Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain
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SPINE Volume 34, Number 10, pp 1066 –1077
©2009, Lippincott Williams & Wilkins
Interventional Therapies, Surgery, and Interdisciplinary
Rehabilitation for Low Back Pain
An Evidence-Based Clinical Practice Guideline From the American
Pain Society
Roger Chou, MD,* John D. Loeser, MD,† Douglas K. Owens, MD, MS,‡§
Richard W. Rosenquist, MD,¶ Steven J. Atlas, MD, MPH,㛳 Jamie Baisden, MD, FACS,**
Eugene J. Carragee, MD,†† Martin Grabois, MD,‡‡ Donald R. Murphy, DC, DACAN,§§
Daniel K. Resnick, MD,¶¶ Steven P. Stanos, DO,㛳㛳 William O. Shaffer, MD,*** and
Eric M. Wall, MD, MPH,††† For the American Pain Society Low Back Pain Guideline Panel
Study Design. Clinical practice guideline. Methods. A multidisciplinary panel was convened by
Objective. To develop evidence-based recommenda- the American Pain Society. Its recommendations were
tions on use of interventional diagnostic tests and thera- based on a systematic review that focused on evidence
pies, surgeries, and interdisciplinary rehabilitation for low from randomized controlled trials. Recommendations
back pain of any duration, with or without leg pain. were graded using methods adapted from the US Preven-
Summary of Background Data. Management of patients tive Services Task Force and the Grading of Recommen-
with persistent and disabling low back pain remains a clin- dations, Assessment, Development, and Evaluation
ical challenge. A number of interventional diagnostic tests Working Group.
and therapies and surgery are available and their use is Results. Investigators reviewed 3348 abstracts. A total
increasing, but in some cases their utility remains uncertain of 161 randomized trials were deemed relevant to the
or controversial. Interdisciplinary rehabilitation has also recommendations in this guideline. The panel developed
been proposed as a potentially effective noninvasive inter- a total of 8 recommendations.
vention for persistent and disabling low back pain. Conclusion. Recommendations on use of interven-
tional diagnostic tests and therapies, surgery, and inter-
disciplinary rehabilitation are presented. Due to impor-
tant trade-offs between potential benefits, harms, costs,
and burdens of alternative therapies, shared decision-
From the *Department of Medicine, Oregon Evidence-based Practice making is an important component of a number of the
Center, Oregon Health and Science University, Portland, OR; †Depart- recommendations.
ment of Neurological Surgery, University of Washington, Seattle, WA; Key words: low back pain, guideline, evidence-based,
‡Veterans Affairs Medical Center, Palo Alto, CA; §Stanford Univer- surgery, fusion, laminectomy, discectomy, injection, ra-
sity, Stanford, CA; ¶Department of Anesthesiology, University of
diofrequency denervation, intradiscal electrothermal
Iowa, Iowa City, IA; 㛳Medical Services,General Medicine Division,
Massachusetts General Hospital, Harvard Medical School, Boston, therapy, botulinum toxin, interdisciplinary therapy, mul-
MA; **Department of Neurosurgery, Medical College of Wisconsin, tidisciplinary therapy, spinal cord stimulation. Spine 2009;
Milwaukee, WI; ††Department of Orthopedic Surgery, Stanford Uni- 34:1066 –1077
versity, Stanford, CA; ‡‡Department of Physical Medicine and Reha-
bilitation, Baylor College of Medicine, The Institute for Rehabilitation
and Research, Houston, TX; §§Department of Community Health,
Rhode Island Spine Center, Alpert Medical School of Brown Univer- Low back pain is extremely common.1,2 Most patients
sity, Pawtucket, RI; ¶¶Department of Neurosurgery, University of with acute low back pain improve substantially over the
Wisconsin, Madison, WI; 㛳㛳Department of Physical Medicine and Re- first month.3 After the first month, improvements are less
habilitation, Northwestern University, Chicago, IL; ***Department of
Orthopaedics, University of Kentucky, Lexington, KY; and †††Qualis pronounced and eventually taper off. In a small minority
Health, Seattle, WA. of patients, back pain is persistent and disabling. Among
Acknowledgment date: October 21, 2008. Revision date: December patients who seek medical care for their low back pain,
19, 2008. Acceptance date: December 22, 2008.
The device(s)/drug(s) is/are FDA-approved or approved by correspond- up to one-third report back pain of at least moderate
ing national agency for this indication. intensity 1 year after an acute episode, and 1 in 5 reports
Professional Organizational funds were received in support of this substantial limitations in activity.4 Five percent of the
work. No benefits in any form have been or will be received from a
commercial party related directly or indirectly to the subject of this people with back pain disability are estimated to account
manuscript. for 75% of the costs associated with low back pain.5
Supported by the American Pain Society (APS). A previous guideline sponsored by the American Pain
This article is based on research conducted at the Oregon Evidence-
based Practice Center. The authors are solely responsible for the con- Society (APS) and the American College of Physicians
tent of this article and the decision to submit for publication. (ACP) focused on the evaluation and management of low
Registered products and procedures: Coblation Technology, Arthro- back pain in primary care settings.6 It recommends sev-
Care Corporation, 7500 Rialto Boulevard, Building Two, Suite 100,
Austin, TX 78735; Dekompressor, Stryker Instruments, 4100 East eral pharmacologic and nonpharmacologic therapies
Milham Avenue, Kalamazoo, MI 49001; and Prodisc II and Prodisc-L, (spinal manipulation, exercise therapy, cognitive-
Synthes Spine, Inc., 1302 Wright Lane East, West Chester, PA 19380. behavioral therapy, progressive relaxation, yoga, mas-
Address correspondence and reprint requests to Roger Chou, MD,
3181 SW Sam Jackson Park Road, Mail code BICC, Portland, OR sage, and acupuncture) as moderately effective treatment
97239; E-mail: chour@ohsu.edu options.
1066LBP Guideline: Interventional, Surgical, Interdisciplinary • Chou et al 1067
Management of patients with persistent and disabling back pain associated with major trauma, tumor, metabolic dis-
back pain despite use of recommended therapies remains ease, inflammatory back disease, fracture, dislocation, major
a challenge. A number of injections, other interventional instability, or major deformity; patients with progressive or
therapies, and surgeries were not addressed in the previ- severe neurologic deficits; children or adolescents with low
back pain; pregnant women, patients with low back pain from
ous APS/ACP guideline, but are also available for treat-
sources outside the back (nonspinal low back pain), and tho-
ment of back pain. In general, these therapies are consid- racic or cervical spine pain.
ered to be more invasive and attempt to target specific
back structures or spinal abnormalities thought to be the Funding and Conflicts of Interest
source of back pain, such as back muscles or soft tissues, The guideline was sponsored by APS. Funding was provided by
degenerated facet or sacroiliac joints, spinal canal steno- APS. The guideline was approved by APS, but the content and
sis, and degenerated or herniated intervertebral discs. publication of the guideline is solely the responsibility of the
Several invasive diagnostic tests are also available. The authors and panel members. All panelists were required to dis-
purpose of such tests is to evaluate potential anatomic close all potential conflicts of interest within the preceding 5
sources for back pain, which could theoretically identify years at all face-to-face meetings and before submission of the
patients more likely to benefit from various interven- guideline for publication, and to recuse themselves from votes
tions. if significant conflicts were present. Potential conflicts of inter-
est of the authors and panel members are listed at the end of the
Rates of certain interventional and surgical proce-
guideline.
dures for back pain are rising.7–9 However, it is unclear if
methods for identifying specific anatomic sources of
Evidence Review
back pain are accurate, and effectiveness of some inter- This guideline is based on a systematic review12 summarized in
ventional therapies and surgery remains uncertain or 2 background papers by Chou et al13,14 in this issue that were
controversial. In addition, interventional and surgical conducted at the Oregon Evidence-Based Practice Center and
therapies do not address the psychological and environ- commissioned by APS to inform the guideline. The panel de-
mental factors that are often associated with chronic low veloped the key questions, scope, and inclusion criteria used to
back pain (see glossary, Supplemental Digital Content 1, guide the evidence review. Literature searches were conducted
http://links.lww.com/A840).10,11 Interdisciplinary reha- through July 2008. The evidence report discusses the evidence
bilitation (see glossary, Supplemental Digital Content 1, for invasive diagnostic tests, interdisciplinary therapy, and in-
http://links.lww.com/A840), on the other hand, does not trathecal therapy,12 and the 2 background papers summarize
the evidence for other interventional therapies and surgery ad-
target a specific anatomic source of back pain, but incor-
dressed in the guideline.13,14
porates psychological interventions and exercise ther-
The background papers provide details about the methods
apy, and could be an alternative treatment option for used for the systematic evidence review.13,14 Briefly, for recom-
persistent and disabling symptoms. mendations on use of different therapies, the guideline is based
The purpose of this guideline is to present evidence- on evidence from all English-language randomized controlled
based recommendations for use of invasive diagnostic trials of nonpregnant adults (age ⬎18 years) with low back
tests, interventional therapies, surgery, and interdiscipli- pain (alone or with leg pain) of any duration that evaluated a
nary rehabilitation for nonradicular low back pain, ra- target interventional therapy or surgery, and reported at least
diculopathy with herniated disc, and symptomatic spinal one of the following outcomes: back-specific function, general
stenosis (see glossary, Supplemental Digital Content 1, health status, pain, work disability, patient satisfaction, or an
http://links.lww.com/A840). overall assessment of treatment benefit. For invasive diagnostic
tests, studies assessing diagnostic accuracy are difficult to inter-
pret because there is no reference standard for reliably identi-
Materials and Methods fying specific anatomic sources of low back pain. Therefore, the
guideline based its recommendations for invasive diagnostic
Panel Composition tests on studies that assessed rates of positive tests in persons
In 2004, the APS convened a multidisciplinary panel of 23
without low back pain and studies that evaluated effects of
experts to formulate low back pain recommendations (panel
invasive diagnostic tests on clinical outcomes.15
members are listed at the end of this manuscript). Three co-
Investigators reviewed 3348 abstracts identified from
chairs (J.L., R.R., and D.O.) were selected to lead the panel. In
searches on electronic databases, reference lists, and sugges-
2007, 3 additional experts in the areas of interventional thera-
tions from expert reviewers.12 A total of 161 randomized trials
pies or surgery were invited to participate in development of
relevant to the recommendations in this guideline were in-
recommendations (M.B., D.R., and W.S.).
cluded in the full evidence report.12
Target Audience and Scope Grading of the Evidence and Recommendations
The target audience for this guideline is all clinicians caring for The evidence for individual diagnostic tests and interventions
patients with low (lumbar) back pain of any duration, either was first evaluated by the APS panel using a system adopted
with or without leg pain. Although the target patient popula- from the US Preventive Services Task Force for grading
tion is adults with persistent (at least subacute in duration) low strength of evidence (Table 1), estimating magnitude of benefits
back pain, we included trials of any of the interventions of (Table 2), and assigning summary ratings (Table 1).16 After
interest for low back pain of any duration. The guideline is not formulating the recommendations, which encompassed evi-
intended to guide evaluation or management of patients with dence from multiple bodies of evidence and interventions, the1068 Spine • Volume 34 • Number 10 • 2009
Table 1. Criteria for Grading the Strength of Evidence and Making Treatment Recommendations*
Recommendation Strength of Evidence
A The panel strongly recommends that clinicians consider offering Good Evidence includes consistent results from well-
the intervention to eligible patients. The panel found good designed, well-conducted studies in
evidence that the intervention improves health outcomes and representative populations that directly
concludes that benefits substantially outweigh harms. assess effects on health outcomes (at least
2 consistent, higher-quality trials).
B The panel recommends that clinicians consider offering the Fair Evidence is sufficient to determine effects on
intervention to eligible patients. The panel found at least fair health outcomes, but the strength of the
evidence that the intervention improves health outcomes and evidence is limited by the No. quality, size,
concludes that benefits moderately outweigh harms, or that or consistency of included studies;
benefits are small but there are no significant harms, costs, generalizability to routine practice; or
or burdens associated with the intervention. indirect nature of the evidence on health
C The panel makes no recommendation for or against the outcomes (at least 1 higher-quality trial of
intervention. The panel found at least fair evidence that the sufficient sample size; 2 or more higher-
intervention can improve health outcomes, but concludes that quality trials with some inconsistency; at
benefits only slightly outweigh harms, or the balance of least 2 consistent, lower-quality trials, or
benefits and harms is too close to justify a general multiple consistent observational studies
recommendation. with no significant methodologic flaws).
D The panel recommends against offering the intervention. The Poor Evidence is insufficient to assess effects on
panel found at least fair evidence that the intervention is health outcomes because of limited no. or
ineffective or that harms outweighs benefits. power of studies, large and unexplained
I The panel found insufficient evidence to recommend for or inconsistency between higher-quality trials,
against the intervention. Evidence that the intervention is important flaws in trial design or conduct,
effective is lacking, of poor quality, or conflicting, and the gaps in the chain of evidence, or lack of
balance of benefits and harms cannot be determined. information on important health outcomes.
*Adapted from methods developed by the US Preventive Services Task Force.16
APS panel assigned an overall grade using methods adapted by ences and values. For grading the quality of a body of evidence
the ACP from the Grading of Recommendations, Assessment, that supports a recommendation, we considered the type, num-
Development, and Evaluation Working Group (Table 3).17 ber, size, and quality of studies; strength of associations or
Each recommendation received a separate grade for the effects; and consistency of results between studies.17 This
strength of the recommendation (strong or weak) and for the guideline considered interventions to have “proven” benefits
quality of evidence (high, moderate, or poor). In general, a only when they were supported by at least fair-quality evidence
strong recommendation is based on the panel’s assessment that from randomized trials and were associated with at least mod-
potential benefits of following the recommendation clearly out- erate benefits. The ratings for individual interventions dis-
weigh potential harms and burdens. Given the available evi- cussed in this guideline are summarized in Tables 4 and 5.
dence, clinicians and patients would generally choose to follow
a strong recommendation. A weak rating is based on more Guideline Development Process
closely balanced benefits to harms or burdens, or weaker evi- The guideline panel met in person on 3 occasions between July
dence. Decisions to follow a weak recommendation could vary 2005 and January 2007 to develop the scope and key questions
depending on specific clinical circumstances or patient prefer- used to guide the systematic evidence review, examine and dis-
cuss the results of the evidence review, and draft and revise
recommendation statements. Following the last panel meeting,
Table 2. Definitions for Estimating Magnitude of Effects the guideline panel finalized and voted on the recommendation
statements through a series of conference calls and electronic
Size of Effect Definition
Small/slight Pain scales: Mean 5- to 10-point improvement on
a 100-point VAS or equivalent
Back-specific functional status: Mean 5- to 10- Table 3. The American College of Physicians Clinical
point improvement on the ODI, 1–2 points on Practice Guidelines Grading System*
the RDQ, or equivalent
All outcomes: SMD, 0.2–0.5 Strength of Recommendation
Moderate Pain scales: Mean 10- to 20-point improvement
on a 100-point VAS or equivalent Benefits Do or Do Not Benefits and Risks and
Back-specific functional status: Mean 10- to 20- Clearly Outweigh Burdens Are Finely
point improvement on the ODI, 2–5 points on Quality of Evidence Risks Balanced
the RDQ, or equivalent
All outcomes: SMD, 0.5–0.8 High Strong Weak
Large/substantial Pain scales: Mean ⬎20-point improvement on a Moderate Strong Weak
100-point VAS or equivalent Low Strong Weak
Back-specific functional status: Mean ⬎20-point Insufficient evidence to I
improvement on the ODI, ⬎5 points on the determine net
RDQ, or equivalent benefits or harms
All outcomes: SMD, ⬎0.8
*From the system developed by the Grading of Recommendations, Assess-
ODI indicates Oswestry Disability Index; RDQ, Roland-Morris Disability Ques- ment, Development, and Evaluation (GRADE) workgroup and adapted by the
tionnaire; SMD, standardized mean difference; VAS, visual analogue scale. American College of Physicians.LBP Guideline: Interventional, Surgical, Interdisciplinary • Chou et al 1069
Table 4. Level of Evidence and Summary Grades for Interdisciplinary Rehabilitation, Injections, Other Interventional
Therapies, and Surgery for Patients With Nonradicular Low Back Pain*
Intervention Condition Level of Evidence Net Benefit Grade
Interdisciplinary Nonspecific low back pain Good Moderate B
rehabilitation
Prolotherapy Nonspecific low back pain Good No benefit D
Intradiscal steroid Presumed discogenic pain Good No benefit D
injection
Fusion surgery Nonradicular low back pain Fair Moderate vs. standard nonsurgical B
with common therapy, no difference vs.
degenerative changes intensive rehabilitation
Facet joint steroid Presumed facet joint pain Fair No benefit D
injection
Artificial disc Single-level degenerative Fair No difference vs. fusion through 2 B (through 2 yr), I (long-term
replacement disc disease yr, unable to estimate for long- outcomes)
term outcomes
Botulinum toxin injection Nonspecific low back pain Poor Unable to estimate I
Local injections Nonspecific low back pain Poor Unable to estimate I
Epidural steroid injection Nonspecific low back pain Poor Unable to estimate I
Medial branch block Presumed facet joint pain Poor Unable to estimate I
(therapeutic)
Sacroiliac joint steroid Presumed sacroiliac joint Poor Unable to estimate I
injection pain
Radiofrequency Presumed facet joint pain Poor Unable to estimate I
denervation
Radiofrequency Presumed discogenic pain Poor Unable to estimate I
denervation
Intradiscal Presumed facet joint pain Poor Unable to estimate I
electrothermal therapy
Percutaneous intradiscal Presumed facet joint pain Poor Unable to estimate I
radiofrequency
thermocoagulation
(PIRFT)
Coblation nucleoplasty Presumed discogenic back No trials Unable to estimate I
pain
Spinal cord stimulation Nonspecific low back pain No trials Unable to estimate I
Intrathecal therapy Nonspecific low back pain No trials Unable to estimate I
*Please refer to Table 1 for explanation of grades.
Table 5. Level of Evidence and Summary Grades for Interdisciplinary Rehabilitation, Injections, Other Interventional
Therapies, and Surgery for Patients With Radiculopathy or Symptomatic Spinal Stenosis*
Intervention Condition Level of Evidence Net Benefit Grade
Open discectomy or microdiscectomy Radiculopathy with prolapsed Good Moderate for short-term (through 3 mo) B
lumbar disc outcomes only
Laminectomy with or without fusion Symptomatic spinal stenosis with Good Moderate through 1–2 yr B
or without degenerative
spondylolisthesis
Chemonucleolysis Radiculopathy with prolapsed Good Moderate vs. placebo, inferior vs. B
lumbar disc surgery
Epidural steroid injection Radiculopathy with prolapsed Fair Moderate for short-term (through 3 mo) B
lumbar disc outcomes only
Spinal cord stimulation Failed back surgery syndrome Fair Moderate B
with persistent radiculopathy
Interspinous spacer device One- to 2-level symptomatic Fair Moderate through 2 yr, unable to B
spinal stenosis relieved with estimate for long-term outcomes
forward flexion
Intradiscal steroid injection Radiculopathy with prolapsed Fair No effect vs. chemonucelolysis (no C
lumbar disc trials vs. placebo)
Epidural steroid injection Symptomatic spinal stenosis Poor Unable to estimate I
Radiofrequency denervation Radiculopathy Poor Unable to estimate I
Coblation nucleoplasty Radiculopathy with prolapsed No trials Unable to estimate I
lumbar disc
Spinal cord stimulation Radiculopathy with prolapsed No trials Unable to estimate I
lumbar disc
*Please refer to Table 1 for explanation of grades.1070 Spine • Volume 34 • Number 10 • 2009
communications. Although a two-third majority was required interpret in the absence of reliable reference standards
for a recommendation to be approved, unanimous agreement for identifying “true” facet joint pain (see glossary, supple-
was achieved on all recommendations except 1, 2, and 3; each mental Digital Content 1, http://links.lww.com/A840), sac-
had 1 panel member voting against. After approval of the rec- roiliac joint pain and radiculopathy. Although positive
ommendations, a guideline draft was written and distributed to
responses are less frequent with controlled rather than
the panel for feedback and revisions. Thirty-one external peer
reviewers were solicited for additional comments. After an-
uncontrolled facet joint and sacroiliac joint blocks,30,31
other round of revisions and panel approval, the guideline was it is not possible to determine whether this finding is due
submitted to the APS Executive Committee for approval. to fewer true- or false-positive cases. Some studies have
APS intends to update its clinical practice guidelines regu- evaluated the association between findings on invasive
larly. This guideline and the evidence report used to develop it diagnostic tests and surgical outcomes,32 but no studies
will be reviewed and updated by 2012. have investigated the effects of using facet joint, medial
branch, sacroiliac joint, or selective nerve root block to
Results
guide choice of therapy or how use of these tests affects
Recommendation 1 subsequent patient outcomes, compared with selecting
In patients with chronic nonradicular low back pain, pro- therapy without using the invasive diagnostic test.15
vocative discography is not recommended as a procedure
for diagnosing discogenic low back pain (strong recom- Recommendation 2
mendation, moderate-quality evidence). There is insuffi- In patients with nonradicular low back pain who do not
cient evidence to evaluate validity or utility of diagnostic respond to usual, noninterdisciplinary interventions, it is
selective nerve root block, intra-articular facet joint block, recommended that clinicians consider intensive interdis-
medial branch block, or sacroiliac joint block as diagnostic ciplinary rehabilitation with a cognitive/behavioral em-
procedures for low back pain with or without radiculopathy. phasis (strong recommendation, high-quality evidence).
Although many studies show strong correlation be- Chronic back pain is a complex condition that invol-
tween results of provocative discography (see glossary, ves biologic, psychological, and environmental fac-
Supplemental Digital Content 1, http://links.lww.com/A840) tors.10,11,33,34 For patients with persistent and disabling
and degenerative disc disease on imaging studies,18,19 back pain despite recommended noninterdisciplinary
diagnostic accuracy for identifying “discogenic” pain is therapies,6 clinicians should counsel patients about in-
uncertain. Degenerative disc disease is common in terdisciplinary rehabilitation (defined as an integrated
asymptomatic persons,20 and no reliable reference stan- intervention with rehabilitation plus a psychological
dard exists for distinguishing symptomatic from asymp- and/or social/occupational component) as a treatment
tomatic imaging findings. In addition, even though pos- option.
itive pain responses with provocative discography are For chronic low back pain, interdisciplinary rehabili-
unlikely in healthy, asymptomatic patients without back tation is moderately superior to noninterdisciplinary re-
pain,21 false-positive responses are common in persons habilitation or usual care for improving short- and long-
without significant back pain but with somatization, term (through up to 60 months) functional
other pain conditions, unresolved worker’s compensa- status.35–37 Interdisciplinary rehabilitation is also similar
tion claims, or previous back surgery,22–24 and can occur in effectiveness to fusion surgery (see glossary, Supple-
even after incorporating low pressure threshold crite- mental Digital Content 1, http://links.lww.com/A840),
ria.25 One study calculated a positive predictive value for for nonradicular low back pain.38 – 40 Interdisciplinary
provocative discography of 55% to 57%, though this rehabilitation is likely to be more effective in patients
estimate is based on critical assumptions regarding the who are more engaged and able to participate in it, as the
comparability of outcomes for different surgical proce- intensity and time commitment are substantial. Al-
dures for different underlying conditions in patients though the composition of interdisciplinary rehabilita-
without risk factors for poor surgical outcomes.26 There tion programs varies, the most effective programs gener-
is no evidence that use of provocative discography to ally involve cognitive/behavioral and supervised exercise
select patients for fusion improves clinical out- components with at least several sessions a week, with
comes.27,28 Discitis is the most serious complication fol- over 100 total hours of treatment.35,36 Barriers to use of
lowing provocative discography, but appears rare either intensive interdisciplinary rehabilitation include rela-
with or without prophylactic antibiotics (mean: 0.24% tively high cost, unavailability in some areas, and limited
based on number of patients and 0.09% based on num- insurance coverage. In workers disabled due to low back
ber of disc injections).29 One small study found that 20% pain, some studies suggest that costs of interdisciplinary
to 67% of patients previously without back pain but with rehabilitation may be offset by fewer lost wages or days
somatization or chronic pain at other sites reported persis- off of work.41– 43 Interdisciplinary rehabilitation may be
tent back pain 1 year after provocative discography.23 a treatment option for patients with persistent low back
No reliable data exist on the diagnostic accuracy or pain (see glossary, Supplemental Digital Content 1,
clinical utility of diagnostic facet joint, medial branch, http://links.lww.com/A840) following back surgery (i.e.,
sacroiliac joint, or selective nerve root blocks. Correla- “failed back surgery syndrome”), though evidence is
tion with imaging findings is variable and difficult to limited to a small number of observational studies thatLBP Guideline: Interventional, Surgical, Interdisciplinary • Chou et al 1071
show similar outcomes following interdisciplinary branch block and intrathecal therapy with opioids or other
therapy for chronic low back pain either with or with- medications).
out previous back surgery.44,45 Insufficient evidence
exists to guide recommendations for interdisciplinary Recommendation 4
rehabilitation for persistent radiculopathy or symp- In patients with nonradicular low back pain, common
tomatic spinal stenosis. degenerative spinal changes, and persistent and disabling
symptoms, it is recommended that clinicians discuss risks
and benefits of surgery as an option (weak recommenda-
Recommendation 3 tion, moderate-quality evidence). It is recommended that
In patients with persistent nonradicular low back pain, shared decision-making regarding surgery for nonspe-
facet joint corticosteroid injection, prolotherapy, and in- cific low back pain include a specific discussion about
tradiscal corticosteroid injection are not recommended intensive interdisciplinary rehabilitation as a similarly
(strong recommendation, moderate-quality evidence). effective option, the small to moderate average benefit
There is insufficient evidence to adequately evaluate ben- from surgery versus noninterdisciplinary nonsurgical
efits of local injections, botulinum toxin injection, epi- therapy, and the fact that the majority of such patients
dural steroid injection, intradiscal electrothermal ther- who undergo surgery do not experience an optimal out-
apy (IDET), therapeutic medial branch block, come (defined as minimum or no pain, discontinuation
radiofrequency denervation, sacroiliac joint steroid in- of or occasional pain medication use, and return of high-
jection, or intrathecal therapy with opioids or other med- level function).
ications for nonradicular low back pain. For persistent nonradicular low back pain with com-
Injections and most interventional therapies for non- mon degenerative changes (most frequently degenerative
radicular low back pain target specific areas of the back disc disease with presumed discogenic back pain), fusion
that are potential sources of pain, including the muscles surgery is superior to nonsurgical therapy without inter-
and soft tissues (botulinum toxin injection, prolother- disciplinary rehabilitation in 1 trial,65 but no more effec-
apy, and local injections [see glossary, Supplemental Dig- tive than intensive interdisciplinary rehabilitation in 3
ital Content 1, http://links.lww.com/A840]), facet joints trials38 – 40 (recommendation 2). Compared with nonin-
(facet joint steroid injection, therapeutic medial branch terdisciplinary, nonsurgical therapy, average benefits are
block, and radiofrequency denervation [see glossary, Sup- small for function (5–10 points on a 100-point scale) and
plemental Digital Content 1, http://links.lww.com/A840]), moderate for improvement in pain (10 –20 points on a
degenerated intervertebral discs (intradiscal steroid injec- 100-point scale).65 More than half of the patients who
tion, IDET, [see glossary, Supplemental Digital Content 1, undergo surgery do not experience an “excellent” or
http://links.lww.com/A840] and related procedures), and “good” outcome (defined as no more than sporadic pain,
sacroiliac joints (sacroiliac joint injection). Intrathecal ther- slight restriction of function, and occasional analge-
apy does not target a specific anatomic source of pain, but sics).65 Although operative deaths are uncommon, early
involves the delivery of medication (usually an opioid) di- complications occur in up to 18% of patients who un-
rectly into the intrathecal space. dergo fusion surgery in randomized trials.39,65 Instru-
There is no convincing evidence from randomized tri- mented fusion is associated with enhanced fusion rates
als that injections and other interventional therapies are compared with noninstrumented fusion, but insufficient
effective for nonradicular low back pain. Facet joint ste- evidence exists to determine whether instrumented fu-
roid injection,46,47 prolotherapy,48 and intradiscal ste- sion improves clinical outcomes, and additional costs are
roid injections49,50 are not recommended because ran- substantial.66,67 In addition, there is insufficient evidence
domized trials consistently found them to be no more to recommend a specific fusion method (anterior, pos-
effective than sham therapies. For local injections, there terolateral, or circumferential), though more technically
is insufficient evidence to accurately judge benefits be- difficult procedures may be associated with higher rates
cause available trials are small, lower-quality, and eval- of complications.65
uate heterogeneous populations and interventions.51–54 Decisions regarding surgery for persistent nonradicu-
Trials of IDET55,56 and radiofrequency denervation57– 60 lar pain should be based on a shared decision-making
reported inconsistent results between small numbers of process68 that includes a discussion about alternative
higher quality trials and (in the case of radiofrequency treatment options (including interdisciplinary rehabilita-
denervation) technical or methodologic shortcomings,61 tion if available), average benefits associated with sur-
making it difficult to reach conclusions about benefits. gery, potential harms, and costs. Appropriate patient se-
For other interventional therapies, data are limited to lection is also important, as benefits of fusion versus
either 1 small placebo-controlled trial randomized trial nonsurgical therapy have only been demonstrated in a
(botulinum toxin injection,62 epidural steroid injec- relatively narrow group of patients with at least moder-
tion for nonradicular low back pain,63 and sacroiliac ately severe pain or disability unresponsive to nonsurgi-
joint steroid injection [see glossary, Supplemental Digital cal therapies for at least 1 year and without serious psy-
Content 1, http://links.lww.com/A840]64), or there are no chiatric or medical comorbidities or other risk factors for
placebo-controlled randomized trials (therapeutic medial poor surgical outcomes.1072 Spine • Volume 34 • Number 10 • 2009
Recommendation 5 ing epidural steroid injection are rare in clinical tri-
In patients with nonradicular low back pain, common als,75,80,81,93,94 there are case reports of paralysis and
degenerative spinal changes, and persistent and disabling infections.95–97 There is insufficient evidence on clinical
symptoms, there is insufficient evidence to adequately eval- outcomes to recommend a specific approach for per-
uate long-term benefits and harms of vertebral disc replace- forming epidural steroid injection93,94,98 –100 or on use of
ment (insufficient evidence). fluoroscopic guidance. In addition, insufficient evidence
For persistent nonradicular low back pain, artificial exists to recommend how many epidural injections to
disc replacement (see glossary, Supplemental Digital perform, though 1 higher-quality trial found that if an
Content 1, http://links.lww.com/A840) with the initial epidural steroid injection did not result in benefits,
CHARITÉ artificial disc69 or Prodisc-II70 is associated additional injections over a 6-week period did not im-
with similar outcomes compared to fusion. However, prove outcomes.75
trial results are only applicable to a narrowly defined Decisions regarding use of epidural steroid injection
subset of patients with single level degenerative disc dis- should be based on a shared decision-making process
ease, and all trials have been funded by the manufacturer that includes a discussion of the inconsistent evidence for
of the relevant artificial disc. Furthermore, in the case of short-term benefit, lack of long-term benefit, potential
the CHARITÉ artificial disc, interpretation of results is risks, and costs. Patient preferences and individual factors
challenging because the type of fusion surgery evaluated should also be considered. For example, epidural steroid
is no longer widely used due to frequent poor out- injection may be a reasonable option for short-term pain
comes.71 relief in patients who are less optimal surgery candidates
Data on long-term (beyond 2 years) benefits and due to comorbidities. There is insufficient evidence to guide
harms following artificial disc replacement are limited. specific recommendations for timing of epidural steroid in-
Although a potential long-term advantage of artificial jection, though most trials enrolled patients with at least
disc replacement over fusion is preservation of spinal subacute (greater than 4 weeks) symptoms.
mobility, observational studies report cases of adjacent Evidence on efficacy of epidural steroid injection for spi-
level disc degeneration and facet joint arthritis, device- nal stenosis is sparse and shows no clear benefit, though
related complications such as migration and subsidence more trials are needed to clarify effects.84,88,101 Although
(settling or sinking into bone), and some patients subse- chymopapain chemonucleolysis (see glossary, Supplemen-
quently undergo fusion.72–74 tal Digital Content 1, http://links.lww.com/A840) is effec-
tive for radiculopathy due to herniated lumbar disc,102,103
Recommendation 6 it is less effective than discectomy (see glossary, Supplemen-
In patients with persistent radiculopathy due to herni- tal Digital Content 1, http://links.lww.com/A840) and is no
ated lumbar disc, it is recommended that clinicians dis- longer widely available in the United States, in part due to
cuss risks and benefits of epidural steroid injection as an risk of severe allergic reactions.
option (weak recommendation, moderate-quality evi-
dence). It is recommended that shared decision-making Recommendation 7
regarding epidural steroid injection include a specific dis- In patients with persistent and disabling radiculopathy
cussion about inconsistent evidence showing moderate due to herniated lumbar disc or persistent and disabling
short-term benefits, and lack of long-term benefits. There is leg pain due to spinal stenosis, it is recommended that
insufficient evidence to adequately evaluate benefits and clinicians discuss risks and benefits of surgery as an op-
harms of epidural steroid injection for spinal stenosis. tion (strong recommendation, high-quality evidence). It
For radiculopathy due to herniated lumbar disc, evi- is recommended that shared decision-making regarding
dence on benefits of epidural steroid injection is mixed. surgery include a specific discussion about moderate av-
Although some higher-quality trials75–78 found epidural erage benefits, which appear to decrease over time in
steroid injection associated with moderate short-term patients who undergo surgery.
(through up to 6 weeks) benefits in pain or function, For persistent and disabling radiculopathy due to her-
others79 – 81 found no differences versus placebo injec- niated lumbar disc, standard open discectomy and mi-
tion. Reasons for the discrepancies between trials is un- crodiscectomy are associated with moderate short-term
certain, but could be related to the type of comparator (through 6 to 12 weeks) benefits compared to nonsurgi-
treatment, as trials76,79 – 88 that compared an epidural cal therapy, though differences in outcomes in some trials
steroid injection to an epidural saline or local anesthetic are diminished or no longer present after 1 to 2 years.104–108
injection tended to report poorer results than tri- In addition, patients tend to improve substantially either
als75,77,78,89 –91 that compared an epidural steroid injec- with or without discectomy, and continued nonsurgical
tion to a soft-tissue (usually interspinous ligament) pla- therapy in patients who have had symptoms for at least 6
cebo injection. Regardless of the comparator weeks does not appear to increase risk for cauda equina
intervention, there is no convincing evidence that epi- syndrome or paralysis.108 Serious complications follow-
dural steroids are associated with long-term benefits and ing discectomy are uncommon. There is insufficient evi-
most trials75,78,79,92 found no reduction in rates of sub- dence to determine whether standard open discectomy or
sequent surgery. Although serious complications follow- microdiscectomy is associated with superior out-LBP Guideline: Interventional, Surgical, Interdisciplinary • Chou et al 1073
comes.109 –112 In addition, insufficient evidence exists to tion (see glossary, Supplemental Digital Content 1,
evaluate alternative surgical methods including laser- or http://links.lww.com/A840) is associated with moder-
endoscopic-assisted techniques, various percutaneous ate benefits compared with repeat surgery128 or contin-
techniques, Coblation nucleoplasty (see glossary, Supple- ued medical management.129 However, over one-quarter
mental Digital Content 1, http://links.lww.com/A840), or of patients experience complications following spinal
the Disc Decompressor.113–117 cord stimulator placement, including electrode migra-
For persistent and disabling leg pain due to spinal tion, infection or wound breakdown, generator pocket-
stenosis, either with or without degenerative spondylolis- related complications, and lead problems.128,129 No trial
thesis, decompressive laminectomy (see glossary, Supple- has compared spinal cord stimulation to intensive inter-
mental Digital Content 1, http://links.lww.com/A840) is disciplinary rehabilitation. Decisions regarding use of
associated with moderate benefits compared to nonsur- spinal cord stimulation should be based on a shared de-
gical therapy through 1 to 2 years, though effects appear cision-making approach that includes a discussion of po-
to diminish with long-term follow-up.118 –121 Although tential benefits, risk of complications, and costs. There is
patients on average do not worsen without surgery, im- insufficient evidence (no randomized trials) to guide rec-
provements are less than those observed in patients with ommendations on spinal cord stimulation for other types
radiculopathy due to herniated lumbar disc.120,121 There of failed back surgery syndrome or for low back pain (with
is insufficient evidence to determine if laminectomy or without leg pain) without previous surgery.130 –133 Pub-
with fusion is more effective than laminectomy with- lished case series of spinal cord stimulation for low back
out fusion. 66,67,122–124 Although an interspinous pain not related to previous back surgery provide very
spacer device (see glossary, Supplemental Digital Con- weak evidence because they used an uncontrolled study
tent 1, http://links.lww.com/A840) is more effective design and were of very low methodologic quality.131
than nonsurgical therapy for symptomatic spinal steno-
Discussion
sis, results are only applicable to patients with 1- or
2-level stenosis and symptoms relieved by forward flex- This guideline was developed by a multidisciplinary
ion, data on long-term (beyond 2 years) follow-up are panel of experts based on a systematic review of the
lacking, and all trials were funded by the manufacturer literature. The panel found sufficient evidence from ran-
of the device.125–127 Dural tears occur in around 10% of domized controlled trials to recommend that interdisci-
patients undergoing laminectomy, and neurologic inju- plinary rehabilitation, surgery, epidural steroid injec-
ries may occur in about 2.5%.119 –121 tion, and spinal cord stimulation be considered in certain
Decisions regarding surgery for radiculopathy due to clinical circumstances. Benefits are moderate, however,
herniated lumbar disc or leg pain due to spinal stenosis and often do not result in complete resolution of pain or
should be based on a shared decision-making approach functional limitations. These therapies are typically per-
that includes a discussion of moderate average benefits formed on an elective basis and decisions about their use
that diminish over time, likelihood of improvement ei- require consideration of important trade-offs between
ther with or without surgery, potential risks, and costs. potential benefits, harms, costs, and burdens of alterna-
Duration of symptoms should also be considered, as tri- tive therapies, both invasive and noninvasive. Treatment
als of surgery for radiculopathy due to herniated lumbar choices are likely to vary between individuals because
disc generally enrolled patients with at least 6 weeks of patients value such trade-offs differently. For example, a
symptoms, and trials of surgery for spinal stenosis en- patient with a herniated disc and lumbar radiculopathy
rolled patients with symptoms present for more than 6 who places a high priority on faster improvement of
months. symptoms is more likely to choose surgery. A patient
with similar symptoms who places a high value on avoid-
Recommendation 8 ing surgery is more likely to select nonsurgical therapy.
In patients with persistent and disabling radicular pain The use of some of the interventions recommended in
following surgery for herniated disc and no evidence of a this guideline may also be influenced by external factors.
persistently compressed nerve root, it is recommended For example, decisions regarding intensive interdiscipli-
that clinicians discuss risks and benefits of spinal cord nary rehabilitation are not only affected by patient pref-
stimulation as an option (weak recommendation, mod- erences regarding the substantial time commitment re-
erate-quality evidence). It is recommended that shared quired for this therapy, but also by factors such as its
decision-making regarding spinal cord stimulation in- limited availability and frequent noncovered status in the
clude a discussion about the high rate of complications United States.
following spinal cord stimulator placement. A shared decision-making approach is appropriate
Failed back surgery syndrome encompasses a broad when 2 or more medically reasonable choices exist, and is a
range of patients with persistent low back pain following key component of several of the recommendations in this
back surgery. In a more narrowly defined group of guideline.134 The goal of shared decision-making is to en-
patients with persistent radicular pain following sur- gage the patient as an active participant in the decision-
gery for herniated disc and no imaging evidence of a making process by providing clear information regarding
persistent compressed nerve root, spinal cord stimula- trade-offs and uncertainties, so that decisions are consistent1074 Spine • Volume 34 • Number 10 • 2009
with his or her preferences, values, and goals. Several rec- trials. Given the increasing use of invasive diagnostic
ommendations include specific guidance on minimum in- tests, interventional therapies, and surgery for low back
formation that the panel deemed necessary to enable pa- pain, more high-quality randomized trials are urgently
tients to make well-informed decisions. Use of formal needed to reduce uncertainties about the use of these
decision aids also could be helpful, as such tools have been interventions and improve the care of patients with low
shown to improve knowledge, make expectations more re- back pain.
alistic, enhance active participation in decision-making, de-
crease the proportion of people remaining undecided, and
improve agreement between values and choices.135 Formal Note
shared decision-making aids have been shown to decrease Clinical practice guidelines are “guides” only and may not
the proportion of patients who choose spine surgery with- apply to all patients and all clinical situations. As part of a
out adversely affecting clinical outcomes, but more studies shared decision-making approach, it may be appropriate
are needed to understand how to best implement shared for the clinician to inform a patient that a particular recom-
decision-making.136,137 mendation may not be applicable, after considering all cir-
The panel recommended against use of lumbar dis- cumstances pertinent to that individual.
cography, prolotherapy, intradiscal steroid injection,
and facet joint steroid injection. These interventions are
not shown by the best currently available evidence to Key Points
improve patient outcomes, though future research that
demonstrates benefits could change these recommenda- ● Provocative discography is not recommended
tions. For other interventions or specific clinical circum- because its diagnostic accuracy remains uncertain,
stances (e.g., epidural steroid injection for spinal steno- false-positives can occur in persons without low
sis), the panel found insufficient evidence from back pain, and its use has not been shown to im-
randomized controlled trials to reliably judge benefits or prove clinical outcomes.
harms. In such cases, the panel did not issue specific ● It is recommended that interdisciplinary rehabil-
recommendations. In general, clinicians should routinely itation be considered as a treatment option for per-
prioritize therapies supported by higher-quality evidence sistent, disabling low back pain that does not re-
over those supported by only weak evidence. Not offer- spond to usual, noninterdisciplinary therapies.
ing therapies supported by weak evidence is consistent ● For persistent nonradicular low back pain, facet
with the principle that clinicians should only recommend joint corticosteroid injection, prolotherapy, and in-
interventions with proven benefits. Clinicians who do tradiscal corticosteroid injection are not recom-
choose to use such interventions should reserve them for mended, and there is insufficient evidence to reliably
patients with at least moderately severe symptoms de- guide recommendations on use of other interven-
spite trials of alternative therapies supported by stronger tional therapies. A shared decision-making process
evidence. In such cases, patients always need to be clearly including a detailed discussion of risks, moderate av-
informed about the substantial uncertainties regarding erage benefits, and treatment alternatives is recom-
potential benefits and harms. mended to guide decisions regarding surgery.
Although numerous positive observational studies ● For radicular low back pain, a shared decision-
have been published on various interventional therapies making process including a detailed discussion of
and surgeries for low back pain, the panel did not base its risks and inconsistent evidence regarding short-term
recommendations on such evidence. Conclusions of ob- benefits is recommended to guide decisions regarding
servational studies can be very misleading for evaluating epidural steroid injection. A shared decision-making
benefits of therapy for low back pain due to important process is also recommended to guide decisions re-
placebo effects,138 –140 a strong psychologicical compo- garding surgery for spinal stenosis and prolapsed
nent in some patients, substantial confounding, and lumbar disc, though supporting evidence is stronger
fewer safeguards against bias compared with well- than for surgery for nonradicular low back pain.
conducted randomized trials.141 For example, a nonran- ● In patients with persistent pain following surgery
domized, controlled clinical trial142 of IDET for low for herniated disc, a shared decision-making pro-
back pain reported results that were substantially supe- cess including a detailed discussion of risks includ-
rior to results from subsequent randomized trials.55,56 ing frequent device-related complications and ben-
Moreover, most observational studies are uncontrolled efits is recommended to guide decisions regarding
case series (one of the weakest forms of evidence for spinal cord stimulation.
evaluating benefits), often with serious methodologic
shortcomings.131 Results from such studies are too un- Supplemental digital content is available for this arti-
reliable and difficult to interpret to serve as the primary cle. Direct URL citations appear in the printed text, and
basis of evidence-based recommendations, resolve im- links to the digital files are provided in the HTML text of
portant discrepancies between higher-quality random- this article on the journal’s Web site (www.spinejournal.
ized trials, or overturn results from negative randomized com).LBP Guideline: Interventional, Surgical, Interdisciplinary • Chou et al 1075
Acknowledgments “discogenic pain” diagnosis as determined by provocative discography.
Spine 2006;31:2115–23.
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manuscript.
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