Guideline:
Diagnosis and treatment of degenerative lumbar spondylolisthesis
Bibliographic Source(s)
- North American Spine Society (NASS). Diagnosis and treatment of degenerative lumbar spondylolisthesis. Burr Ridge (IL): North American Spine Society (NASS); 2008. 133 p. [191 references]
Guideline Status
This is the current release of the guideline.
Guideline Category
Assessment of Therapeutic Effectiveness
Diagnosis
Evaluation
Management
Treatment
Intended Users
Allied Health Personnel
Health Care Providers
Physician Assistants
Physicians
Guideline Objective(s)
- To provide a tool that assists practitioners in improving the quality and efficiency of care delivered to patients with degenerative lumbar spondylolisthesis
- To provide evidence-based recommendations to address key clinical questions surrounding the diagnosis and treatment of degenerative lumbar spondylolisthesis
- To reflect contemporary treatment concepts for symptomatic degenerative lumbar spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of June 2007
Target Population
Adults (18 years or older) with a chief complaint of low back pain and/or lower extremity symptoms related to spinal stenosis
Interventions and Practices Considered
Diagnosis
- History and physical examination
- Imaging studies
- Lateral radiograph
- Magnetic resonance imaging (MRI)
- Plain and computed tomography (CT) myelography
- Computed tomography (CT) scan
- Outcome tools
- Zurich Claudication Questionnaire (ZCQ)/Swiss Spinal Stenosis Questionnaire (SSS) Oswestry Disability Index (ODI) Likert Five-Point Pain Scale and 36-Item Short Form Health Survey
- Japanese Orthopedic Association (JOA) Score and the calculated Recovery Rate
- Shuttle Walking Test (SWT) Oxford Claudication Score (OCS) Low Back Pain Bothersome Index and the Stenosis Bothersome Index)
Treatment
- Medical and interventional treatments
- Surgical Treatments
- Direct surgical decompression
- Indirect surgical decompression
- Surgical decompression with fusion
- Instrumentation in addition to decompression and fusion
Major Outcomes Considered
- Sensitivity and specificity of diagnostic tests
- Quality of life
- Symptom relief
- Patient satisfaction
- Complication rates
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Identification of Clinical Questions
Trained guideline participants were asked to submit a list of clinical questions that the guideline should address. The lists were compiled into a master list which was then circulated to each member with a request that they independently rank the questions in order of importance for consideration in the guideline. The most highly ranked questions as determined by the participants served to focus the guideline.
Identification of Search Terms and Parameters
One of the most crucial elements of evidence analysis to support development of recommendations for appropriate clinical care is the comprehensive literature search. Thorough assessment of the literature is the basis for the review of existing evidence and the formulation of evidence-based recommendations. In order to ensure a thorough literature search North American Spine Society (NASS) has instituted a Literature Search Protocol (Appendix D in the original guideline document) which has been followed to identify literature for evaluation in guideline development. In keeping with the Literature Search Protocol work group members have identified appropriate search terms and parameters to direct the literature search.
Specific search strategies including search terms parameters and databases searched are documented in the appendices (See Appendix E in the original guideline document).
Completion of the Literature Search
Once each work group identified search terms/parameters the literature search was implemented by a medical/research librarian consistent with the Literature Search Protocol.
Following these protocols ensures that NASS recommendations (1) are based on a thorough review of relevant literature; (2) are truly based on a uniform comprehensive search strategy; and (3) represent the current best research evidence available. NASS maintains a search history for future use or reference.
Review of Search Results/Identification of Literature to Review
Work group members reviewed all abstracts yielded from the literature search and identified the literature they will review in order to address the clinical questions in accordance with the Literature Search Protocol. Members have identified the best research evidence available to answer the targeted clinical questions. That is if Level I II and or III literature is available to answer specific questions the work group was not required to review Level IV or V studies.
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Subjective Review
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Levels of Evidence for Primary Research Question1
| Types of Studies | ||||
|---|---|---|---|---|
| Therapeutic Studies – Investigating the results of treatment | Prognostic Studies – Investigating the effect of a patient characteristic on the outcome of disease | Diagnostic Studies – Investigating a diagnostic test | Economic and Decision Analyses – Developing an economic or decision model | |
| Level I |
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| Level II |
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| Level III |
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| Level IV | Case Series8 | Case Series |
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| Level V | Expert Opinion | Expert Opinion | Expert Opinion | Expert Opinion |
RCT = randomized controlled trial
1 A complete assessment of quality of individual studies requires critical appraisal of all aspects of the study design.
2 A combination of results from two or more prior studies.
3 Studies provided consistent results.
4 Study was started before the first patient enrolled.
5 Patients treated one way (e.g. cemented hip arthroplasty) compared with a group of patients treated in another way (e.g. uncemented hip arthroplasty) at the same institution.
6 The study was started after the first patient enrolled.
7 Patients identified for the study based on their outcome called "cases" (e.g. failed total arthroplasty) are compared to those who did not have outcome called "controls" (e.g. successful total hip arthroplasty).
8 Patients treated one way with no comparison group of patients treated in another way.
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Evidence Analysis
Members have independently developed evidentiary tables summarizing study conclusions identifying strengths and weaknesses and assigning levels of evidence. In order to systematically control for potential biases at least two work group members have reviewed each article selected and independently assigned levels of evidence to the literature using the North American Spine Society (NASS) levels of evidence. Any discrepancies in scoring have been addressed by two or more reviewers. The consensus level (the level upon which two-thirds of reviewers were in agreement) was then assigned to the article.
As a final step in the evidence analysis process members have identified and documented gaps in the evidence to educate guideline readers about where evidence is lacking and help guide further needed research by NASS and other societies.
Methods Used to Formulate the Recommendations
Expert Consensus (Nominal Group Technique)
Description of Methods Used to Formulate the Recommendations
Identification of Work Groups
Multidisciplinary teams were assigned to work groups and assigned specific clinical questions to address. Because North American Spine Society (NASS) is comprised of surgical medical and interventional specialists it is imperative to the guideline development process that a cross-section of NASS membership is represented on each group. This also helps to ensure that the potential for inadvertent biases in evaluating the literature and formulating recommendations is minimized.
Formulation of Evidence-Based Recommendations and Incorporation of Expert Consensus
Work groups held face-to-face meetings to discuss the evidence-based answers to the clinical questions the grades of recommendations and the incorporation of expert consensus. Expert consensus has been incorporated only where Level I-IV evidence is insufficient and the work group has deemed that a recommendation is warranted. Transparency in the incorporation of consensus is crucial and all consensus-based recommendations made in this guideline very clearly indicate that Level I-IV evidence is insufficient to support a recommendation and that the recommendation is based only on expert consensus.
Consensus Development Process
Voting on guideline recommendations was conducted using a modification of the nominal group technique in which each work group member independently and anonymously ranked a recommendation on a scale ranging from 1 ("extremely inappropriate") to 9 ("extremely appropriate").
Consensus was obtained when at least 80% of work group members ranked the recommendation as 7 8 or 9. When the 80% threshold was not attained up to three rounds of discussion and voting were held to resolve disagreements. If disagreements were not resolved after these rounds no recommendation was adopted.
After the recommendations were established work group members developed the guideline content addressing the literature which supports the recommendations.
Rating Scheme for the Strength of the Recommendations
Grades of Recommendation for Summaries or Reviews of Studies
A. Good evidence (Level I Studies with consistent finding) for or against recommending intervention.
B. Fair evidence (Level II or III Studies with consistent findings) for or against recommending intervention.
C. Poor quality evidence (Level IV or V Studies) for or against recommending intervention.
I. Insufficient or conflicting evidence not allowing a recommendation for or against intervention.
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
Submission of the Draft Guidelines for Review/Comment
Guidelines were submitted to the full Evidence- Based Guideline Development Committee the Clinical Care Council Director and the Advisory Panel for review and comment. The Advisory Panel is comprised of representatives from physical medicine and rehab pain medicine/management orthopedic surgery neurosurgery anesthesiology rheumatology psychology/psychiatry and family practice. Revisions to recommendations were considered for incorporation only when substantiated by a preponderance of appropriate level evidence.
Submission for Board Approval
Once any evidence-based revisions were incorporated the drafts were prepared for North American Spine Society (NASS) Board review and approval. Edits and revisions to recommendations and any other content were considered for incorporation only when substantiated by a preponderance of appropriate level evidence.
Major Recommendations
The grades of recommendations (A-C I) and levels of evidence (I-V) are defined at the end of the Major Recommendations field.
Recommendations for Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis
- Diagnosis and Imaging
What are the most appropriate historical and physical examination findings consistent with the diagnosis of degenerative lumbar spondylolisthesis?
Obtaining an accurate history and physical examination is essential to the formulation of the appropriate clinical questions to guide the physician in developing a plan for the treatment of patients with degenerative lumbar spondylolisthesis.
In older patients presenting with radiculopathy and neurogenic intermittent claudication with or without back pain a diagnosis of degenerative lumbar spondylolisthesis should be considered.
Grade of Recommendation: B
Diagnosing Spondylolisthesis with Imaging
What are the most appropriate diagnostic tests for degenerative lumbar spondylolisthesis?
The most appropriate noninvasive test for detecting degenerative lumbar spondylolisthesis is the lateral radiograph.
Grade of Recommendation: B
The most appropriate noninvasive test for imaging the stenosis accompanying degenerative lumbar spondylolisthesis is the magnetic resonance imaging (MRI).
Plain myelography or computed tomography (CT) myelography are useful studies to assess spinal stenosis in patients with degenerative lumbar spondylolisthesis.
Grade of Recommendation: B
CT is a useful noninvasive study in patients who have a contraindication to MRI for whom MRI findings are inconclusive or for whom there is a poor correlation between symptoms and MRI findings and in whom CT myelogram is deemed inappropriate.
- Outcome Measures for Medical/Interventional and Surgical Treatment
What are the appropriate outcome measures for the treatment of degenerative lumbar spondylolisthesis?
The Zurich Claudication Questionnaire (ZCQ)/Swiss Spinal Stenosis Questionnaire (SSS) Oswestry Disability Index (ODI) Likert Five-Point Pain Scale and 36-Item Short Form Health Survey (SF-36) are appropriate measures for assessing treatment of degenerative lumbar spondylolisthesis.
Grade of Recommendation: A
Note: The Zurich Claudication Questionnaire (ZCQ) represents an evolution of Swiss Spinal Stenosis Questionnaire (SSS). Conclusions made about either questionnaire have a high likelihood of being applicable to the other.
The Japanese Orthopedic Association (JOA) Score and the calculated Recovery Rate may be useful in assessing outcome in degenerative lumbar spondylolisthesis.
Grade of Recommendation: B
The Shuttle Walking Test (SWT) Oxford Claudication Score (OCS) Low Back Pain Bothersome Index and Stenosis Bothersome Index are potential outcome measures in studying degenerative lumbar spondylolisthesis.
Grade of Recommendation: I (Insufficient Evidence)
- Medical and Interventional Treatment
Medical/interventional treatment for degenerative lumbar spondylolisthesis when the radicular symptoms of stenosis predominate most logically should be similar to treatment for symptomatic degenerative lumbar spinal stenosis.
- Surgical Treatment
Do surgical treatments improve outcomes in the treatment of degenerative lumbar spondylolisthesis compared to the natural history of the disease?
Surgery is recommended for treatment of patients with symptomatic spinal stenosis associated with low grade degenerative spondylolisthesis whose symptoms have been recalcitrant to a trial of medical/interventional treatment.
Grade of Recommendation: B
Does surgical decompression alone improve surgical outcomes in the treatment of degenerative lumbar spondylolisthesis compared to medical/interventional treatment alone or the natural history of the disease?
Direct surgical decompression is recommended for treatment of patients with symptomatic spinal stenosis associated with low grade degenerative lumbar spondylolisthesis whose symptoms have been recalcitrant to a trial of medical/interventional treatment.
Grade of Recommendation: I (Insufficient Evidence)
Indirect surgical decompression is recommended for treatment of patients with symptomatic spinal stenosis associated with low grade degenerative lumbar spondylolisthesis whose symptoms have been recalcitrant to a trial of medical/interventional treatment.
Grade of Recommendation: I (Insufficient Evidence)
Does the addition of lumbar fusion with or without instrumentation to surgical decompression improve surgical outcomes in the treatment of degenerative lumbar spondylolisthesis compared to treatment by decompression alone?
Surgical decompression with fusion is recommended for the treatment of patients with symptomatic spinal stenosis and degenerative lumbar spondylolisthesis to improve clinical outcomes compared with decompression alone.
Grade of Recommendation: B
Does the addition of instrumentation to decompression and fusion for degenerative lumbar spondylolisthesis improve surgical outcomes compared with decompression and fusion alone?
The addition of instrumentation is recommended to improve fusion rates in patients with symptomatic spinal stenosis and degenerative lumbar spondylolisthesis.
Grade of Recommendation: B
The addition of instrumentation is not recommended to improve clinical outcomes for the treatment of patients with symptomatic spinal stenosis and degenerative lumbar spondylolisthesis.
Grade of Recommendation: B
How do outcomes of decompression with posterolateral fusion compare with those for 360° fusion in the treatment of degenerative lumbar spondylolisthesis?
Because of the paucity of literature addressing this question the work group was unable to generate a recommendation to answer this question.
What is the role of reduction (deliberate attempt to reduce via surgical technique) with fusion in the treatment of degenerative lumbar spondylolisthesis?
Reduction with fusion and internal fixation of patients with low grade degenerative lumbar spondylolisthesis is not recommended to improve clinical outcomes.
Grade of Recommendation: I (Insufficient Evidence)
What is the long-term result (four+ years) of surgical management of degenerative lumbar spondylolisthesis?
Decompression and fusion is recommended as a means to provide satisfactory long-term results for the treatment of patients with symptomatic spinal stenosis and degenerative lumbar spondylolisthesis.
Grade of Recommendation: C
Definitions:
Grades of Recommendation for Summaries or Reviews of Studies
A. Good evidence (Level I Studies with consistent finding) for or against recommending intervention.
B. Fair evidence (Level II or III Studies with consistent findings) for or against recommending intervention.
C. Poor quality evidence (Level IV or V Studies) for or against recommending intervention.
I. Insufficient or conflicting evidence not allowing a recommendation for or against intervention.
Levels of Evidence for Primary Research Question1
| Types of Studies | ||||
|---|---|---|---|---|
| Therapeutic Studies – Investigating the results of treatment | Prognostic Studies – Investigating the effect of a patient characteristic on the outcome of disease | Diagnostic Studies – Investigating a diagnostic test | Economic and Decision Analyses – Developing an economic or decision model | |
| Level I |
|
|
|
|
| Level II |
|
|
|
|
| Level III |
|
|
|
|
| Level IV | Case Series8 | Case Series |
|
|
| Level V | Expert Opinion | Expert Opinion | Expert Opinion | Expert Opinion |
RCT = randomized controlled trial
1 A complete assessment of quality of individual studies requires critical appraisal of all aspects of the study design.
2 A combination of results from two or more prior studies.
3 Studies provided consistent results.
4 Study was started before the first patient enrolled.
5 Patients treated one way (e.g. cemented hip arthroplasty) compared with a group of patients treated in another way (e.g. uncemented hip arthroplasty) at the same institution.
6 The study was started after the first patient enrolled.
7 Patients identified for the study based on their outcome called "cases" (e.g. failed total arthroplasty) are compared to those who did not have outcome called "controls" (e.g. successful total hip arthroplasty).
8 Patients treated one way with no comparison group of patients treated in another way.
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified and graded for most of the recommendations (see "Major Recommendations" field).
Potential Benefits
Accurate diagnosis and effective treatment of degenerative lumbar spondylolisthesis
Potential Harms
- Although reduction and fusion can be performed it may increase the risk of neurological complications.
- Bilateral foraminotomies with reduction and instrumented fusion has a 7% major complication rate.
Qualifying Statements
- This guideline does not represent a "standard of care" nor is it intended as a fixed treatment protocol. It is anticipated that there will be patients who will require less or more treatment than the average. It is also acknowledged that in atypical cases treatment falling outside this guideline will sometimes be necessary. This guideline should not be seen as prescribing the type frequency or duration of intervention. Treatment should be based on the individual patient's need and physician's professional judgment. This document is designed to function as a guideline and should not be used as the sole reason for denial of treatment and services. This guideline is not intended to expand or restrict a health care provider's scope of practice or to supersede applicable ethical standards or provisions of law.
- The clinical guideline should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution.
Description of Implementation Strategy
The recommendations will be reviewed by a group experienced in performance measure development (e.g. the AMA Physician's Consortium for Performance Improvement) to identify those recommendations rigorous enough for measure development.
This guideline will be pilot tested among spine care specialists and primary care physicians for one year following publication. Findings of the pilot test will be considered to inform future guideline development.
IOM Care Need
Getting Better
Living with Illness
IOM Domain
Effectiveness
Bibliographic Source(s)
- North American Spine Society (NASS). Diagnosis and treatment of degenerative lumbar spondylolisthesis. Burr Ridge (IL): North American Spine Society (NASS); 2008. 133 p. [191 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
North American Spine Society (NASS)
Guideline Committee
North American Spine Society (NASS) Evidence-Based Guideline Development Committee
Composition of Group that Authored the Guideline
Committee Members: William C. Watters III MD Committee Chair; Christopher Bono MD Surgical Treatment Chair; Thomas Gilbert MD Diagnosis/Imaging Chair; D. Scott Kreiner MD Natural History Chair; Daniel Mazanec MD Medical/Interventional Treatment Chair; William O. Shaffer MD Outcome Measures Chair; Jamie Baisden MD; John Easa MD; Robert Fernand MD; Gary Ghiselli MD; Michael Heggeness MD PhD; Richard Mendel MD; Conor O'Neill MD; Charles Reitman MD; Daniel Resnick MD; Jeffrey Summers MD; Reuben Timmons MD; John Toton MD
Financial Disclosures/Conflicts of Interest
All participants involved in guideline development have disclosed potential conflicts of interest to their colleagues and their potential conflicts have been documented for future reference. They will not be published in any guideline but kept on file at North American Spine Society (NASS) for reference if needed. Participants have been asked to update their disclosures regularly throughout the guideline development process.
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available in Portable Document Format (PDF) from the North American Spine Society (NASS) Web site.
Print copies: Available from the North American Spine Society (NASS) 7075 Veterans Boulevard Burr Ridge IL 60527; Toll-free: (866) 960-6277. An order form is available from the North American Spine Society Web site.
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI Institute on September 5 2008. The information was verified by the guideline developer on September 8 2008.
COPYRIGHT STATEMENT
Full-text guidelines can only be acquired through the North American Spine Society (NASS). Questions regarding use and reproduction should be directed to NASS attention Belinda Duszynski Research Manager.
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Details
FDA Warning
- Category:
- Anesthesiology, Chiropractic, Family Practice, Internal Medicine, Neurological Surgery, Neurology, Orthopedic Surgery, Physical Medicine and Rehabilitation, Psychology, Radiology, Rheumatology
- Conditions:
- Degenerative lumbar spondylolisthesisNote: Degenerative lumbar spondylolisthesis is an acquired anterior displacement of one vertebra over the subjacent vertebra associated with degenerative changes without an associated disruption or defect in the vertebral ring.
- Published:
- 2008
- Endorsed by:
- North American Spine Society