions was not influenced by the Choosing Wisely campaign: the baseline rate in 2010 was 53.7% (95% CI 52.5–54.9), and by the end of 2013 it was exactly the same, at 53.7% (52.5–54.9) [27]
A survey of all Australian chiropractors (n = 4,859, 10% response rate) showed that 54% agreed that lumbar radiography is indicated for acute low back pain [43]
Low-income or middle-income settings
A prospective study in the period 2008–10, of 251 patients with chronic low back pain reviewed in an Indian orthopaedic clinic, reported that 100% of patients underwent imaging, with 76% diagnosed with non-specific low back pain and 10% with spondylosis [44]
A review of the lumbar spine MRI scans of 3,107 patients from Hangzhou, eastern China, in 2013, showed that simple back pain was the most common reason for ordering an MRI (41.3%) [45]
400 consecutive patients with low back pain referred to four radiology clinics for MRI scans in Tehran, Iran, in 2012, completed a questionnaire to establish if the imaging was indicated; of these, only 187 (46.7%) had an indication for MRI [46]
70% of Brazilian rheumatologists order imaging at first visit for a patient with acute low back pain [40]
A study in hospital outpatients with low back pain in Moscow, Russia, (n = 1,300) concluded that the most frequent diagnostic method used was radiography of the spine [47]
Guideline message:
first choice of therapy should be non-pharmacological
Practice: surveys of care show that this approach is usually not followed
High-income settings
A survey of Australian general practice care from 2000 to 2010 (21,350 patient encounters) showed that 64.5% of patients were prescribed a medicine at the first visit for a new episode of low back pain [48]
A potential reason is the way in which health-care systems preferentially fund surgery and medicines over physical and psychological therapies
Low-income or middle-income settings
90% of primary care patients in South Africa received pain medicines as their only form of treatment [35]
A potential reason is that health-care systems do not have the capacity to deliver non-pharmacological care
Guideline message:
most guidelines advise against electrical physical modalities
(eg, short-wave diathermy, traction)
Practice: worldwide these ineffective treatments are still used by the professionals who administer physical therapies
High-income settings
A survey of Swedish physiotherapists (n = 271, 65% response rate) showed that around 38% advocated transcutaneous electrical nerve stimulation for low back pain [49]
A 2013 survey of US orthopaedic physical therapists (n = 1,001, 25% response rate) showed that 75% used lumbar traction [50]
A 2009 survey in three Australian states (n = 203, 36% response rate) asked for treatment choices for five patient vignettes and showed that 17–34% of physiotherapists advocated physical modalities for low back pain depending on the vignette [51]
A study of Spanish National Health Service data for 2004–07 showed that 38.6% of expenditure for physical therapies was for treatments that are known to be ineffective [52]
Low-income or middle-income settings
A 2008 survey in the state of Maharashtra, India, (n = 186, 70% response rate) showed that physical modalities were the first treatment preference of 33% of all registered physiotherapists [38]
A 2000 survey of Thai physiotherapists (n = 559, 77.2% response rate) reported that 61.2% advocated ultrasound for low back pain and 61.0% advocated traction [53]
A survey of practice in Ghana showed that over 60% of treatment sessions included multiple therapies (exercises, advice, massage, electrotherapy, and manual therapy) [54]
Guideline message:
due to unclear evidence of efficacy and concerns of harm,
the use of opioid analgesic medicines is now discouraged
Practice: these medicines have been overused in some, but not all, high-income countries; low-income and middle-income countries seem to have very low rates of use
High-income settings
In 2009, opioids were prescribed for around 60% of presentations to emergency departments for low back pain in the USA [55]
An Italian study of 746 patients with low back pain presenting to an emergency department showed that 42% were prescribed an opioid [41]
A 2006 US population-based survey of people with chronic low back pain (n = 706, mean pain duration 9.8 years), showed that of those who had seen a provider in the past year, 47.0% had taken a strong narcotic and 32.8% a weak narcotic (60.5% took some sort of narcotic) in the month before survey; of those who had not seen a provider, 5.9% had taken a strong narcotic and 14.7% had taken a weak narcotic [56]
A 2004 US study based on health-care insurer data of 26,014 patients with low back pain managed in primary care, showed that 61.0% were prescribed an opioid and 18.8% were on long-term opioid therapy [57]
Low-income or middle-income settings
Low-income and middle-income countries typically have low consumption of opioids (eg, in 2015, prescription of opioid medicines in Africa was 2.0 mg/head of population vs 677.0 mg/head of population in the USA) [58]
Guideline message:
interventional procedures and surgery have a very limited role,
if any, in the management of low back pain
Practice: these approaches are used widely in high-income countries; little evidence on their use is available for low-income and middle-income settings
High-income settings
In the USA, in 2011, spinal fusion was responsible for the highest aggregate hospital costs of any surgical procedure (US$12.8 billion) [59]
990,449 lumbar or sacral facet injections and 406,378 lumbar or sacral facet neurotomy procedures were funded by US Medicare in 2011 [60]
252,654 sacroiliac joint injections were funded by US Medicare in 2011 [61]
A survey of Dutch spinal surgeons (132 active surgeons surveyed, 70% response rate) showed that two-thirds do spinal fusion procedures for low back pain [62]
In Australia from 2003 to 2013, the fastest increasing surgical procedure for spinal stenosis was complex fusion, although the surgery provides no added benefit compared with decompression alone, and is more costly and associated with greater harms [63]
Use of epidural injections increased substantially in the US Medicare population from 2000 to 2011, with 2,023,481 epidural injections funded in 2011 [64]
Low-income or middle-income settings
Guideline message:
exercise is recommended for chronic low back pain
Practice: clinician treatment preferences and health-care constraints limit uptake
High-income settings
54% of people with chronic low back pain in the USA had not been prescribed exercise [56]
Australia's universal health-care system, Medicare, has a limit of five allied health consultations, which is too few to deliver a typical exercise programme for chronic low back pain [66, 67]
Low-income or middle-income settings
Guideline message:
a biopsychosocial framework should guide management
of low back pain
Practice: the psychosocial aspects of low back pain are poorly managed in high-income, low-income, and middle-income settings
High-income settings
Only 12% of people with chronic low back pain with depression in the USA had seen a psychiatrist or psychologist in the previous year [56]
Only 8.4% of patients with low back pain in the USA were prescribed cognitive behavioural therapy [69]
Low-income or middle-income settings
“Structured assessment of psychosocial factors is not part of routine management of low back pain in Iran, mainly because of absence of standard instruments” [29]
“Management of patients with low back pain in Iran is dominantly based on a traditional biomedical model and therapeutic interventions based on a biopsychosocial approach are implemented only in a few university-affiliated physical therapy clinics” [29]
|
In high-income countries, guidelines recommend
education and advice to keep active and at work; yet,
data from Australia [36] and Qatar [37] show that such advice is
provided only in a few consultations. By contrast with
the guideline message that first-line care should be nonpharmacological,
a study from the USA showed that only
about half of people with chronic low back pain are
prescribed exercise. [56] In Australian primary care [48] and in
the emergency department setting in Canada, [70] the most
common treatment is prescribed medication. Although
physical therapists are in an excellent position to provide
exercise advice, surveys from Sweden, [49] the USA, [50] and
Australia [21] show high rates of use of electrical modalities,
which the evidence shows are ineffective.
Despite the guideline message that low back pain
should be managed in primary care, since few cases
constitute medical emergencies, studies from France, [24]
Australia, [26] Italy, [41] and the USA [71] show that patients often
present to the emergency department. Although imaging
has a very limited role, imaging rates are high; 39% of
patients with low back pain are referred for imaging by
general practitioners in Norway, [42] 54% in the USA, [27] and
56% in Italy. [41]
Although guidelines discourage the use of
opioids, they are widely used in many high-income
countries, especially in, but not limited to, North
America. [55, 72] Although data for effects of opioids for
acute low back pain are sparse, [73] one study showed that
they were prescribed for around 60% of emergency
department presentations for low back pain in the USA. [55]
More than half the total number of people taking opioids
long-term have low back pain, [72] although no randomised
controlled trial evidence is available about long-term
effects. [73, 74]
Surgery has, at best, a very limited role for low
back pain, but studies from the USA, [59] Australia, [63] and
the Netherlands [62] show frequent use of spinal fusion.
Interventional procedures are also overused, with studies
showing 990,449 lumbar or sacral facet injections and
406,378 lumbar or sacral facet neurotomy procedures
funded by Medicare in the USA in 2011. [60]
The waste of health-care resources is an obvious
consequence of overuse, but implications for patients
also exist. The most obvious consequence of unnecessary
lumbar imaging is exposure to radiation, but studies also
suggest that more liberal use of imaging triggers
additional medical care (eg, additional testing, specialist
referral, surgery, and interventional procedures) and
increases the risk of adverse outcomes, such as absence
from work. [75] The most disturbing risks related to use of
opioids are addiction, overdose, and death. In the USA,
prescription opioid-related deaths were around 15,000 in
2015. [76] The growing use of complex fusion procedures
in patients older than 60 years undergoing decompressive
surgery for spinal stenosis is concerning, since fusion
operations are three times more expensive than decompression
alone, and have double the rates of wound
complications, cardiopulmonary complications (such as
stroke), and 30-day mortality. [77] Importantly, trials have
clarified that adding fusion to decompressive surgery
for symptomatic spinal stenosis does not improve
outcomes. [78]
Even in high-income countries, access to best practice
can be constrained by availability (eg, in rural and remote
regions), payment models (eg, health-care systems’
coverage of medication and surgery, but not physical
and psychological treatments), and patients’ uncertainty
about when or where to seek care. [79] A systematic review of
21 studies from 12 countries, four of which were medium-income
(Cambodia, Cameroon, Barbados, Brazil), and
eight high-income (Australia, Canada, Greece, Italy,
France, Spain, the USA, and the UK) showed that many
people go straight to emergency departments for their low
back pain. [80] The authors estimated the prevalence of low
back pain in the emergency department setting to be
4.39% (95% CI 3.67–5.18), similar to that of shortness of
breath and fever and chills. [80] Many high-income countries,
such as Australia and Canada, have culturally diverse
populations with both an indigenous population and a
large migrant population. The guideline-recommended
treatments present real challenges in these diverse
populations; for example, delivery of cognitive behavioural
therapy or mindfulness-based stress reduction could be
challenging if the therapist does not speak the same
language as the patient, or does not appreciate the various
ways low back pain could be conceptualised in different
cultural groups.
For low-income and middle-income countries, although
much less published evidence is available about current
practice for low back pain, available data show that gaps
between evidence and practice are also apparent in these
countries (panel 1). [35] For example, in Cambodia, [30] Brazil, [31]
and Argentina, [33] it is not uncommon for people with low
back pain to present to the emergency department and
then stay in hospital for several days. The previously
mentioned systematic review of low back pain in the
emergency department showed that middle-income
countries have prevalences that are similar to those in
high-income countries (eg, Cambodia 5.6%, Italy 4.9%). [80]
In Iran, [29] most people with low back pain consult with
specialists (eg, an orthopaedic surgeon, neurosurgeon, or
rheumatologist) in view of the paucity of patient referral
systems from general practice. A South African study [35]
showed that 90% of patients with low back pain seen in
primary care received pain medicines as the only form of
treatment. Imaging rates for low back pain also seem to be
inappropriately high in several low-income and middle-income
countries, including India, [44] China, [45] Iran, [46] Brazil, [40]
and Russia, [47] and although the availability of published
data is limited, those that are available (from Brazil)
suggest large increases in spinal surgery costs over the
past 20 years. [65]
The paucity of comparative data makes comparisons of
high-income, low-income, and middle-income countries
challenging. However, the examples in panel 1 seem to
suggest greater use of advice to rest and of passive electrical
modalities in low-income and middle-income countries.
In all countries, access to structured exercise programmes
is variable, and poor access to cognitive behavioural
therapy and multi-disciplinary rehabilitation programmes
remains a barrier to widespread use. [81] Clear evidence
exists of lower consumption of opioids in low-income
and middle-income countries than in high-income
countries; but examples exist of high-income countries
(eg, Japan) that have very low rates of opioid use, so the
high consumption in countries such as the USA and
Canada is not fully explained by the countries’ wealth. The
above information shows that many of the mistakes of
high-income countries are already well established in
low-income and middle income-countries. Initiatives are
urgently needed that both reduce low-value health care for
low back pain and help health-care professionals, patients,
and policy makers make decisions more in line with
best available evidence. The following section provides
examples of effective, promising, and emerging directions.
Promising directions
Table 3
|
Examples of effective, promising, and emerging solutions
that target health care, public health, or both, are
summarised in table 3. We particularly searched for
examples from low-income and middle-income countries
but found very few assessments of solutions within these
countries that suggest they might offer helpful alternatives
to current care. More data are urgently needed about
effective and affordable strategies for prevention and
management of low back pain in such countries. In these
settings, strategies probably need to be integrated with
other musculoskeletal and non-communicable disease
initiatives to ensure maximum benefit from available
resources. The examples in table 3 are mainly drawn from
high-income countries, and for each we have added a
judgment about the amount of evidence, which shows that
many are still understudied or are confined to single, often
observational, studies. Even those judged to be effective
have underpinning evidence for effectiveness from only
one country, and many were the focus of a research study,
and not implemented or tested in new contexts outside a
research setting. Therefore, important questions remain
about effectiveness, cost-effectiveness, and scalability of
these innovations.
Implementation of best available evidence
That guidelines without effective strategies to implement
their recommendations have little or no effect on clinical
practice has been repeatedly shown. Implementation
strategies need to be tailored to overcome specific barriers
to change [106] and feature education and training, social
interaction, clinical decision support systems, and
targeted reminders. [107, 108] Some of the key challenges to
implementing best practice for low back pain are known,
including short consultation times, clinicians’ poor
knowledge of and misconceptions about clinical guidelines,
fear of litigation in the event of missed, rare,
serious pathology, and a desire to maintain harmonious
relationships with patients. [108] Yet, successful examples
exist of focused guideline implementation efforts
(table 3). In the USA and UK, approaches that better
support clinical decision making have changed clinical
practice; use of a special radiograph requisition form that
allowed only three guideline-appropriate indications
led to a 36.8% reduction in lumbar spine imaging, [82]
and the addition of short educational messages to all
reports of lumbar spine MRIs significantly reduced
imaging rates by 22.5%. [83] In Denmark, a multifaceted
implementation strategy consisting of outreach visits,
reports about the quality of care, and a self-completed
questionnaire to help general practitioners to identify
patients’ risk of persistent pain led to reduced referral
to secondary care and was cost-saving. [84, 85] Reviews
have shown no differences in effect on practice between
multifaceted strategies compared with minimal, single,
or no implementation strategy, [109] and the ineffectiveness
of one-off implementation efforts, such as a single educational
event. [110] Rather, it seems that implementation
efforts need regular repetition or to be continuous
to effectively change practice for low back pain. [110] Key
challenges include identifying ways to remove existing
unhelpful but well established practice patterns, and
identify the most effective and cost-effective implementation
strategies that ensure improvements are sustained
over time. Very few randomised trials of implementation
strategies have assessed costs. [111] Tough policy decisions
are also needed that reduce the unhelpful influence of
industry and reduce or remove reimbursement
for low value care.
Improved and better integrated education of health-care
professionals could support implementation of best
practice for low back pain, help to break down professional
barriers, develop a common language, and create new
and innovative strategies for practice. [112] Examples of such
support include, the integrated education of medical
doctors with chiropractors in Denmark; [112, 113] the Centers
for Excellence in Pain Education, funded by the National
Institutes of Health in the USA that include e-learning
modules focused on interactivity, expert modelling, and
feedback; [114] and the promising results of a training course
with Swedish physiotherapists aimed at identifying and
addressing psychosocial obstacles to recovery in patients
with low back pain. [115]
Clinical systems and pathways
A more radical health-care solution is to change the
clinical-care model for low back pain. An example of this
is a new model of stratified primary care for non-specific
low back pain known as STarT Back that involves two
components; first, a brief self-completed questionnaire
to identify patients’ risk of persistent disabling pain
(low, medium, or high risk) [86] and second, treatments that
are matched to each risk subgroup. Summarised in
Table 3 are two studies within the UK’s National Health
Service (NHS) that have shown stratified care to be more
effective than a best care comparison group, [87] and more
cost-effective than usual primary care. [88] On the basis
of this evidence, the current UK clinical guideline
now recommends risk stratification. [8] Stratified care
approaches, such as STarT Back, that target resources to
those most likely to benefit might allow more effective
prioritisation of health-care resources.
Another potential health-care solution is to reconfigure,
with agreement from all stakeholders, the whole clinical
pathway from care at first contact through to specialised
care. A clinical pathway has been defined as a “complex
intervention for the mutual decision-making and
organisation of care processes for a well-defined group of
patients during a well-defined period” [116] and “an integrated,
multi-disciplinary strategy to organise the timing,
sequencing, and coordination of care to optimise patient
outcomes and enhance efficiency”. [117] A major barrier to
changing clinical pathways relates to current models of
health-care reimbursement, which reward volume rather
than quality, perversely providing remuneration not for
how effectively patients are treated, but for how much they
are treated. [118] A 2011 systematic review of clinical pathways
for low back pain identified four pathways, but none had
outcome data available. [89] Since then, several further care
pathways have been developed and implemented with
some evaluation, albeit of weak design (Table 3).
An
emerging example from Canada, the Saskatchewan Spine
Pathway, is a co-ordinated multidisciplinary pathway that
seems to reduce both requests for MRI and referrals to
spinal surgery, and results in appropriate candidates for
surgery being referred to spine surgeons. [90] In the UK,
NHS England’s national pathway for treatment of low back
and radicular pain was first published in June, 2014, and
updated in February, 2017. [92] The pathway was agreed by
30 stakeholders, is being implemented in many Clinical
Commissioning Groups (NHS organisations that organise
the delivery of NHS services in England, each typically
responsible for services for around 300,000 people), with
emerging evidence of benefits for patients and the healthcare
system. [93]
Integrate health and occupational interventions
A further promising direction could be to target both
the health-care system and, more broadly, public health
through integrated health-care and occupational interventions.
If back pain symptoms are reduced, then return
to work is expected to follow. The association between
pain, function, and return to work is, however, weak with
reviews suggesting that the association changes with low
back pain duration (positive association in the acute
phase, no association in the subacute phase, and negative
association in the chronic phase). [119, 120] People can
improve in function and return to work even if pain
remains, and evidence shows that return to work occurs
before symptom recovery. [121] Therefore, health-care and
occupational health interventions should be considered
together in people with low back pain and work disability
issues. Examples are available from the USA and Sweden
of integrated and early interventions that shift the focus to
problem-solving at work, and lead to fewer disability days,
earlier return to work, and reductions in use of health
care. [95, 96] The new Department of Health Framework and
Strategy for Disability and Rehabilitation Services in
South Africa [122] includes goals to integrate comprehensive
disability and rehabilitation services within priority health
programmes and to foster intersectoral collaboration to
address social determinants of ill health.
Although low
back pain is not specifically mentioned, opportunities
could exist for inclusion of low back pain within their
stated priority programmes of District Health Services
and Health Promotion. Whether integration of health and
occupational care is possible or desirable in low-income
and middle-income countries with high reliance on
temporary and unstable jobs, where little or no protection
of employment due to low back pain exists, and where
many depend on their pain as a source of income,
is unknown. However, data provide evidence of the
benefits of a participatory return-to-work programme for
this group of workers in the Netherlands, [123] where the
programme resulted in twice as high a rate of return to
work and greater societal benefit (€2,073 per worker)
compared with usual care. Individuals with higher annual
income seem more likely to believe that one should stay
active during an episode of low back pain; [124] therefore,
specific targeted interventions need to be developed and
tested for those from lower socioeconomic groups to
reduce health disparities, address barriers to reintegration
into the workforce, and facilitate getting out of poverty.
Multisystem approaches to returning and staying at
work could reduce the economic and societal burden
of work disability pensions due to low back pain. The
example provided in Table 3 is of a Dutch integrated care
programme for patients with low back pain on long-term
disability benefits (on average 5–6 months) that resulted
in twice as high a return to work rate, 4 months earlier
sustainable return to work, and a return on investment of
£26 for every £1 invested compared with usual care. [97, 98]
Figure
|
Changes to compensation and disability policies offer
another potential solution. Substantial differences exist
between countries in the prevalence of claims for disability
benefits related to back pain, with the back claim
rate in the USA being 60 times higher than in Japan, [125]
and musculoskeletal claims between states in Brazil being
five to six times greater within highly developed states. [126]
One of the first studies [127] to document the effect of
compensation systems on claims for back pain showed in
Canada that changing from a tort compensation insurance
system with payments for pain and suffering to a no-fault
system without such payments, led to a decrease in the
incidence of claims and time to claim closure. An
Australian study showed worse health outcomes in a fault-based
system in New South Wales compared with a nofault
system in Victoria. [128] In Brazil, providing a large
amount of income replacement (>100%) from the National
Social Security Institute resulted in workers with
musculoskeletal pain claiming benefits for longer. [129]
Making changes to compensation systems aligns with
recommendations from the Organisation for Economic
Co-operation and Development (OECD). [130, 131]
The effect of
different compensation policies on return to work and
claim duration is evidenced by an Australian study of all-cause
work disability claimants, [132] and a six-country study
of 2,825 compensation claimants with chronic low back
pain who were off work for 3–4 months. [133] In the
six-country study, sustainable return to work rates ranged
widely between countries, from 22% in Germany to 62%
in the Netherlands. The differences were largely due to
the Dutch compensation system encouraging greater
work interventions than did those of the other countries.
The effects of the reform of the Dutch system (panel 2 and
figure), in line with OECD recommendations, are
evidenced by reductions in sickness absence and disability
pensions for back pain from 2002 to 2007. [99, 100] Although the
absence of a control comparison is a limitation,
this multisystem solution from the Netherlands is one
that other countries could consider emulating. The
Netherlands’ approach, and a 2017 international evidence
synthesis, [134] highlight the need for, and power of, policy
changes that encourage work interventions supported by
less strict compensation policies for disability benefits.
Panel 2
Case study: policy reform in the Netherlands
In the past two decades, new health insurance and sickness benefit laws in the Netherlands have required employers to
(1) pay 70–100% wages to their sick employees for 2 years, and
(2) make a return-to-work plan agreed by employer and employee, detailing all actions
for the employer and employee.
Figure
|
Medical assessments for work disability benefits are postponed to 2 years after reporting sick to give the employee and employer the opportunity to achieve full and sustainable return to work. After 2 years, an independent medical assessment is done to decide on the full benefit for workers with complete sustainable work disability, or on a partial and temporary benefit—based on limitations in functional abilities — for workers who are temporarily or partly disabled; this group is stimulated by financial incentives to resume work for their remaining work capacity. These changes led to a large drop in sickness absence and disability pensions. [99] In line with these reductions, sick leave for low back pain fell by a third between 2002 and 2007 (figure). The total costs of back pain fell from €4.3 billion in 2002 to €3.5 billion in 2007. [100]
|
Public health interventions
Approaches that target public health also offer a possible
solution. Public health interventions aim to change the
public’s back pain beliefs and behaviours. Mass-media
campaigns about back pain have been studied in four
high-income countries (Australia, [101] Scotland, [135] Norway, [136]
and Canada [104]), and have proved to have some success (Table 3). The campaign in Alberta, Canada, had a modest
effect on the public’s beliefs (regarding the importance of
staying active) compared with a control population, [104] with
positive effects on beliefs persisting 7 years after the initial
assessment, with annual bursts of campaign activity. [105] The
Australian mass-media campaign resulted in changes to
beliefs and behaviours. [102, 103] The campaign was well funded,
predominantly used television commercials featuring
recognisable spokespeople, provided practical information
about how to stay active and at work despite pain, and had
clinical, employer, and employee organisations as partners.
Perhaps most importantly, supportive laws and public
policies were in place, including financial penalties for
employers who did not provide modified work options to
employees with back pain. Mass-media campaigns with a
clear focus on behaviours rather than beliefs alone, and
that incorporate new ways to disseminate information,
such as personalised marketing, social networks, and
customised digital communications, could be considered.
Such campaigns might be less expensive than traditional
media, and allow more direct access to the public and
greater targeting of messages.
Public health strategies are likely to be especially
important for low-income and middle-income
countries, [137] where, to date, greater focus and resources
have centred on prevention and public health campaigns
in infectious diseases. An example strategy in villages in
rural Tibet, where 34% of people reported low back pain,
consisted of training in back pain prevention and
management in combination with a stand to support
water containers. The intervention eased the burden of
collecting water with the potential to also reduce back
pain prevalence and associated disability. [138] In South
Africa, information about back health has been integrated
into the Western Cape on Wellness project, promoting
healthy lifestyles to reduce the burden of non-communicable
diseases across community, work, and
school settings. [139] However, we could not find any
assessments or published data for the effectiveness of
public health interventions for low back pain in low-income
or middle-income countries.
Conclusions
Despite many clinical guidelines with similar
recommendations
for the management of low back pain,
the gap between evidence and practice is pervasive. We
have provided examples of effective, promising, and
emerging directions that deserve greater attention and
more rigorous assessment. Even the solutions judged
effective draw on limited evidence, but they could
potentially be replicable and cost-effective in other
settings. Focusing on key principles, such as the need
to reduce unnecessary health care for low back pain,
support people to be active and stay at work, and reform
unhelpful patient clinical pathways and reimbursement
models, could guide next steps. The starting point in
high-income countries will be different from low-income
and middle-income countries, and their priorities are
likely to differ. No single solution will be effective, and a
collective, global effort will take time, determination,
and organisation. Without the collaborative efforts of
people with low back pain, policy makers, clinicians, and
researchers necessary to develop and implement
effective solutions, disability rates, and expenditure for
low back pain will continue to rise.
Contributors
NEF, CGM, and DC were part of the team that developed the original
proposal for the Series and coordinated production of papers. All authors
drafted key sections of the paper, and NEF and CGM revised all sections.
All authors have contributed to all sections of the paper and have edited it
for intellectual content. NEF, CGM, DC, JRA, DPG, JMF, BWK, and PHF
participated in the authors’ meeting and discussion during the drafting
process. All other authors have read and provided substantive intellectual
comments on the draft and approved the final version of the paper.
The Lancet Low Back Pain Series Working Group
Steering Committee:
Rachelle Buchbinder (Chair) Monash University, Melbourne, Australia;
Jan Hartvigsen (Deputy Chair), University of Southern Denmark, Odense, Denmark;
Dan Cherkin, Kaiser Permanente Washington Health Research Institute, Seattle, USA;
Nadine E Foster, Keele University, Keele, UK;
Chris G Maher, University of Sydney, Sydney, Australia;
Martin Underwood, Warwick University, Coventry, UK;
Maurits van Tulder, Vrije Universiteit, Amsterdam, Netherlands.
Members:
Johannes R Anema, VU University Medical Centre,
Amsterdam, Netherlands; Roger Chou, Oregon Health and Science
University, Portland, USA; Stephen P Cohen, Johns Hopkins School of
Medicine, Baltimore, USA; Lucíola Menezes Costa, Universidade Cidade
de Sao Paulo, Sao Paulo, Brazil; Peter Croft, Keele University, Keele, UK;
Manuela Ferreira, Paulo H Ferreira, Damian Hoy, University of Sydney,
Sydney, Australia; Julie M Fritz, University of Utah, Salt Lake City, USA;
Stéphane Genevay, University Hospital of Geneva, Geneva, Switzerland;
Douglas P Gross, University of Alberta, Edmonton, Canada;
Mark Hancock, Macquarie University, Sydney, Australia; Jaro Karppinen,
University of Oulu and Oulu University Hospital, Oulu, Finland;
Bart W Koes, Erasmus MC, University Medical Center Rotterdam,
Rotterdam, Netherlands; Alice Kongsted, University of Southern
Denmark, Odense, Denmark; Quinette Louw, Stellenbosch University,
Tygerberg, South Africa; Birgitta Öberg, Linkoping University, Linkoping,
Sweden; Wilco Peul, Leiden University, Leiden, Netherlands; Glenn
Pransky, University of Massachusetts Medical School, Worcester, USA;
Mark Schoene, The Back Letter, Lippincott Williams & Wilkins,
Newburyport, USA; Joachim Sieper, Charite, Berlin, Germany;
Rob Smeets, Maastricht University, Maastricht, Netherlands;
Judith A Turner, University of Washington School of Medicine, Seattle,
USA; Anthony Woolf, Royal Cornwall Hospital and University of Exeter
Medical School, Truro, UK.
Declaration of interests
Please see appendix for authors’ declaration of interests.
Acknowledgments
There were no sources of funding for this paper. NEF is a UK National
Institute for Health Research Senior Investigator, and was supported by a
UK National Institute for Health Research Professorship
(NIHR-RP-011-015). CGM is supported by Australian National Health and
Medical Research Council Research Fellowships. JRA is supported
through a Professorship in Insurance Medicine from the Dutch Social
Security Agency. The conclusions in this Series paper are those of the
authors and do not necessarily reflect the official position of any of the
organisations, institutions, or agencies to which the authors are affiliated.
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