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An evidence-based clinical guideline for the


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The Spine Journal 9 (2009) 609614

Review Article

An evidence-based clinical guideline for the diagnosis and treatment


of degenerative lumbar spondylolisthesisy
William C. Watters, III, MDa,*, Christopher M. Bono, MDb, Thomas J. Gilbert, MDc,
D. Scott Kreiner, MDd, Daniel J. Mazanec, MDe, William O. Shaffer, MDf, Jamie Baisden, MDg,
John E. Easa, MDh, Robert Fernand, MDi, Gary Ghiselli, MDj,
Michael H. Heggeness, MD, PhDk, Richard C. Mendel, MDl, Conor ONeill, MDm,
Charles A. Reitman, MDk, Daniel K. Resnick, MDn, Jeffrey T. Summers, MDo,
Reuben B. Timmons, MDp, John F. Toton, MDq
a
Bone & Joint Clinic of Houston, 6624 Fannin Street, Suite 2600, Houston, TX 77030-2338, USA
b
Department of Orthopaedic Surgery, Brigham & Womens Hospital, 75 Francis Street, Boston, MA 02115-6110, USA
c
Center for Diagnostic Imaging, 5775 Wayzata Boulevard, Suite 140, Saint Louis Park, MN 55416-2660, USA
d
Ahwatukee Sports & Spine, 4530 E. Muirwood Drive, Suite 110, Phoenix, AZ 85048-7639, USA
e
Cleveland Clinic Spine Institute, 9500 Euclid Avenue, Cleveland, OH 44195-0001, USA
f
University of Kentucky, 740 S. Limestone Street, Kentucky Clinic K-416, Lexington, KY 40536-0001, USA
g
Department of Neurosurgery, Medical College of Wisconsin, 9200 W. Wisconsin Avenue, Milwaukee, WI 53226-3522, USA
h
Michigan Medical, PC, 12662 Riley Street, Suite 120, Holland, MI 49424-8023, USA
i
North Jersey Medical Village, 516 Hamburg Turnpike, Wayne, NJ 07470-2062, USA
j
Denver Spine, 7800 E. Orchard Road, Suite 100, Greenwood Village, CO 80111-2584, USA
k
Orthopaedic Department, Baylor College of Medicine, 1709 Dryden Road, Suite 1230, Houston, TX 77030-2400, USA
l
122 Via Castilla, Jupiter, FL 33458-6919, USA
m
San Francisco Spine Diagnostics, 2100 Webster Street, Suite 110, San Francisco, CA 94115-2374, USA
n
Department of Neurosurgery, University of Wisconsin Medical School, 600 Highland, K4/834 Clinical Science Center, Madison, WI 53792-0001, USA
o
Mississippi Pain Management, One Layfair Drive, #400, Jackson, MS 39232-9717, USA
p
Comprehensive Pain Medicine, 510 Corday Street, Pensacola, FL 32503-2021, USA
q
1310 Prentice Drive, Suite G, Healdsburg, CA 95448-5005, USA
Received 11 August 2008; accepted 20 March 2009

Abstract BACKGROUND CONTEXT: The objective of the North American Spine Society (NASS)
evidence-based clinical guideline on the diagnosis and treatment of degenerative lumbar spondylo-
listhesis is to provide evidence-based recommendations on key clinical questions concerning the
diagnosis and treatment of degenerative lumbar spondylolisthesis. The guideline is intended to
address these questions based on the highest quality clinical literature available on this subject
as of January 2007. The goal of the guideline recommendations is to assist the practitioner in
delivering optimum, efficacious treatment of and functional recovery from this common disorder.

consultant for Abbott Spine; stockholder at Allez Spine and DiFusion;


y This review article summarizes a published evidence-based guide-
speaker and travel support from Stryker Spine; member of scientific advi-
line, and as such it followed an expedited peer-review process. It was eval-
sory board at DiFusion); MHH (royalties, stockholder, consultant, member
uated for format by the Special Features Editor and Editor-in-Chief before
of scientific advisory board at Relievant Medsystems; research support
being accepted for publication in The Spine Journal.
from Department of Defense); DSK (speaker and travel support from
FDA device/drug status: not applicable.
Smith & Nephew); CO (stockholder at Relievant and Nocimed; consultant
Author disclosures: WCW (consultant for Stryker; member of scien-
for SpineView, ISTO, and Alleva; member of scientific advisory board at
tific advisory board at Intrinsic Therapeutics; receives remuneration from
Relievant); DKR (consultant for medtronic); WOS (consultant for DePuy
Blackstone Medical, Inc.); CMB (receives royalties from Life Spine; con-
Spine; travel support from BrainLab; royalties from Depuy Spine).
sultant for Depuy Spine and Medtronic Sofamor Danek; speaker for Depuy
* Corresponding author. Bone & Joint Clinic, 6624 Fannin Street,
Spine and Stryker Spine; fellowship support from Depuy Spine; grant from
Suite 2600, Houston, TX 77030-2312, USA. Tel.: (713) 790-1818 ext
Stryker Spine; member of board of directors at North American Spine So-
120; fax: (713) 790-7530.
ciety; research support from Archus Orthopedics and Synthes Spine; re-
E-mail address: spinedoc@pdq.net (W.C. Watters)
ceives financial support from Applied Spine); GG (receives royalties and

1529-9430/09/$ see front matter 2009 Elsevier Inc. All rights reserved.
doi:10.1016/j.spinee.2009.03.016
610 W.C. Watters et al. / The Spine Journal 9 (2009) 609614

PURPOSE: To provide an evidence-based, educational tool to assist spine care providers in im-
proving the quality and efficiency of care delivered to patients with degenerative lumbar
spondylolisthesis.
STUDY DESIGN: Systematic review and evidence-based clinical guideline.
METHODS: This report is from the Degenerative Lumbar Spondylolisthesis Work Group of the
NASS Evidence-Based Clinical Guideline Development Committee. The work group was comprised
of multidisciplinary spine care specialists, all of whom were trained in the principles of evidence-
based analysis. Each member participated in the development of a series of clinical questions to be
addressed by the group. The final questions agreed on by the group are the subject of this report.
A literature search addressing each question and using a specific search protocol was performed on
English language references found in MEDLINE, EMBASE (Drugs and Pharmacology) and four ad-
ditional, evidence-based, databases. The relevant literature was then independently rated by at least
three reviewers using the NASS-adopted standardized levels of evidence. An evidentiary table was
created for each of the questions. Final grades of recommendation for the answer to each clinical ques-
tion were arrived at via face-to-face meetings among members of the work group using standardized
grades of recommendation. When Level IIV evidence was insufficient to support a recommendation
to answer a specific clinical question, expert consensus was arrived at by the work group through the
modified nominal group technique and is clearly identified as such in the guideline.
RESULTS: Nineteen clinical questions were formulated, addressing issues of prognosis, diagno-
sis, and treatment of degenerative lumbar spondylolisthesis. The answers to these 19 clinical
questions are summarized in this document. The respective recommendations were graded by the
strength of the supporting literature that was stratified by levels of evidence.
CONCLUSIONS: A clinical guideline for degenerative lumbar spondylolisthesis has been created
using the techniques of evidence-based medicine and using the best available evidence as a tool to
aid practitioners involved with the care of this condition. The entire guideline document, including
the evidentiary tables, suggestions for future research, and all references, is available electronically
at the NASS Web site (www.spine.org) and will remain updated on a timely schedule. 2009
Elsevier Inc. All rights reserved.
Keywords: Degenerative lumbar spondylolisthesis definition; Diagnosis; Imaging; Medical/interventional treatment;
Surgical treatment; Outcome measures

Introduction reformulated as recommendations that are assigned grades of


strength related to the soundness of the best evidence available
In an attempt to improve and evaluate the knowledge base
at the time of answering each question. The intent of the grade
concerning the diagnosis and treatment of degenerative lum-
of recommendation is to indicate the strength of the evidence
bar spondylolisthesis, the Degenerative Lumbar Spondylolis-
used by the work group in answering the question asked.
thesis Work Group of the North American Spine Society
(NASS) Evidence-Based Clinical Guideline Development
Committee has developed an evidence-based clinical guide-
Methods
line on degenerative lumbar spondylolisthesis. The Institute
of Medicine has defined a clinical guideline as systemati- For this clinical guideline, the guideline development
cally developed statements to assist practitioner and patient process was broken down into 12 steps. In Step #1, guide-
decisions about health care for specific clinical situations [1]. line participants, trained in the principles of EBM, submit-
The application of the principles of evidence-based ted a list of clinical questions focused on diagnosis and
medicine (EBM) to guideline development helps create an ex- treatment of degenerative lumbar spondylolisthesis that
plicit linkage between the final recommendations in the guide- the guideline should address. In Step #2 multidisciplinary
line and the evidence on which these recommendations are teams composed of surgical, medical, interventional, and
based [2]. When using the principles of EBM, the clinical lit- radiologic specialists were assigned to groups, each of
erature is extensively searched to answer specific questions which was assigned a subset of the questions to be an-
about a disease state or medical condition. The literature that swered. Step #3 consisted of each group identifying appro-
is identified in the search is then rated as to its scientific merit priate search terms and parameters to direct the literature
using levels of evidence, determined by specific rule sets that search according to the NASS-instituted Literature Search
apply to human, clinical investigations. The specific questions Protocol. The literature search was then completed in Step
asked are then answered using studies of the highest possible #4 by a medical research librarian according to the NASS
levels of evidence that have been obtained from the searches. Literature Search Protocol and stored in a cross referencing
As a final step, the answers to the clinical questions are database for future use or reference. The following
W.C. Watters et al. / The Spine Journal 9 (2009) 609614 611

electronic databases were searched for English language In Step #11, the recommendations will be submitted to the
publications: MEDLINE (PubMed), EMBASE (Drugs and American Medical Association-convened Physician Consor-
Pharmacology), ACP Journal Club, Cochrane Database of tium for Performance Improvement, a multispecialty collab-
Systematic reviews, Database of Abstracts of Reviews of orative group engaged in the development of evidence-based
Effectiveness and Cochrane Central Register performance measures. In Step #12, the guideline recom-
of Controlled Trials. Work group members then reviewed mendations will be reviewed every 3 years and the literature
all abstracts from the literature search in Step #5. The best base updated by an EBM-trained multidisciplinary team with
research evidence available was identified and used to revisions to the recommendations developed in the same
answer the targeted clinical questions. That is, if adequate manner as in the original guideline development.
Level I, Level II, or Level III studies were available to
answer a specific question, the work group was not required
Results
to review Level IV or Level V studies. In Step #6, the
members independently developed evidentiary tables sum- Definition and natural history
marizing study conclusions, identifying strengths and
weaknesses, and assigning levels of evidence. To systemat- Question #1: What is the best working definition
ically control for bias, at least three work group members of degenerative lumbar spondylolisthesis?
reviewed each article selected and independently assigned An acquired anterior displacement of one vertebra over
a level of evidence per the NASS Levels of Evidence table. the subjacent vertebra, associated with degenerative
The final level of evidence assigned was that agreed on by changes, without an associated disruption or defect in the
at least two-thirds of the reviewers. vertebral ring.
To formulate evidence-based recommendations and Work Group Consensus Statement
incorporate expert opinion when necessary, work groups Question #2: What is the natural history of degener-
participated in webcasts in Step #7. Expert opinion was in- ative lumbar spondylolisthesis?
corporated only where Level IIV evidence was insufficient Most of the patients with symptomatic degenerative lum-
and the work groups deemed that a recommendation was bar spondylolisthesis and an absence of neurologic deficits
warranted. For transparency in the incorporation of consen- will do well with conservative care. Patients who present with
sus, all consensus-based recommendations in this guideline sensory changes, muscle weakness, or cauda equina syn-
are clearly stated as such. Voting on guideline recommen- drome, are more likely to develop progressive functional de-
dations was conducted using a modification of the nominal cline without surgery. Progression of slip correlates with jobs
group technique in which each work group member inde- that require repetitive anterior flexion of the spine. Slip pro-
pendently and anonymously ranked a recommendation on gression is less likely to occur when the disc has lost over
a scale ranging from 1 (extremely inappropriate) to 9 80% of its native height and when intervertebral osteophytes
(extremely appropriate) [3]. Consensus was obtained have formed. Progression of clinical symptoms does not cor-
when at least 80% of work group members ranked the rec- relate with progression of the slip [48].
ommendation as 7, 8, or 9. When the 80% threshold was Work Group Consensus Statement
not attained, up to three rounds of discussion and voting
Diagnosis and imaging
were held to resolve disagreements. If disagreements were
not resolved after these rounds no recommendation was Question #3: What are the most appropriate histori-
adopted. When the recommendations were established, cal and physical examination findings consistent with
work group members developed guideline content, refer- the diagnosis of degenerative lumbar spondylolisthesis?
encing the literature that supported the recommendations. Obtaining an accurate history and physical examination is
In Step #8, the completed guideline was submitted to the essential to the formulation of the appropriate clinical ques-
NASS Evidence-Based Guideline Development Commit- tions to guide the physician in developing a plan for the treat-
tee, the NASS Clinical Care Council Director, and an ment of patients with degenerative lumbar spondylolisthesis.
Advisory Panel for review and comment. The Advisory Work Group Consensus Statement
Panel consisted of members from societies of physical In older patients presenting with radiculopathy and
medicine/rehabilitation, pain medicine/management, ortho- neurogenic intermittent claudication, with or without back
pedic surgery, neurosurgery, anesthesiology, rheumatology, pain, a diagnosis of degenerative lumbar spondylolisthesis
psychology/psychiatry, and family practice. Revisions to should be considered [6,912].
recommendations were considered only when substantiated Grade of Recommendation: B
by a preponderance of appropriate levels of evidence. Once Question #4: What are the most appropriate diagnos-
evidence-based revisions were incorporated, the guideline tic tests for degenerative lumbar spondylolisthesis?
was submitted to the NASS Board of Directors for review The most appropriate, noninvasive test for detecting
and approval in Step #9. In Step #10, the NASS Board- degenerative lumbar spondylolisthesis is the lateral radio-
approved guidelines were submitted for inclusion in the graph [911,13,14].
National Guidelines Clearinghouse. Grade of Recommendation: B
612 W.C. Watters et al. / The Spine Journal 9 (2009) 609614

The most appropriate, noninvasive test for imaging the Question #11: What is the role of ancillary treat-
stenosis accompanying degenerative lumbar spondylolis- ments, such as bracing, traction, electrical stimulation,
thesis is the magnetic resonance imaging (MRI) [15]. and transcutaneous electrical stimulation in the treat-
Work Group Consensus Statement ment of degenerative lumbar spondylolisthesis?
Plain myelography or computed tomography (CT) Question #12: What is the long-term result of medi-
myelography are useful studies to assess spinal stenosis cal/interventional management of degenerative lumbar
in patients with degenerative lumbar spondylolisthesis spondylolisthesis?
[912,16]. A systematic review of the literature yielded no studies
Grade of Recommendation: B to adequately address any of the medical/interventional
CT is a useful noninvasive study in patients who have treatment questions posed above.
a contraindication to MRI, for whom MRI findings are in- Medical/interventional treatment for degenerative lumbar
conclusive or for whom there is a poor correlation between spondylolisthesis, when the radicular symptoms of stenosis
symptoms and MRI findings, and in whom CT myelogram predominate, most logically should be similar to treatment
is deemed inappropriate [15,17]. for symptomatic degenerative lumbar spinal stenosis [15].
Work Group Consensus Statement Work Group Consensus Statement

Surgical treatment
Outcome measures for medical/interventional and
surgical treatment Question #13: Do surgical treatments improve out-
comes in the treatment of degenerative lumbar spondy-
Question #5: What are the appropriate outcome
lolisthesis compared with the natural history of the
measures for the treatment of degenerative lumbar
disease?
spondylolisthesis?
Surgery is recommended for treatment of patients with
The Zurich Claudication Questionnaire/Swiss Spinal
symptomatic spinal stenosis associated with low-grade de-
Stenosis Questionnaire, Oswestry Disability Index, Likert
generative spondylolisthesis whose symptoms have been
Five-Point Pain Scale, and 36-Item Short Form Health
recalcitrant to a trial of medical/interventional treatment
Survey are appropriate measures for assessing treatment
[18,26].
of degenerative lumbar spondylolisthesis [1826].
Grade of Recommendation: B
Grade of Recommendation: A
Question #14: Does surgical decompression alone
The Japanese Orthopedic Association Score and the cal-
improve surgical outcomes in the treatment of degener-
culated recovery rate may be useful in assessing outcome in
ative lumbar spondylolisthesis compared with medical/
degenerative lumbar spondylolisthesis [27,28].
interventional treatment alone or the natural history
Grade of Recommendation: B
of the disease?
The Shuttle Walking Test, Oxford Claudication Score,
Direct surgical decompression is recommended for treat-
Low Back Pain Bothersome Index, and Stenosis Bother-
ment of patients with symptomatic spinal stenosis associated
some Index are potential outcome measures in studying de-
with low-grade degenerative lumbar spondylolisthesis
generative lumbar spondylolisthesis [23,26].
whose symptoms have been recalcitrant to a trial of medi-
Grade of Recommendation: I (insufficient evidence)
cal/interventional treatment [29].
Grade of Recommendation: I (insufficient evidence)
Medical/interventional treatment Indirect surgical decompression is recommended for
treatment of patients with symptomatic spinal stenosis as-
Question #6: Do medical/interventional treatments sociated with low-grade degenerative lumbar spondylolis-
improve outcomes in the treatment of degenerative thesis whose symptoms have been recalcitrant to a trial of
lumbar spondylolisthesis compared with the natural medical/interventional treatment [18].
history of the disease? Grade of Recommendation: I (insufficient evidence)
Question #7: What is the role of pharmacologic Question #15: Does the addition of lumbar fusion,
treatment in the management of degenerative lumbar with or without instrumentation, to surgical decompres-
spondylolisthesis? sion improve surgical outcomes in the treatment of
Question #8: What is the role of physical therapy/ degenerative lumbar spondylolisthesis compared with
exercise in the treatment of degenerative lumbar treatment by decompression alone?
spondylolisthesis? Surgical decompression with fusion is recommended for
Question #9: What is the role of manipulation in the the treatment of patients with symptomatic spinal stenosis
treatment of degenerative lumbar spondylolisthesis? and degenerative lumbar spondylolisthesis to improve
Question #10: What is the role of epidural steroid clinical outcomes compared with decompression alone
injections for the treatment of degenerative lumbar [8,2932].
spondylolisthesis? Grade of Recommendation: B
W.C. Watters et al. / The Spine Journal 9 (2009) 609614 613

Question #16: Does the addition of instrumentation diagnosis and treatment of degenerative lumbar spondylo-
to decompression and fusion for degenerative lumbar listhesis. High-quality clinical guidelines ideally identify
spondylolisthesis improve surgical outcomes compared and suggest future research topics to improve guideline de-
with decompression and fusion alone? velopment and thus patient care, as detailed in the current
The addition of instrumentation is recommended to guideline. The NASS Web site, www.spine.org, contains
improve fusion rates in patients with symptomatic spinal the complete clinical guideline summarized in this article,
stenosis and degenerative lumbar spondylolisthesis along with extensive descriptive narratives on each topic
[8,30,3235]. outlining the evidence and the work group rationale for
Grade of Recommendation: B the answers to each question. In addition, more extensive
The addition of instrumentation is not recommended to descriptions are provided of the guideline development
improve clinical outcomes for the treatment of patients with process used at NASS, along with all of the references used
symptomatic spinal stenosis and degenerative lumbar spon- in this guideline and suggestions for future research studies
dylolisthesis [8,30,3235]. on the diagnosis and treatment of degenerative lumbar
Grade of Recommendation: B spondylolisthesis. The core clinical guideline on the Web
Question #17: How do outcomes of decompression site is intended to be a living document with periodic

with posterolateral fusion compare with those for 360 updates of the literature and recommendations.
fusion in the treatment of degenerative lumbar
spondylolisthesis?
Because of the paucity of literature addressing this ques- References
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