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## Complete Summary

#### GUIDELINE TITLE

Practice advisory: utility of surgical decompression for treatment of
diabetic neuropathy. Report of the Therapeutics and Technology
Assessment Subcommittee of the American Academy of Neurology.

#### BIBLIOGRAPHIC SOURCE(S)

Therapeutics and Technology Assessment Subcommittee of the American
Academy of Neurology, Chaudhry V, Stevens JC, Kincaid J, So YT. Practice
advisory: utility of surgical decompression for treatment of diabetic
neuropathy: report of the Therapeutics and Technology Assessment
Subcommittee of the American Academy of Neurology. Neurology 2006 Jun
27;66(12):1805-8. \[28 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16801641)

#### 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\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Diabetic neuropathy

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Treatment

#### CLINICAL SPECIALTY

Endocrinology\
Neurology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To provide recommendations on the utility of surgical decompensation for
treatment of diabetic neuropathy

#### TARGET POPULATION

Patients with diabetic neuropathy

#### INTERVENTIONS AND PRACTICES CONSIDERED

Surgical decompression

#### MAJOR OUTCOMES CONSIDERED

-   Subjectively reported pain

-   Two-point discrimination

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

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

A MEDLINE, EMBASE, and PUBMED literature search was conducted for all
articles published between 1966 and July 2005, in the English language
with the key words \"diabetes mellitus,\" \"diabetic neuropathy,\" and
\"surgical decompression.\" Seventy-five articles were identified by
this search. An additional two articles, published in September 2005,
identified after the initial search, were reviewed. Since the intent of
this review was to provide a statement for length dependent sensory
motor distal neuropathy, articles solely dealing with upper extremity
decompressive surgery for documented entrapments were excluded.
Abstracts of the articles were reviewed and 18 full articles that
pertained to the topic were selected. Accompanying editorials and
related discussions were reviewed for content.

#### NUMBER OF SOURCE DOCUMENTS

Eleven articles were identified that dealt with decompressive surgery
for the treatment of diabetic neuropathy.

#### 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

**Classification of Evidence for Therapeutic Articles**

**Class I**: Prospective, randomized, controlled clinical trial (RCT)
with masked outcome assessment, in a representative population. The
following are required:

a.  Primary outcome(s) is/are clearly defined.

b.  Exclusion/inclusion criteria are clearly defined.

c.  Adequate accounting for dropouts and crossovers with numbers
    sufficiently low to have minimal potential for bias.

d.  Relevant baseline characteristics are presented and substantially
    equivalent among treatment groups or there is appropriate
    statistical adjustment for differences.

**Class II**: Prospective, matched, group cohort study in a
representative population with masked outcome assessment that meets a--d
above OR a RCT in a representative population that lacks one criterion
a--d.

**Class III**: All other controlled trials including well-defined
natural history controls or patients serving as own controls in a
representative population, where outcome assessment is independently
assessed or independently derived by objective outcome measurement (an
outcome measure that is unlikely to be affected by an observer\'s
\[patient, treating physician, investigator\] expectation or bias
\[e.g., blood tests, administrative outcome data\]).

**Class IV**: Evidence from uncontrolled studies, case series, case
reports, or expert opinion.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

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

Evidence tables were constructed from 10 selected articles which dealt
directly with surgical decompression in human subjects with diabetic
neuropathy.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Other

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

The Therapeutic and Technology Assessment Subcommittee (TTA) oversees
the development of American Academy of Neurology (AAN) technology
assessments and therapeutic assessments, which are evidence-based
statements that assess the safety, utility and effectiveness of new,
emerging, or established therapeutic agents or technologies in the field
of neurology. Technology assessments and therapeutic assessments are
developed through a rigorous process of defining the topic, evaluating
and rating the quality of the evidence, and translating the conclusions
of the evidence into practical assessments that can be used to guide the
use of technologies and therapeutic agents in the practice of neurology.

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

**Classification of Recommendations**

**A** = Established as effective, ineffective, or harmful for the given
condition in the specified population (Level A rating requires at least
two consistent Class I studies.)

**B** = Probably effective, ineffective, or harmful for the given
condition in the specified population (Level B rating requires at least
one Class I study or at least two consistent Class II studies.)

**C** = Possibly effective, ineffective, or harmful for the given
condition in the specified population (Level C rating requires at least
one Class II study or two consistent Class III studies.)

**U** = Data inadequate or conflicting given current knowledge,
treatment is unproven.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

This practice advisory was approved by the Therapeutics and Technology
Assessment Subcommittee on October 23, 2005; by the Practice Committee
on April 5, 2006; and by the American Academy of Neurology (AAN) Board
of Directors on May 4, 2006.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Definitions of the strength of the recommendations (A, B, C, U) and
classification of the evidence (Class I through Class IV) are provided
at the end of the \"Major Recommendations\" field.

**Conclusions and Recommendations**

-   There are inadequate data concerning the efficacy of decompressive
    surgery for the treatment of diabetic neuropathy. Given our current
    knowledge, this treatment is unproven (**Level U**).

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

**Classification of Recommendations**

**A** = Established as effective, ineffective, or harmful for the given
condition in the specified population (Level A rating requires at least
two consistent Class I studies.)

**B** = Probably effective, ineffective, or harmful for the given
condition in the specified population (Level B rating requires at least
one Class I study or at least two consistent Class II studies.)

**C** = Possibly effective, ineffective, or harmful for the given
condition in the specified population (Level C rating requires at least
one Class II study or two consistent Class III studies.)

**U** = Data inadequate or conflicting given current knowledge,
treatment is unproven.

**Classification of Evidence for Therapeutic Articles**

**Class I**: Prospective, randomized, controlled clinical trial (RCT)
with masked outcome assessment, in a representative population. The
following are required:

a.  Primary outcome(s) is/are clearly defined.

b.  Exclusion/inclusion criteria are clearly defined.

c.  Adequate accounting for dropouts and crossovers with numbers
    sufficiently low to have minimal potential for bias.

d.  Relevant baseline characteristics are presented and substantially
    equivalent among treatment groups or there is appropriate
    statistical adjustment for differences.

**Class II**: Prospective, matched, group cohort study in a
representative population with masked outcome assessment that meets a--d
above OR a RCT in a representative population that lacks one criterion
a--d.

**Class III**: All other controlled trials including well-defined
natural history controls or patients serving as own controls in a
representative population, where outcome assessment is independently
assessed or independently derived by objective outcome measurement (an
outcome measure that is unlikely to be affected by an observer\'s
\[patient, treating physician, investigator\] expectation or bias
\[e.g., blood tests, administrative outcome data\]).

**Class IV**: Evidence from uncontrolled studies, case series, case
reports, or expert opinion.

#### 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 utility of surgical decompensation for treatment of diabetic
neuropathy

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

This statement is provided as an educational service of the American
Academy of Neurology (AAN). It is based on an assessment of current
scientific and clinical information. It is not intended to include all
possible proper methods of care for a particular neurologic problem or
all legitimate criteria for choosing to use a specific procedure.
Neither is it intended to exclude any reasonable alternative
methodologies. The AAN recognizes that specific care decisions are the
prerogative of the patient and the physician caring for the patient,
based on all of the circumstances involved.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Patient Resources\
Quick Reference Guides/Physician Guides\
Staff Training/Competency Material

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

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

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Therapeutics and Technology Assessment Subcommittee of the American
Academy of Neurology, Chaudhry V, Stevens JC, Kincaid J, So YT. Practice
advisory: utility of surgical decompression for treatment of diabetic
neuropathy: report of the Therapeutics and Technology Assessment
Subcommittee of the American Academy of Neurology. Neurology 2006 Jun
27;66(12):1805-8. \[28 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16801641)

#### ADAPTATION

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

#### DATE RELEASED

2006 Jun

#### GUIDELINE DEVELOPER(S)

American Academy of Neurology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Academy of Neurology (AAN)

#### GUIDELINE COMMITTEE

Therapeutics and Technology Assessment Subcommittee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Authors*: Vinay Chaudhry, MD; James C. Stevens, MD; John
Kincaid, MD; Yuen T. So, MD, PhD

*Therapeutics and Technology Assessment Subcommittee Members*: Janis
Miyasaki, MD (*Co-Chair*); Yuen T. So, MD, PhD (*Co-Chair*); Carmel
Armon, MD, MHS (ex-officio); Vinay Chaudhry, MD; Richard M. Dubinsky,
MD, MPH: Douglas S. Goodin, MD (ex-officio); Mark Hallett, MD; Cynthia
Harden, MD; Kenneth J. Mack, MD, PhD; Fenwick T. Nichols III, MD;
Michael A. Sloan, MD, MS; James C. Stevens, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The authors report no conflicts of interest.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: A list of American Academy of Neurology (AAN)
guidelines, along with a link to a Portable Document Format (PDF) file
for this guideline, is available at the [AAN Web
site](http://aan.com/go/practice/guidelines).

Print copies: Available from the AAN Member Services Center, (800)
879-1960, or from AAN, 1080 Montreal Avenue, St. Paul, MN 55116.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   AAN guideline development process \[online\]. St. Paul (MN):
    American Academy of Neurology. Available from the [American Academy
    of Neurology (AAN) Web
    site](http://www.aan.com/go/practice/guidelines/development).

-   Utility of surgical decompression for treatment of diabetic
    neuropathy. AAN summary of evidence-based guideline for clinicians.
    St. Paul (MN): American Academy of Neurology. 2 p. Available in
    Portable Document Format (PDF) from the [AAN Web
    site](http://www.aan.com/professionals/practice/guidelines/surgicaldecom_clinician.pdf)

-   Utility of surgical decompression for treatment of diabetic
    neuropathy. CME quiz. Available online to subscribers of *Neurology*
    at the [Neurology Web
    site](http://cme.neurology.org/cgi/hierarchy/aancme_course;neurology_66_12).

#### PATIENT RESOURCES

The following is available:

-   Surgical decompression for treatment of diabetic neuropathy. AAN
    summary of evidence-based guideline for patients and their families.
    St. Paul (MN): American Academy of Neurology (AAN). 1 p.

Electronic copies: Available in Portable Document Format (PDF) from the
[AAN Web
site](http://www.aan.com/professionals/practice/guidelines/surgicaldecom_patient.pdf).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on October 2, 2006. The
information was verified by the guideline developer on November 1, 2006.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is
copyrighted by the American Academy of Neurology.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008