This is the current release of the guideline.

Radicular lumbosacral pain (sciatica)

Assessment of Therapeutic Effectiveness
Treatment

Neurology

Physicians

To provide recommendations on the utility of epidural steroid injections to treat lumbosacral pain

Individuals with radicular lumbosacral pain

Epidural steroid injections to treat radicular lumbosacral pain

• Improvement in radicular lumbosacral pain
• Functionality
• Need for surgery
• Long-term pain relief
• Safety

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

Efficacy

Medline searches were conducted in April 2003 and February 2005 using combinations of the terms "epidural injections" or "epidural steroids," "double-blind," "placebo-controlled," and "radiculopathy." A search of the Cochrane database of systematic reviews found no review on the use of epidural steroid injections to treat radicular pain. The following inclusion criteria were used: 1) clear case definition; 2) clear measure of outcome (pain relief) using a standardized measure; 3) use of a control group (placebo or active); 4) randomization; 5) at least double-blind study design, so that neither patient nor assessor of measure of outcome would know the treatment arm; or triple-blind, if the physician injecting the treatment also did not know what treatment was administered; 6) prospective study design; 7) adequate statistical analysis.

The references of articles identified primarily and within select review articles were scanned for additional articles meeting the inclusion criteria: none were found. Articles identified by reviewers of earlier versions of the manuscript were considered also. The highest level of evidence was used to make the conclusions and recommendations for this parameter. Since articles on epidural steroid treatment of radicular cervical pain did not meet these criteria, epidural steroids to treat radicular lumbosacral pain alone will be considered.

Safety

A separate Medline search using the key words "epidural steroid" and "complications" was performed to identify reported complications with the procedure. Results from selected articles and from the efficacy studies selected for inclusion are summarized briefly.

The search yielded 37 articles, 4 of which met the predetermined inclusion criteria.

Weighting According to a Rating Scheme (Scheme Given)

Classification of Evidence for Therapeutic Intervention

Class I: Prospective, randomized, controlled clinical trial with masked outcome assessment, in a representative population. The following are required: a) primary outcome(s) clearly defined; b) exclusion/inclusion criteria clearly defined; c) adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias; and 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 randomized controlled trial (RCT) in a representative population that lacks one criteria 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 is independently assessed, or independently derived by objective outcome measurement.*

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

* 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).

Systematic Review with Evidence Tables

The search of electronic databases yielded 37 articles, 4 of which met the predetermined inclusion criteria. These are summarized in an evidence table (Table 2 in the original guideline document). Full review of a fifth article resulted in its exclusion since outcome measures were unclear, times for the reported outcomes were uncertain, and results of statistical analysis for the outcomes of interest were unavailable. The two articles identified as of the highest quality in the Institute of Clinical Systems Improvement review were summarized also in Table 2 in the original guideline document. Some of the studies combined steroids with a local anesthetic, using the local anesthetic as a control or normal saline as the control, while others compared steroids to normal saline.

Expert Consensus

Not stated

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.

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

External Peer Review
Internal Peer Review

Draft guidelines were reviewed for accuracy, quality, and thoroughness by the American Academy of Neurology (AAN) members, topic experts, and pertinent physician organizations.

Final guidelines were approved by the Therapeutics and Technology Assessment Subcommittee on July 28, 2006; by the Practice Committee on November 11, 2006; and by the AAN Board of Directors on December 7, 2006.

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.

1. Epidural steroid injections may result in some improvement in radicular lumbosacral pain when determined between 2 and 6 weeks following the injection, compared to control treatment (Level C, Class I–III evidence). The average magnitude of effect is small, and the generalizability of the observation is limited by the small number of studies, limited to highly selected patient populations, the few techniques and doses studied, and variable comparison treatments.
2. In general, epidural steroid injections for radicular lumbosacral pain have shown no impact on average impairment of function, on need for surgery, or on long-term pain relief beyond 3 months. Their routine use for these indications is not recommended (Level B, Class I–III evidence).
3. Data on use of epidural steroid injections to treat cervical radicular pain are inadequate to make any recommendation (Level U).

Definitions

Classification of Evidence for Therapeutic Intervention

Class I: Prospective, randomized, controlled clinical trial with masked outcome assessment, in a representative population. The following are required: a) primary outcome(s) clearly defined; b) exclusion/inclusion criteria clearly defined; c) adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias; and 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 criteria 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 is independently assessed, or independently derived by objective outcome measurement.*

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

* 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).

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.

None provided

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

Appropriate use of epidural steroid injections to treat lumbosacral pain

The most common complication is a transient headache whether or not associated with identifiable dural puncture. More serious complications, summarized in a 1996 review, were several cases of aseptic meningitis, arachnoiditis, and conus medullaris syndrome, typically after multiple subarachnoid injections. Two cases of epidural abscess, one case of bacterial meningitis, and one case of aseptic meningitis were also listed (subarachnoid drug placement could not be ruled out in the meningitis cases). A retroperitoneal hematoma was reported in one patient on anticoagulant therapy who received a fluoroscopically guided transforaminal injection of steroids. Transient complications have been encountered also during fluoroscopically guided caudal epidural injections, including insomnia, transient non-positional headaches, increased back pain, facial flushing, vasovagal reactions, nausea, and increased leg pain. No major neurologic complications (spinal hematomas) were encountered in a series of 1,035 individuals who received epidural steroid injections while on antiplatelet therapy. Minor complications (blood during needle placement) were encountered in 5.2%, and transient worsening of symptoms or emergence of new neurologic symptoms for more than 24 hours after the injection occurred in 4% of patients with median duration of 3 days and range 1 to 20 days. Additional qualitative safety data reporting serious complications were rare. An additional potential risk of radiographically guided transforaminal injections is radiation exposure; however, the radiation exposure of the spinal interventionalist was well within safety limits if proper techniques were followed

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 patient care decisions are the prerogative of the patient and the physician caring for the patient, based on all of the circumstances involved.

An implementation strategy was not provided.

Getting Better
Living with Illness

Effectiveness

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

2007 Mar 6

American Academy of Neurology - Medical Specialty Society

American Academy of Neurology (AAN)

Therapeutics and Technology Assessment Subcommittee

Primary Authors: Carmel Armon, MD, MHS; Charles E. Argoff, MD; Jeffrey Samuels, MD; Misha-Miroslav Backonja, MD

Therapeutics and Technology Assessment Subcommittee Members: Yuen T. So, MD, PhD (Co-Chair); Janis Miyasaki, MD, FAAN (Co-Chair); Douglas S. Goodin, MD (ex-officio); Carmel Armon, MD, MHS, FAAN (ex-officio); Richard M. Dubinsky, MD, MPH, FAAN; Mark Hallett, MD, FAAN; Cynthia L. Harden, MD; Michael A. Sloan, MD, MS, FAAN; James C. Stevens, MD, FAAN; Fenwick T. Nichols, III, MD; Kenneth J. Mack, MD, PhD; Paul W. O'Connor, MD; Vinay Chaudhry, MD, FAAN

This is the current release of the guideline.

None available

This summary was completed by ECRI Institute on May 14, 2007.

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