European Spine Journal 2018 (Sep); 27 (Suppl 6): 870–878 ~ FULL TEXT
Emre Acaroglu, Margareta Nordin, Kristi Randhawa, Roger Chou, Pierre Côté, Tiro Mmopelwa, Scott Haldeman
ARTES Spine Center,
PURPOSE:   The purpose of this study was to synthesize recommendations on the use of common elective surgical and interventional procedures for individuals with persistent and disabling non-radicular/axial with or without myelopathy, radicular back pain, cervical myelopathy, symptomatic spinal stenosis, and fractures due to osteoporosis. This review was to inform a clinical care pathway on the patient presentations where surgical interventions could reasonably be considered.
METHODS:   We synthesized recommendations from six evidence-based clinical practice guidelines and one appropriate use criteria guidance for the surgical and interventional management of persistent and disabling spine pain.
RESULTS:   Lower priority surgery/conditions include fusion for lumbar/non-radicular neck pain and higher priority surgery/conditions include discectomy/decompressive surgery for cervical or lumbar radiculopathy, cervical myelopathy, and lumbar spinal stenosis. Epidural steroid injections are less expensive than most surgeries with fewer harms; however, benefits are small and short lived. Vertebroplasty should be considered over kyphoplasty as an option for patients with severe pain and disability due to osteoporotic vertebral compression fracture.
CONCLUSION:   Elective surgery and interventional procedures could be limited in medically underserved areas and low- and middle-income countries due to a lack of resources and surgeons and thus surgical and interventional procedures should be prioritized within these settings. There are non-invasive alternatives that produce similar outcomes and are a recommended option where surgical procedures are not available. These slides can be retrieved under Electronic Supplementary Material.
KEYWORDS:   Back pain; General surgery; Neck pain; Orthopedics; Spine
From the FULL TEXT Article:
Spinal disorders, including neck and back pain, are a
leading source of global disability and place a substantial
burden on the healthcare system and society through
use of health resources and lost productivity [1–3]. Surgical
and interventional procedures target specific back or
neck structures or abnormalities that are thought to be the
cause of pain or functional limitation (e.g., muscles or soft
tissues, stenosis, herniated disc, osteoporotic fractures).
Although many cases of spine pain are mild and improve
spontaneously, spine pain can also be chronic and recurrent
[4–7]. Many patients with acute or chronic low back
pain (LBP) improve within the first 6 weeks; however,
improvement slows past this point .
than one-third of cases resolve annually, and nearly 30%
will experience a recurrence within 6 months . For neck
pain, studies show that cases will either resolve within the
first few months or it will persist and have a high probably
of becoming a chronic complaint [6, 8]. For myelopathy,
the natural history varies between individuals, with the
evidence suggesting that 20–60% of patients will deteriorate
neurologically over time without surgery . Therefore,
invasive interventions such as injections or surgery
may be considered in patients with persistent and disabling
spine pain following unsuccessful non-invasive treatments.
Many guidelines on the use of surgery and interventional
procedures for spinal conditions are available.
However, they were all developed from evidence obtained
from high-income countries and tailored to the needs of
these settings [10–15]. In such settings, surgeries and
interventional treatments are often performed as elective
procedures, and are generally not associated with clearly
superior outcomes when compared to non-invasive therapies
[10, 16]. The generalizability of these guidelines to
low- and middle-income countries is uncertain because of
limited healthcare resources, including surgical/medical
expertise, resources and infrastructure.
The purpose of this article was to synthesize recommendations
on the management of spinal disorders using
surgical and interventional procedures for individuals with
persistent and disabling spinal pain to inform the Global
Spine Care Initiative (GSCI) Care Pathway for patient
presentations where surgical interventions could reasonably
be considered. This study pertains to “elective” surgical
and interventional (i.e., injections) procedures to
reduce persistent pain and improve function. Patients with
cauda equina, progressive neurological deficits, and serious
conditions such as cancer, severe trauma, infection, or
other “Red Flag” conditions generally requiring surgical or
specialized evaluation were not considered in this review.
Development of recommendations
We selected spinal disorders associated with persistent
pain and loss of function that may be referred to surgery
or injections . These conditions are non-radicular/axial
neck and back pain, radicular neck pain due to degenerative
foraminal stenosis with or without myelopathy, radicular
back pain due to herniated disc, and symptomatic spinal
stenosis and osteoporotic fracture.
Six evidence-based clinical practice guidelines for the
surgical and interventional management of persistent and
disabling spine disorders were selected by consensus of
the GSCI executives (SH, MN, PC, EH, RC) [10–15]. One
guideline focused on low back pain was developed by the
American Pain Society (APS) [one of the lead authors of
this guideline is an author of this article (RC)] . One
guideline focused on percutaneous vertebroplasty and percutaneous
balloon kyphoplasty for treating osteoporotic
vertebral compression fractures and was developed by the
National Institutes of Health Care Excellence (NICE) .
The other four guidelines were developed by the North
American Spine Society (NASS) [12–15].
We appraised the quality of the guidelines using the
Appraisal of Guidelines for Research and Evaluation
(AGREE) II instrument . All guidelines met criteria
for high-quality guidelines scoring five out of seven (highest
score) or higher.
We found no guidelines to inform the management of
axial neck pain or cervical myelopathy. These conditions
are common indications for surgery for neck pain. For
these conditions we used NASS Appropriate Use Criteria
. Appropriate use criteria is developed for procedures
that are done frequently, consume significant resources,
have wide variations in their use, are associated with
substantial morbidity and mortality, procedures that are
controversial or a combination of these. The objective of
NASS Appropriated Use Criteria is to define appropriate
(reasonable) care of spinal disorders. The criteria are
based on available evidence combined with a rigorous,
transparent recommendation process and well-defined
Synthesis of recommendations
For each intervention, one reviewer (EA) extracted the
available information regarding the clinical benefits
and harms of the interventions from the guidelines (see
Online Resource Table 1). A second reviewer (KR)
checked data extraction for accuracy and completeness.
Through consensus, we categorized the magnitude of benefits
and harms, costs and feasibility as uncertain, low/
small, moderate, or high based on the categories used in
the recent Agency for Healthcare Research and Quality
(AHRQ) review on LBP interventions  (see Online
Resource Table 1).
We classified each recommendation using the system
proposed by NICE (see Online Resource Table 2) .
Recommendations from the APS guideline , the
North American Spine Society guidelines [12–15] and
the NASS Appropriate Use Criteria  were adapted
to conform to the NICE wording by taking into consideration
the benefits (effectiveness) and harms (adverse
events, ineffectiveness). Based on this methodology, we
worded our recommendations as:
‘‘offer (recommended)’’ (for interventions that are of
superior effectiveness compared to other interventions,
placebo/sham interventions, or no intervention);
‘‘consider (recommended for consideration)’’ (for interventions
providing similar effectiveness to other interventions);
‘‘do not offer (recommended against)’’ (for interventions
providing no benefit beyond placebo/sham or
where harms outweigh benefits) the intervention; or
insufficient—insufficient evidence was available to
develop a recommendation.
Additional interventions that had insufficient evidence
of efficacy or ineffectiveness (insufficient) or were shown
to have no benefit (recommended against) are not discussed
in the summary of recommendations but are listed
in Table 1 for completeness.
After synthesizing recommendations from the guidelines,
we developed eight recommendations for the GSCI
Care Pathway, taking into consideration possible adaptions
for low- and middle-income settings and implementation
within these settings.
Summary of recommendations
For patients with persistent (> 3 months) and/or disabling
spine pain who do not respond to non-invasive treatments,
invasive treatments may be considered. Surgical
and injection treatments are elective procedures, and it
is important that risks, potential harm and benefits of
each intervention are discussed between the healthcare
provider and patient. The summary of information is
included in Table 1.
Potential harms due to surgical and interventional procedures for spinal disorders
Although surgery may be beneficial for certain patients,
harms must also be considered. As with most invasive
procedures, potential complications of surgical spine procedures
may include infection, poor wound healing, dural
tears, neural injury, bleeding, thrombosis, acute respiratory
distress syndrome, pulmonary edema, heart failure,
and pain [22–24].
Management of cervical axial pain
Recommendation 1: Cervical axial pain is a common spinal
disorder. Due to insufficient evidence, surgery is not
indicated for the treatment of cervical axial pain.
Management of cervical radiculopathy from degenerative disorders
Recommendation 2: Cervical Consider anterior cervical discectomy
(commonly with fusion) for patients with persistent cervical
radiculopathy secondary to degenerative disorders for
more rapid pain relief (one guideline) .
Surgery is an option in patients with persistent, moderate
to severe cervical radiculopathy who do not respond
to a course of non-invasive therapy. In patients with cervical
radiculopathy from degenerative disorders, surgery
(anterior cervical discectomy, with or without fusion) is
associated with more rapid pain relief than non-invasive
therapy. However, patients generally experience improvement
with or without surgery. Therefore, GSCI recommends
that surgery should be reserved for individuals with
persistent and moderate to severe symptoms unresponsive
to recommended non-invasive interventions.
A anterior cervical discectomy (ACD) and anterior
cervical discectomy with fusion (ACDF) are associated
with similar short-term clinical outcomes in regard to pain
relief. However, adding fusion may result in a more complex
surgical procedure with increased risk of complications.
Recent literature suggests that ACDF may be associated
with better longer term results and cost effectivity
[25, 26]. Therefore, ACD without fusion (vs ACDF) may
only be recommended in very low resource setting in the
absence of a clear indication for fusion (e.g., significant
Disc arthroplasty is comparable to anterior cervical discectomy
with fusion for short-term outcomes but may be more
costly and require additional technical skills. In addition,
data on long-term outcomes are relatively limited. In addition
to general risks of surgery, artificial disc replacement
may be associated with additional complications, including
prosthesis migration or subsidence (settling or sinking into
bone), as well as adjacent level disc degeneration, facet joint
arthritis, and need for subsequent artificial disc removal .
Therefore, GSCI recommends that discectomy (± fusion) be
preferred over arthroplasty in low-resource settings.
Management of cervical stenosis due to spondylosis or disc herniation with myelopathy
Recommendation 3: Cervical Consider fusion for the management
of cervical stenosis due to spondylosis or disc herniation
with myelopathy (Table 1) (Appropriate Use Criteria) .
There is a lack of evidence for the effectiveness of fusion
(anterior and/or posterior) for cervical stenosis due to spondylosis
or disc herniation with myelopathy, but based on the
Appropriate Use Criteria it may be appropriate to perform
fusion if improvement is not evident following non-invasive
treatment. In patients with moderate to severe myelopathy,
non-invasive treatment may not be effective as myelopathy is
typically a progressive disorder with little evidence showing
that non-invasive treatment halts or reverses its progression
With cervical fusion there is a risk of pseudoarthritis
and risks factors for pseudoarthritis (e.g., smoking, obesity,
diabetes, age, vascular abnormalities) should be considered
prior to surgery .
Management of non-radicular low back pain with common degenerative changes
Recommendation 4: Cervical Consider fusion surgery for non-radicular
low back pain with common degenerative changes in
individuals with persistent disability in patients who do not
improve following recommended non-invasive treatments
(Table 1) (one guideline) .
Fusion surgery and intensive rehabilitation appear to be
similarly effective for persistent non-radicular low back pain
thought to be due to degenerative disc diseases and associated
with moderate to severe disability. Furthermore, a
proportion of patients who undergo fusion surgery do not
experience optimal outcomes. Therefore, fusion should
be reserved for patients with persistent, or at least severe
symptoms not responding to non-invasive therapies. It is recommended
that intensive rehabilitation be provided prior to
fusion surgery, if available. Elective surgery for axial (nonradicular)
LBP is an option, but given the similar effectiveness
of non-invasive treatments to fusion and higher costs,
the GSCI does not recommend fusion for persistent nonradicular
low back pain without instability as a high priority
for resource allocation in settings with limited resources [10,
If fusion is considered, the data generally suggest that
more complex and costly surgical techniques [e.g., circumferential
fusion vs. anterior lumbar interbody fusion or
posterior lumbar interbody fusion, instrumentation vs. noninstrumented,
bone morphogenetic protein-2 (BMP-2 vs. no
BMP-2)] result in no additional benefits or better outcomes,
and may result in additional complications.
Disc arthroplasty is comparable to fusion for short-term
outcomes but is generally a more costly surgery requiring
additional technical skills and training. In addition to the
typical complications of surgery, artificial disc replacement
may also result in prosthesis migration or subsidence as well
as adjacent level disc degeneration, facet joint arthritis, or
require subsequent artificial disc removal [22–24]. Due to
the costs and potential additional complications, GSCI recommends
that fusion be provided over arthroplasty in lowresource
Management of persistent radiculopathy due to prolapsed/herniated lumbar disc
Epidural steroid injection
Recommendation 5: Cervical Consider epidural steroid injection for
short-term benefits in patients with persistent radiculopathy
due to prolapsed/herniated lumbar disc (Table 1) (one
guideline) [10, 13].
Epidural steroid injection should be reserved for patients
with persistent symptoms with moderate to severe disability
who do not improve with non-invasive interventions. This
recommendation is based on trials focused on patients with
persistent moderate to severe disability despite non-invasive
treatments. The expected benefits from lumbar epidural steroid
injections are for short-term small pain relief [10, 13].
Lumbar epidural steroid injections are not associated with
a reduction in the risk of subsequent surgery . Epidural
lumbar steroid injection could be an option in some lowresource
settings for short-term symptomatic relief, but
GSCI does not consider this a high-priority intervention
given the short-term, relatively small benefits associated
Serious adverse events for epidural injections are rare;
minor adverse events include local hematoma, bleeding, and
dural puncture .
Recommendation 6: Cervical Consider discectomy (open discectomy
or microdiscectomy) for radiculopathy due to prolapsed/herniated
lumbar disc in patients with severe pain and disabling
symptoms (Table 1) (two guidelines) [10, 13].
Discectomy may benefit individuals with radiculopathy
with severe pain and/or loss of function. On average, patients
improve with or without discectomy; however, patients tend
to improve more slowly without surgery. In some trials, the
medium-term outcomes (1–4 years) are similar for patients
who receive discectomy and those who do not. In lowresource
settings, GSCI recommends that elective discectomy
be considered for patients with persistent radiculopathy
due to herniated disc who have severe disabling symptoms
that are not improving.
Therefore, the GSCI recommends decompression as a
higher priority for resource allocation in low- and middleincome
settings, given the benefits, the relatively straightforward
procedure, and cost compared to fusion and artificial
Management of lumbar spinal stenosis and degenerative spondylolisthesis
Decompression and fusion
Recommendation 7: Cervical Consider decompression surgery (laminectomy)
for the management of patients with spinal stenosis
(with or without degenerative spondylolisthesis) with moderate
to severe symptoms (radiculopathy or pseudoclaudication)
(Table 1) (two guidelines) [6, 7].
The evidence indicates that surgery (typically decompressive
laminectomy) is associated with small to moderate benefits
compared to non-surgical treatment. Therefore, GSCI
recommends that decompressive surgery be considered as
an option for patients with persistent pain (including radiculopathy/
pseudoclaudication due to stenosis) and functional
symptoms that do not improve with non-surgical treatment.
In most trials, the benefits of decompression surgery for spinal
stenosis appear to be longer lasting than for discectomy
for herniated disc. Surgery should generally not be considered
within the first 3 months, as patients enrolled in RCTs
typically had prolonged (often years) symptoms. For patients
with mild to moderate symptoms of spinal stenosis or who
can adequately function, non-invasive treatment should be
considered, such as rehabilitation including exercise and
In the absence of instability, fusion should not be used
for the management of stenosis with or without degenerative
spondylolisthesis. Fusion with laminectomy is generally not
associated with better outcomes than laminectomy alone,
and associated with more costs and increased harms .
Therefore, the GSCI recommends discectomy and/or
laminectomy as a higher priority for resource allocation
in low- and middle-income settings, given the benefits, the
relatively straightforward procedure, and cost compared to
Management of osteoporotic fracture
Balloon kyphoplasty and vertebroplasty
Recommendation 8: Cervical Consider percutaneous vertebroplasty
in patients who have severe ongoing pain after a recent,
unhealed vertebral compression fracture despite optimal
pain management (Table 1) (one guideline) .
Intense and severe pain confirmed at the level of osteoporotic
fractures [diagnosed by radiographs, computed
tomography (CT) or magnetic resonance imaging (MRI)]
may benefit from a percutaneous vertebroplasty or balloon
kyphoplasty. In the absence of the need for surgical stabilization,
balloon kyphoplasty or vertebroplasty should be
considered for patients who did not experience significant
pain reduction after a course of conservative treatment.
The effectiveness of balloon kyphoplasty and vertebroplasty
are shown similar when compared to each other;
however, there are no sham-controlled studies that assess
the effectiveness of balloon kyphoplasty. Among three
sham-controlled trials of vertebroplasty, it was ineffective
in two [30, 31]; one trial that restricted enrollment to people
with very acute (< 6 weeks) symptoms found some benefits
. If it is used, vertebroplasty should be done in the first
6 weeks . The GSCI recommends vertebroplasty over
balloon kyphoplasty as the evidence is stronger for vertebroplasty,
which is a technically easier procedure and generally
less costly than kyphoplasty.
Adverse reactions may occur,
as described in the NICE guidelines: “for both vertebroplasty
and kyphoplasty, adverse reactions can be caused by:
needle insertion (such as local or systemic infection, bleeding,
and damage to neural or other structures); leakage of
bone cement; displacement of bone marrow and other material
by the cement; systemic reactions to the cement (such as
hypotension and death); and complications related to anesthesia
and patient positioning (such as additional fractures
of a rib or the sternum). In addition, there is a small risk
that the balloon can rupture in kyphoplasty, which can result
in the retention of balloon fragments within the vertebral
We reviewed and appraised six evidence-based clinical
practice guidelines and one appropriate use criteria document
to generate eight recommendations and suggestions
for prioritization for elective invasive interventions for the
management of spinal pain and disabling disorders in lower
resource settings [10, 12–15, 19]. Prior recommendations
were developed for use in high-resource settings; we adapted
and prioritized recommendations on elective invasive interventions
to lower resource settings.
The benefits of elective surgical and interventional procedures
for cervical and lumbar axial spine pain may be
comparable to non-invasive interventions and are associated
with additional harms and possible increased costs. Surgery
should be reserved for individuals who do not respond to
non-invasive interventions and who have progressive, persistent
and disabling pain. A shared decision-making approach
is warranted. The care providers should provide information
regarding potential benefits and harms, and discuss preferences
and expectations, values and goals for the patient to
play an active role in the decision making process.
Patients with signs of psychological distress, such as somatization,
depression, fear avoidance and catastrophizing,
have a worse prognosis after surgery than patients without
such signs (i.e., slower recovery). An important component
of reducing psychological distress is education, reassurance
and thorough explanation by the healthcare provider .
Patient expectation can also affect the outcomes following
surgical or invasive procedures [28, 34–37]. Other important
factors that may impact outcomes of surgery and could be
used to inform decisions include use of opioids, smoking
status, and medical comorbidities (e.g., diabetes).
Based on relatively small benefits relative to harms and
costs, lower priority surgery/conditions include fusion for
lumbar/non-radicular neck pain; based on greater benefits
relative to harms and costs, higher priority surgery/conditions
include discectomy/decompressive surgery for cervical
or lumbar radiculopathy, cervical myelopathy, and lumbar
spinal stenosis. Epidural steroid injections are less expensive
than most surgeries with fewer harms; however, benefits are
small and short lived. Vertebroplasty should be considered
over kyphoplasty as an option for patients with severe pain
and disability due to osteoporotic vertebral compression
fracture in patients who do not improve following a short
course of non-invasive treatment.
Spine surgery may result in complications or adverse
events. Knop et al., a Study Group of the German Trauma
Association (DGU), analyzed operative complications of
682 spine patients spanning 18 centers in Germany .
Overall surgical complication rate for thoraco-lumbar spine
was 15%. Anterior spine surgery was associated with a
higher complication rate of 30%. Treatment-related mortality
was mainly due to pulmonary embolism at 1% . Deep
infection was the most common procedure-related complication
at 2.2%. Neurological complications occurred in 2%
of patients and despite immediate revision, most of them
did not improve. Hematoma and wound healing problems
occurred in 1.8% of patients. Implant-related complications
and cerebrospinal fluid (CSF) leakage were not very common,
1.3 and 0.3%, respectively . There is little information
on complication rates from underserved areas.
All guidelines and appropriate use criteria were developed
in North America and UK and were not developed specifically
for low- and middle-income communities. However,
we chose these guidelines and criteria because they adhered
to methodological standards for developing guidelines. The
included guidelines did not provide formal information
on cost-effectiveness, but we provided some suggestions
for prioritization of resources regarding elective invasive
procedures based on estimated relative costs and expected
Evidence from high-quality clinical practice guidelines suggests
that most surgical interventions lead to similar outcomes
as non-invasive procedures for cervical and lumbar
spine axial pain-related conditions. We have provided recommendations
for surgical and interventional procedures
based on evidence, these interventions should be reserved
for patients with persistent and disabling spinal pain that fail
to improve with non-invasive treatment. In low- and middleincome
communities, prioritization of elective surgical procedures
should be based on estimated benefits relative to
harms and costs.
The Global Spine Care Initiative and this study were funded
by Grants from the Skoll Foundation and NCMIC Foundation. World
Spine Care provided financial management for this project. The funders
had no role in study design, analysis, or preparation of this paper.
Conflict of interest
EA declares Grants: Depuy Synthes Spine,
Medtronic; speaker’s bureau: AOSpine, Zimmer Biomet. MN declares
funding from Skoll Foundation and NCMIC Foundation through
World Spine Care; Co-Chair, World Spine Care Research Committee,
Palladian Health, Clinical Policy Advisory Board member. Book
Royalties: Wolters Kluwer and Springer. Honoraria for speaking at
research method courses. KR declares funding to UOIT from Skoll
Foundation, NCMIC Foundation through World Spine Care. RC declares
funding from AHRQ to conduct systematic reviews on treatments
for low back pain within last 2 years. Honoraria for speaking
at numerous meetings of professional societies and non-profit groups
on topics related to low back pain (no industry sponsored talks). PC
is funded by a Canada Research Chair in Disability Prevention and
Rehabilitation at the University of Ontario Institute of Technology, and
declares funding to UOIT from Skoll Foundation, NCMIC Foundation
through World Spine Care. Canadian Institutes of Health Research
Canada. Research Chair Ontario Ministry of Finance. Financial Services
Commission of Ontario. Ontario Trillium Foundation, ELIB Mitac.
Fond de Recherche and Sante du Quebec. TM declares Fellowship
Grant—Medtronics. SH declares funding to UOIT from Skoll Foundation,
NCMIC Foundation through World Spine Care. Clinical Policy
Advisory Board and stock holder, Palladian Health. Advisory Board,
SpineHealth.com. Book Royalties, McGraw Hill. Travel expense reimbursement—
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