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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Agency for Healthcare Research and Quality (AHRQ): The Agency for Health Care Policy and Research (AHCPR), now the AHRQ, issued clinical practice guidelines on acute low back problems in adults in December 1994 (Bigos, 1994). Acute was defined as less than 3 months in duration, whereas chronic referred to longer than 3 months. The guidelines were developed by a 23-member multidisciplinary, private-sector panel. Guideline development included a systematic review and analysis of the scientific literature. The guidelines were limited to back problems, defined as activity intolerance due to back-related symptoms, of less than 3 months duration in persons 18 years of age or older. The panel's literature review included the randomized controlled trials described in this section. Although the AHCPR panel was specifically concerned with developing clinical practice guidelines for acute low back problems, the studies reviewed concerned mostly chronic problems or included a mix of acute and chronic problems. The panel's findings, therefore, might reasonably be Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline applied to chronic low back conditions. The panel concluded that facet joint injections appeared to be associated with rare potential serious complications and did not appear to be effective for treating acute low back problems. Many orthopaedic surgeons and physician groups vigorously opposed this clinical pracatice guideline, and it was eventually withdrawn by the AHCPR. It is no longer in use and will not be updated or revised.

Epidural steroid injections Abdi et al. conducted a systemic review of published trials and abstracts of scientific meetings, published between January 1966 and October 2006, to determine the efficacy and safety of ESIs (Abdi, 2007). The primary outcome measure was pain relief. Other outcome measures were functional improvement, improvement of psychological status, and return to work. They identified 11 randomized trials of lumbar interlaminar ESI. Of these studies, 8 had favorable results for short-term ( 6 weeks) relief and 1 was positive for long-term (6 weeks) relief. The level of evidence for interlaminar ESIs was considered strong for short-term pain relief and limited for long-term pain relief. There were 7 randomized trials of lumbar transforaminal ESI (TFESI), 5 of which had favorable results for both short- and long-term pain relief. The level of evidence for TFESI was considered strong for short-term pain relief and moderate for long-term pain relief. Of the 8 randomized trials of caudal ESIs, 5 had favorable results for short-term pain relief and 4 had favorable results for long-term pain relief. The level of evidence for caudal epidural injections was considered strong for short-term relief and moderate for long-term relief.

Karppinen et al. conducted a double-blind, randomized controlled trial of methylprednisolone plus bupivacaine for the treatment of sciatica (Karppinen, 2001). Patients received an epidural injection of either saline (n=80) or steroid (n=80). At 2 weeks postinjection, the steroid group had significantly greater improvement in leg pain, straight leg raising, lumbar flexion and more patient satisfaction than the saline group. The saline group had significantly reduced back pain at the 3-month and 6-month follow-ups and significantly reduced leg pain at 6 months. One year postinjection, there were no differences between groups.

Valat et al. conducted a multicenter, double-blind, randomized controlled study of prednisolone for hospitalized patients with sciatica (Valat, 2003). The 85 patients in the study were treated with 3 epidural injections at 2-day intervals of either prednisolone (n=43) or saline (n=42). The patients were evaluated at 5 days, 20 days, and 35 days postinjection, and there were no significant differences between groups for any outcome measures. The results suggested that epidural prednisolone had no effect on sciatica. However, because only hospitalized patients were included in the study, patients selected for this study may have had more serious disease than those in the general population with sciatica.

A total of 206 patients with a diagnosis of "postlaminectomy syndrome" were enrolled in Aldrete's randomized, blinded, comparative study of indomethacin or methylprednisolone (Aldrete, 2003). The results of the study suggested that epidural injection of indomethacin and methylprednisolone were Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline equally effective at reducing back pain.

Buttermann conducted a randomized comparative study of epidural betamethasone injections or discectomy for the treatment of herniated nucleus pulposus (Buttermann, 2004). Initially the patients were treated with either epidural injections of betamethasone (n=50) or discectomy (n=50). Patients who failed to obtain relief with steroid injections were entered into a crossover group (n=27) and treated with discectomy. The discectomy group had earlier motor recovery than the steroid group;

however, there were no other significant differences between groups. The results suggested that epidural betamethasone injections were not as effective as discectomy. However, steroid injections were effective for up to 3 years in nearly half of the patients who had not responded to conservative treatment.

Khot et al. performed a single-blind, randomized, placebo-controlled study of epidural steroid injection for patients with low back pain of discogenic origin (Khot, 2004). In this study, 60 patients were randomly assigned to receive epidural methylprednisolone, while 60 patients received a placebo epidural injection. After 1 year, there was no difference in outcome between the treatment and placebo groups.

Wilson-MacDonald et al. conducted a double-blind, randomized controlled study of methylprednisolone plus local anesthetic for the treatment of nerve root compression (WilsonMacDonald, 2005). Patients received either an epidural (n=44) or intramuscular (n=48) injection of methylprednisolone plus bupivacaine. To maintain patient blinding, the initial injection technique was the same for both groups. After the needle made contact with the lamina of the vertebra, it was withdrawn and redirected for the intramuscular injection or advanced into the epidural space. Thirtyfive days after the injection, the epidural group had significantly less pain than the control group. The proportion of patients who eventually had surgery was the same in each group. The results suggested that the effects of epidural steroid injections were only short lived.

In one of the largest recent double-blind, randomized studies, Price et al. evaluated the effect of epidural steroid injection on 228 patients with either acute or chronic sciatica (Price, 2005). Patients received either epidural steroid or placebo injection, up to 3 injections, and were then evaluated periodically for a 12-month period. At 3 weeks after injection, more patients in the steroid group reported reduction in pain and showed improvement in the Oswestry Disability Index score than did patients in the placebo group; however, at all other follow-up times, there were no significant differences in any outcomes between the treatment and control group. This suggested that any effect of epidural steroid was transient.

Cyteval et al. prospectively followed 229 patients with lumbar radiculopathy (herniated disc and degenerative lesions) at 2 weeks and 1 year after percutaneous periradicular (transforaminal) steroid infiltration (Cyteval, 2006). The aim of the study was to find predictive factors of efficacy of the steroid injection procedure. ESIs were performed under fluoroscopic guidance, and periradicular flow Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline was confirmed with contrast medium. Short- and long-term pain relief was demonstrated. The only predictive factor of pain relief was symptom duration before the procedure. The authors concluded that periradicular (transforaminal) infiltration was a simple, safe, and effective (short- and long-term relief) nonsurgical procedure with an improved benefit when performed early in the course of the illness. The primary limitation of the study was the lack of a control group.

Complications associated with epidural injections include steroid side effects, dural puncture, transient increased pain, transient paresthesias, aseptic and/or bacterial meningitis, neurological dysfunction or damage, epidural abscess, intracranial air, allergic reaction, epidural hematoma, persistent dural leak, nausea, headache, paraplegia, tetraplegia, seizure, stroke, and death (Derby, 2004; Everett, 2004).

ESIs should not be performed at the site of congenital anatomic anomalies or in persons who have had previous surgery in which the epidural space is absent, altered, or eliminated. The treatment is contraindicated in patients with systemic infections or bleeding tendencies; infection at the injection site; patients undergoing active anticoagulation therapy; patients at risk for medical decompensation from fluid retention, such as those with severe congestive heart failure or poorly controlled hypertension; and patients with other unstable medical conditions. Steroid injections may lower resistance to infection and should be used with caution in patients with poorly controlled diabetes, since the corticosteroid injection may transiently increase the blood glucose levels. In addition, fluoroscopy should not be used to guide epidural injections for pregnant women to avoid radiation exposure of the fetus (McLain, 2005).

Professional Societies American Society of Anesthesiologists (ASA): The ASA has not issued a statement specifically on the use of epidural steroids for the management of low back pain and/or sciatica. However, the ASA Task Force on Pain Management issued more general practice guidelines for chronic pain management. The ASA recommended that: "Multiple modalities, such as the combined use of neural blockade, medications, or rehabilitative therapies should be considered when analgesia with acceptable adverse effects is no longer attained with single modalities (ASA, 1997)." The ASA lists a local steroid as an example of a neural blockade. Concluding that "the literature suggests that locally injected corticosteroids are effective in providing analgesia" the ASA recommended that anesthesiologists provide local injections of corticosteroid within the context of the patient's overall treatment plan (ASA, 1997).

The Agency for Healthcare Research and Quality (AHRQ): A technology assessment of treatment of degenerative lumbar spinal stenosis published in 2001 by the AHRQ concluded that evidence was lacking for the efficacy of conservative treatments for lumbar spinal stenosis, including epidural steroid injections. This assessment noted that one randomized controlled trial provided evidence that patients with severe symptoms will benefit more from surgery than conservative therapy. However, in general, data are lacking on the effect of conservative treatment on patients with severe stenosis, since Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline these patients seem to receive surgery shortly after diagnosis. The assessment also concluded that there was limited, contradictory evidence on whether patients with moderate pain benefit more from surgery or from conservative treatment (AHRQ, 2001).

American Academy of Neurology (AAN): In 2007, the Therapeutics and Technology Assessment Subcommittee of the AAN released an assessment addressing the use of epidural steroid injections (ESIs) to treat radicular lumbosacral pain. The Subcommittee concluded that there was some evidence that, when compared with control treatments, ESIs may result in some improvement in radicular lumbosacral pain when assessed between 2 and 6 weeks following the injection. However, they noted that the average magnitude of effect is small and, in general, ESIs for radicular lumbosacral pain does not impact average impairment of function, need for surgery, or provide long-term pain relief beyond 3 months. Therefore, the routine use of ESIs for radicular lumbosacral pain was not recommended.

The Subcommittee did not make any recommendation for the use of ESIs to treat radicular cervical pain due to the paucity of evidence for this indication (Armon, 2007).

American Society of Interventional Pain Physicians (ASIPP): The 2007 ASIPP practice guidelines for interventional techniques in the management of chronic spinal pain state that the evidence for caudal ESIs is strong for short-term relief and moderate for long-term relief in managing chronic low back and radicular pain. The guidelines also state that the evidence for interlaminar ESIs is strong for short-term relief and limited for long-term relief in managing chronic low back pain and sciatica. The evidence for transforaminal ESIs is strong for short-term and moderate for long-term improvement in managing chronic low back pain and sciatica. (Boswell et al., 2007).

The ASIPP recommends that the suggested frequency of epidural injections should be 2 months or longer between each injection provided that at least 50% relief is obtained for 6 to 8 weeks. Injections should be limited to a maximum of 6 times per year (Boswell, 2005).

American Association of Neurological Surgeons and the Congress of Neurological Surgeon: A guideline from the American Association of Neurological Surgeons and the Congress of Neurological Surgeons states that there is no evidence in the clinical literature supporting the long-term benefit of epidural injections or facet joint injections (Resnick, 2005).

North American Spine Society (NASS): The NASS has developed clinical guidelines that address the diagnosis and treatment of degenerative lumbar spinal stenosis (NASS, 2007). The guidelines state that while there is evidence that nonfluoroscopically guided interlaminar and single radiographically guided transforaminal ESIs can result in short-term symptom relief in patients with neurogenic claudication or radiculopathy, there is conflicting evidence concerning long-term efficacy.

The guidelines also note that there is some evidence that a multiple injection regimen of radiographically guided transforaminal ESIs or caudal injections can produce long-term relief of pain in patients with radiculopathy or neurogenic intermittent claudication from lumbar spinal stenosis.

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