This is the current release of the guideline.

Low-back pain due to degenerative disease of the lumbar spine

Evaluation
Management
Prevention
Treatment

Internal Medicine
Neurological Surgery
Neurology
Physical Medicine and Rehabilitation

Advanced Practice Nurses
Health Plans
Managed Care Organizations
Physicians

To examine the medical evidence for the utility of brace therapy as a treatment of low-back pain, as a predictor of outcome following lumbar fusion surgery, and as an adjunct to lumbar fusion procedures

Patients with low-back pain due to degenerative disease of the lumbar spine

Lumbar braces

Note: See "Major Recommendations" field for specific indications.

• Sensitivity, specificity, and positive and negative predictive value of brace therapy and temporary external pedicle fixation (TEPF) as diagnostic tools
• Effectiveness of brace therapy in terms of pain relief, lost work days, work productivity, incidence of back injury, usage of pain medication, range of motion, and patient satisfaction

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

A computerized search of the National Library of Medicine from 1966 to 2003 was conducted using the following search terms: "lumbar support and low-back pain," "brace and low-back pain," and "orthosis and low-back pain." After discarding duplicates, 760 papers were identified. After reviewing the abstracts of each paper, 17 relevant studies were identified. The guideline developers then searched the database using the following phrases: "orthosis and fusion," "brace and fusion," "external lumbar fixation and fusion," and "lumbar support and fusion." After discarding duplicates, 1951 papers were identified. After reviewing the abstracts of each paper, 12 relevant studies were identified. Several review papers, meta-analyses, biomechanical studies, technical notes, and small case series serve as supporting data. The bibliography of each paper was reviewed and other relevant studies were identified. All clinical studies providing Class III medical evidence or better regarding the use of lumbar brace therapy for the prevention and treatment of low-back pain, for the prediction of outcome following lumbar fusion surgery, and as an adjunct to fusion surgery are summarized in Tables 1 through 4 in the original guideline document.

25 papers providing Class III medical evidence or better regarding the use of lumbar brace therapy for the prevention and treatment of low-back pain, for the prediction of outcome following lumbar fusion surgery, and as an adjunct to fusion surgery are summarized in Tables 1 through 4 in the original guideline document.

Weighting According to a Rating Scheme (Scheme Given)

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

Review of Published Meta-Analyses
Systematic Review with Evidence Tables

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.

Expert Consensus

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.

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

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.

External Peer Review
Internal Peer Review

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.

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. There is insufficient evidence to recommend a treatment standard.

Guidelines. The short-term use of a rigid lumbar support (1 to 3 weeks) is recommended as a treatment for low-back pain of relatively short duration (<6 months). The use of a lumbar brace for patients with chronic low-back pain is not recommended because there is no pertinent medical evidence of any long-term benefit or evidence that brace therapy is effective in the treatment of patients with chronic (> 6 months) low-back pain.

Options. 1) Lumbar braces are recommended as a means of decreasing the number of sick days lost due to low-back pain among workers with a previous lumbar injury. They are not recommended as a means of decreasing low-back pain in the general working population. 2)The use of lumbar brace therapy as a preoperative diagnostic tool to predict outcome following lumbar fusion surgery is not recommended. 3) The use of transpedicular external fixation as a tool to predict outcome following lumbar fusion surgery is not recommended.

Summary

Although conflicting reports have been presented in the literature regarding the utility of lumbar braces for the prevention of low-back pain, most Class III medical evidence suggests that these supports used prophylactically do not reduce the incidence of low-back pain or decrease the amount of time lost from work in the general working population. Among workers with a history of a back injury, their use appears to decrease the number of work days lost due to back pain. Lumbar braces appear to be an effective treatment for acute low-back pain in some populations. They do not appear to be effective in the chronic low-back pain population. If a brace is used, rigid braces offer some benefit over soft braces.

There are no data to suggest that relief of low-back pain with preoperative external bracing predicts a favorable outcome following lumbar spinal fusion. No information is available on the benefit of bracing for improving fusion rates or clinical outcomes following instrumented lumbar fusion for degenerative disease.

Definitions:

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

None provided

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

Appropriate use of lumbar braces in patients with degenerative disease of the lumbar spine

Not stated

• No information is available on the benefit of bracing for improving fusion rates or clinical outcomes following instrumented lumbar fusion for degenerative disease.
• The strength of an evidence-based document is only as strong as the foundation on which it is built. This comprehensive document chronicles the state of scientific information in 2005. Many of the published reviews presented flawed results due to poorly defined outcome measures, inadequate numbers of patients, and comparison of dissimilar treatment groups. These studies of "apples and oranges" gleaned little scientific information; therefore, for the purpose of this review, the authors have discarded Class III studies whenever stronger scientific evidence was available. The result is that most of the published studies on lumbar fusion were not included on this document. When Class I or II scientific evidence was available, standards and guidelines were formulated; however, in most cases, the scientific data were only adequate to support recommendations for treatment options. The aforementioned results do not detract from the importance of this document; rather, the need for the neurosurgical community to design and complete prospective randomized controlled studies to answer the many lingering clinical questions with rigorous scientific power can clearly be seen. As more data continue to be accumulated, revisions of this document will be needed.

An implementation strategy was not provided.

Getting Better
Living with Illness
Staying Healthy

Effectiveness

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

2005 Jun

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

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.

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

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

Not stated

North American Spine Society - Medical Specialty Society

This is the current release of the guideline.

None available

This NGC summary was completed by ECRI on January 8, 2007. The information was verified by the guideline developer on January 29, 2007.

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