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Brief Summary

GUIDELINE TITLE

Acute low back pain.

BIBLIOGRAPHIC SOURCE(S)

  • University of Michigan Health System. Acute low back pain. Ann Arbor (MI): University of Michigan Health System; 2003 Apr [rev. Oct 2004]. 13 p. [8 references]

GUIDELINE STATUS

This is the current release of the guideline.

This updates a previous version: University of Michigan Medical Center. Acute low back pain. Ann Arbor (MI): University of Michigan Health System; 1997. 13 p.

This guideline was updated by the guideline developer in October 2004 following the removal of Vioxx (rofecoxib) from the worldwide markets. See the U.S. Food and Drug Administration (FDA) Web site for more information. This guideline was updated again by the guideline developer in December 2004 following the release of a public health advisory from the U.S. Food and Drug Administration regarding the use of some non-steroidal anti-inflammatory drug products. See the FDA Web site for more information.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory information has been released.

On September 30, 2004, Vioxx (rofecoxib) was withdrawn from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events. See the U.S. Food and Drug Administration (FDA) Web site for more information.

Subsequently, on April 7, 2005, after concluding that the overall risk versus benefit profile is unfavorable, the FDA requested that Pfizer, Inc voluntarily withdraw Bextra (valdecoxib) from the market. The FDA also asked manufacturers of all marketed prescription nonsteroidal anti-inflammatory drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning and a Medication Guide. Finally, FDA asked manufacturers of non-prescription (over the counter [OTC]) NSAIDs to revise their labeling to include more specific information about the potential gastrointestinal (GI) and cardiovascular (CV) risks, and information to assist consumers in the safe use of the drug. See the FDA Web site for more information.

Most recently, on June 15, 2005, the FDA requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. See the FDA Web siteFDA Web site for more information.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Note from the National Guideline Clearinghouse (NGC): The following key points summarize the content of the guideline. Refer to the full text of the original guideline document for detailed information on diagnosis; "red flags" for serious disease; risks for chronic disability; differential diagnoses; assessing muscle strength and reflexes; treatment and medications.

Definitions for the levels of evidence (A, B, C, D) are provided at the end of the Major Recommendations field.

  • Natural History. Low back pain occurs in about 80% of people [evidence C]. Within 6 weeks 90% of episodes will resolve satisfactorily regardless of treatment [C]. Of all persons disabled for more than 1 year, 90% will never work again without intense intervention [C].
  • Initial Visit
    • Assess for "red flags" of serious disease (see Table 1 in the original guideline document), as well as psychological and social risks for chronic disability (see Table 2 in original guideline document). Diagnostic tests are usually unnecessary [C]
    • Educate about good prognosis [B].
    • Treatment options include: ice [D], nonsteroidal anti-inflammatory drugs (NSAIDs) [A], and return to usual activities - bed rest is not recommended [A]. (Cyclo-oxygenase-2 [COX-2] inhibitors are no more effective than traditional NSAID agents and should be reserved for carefully selected patients [see Table 8 in the original guideline document for COX-2 criteria]. [A])

      Refer to the following tables in the original guideline document for detailed information on:

      • Non-Radiating (Axial) Low-Back Pain: Treatment and Follow Up (Pain Not Below the Knee) (Table 5)
      • Radiating Low-Back Pain: Treatment and Follow Up (Sciatica – Pain Below the Knee) (Table 6)
      • Medications for Low Back Pain (Non-Radiating and Radiating) (Table 7)
    • Close clinical follow up until return to work or key life activities [D].
  • By 2 weeks (acute). If work disability persists, consider physiatric consultation [A] especially if psychosocial risks to return to work exist.
  • For radicular pain, by 2-4 weeks: If no improvement obtain magnetic resonance image (MRI) [B]. If not diagnostic, obtain electromyography (EMG). If pathology proven, consider acute physiatric evaluation (for injection therapy) or surgical evaluation [A]. If pathology not proven, consider physiatrist referral [D].
  • By 6 weeks (subacute). If activities are still limited, consider physiatric consultation regarding a complex rehabilitation program [A].
  • By 12 weeks (chronic). If still disabled from major life activities or work, strongly consider referral to a physiatrist or specialized spinal pain team for a complex rehabilitation team [A].

Special Circumstances (see discussion in original guideline document):

  • Primary prevention
  • Chronic low back pain
  • Recurrent low back pain
  • Pregnancy and low back pain

Definitions:

Levels of Evidence

*Levels of evidence for the most significant recommendations.

  1. Randomized controlled trials
  2. Controlled trials, no randomization
  3. Observational trials
  4. Opinion of expert panel

CLINICAL ALGORITHM(S)

The original guideline document contains a clinical algorithm for diagnosis and treatment of acute low back pain.

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).

Conclusions were based on prospective randomized clinical trials, when possible. In the absence of randomized controlled trials, observational studies were considered. If none were available, expert opinion was used.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • University of Michigan Health System. Acute low back pain. Ann Arbor (MI): University of Michigan Health System; 2003 Apr [rev. Oct 2004]. 13 p. [8 references]

ADAPTATION

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

DATE RELEASED

1997 (revised 2003 Apr; modified 2004 Oct following FDA drug withdrawal)

GUIDELINE DEVELOPER(S)

University of Michigan Health System - Academic Institution

SOURCE(S) OF FUNDING

University of Michigan Health System

GUIDELINE COMMITTEE

Low Back Pain Guideline Team

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Team Leader: Anthony Chiodo, MD, Physical Medicine and Rehabilitation

Team Members: David Alvarez, DO, Family Medicine; Gregory Graziano, MD, Orthopedic Surgery; Andrew Haig, MD, Physical Medicine and Rehabilitation; Van Harrison, PhD, Medical Education; John McGillicuddy, MD, Neurosurgery; Connie Standiford, MD, General Internal Medicine; Amy Tremper, MD, Obstetrics and Gynecology

Guidelines Oversight Team: Connie Standiford, MD Lee Green, MD, MPH Van Harrison, PhD

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The University of Michigan Health System endorses the Guidelines of the Association of American Medical Colleges and the Standards of the Accreditation Council for Continuing Medical Education that the individuals who present educational activities disclose significant relationships with commercial companies whose products or services are discussed. Disclosure of a relationship is not intended to suggest bias in the information presented, but is made to provide readers with information that might be of potential importance to their evaluation of the information.

Team Member, Company, Relationship

  • David Alvarez, DO (none)
  • Anthony Chiodo, MD (none)
  • Gregory Graziano, MD (none)
  • Andrew Haig, MD, Rehabilitation Team Assessments, LLC, President
  • Van Harrison, PhD (none)
  • John McGillicuddy, MD (none)
  • Connie Standiford, MD (none)
  • Amy Tremper, MD (none)

GUIDELINE STATUS

This is the current release of the guideline.

This updates a previous version: University of Michigan Medical Center. Acute low back pain. Ann Arbor (MI): University of Michigan Health System; 1997. 13 p.

This guideline was updated by the guideline developer in October 2004 following the removal of Vioxx (rofecoxib) from the worldwide markets. See the U.S. Food and Drug Administration (FDA) Web site for more information. This guideline was updated again by the guideline developer in December 2004 following the release of a public health advisory from the U.S. Food and Drug Administration regarding the use of some non-steroidal anti-inflammatory drug products. See the FDA Web site for more information.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

The following are available:

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 January 19, 2004. The information was verified by the guideline developer on February 6, 2004.

This guideline was updated by the guideline developer in October 2004 following the removal of Vioxx (rofecoxib) from the worldwide markets. This guideline was updated again by the guideline developer in December 2004 following the release of a public health advisory from the U.S. Food and Drug Administration regarding the use of some non-steroidal anti-inflammatory drug products. This summary was updated on April 15, 2005 following the withdrawal of Bextra (valdecoxib) from the market and the release of heightened warnings for Celebrex (celecoxib) and other nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). This summary was updated by ECRI on June 16, 2005, following the U.S. Food and Drug Administration advisory on COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs).

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is copyrighted by the University of Michigan Health System (UMHS).

DISCLAIMER

NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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