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## Complete Summary

#### GUIDELINE TITLE

Guidelines for the performance of fusion procedures for degenerative
disease of the lumbar spine. Part 7: intractable low-back pain without
stenosis or spondylolisthesis.

#### BIBLIOGRAPHIC SOURCE(S)

Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni
P, Watters WC 3rd, Wang J, Walters BC, Hadley MN, American Association
of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines
for the performance of fusion procedures for degenerative disease of the
lumbar spine. Part 7: intractable low-back pain without stenosis or
spondylolisthesis. J Neurosurg Spine 2005 Jun;2(6):670-2. \[7
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028735)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Degenerative disease of the lumbar spine: intractable low-back pain
without stenosis or spondylolisthesis

#### GUIDELINE CATEGORY

Management\
Treatment

#### CLINICAL SPECIALTY

Internal Medicine\
Neurological Surgery\
Neurology\
Orthopedic Surgery\
Physical Medicine and Rehabilitation

#### INTENDED USERS

Health Plans\
Managed Care Organizations\
Physical Therapists\
Physicians

#### GUIDELINE OBJECTIVE(S)

To evaluate the published literature regarding the use of lumbar fusion
in patients with low-back pain without stenosis or spondylolisthesis

#### TARGET POPULATION

Patients with low-back pain without stenosis or spondylolisthesis

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Lumbar fusion in carefully selected patients

2.  Physical therapy and cognitive therapy in patients in whom
    conventional medical management has failed

#### MAJOR OUTCOMES CONSIDERED

Effectiveness of treatment in terms of pain relief, degree of disability
as measured by the Oswestry Disability Index (ODI), daily use of
medication, return-to-work status, and degree of patient and independent
observer satisfaction

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The database of the National Library of Medicine was searched using the
search terms \"spinal fusion and randomized clinical trial,\" \"lumbar
fusion and randomized clinical trial,\" \"spinal fusion and outcomes,\"
\"lumbar fusion and outcomes,\" and \"lumbar fusion and physical
therapy.\" The Cochrane Central Register of Controlled Trials was
searched using the search term \"spinal fusion.\" Reference lists from
relevant papers as well as from the Cochrane Review were reviewed, and
all randomized clinical trials comparing lumbar fusion with nonoperative
management were identified. Both of these trials are identified in Table
1 of the original guideline document. A number of case series, cohort
studies, and studies evaluating different fusion techniques were also
identified and provide supportive scientific evidence.

#### NUMBER OF SOURCE DOCUMENTS

2 randomized clinical trials comparing lumbar fusion with nonoperative
management were identified.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Classes of Evidence**

**Class I** Evidence from one or more well-designed, randomized
controlled clinical trials, including overviews of such trials

**Class II** Evidence from one or more well-designed comparative
clinical studies, such as nonrandomized cohort studies, case-control
studies, and other comparable studies, including less well-designed
randomized controlled trials

**Class III** Evidence from case series, comparative studies with
historical controls, case reports, and expert opinion as well as
significantly flawed randomized controlled trials

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The group culled through literally thousands of references to identify
the most scientifically robust citations available concerning each
individual topic. Not every reference identified is cited. In general,
if high-quality (Class I or II) medical evidence was available on a
particular topic, poorer-quality evidence was only briefly summarized
and rarely included in the evidentiary tables. If no high-quality
evidence existed, or if there was significant disagreement between
similarly classified evidence sources, then the Class III and supporting
medical evidence were discussed in greater detail. If multiple reports
were available that provided similar information, a few were chosen as
illustrative examples.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

In January 2003, a group was formed at the request of the leadership of
the Congress of Neurological Surgeons (CNS) by the executive committee
of the American Association of Neurological Surgeons/CNS Joint Section
on Disorders of the Spine and Peripheral Nerves to perform an
evidence-based review of the literature on lumbar fusion procedures for
degenerative disease of the lumbar spine and to formulate treatment
recommendations based on this review. In March 2003, this group was
convened. Invitations were extended to approximately 12 orthopedic and
neurosurgical spine surgeons active in the Joint Section or in the North
American Spine Society to ensure participation of nonneurosurgical spine
surgeons. The recommendations that were developed represent the product
of the work of the group, with input from the Guidelines Committee of
the American Association of Neurological Surgeons/CNS and the Clinical
Guidelines Committee of North American Spine Society.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grades of Recommendation**

**Standards** Recommendations of the strongest type, based on Class I
evidence reflecting a high degree of clinical certainty

**Guidelines** Recommendations based on Class II evidence reflecting a
moderate degree of clinical certainty

**Options** Recommendations based on Class III evidence reflecting
unclear clinical certainty

#### COST ANALYSIS

Lumbar fusion may be associated with a high short-term cost, especially
if instrumentation is placed; however, there appear to be long-term
economic benefits associated with lumbar fusion including resumption of
employment. To describe the economic impact of lumbar fusion for
degenerative disease adequately, it is important to define the patient
population treated with fusion and to compare efficacy as well as the
costs of other treatment alternatives. Any such analysis should include
both short- and long-term costs and benefits.

See \"Part 3: assessment of economic outcome\" in the \"Availability of
Companions Documents\" field for the complete analysis.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The committee presents data that have been reviewed by the major
organizations representing neurological surgery and orthopedic surgery.
The Board of Directors of the American Association of Neurological
Surgeons (AANS) and the Congress of Neurological Surgeons (CNS)
Executive Committee have reviewed these Lumbar Fusion Guidelines and
formally voted their approval. In addition, input and approval was
received and greatly appreciated from the AANS/CNS Guidelines committee.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The grades of recommendations (standards, guidelines, and options) and
classes of evidence (I--III) are defined at the end of the \"Major
Recommendations\" field.

***Standards***. Lumbar fusion is recommended as a treatment for
carefully selected patients with disabling low-back pain due to one- or
two-level degenerative disease without stenosis or spondylolisthesis.

***Guidelines***. There is insufficient evidence available to support a
treatment guideline.

***Options***. An intensive course of physical therapy and cognitive
therapy is recommended as a treatment option for patients with low-back
pain in whom conventional medical management has failed.

**Summary**

Class I medical evidence exists in support of the use of lumbar fusion
as a treatment standard for carefully selected patients with low-back
pain intractable to the best medical management. There is Class III
medical evidence that suggests that a course of intensive cognitive and
physical therapy may be an efficacious treatment option for the
treatment of patients with chronic disabling low-back pain.

**[Definitions]{.underline}**:

**Grades of Recommendation**

**Standards** Recommendations of the strongest type, based on Class I
evidence reflecting a high degree of clinical certainty

**Guidelines** Recommendations based on Class II evidence reflecting a
moderate degree of clinical certainty

**Options** Recommendations based on Class III evidence reflecting
unclear clinical certainty

**Classes of Evidence**

**Class I** Evidence from one or more well-designed, randomized
controlled clinical trials, including overviews of such trials

**Class II** Evidence from one or more well-designed comparative
clinical studies, such as nonrandomized cohort studies, case-control
studies, and other comparable studies, including less well-designed
randomized controlled trials

**Class III** Evidence from case series, comparative studies with
historical controls, case reports, and expert opinion as well as
significantly flawed randomized controlled trials

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate treatment of patients with degenerative disease of the
lumbar spine with intractable low-back pain without stenosis or
spondylolisthesis

#### POTENTIAL HARMS

Lumbar spinal fusion procedures are associated with significant cost and
the potential for complications.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni
P, Watters WC 3rd, Wang J, Walters BC, Hadley MN, American Association
of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines
for the performance of fusion procedures for degenerative disease of the
lumbar spine. Part 7: intractable low-back pain without stenosis or
spondylolisthesis. J Neurosurg Spine 2005 Jun;2(6):670-2. \[7
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16028735)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005 Jun

#### GUIDELINE DEVELOPER(S)

American Association of Neurological Surgeons - Medical Specialty
Society\
Congress of Neurological Surgeons - Professional Association

#### SOURCE(S) OF FUNDING

This project was funded entirely by a grant from AANS/CNS Section on
Disorders of the Spine. No funding was received from any commercial
entity to support the production or publication of these guidelines.

#### GUIDELINE COMMITTEE

Guidelines Committee of the American Association of Neurological
Surgeons/Congress of Neurological Surgeons (CNS)

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Authors*: Daniel K. Resnick, MD; Tanvir F. Choudhri, MD; Andrew
T. Dailey, MD; Michael W. Groff, MD; Larry Khoo, MD; Paul G. Matz, MD;
Praveen Mummaneni, MD; William C. Watters III, MD; Jeffery Wang, MD;
Beverly C. Walters, MD, MPH; Mark N. Hadley, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### ENDORSER(S)

North American Spine Society - Medical Specialty Society

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves
Web
site](http://www.spinesection.org/files/pdfs/fusion_guidelines/07 - Intractable Low-Back Pain Without Stenosis or Spondylolisthesis.pdf).

Print copies: Available from Daniel K. Resnick, M.D., Department of
Neurological Surgery, University of Wisconsin Medical School, K4/834
Clinical Science Center, 600 Highland Avenue, Madison, Wisconsin 53792;
Email: <Resnick@neurosurg.wisc.edu>.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Introduction to the guidelines for the performance of fusion
    procedures for degenerative disease of the lumbar spine. 2005 Jun.
    1 p. Available in Portable Document Format (PDF) from the [AANS/CNS
    Joint Section on Disorders of the Spine and Peripheral Nerves Web
    site](http://www.spinesection.org/files/pdfs/fusion_guidelines/00 - Introduction - Dr Robert Heary.pdf).

-   Guidelines for the performance of fusion procedures for degenerative
    disease of the lumbar spine. Part 1: introduction and methodology.
    2005 Jun. 2 p. Available in Portable Document Format (PDF) from the
    [AANS/CNS Joint Section on Disorders of the Spine and Peripheral
    Nerves Web
    site](http://www.spinesection.org/files/pdfs/fusion_guidelines/01 - Introduction and Methodology.pdf).

-   Guidelines for the performance of fusion procedures for degenerative
    disease of the lumbar spine. Part 3: assessment of economic outcome.
    2005 Jun. 6 p. Available in Portable Document Format (PDF) from the
    [AANS/CNS Joint Section on Disorders of the Spine and Peripheral
    Nerves Web
    site](http://www.spinesection.org/files/pdfs/fusion_guidelines/03 - Assessment of Economic Outcome.pdf).

Print copies: Available from Daniel K. Resnick, M.D., Department of
Neurological Surgery, University of Wisconsin Medical School, K4/834
Clinical Science Center, 600 Highland Avenue, Madison, Wisconsin 53792;
Email: <Resnick@neurosurg.wisc.edu>.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on January 5, 2007. The
information was verified by the guideline developer on January 29, 2007.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008