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

-- [ Page 99 ] --

Additional information may be obtained from the U.S. Food and Drug Administration [Website] Center for Drug Evaluation and Research (CDER) at: http://www.fda.gov/cder/drug/default.htm.

Accessed November 6, 2008.

Research Evidence Background Back pain is one of the most common types of chronic pain in the United States, affecting about 59% of adults during their lifetime (ECRI, 2008a). Spinal pain, particularly low back and neck pain, is a leading cause of disability and a major health problem worldwide. However, despite its high incidence, most back pain is acute and self-limited, requiring minimaly treatment. Chronic nonmalignant back pain is defined as pain lasting 3 - 6 months or more that is not due to cancer.

Chronic back pain may be due to a variety of causes, such as neuropathy/neuralgia, arthritis, injury or disorders (e.g., cervical stenosis, degenerative disc disease, other disc disorders), fibromyalgia, reflex sympathetic dystrophy, multiple sclerosis, lupus, and other systemic autoimmune/connective tissue conditions (ECRI, 2008b). Facet and epidural injections can be utilized to diagnose and treat back (spinal) pain.

Facet or zygapophysial joints have long been considered a common source of chronic back pain.

Facet joint syndrome is a condition that some experts believe causes chronic spinal pain. The diagnosis of facet joint syndrome is one of exclusion, since there are no historical, physical, or imaging studies that are diagnostic of facet joint pain. The classic findings of facet joint syndrome are pain in the cervical or thoracic spine or low back radiating to the buttock and posterior thigh, pain due to hyperextension, pain on palpation of joint, and absence of both radiculopathy below the knee and neurologic deficits.

According to the International Association for the Study of Pain (IASP), facet joints may be the Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline source of chronic pain in 15% to 45% of patients with chronic low back pain, 36% to 60% of patients with chronic neck pain, and 34% to 48% of patients with thoracic pain (ECRI, 2008a).

Facet joint injections (sometimes called blocks) are commonly used to alleviate back pain caused by facet joint syndrome. They are also used to determine whether the facet joint is a source of pain.

Injection therapy for back pain from any cause helps the patient maintain ambulatory or outpatient treatment status, maintain participation in physical or rehabilitation therapy, decrease the need for other analgesics, and avoid or delay surgery (ECRI, 2008a). Injections are usually fluoroscopically guided; however, ultrasound, or CT-guided imaging may also be used to visualize the facet joint space and localize the needle within it. Once a facet joint is pinpointed as a source of pain, therapeutic injections of anesthesia (usually lidocaine or bupivacaine) and anti-inflammatory (usually a corticosteroid) medications are given for pain relief.

Epidural steroid injections (ESI) have been used as treatment for sciatica or radicular pain of the low back and neck that is due to encroachment by bone or disc herniation. Although sciatica caused by lumbar intervertebral disc herniations often resolves with conservative treatment, it can persist and eventually require surgery. The rationale for use of epidural steroid injections is based on the presumption that inflammation may contribute to radicular pain and prevent healing. Steroids are believed to exert their effects by reducing inflammation and stabilizing hyperexcitable nerve membranes.

ESI is an outpatient procedure that usually takes approximately 30 minutes. Cervical, thoracic, and lumbar epidural injections can be performed through translaminar (also known as interlaminar) and transforaminal approaches. Lumbar injections can also be performed through a third approach, caudal injection. ESIs are normally performed under fluoroscopic or other imaging guidance to document appropriate placement of the needle. Fluoroscopic, ultrasound, or CT-guided imaging is required for all transforaminal epidural steroid injections. It is encouraged, although not required for interlaminar or caudal approaches to increase the safety and accuracy of the procedure.

Research Facet injections Diagnostic Facet Blocks: Use of diagnostic blocks with injection of local anesthesia into the facet joints or around the medial branch nerves to identify the possible sources of spinal pain appears to be an established diagnostic procedure. However, there is no gold standard for the diagnosis of facet syndrome against which the accuracy of diagnostic facet blocks can be assessed. Single blocks have been compared to what are regarded as diagnostically more valid double blocks using local anesthetic agents with different pharmacologic properties and durations of action. With double blocks, a shortand a long-acting anesthetic are used, preferably administered in a double-blind, random order on separate occasions. In a positive response, pain relief occurs with both but lasts longer with the longacting anesthetic. Compared to a single-blind, double block, Schwarzer et al. found that a single lumbar facet joint diagnostic block had a 38% false-positive rate (Schwarzer, 1994).

Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline Therapeutic Local Anesthetics and/or Corticosteroid Facet Injections: Injections with local anesthetics and/or corticosteroids into or around facet joints of the spine have not been validated as a treatment for facet joint syndrome pain. Although some uncontrolled studies have reported a wide range of pain relief from facet joint injections, controlled studies evaluating this treatment modality found that injection of local anesthetic and/or corticosteroids had little value in relieving pain in patients with chronic back pain. Lilius et al., in a randomized controlled trial that included patients with low back pain for over 3 months, compared bupivacaine and methylprednisolone acetate injected into 2 facet joints (n=28), the same mixture injected around 2 facet joints (n=39), and saline injected into 2 facet joints (n=42) (Lilius, 1989). No differences were found between the groups in return to work, pain relief, or on clinical examination. This was a reasonably well-designed trial except that the sample sizes were relatively small and the method of randomization was not described.





Carette et al. conducted a well-designed, randomized controlled trial that included patients with low back pain of at least 6 months duration (Carette, 1991). Patients were assigned to receive either facet joint injection with methylprednisolone acetate (n=49) or saline (n=48). At 1 and 3 months after the injections, the 2 groups did not differ on measures of pain relief, functional status, or back flexion. At 6 months, those who received corticosteroid injections reported more improvement, less pain, and less physical disability, but this might have been explained in part by more use of other concurrent interventions.

Jackson randomized patients with pain for a mean of 3.5 months (range, 1 to 12 months) to lumbar facet joint injection with either lidocaine (n=12) or saline (n=13) and found no differential effect on pain scores (Jackson, 1992). The major weakness of this trial was that its sample size was too small.

Revel et al. conducted a randomized study of 80 patients with low back pain to receive facet injections of lidocaine or saline (Revel, 1998). The investigators indicated that lidocaine gave greater pain relief than saline.

Very few relevant new studies on facet joint injection were identified that were published after 2000.

Most of the articles published since those times have been review articles or uncontrolled case series.

Nelemans et al. systematically reviewed the Medline and Embase databases for randomized controlled trials evaluating the effectiveness of injection therapy in patients with low back pain (Nelemans, 2001). Their search criteria captured articles published prior to 1998 and included 21 randomized trials. They concluded that evidence and long-term outcome data is lacking to support the efficacy of injections therapy for chronic low back pain.

Mayer et al. conducted a randomized controlled trial to investigate the use of facet injections as an adjunct to lumbar exercises in 70 patients with lumbar segmental rigidity (Mayer, 2004). Patients were assigned to facet injections and exercise (n=36) or exercise alone (n=34). A higher proportion of injection patients (87-95%) displayed range of motion improvement compared to the exercise only Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline patients (64-79%). No significant differences in self-reported pain or disability were found between the 2 groups.

A study by Shih et al. was conducted to investigate the diagnostic and clinical value of lumbar facet joint injections in 277 patients with low back pain (Shih, 2005). Good response was demonstrated in 72.1% of patients after 3 weeks, 40.7% of patients after 6 weeks, and 31.4% of patients after 12 weeks.

In a study conducted by Manchikanti et al., 100 consecutive patients with facet joint neck pain received cervical facet joint nerve blocks (Manshikanti, 2004). Ninety-two percent of patients had pain relief at 3 months, 82% had pain relief at 6 months, and 56% had pain relief at 12 months compared to baseline measurements.

Manchikanti also investigated 55 consecutive patients with thoracic facet joint pain treated with medial branch blocks (Manchikanti, 2006). Significant pain relief was achieved in 71% of patients at 3 and 6 months, 71% at 24 months, and 69% at 36 months. The investigators concluded that thoracic medial branch blocks were an effective treatment for managing thoracic facet joint pain.

In a prospective, randomized, double-blind trial by Manchikanti et al., data from a total of 60 patients were included, with 15 patients in each of 4 groups (Manchikanti, 2007). Thirty patients were in a non-steroid group consisting of Groups I (control, with lumbar facet joint nerve blocks using bupivacaine ) and II (with lumbar facet joint nerve blocks using bupivacaine and Sarapin); another 30 patients were in a steroid group consisting of Groups III (with lumbar facet joint nerve blocks using bupivacaine and steroids) and IV (with lumbar facet joint nerve blocks using bupivacaine, Sarapin, and steroids). Significant improvement in pain and functional status were observed at 3 months, 6 months, and 12 months, compared to baseline measurements. The average number of treatments for 1 year was 3.7 with no significant differences among the groups. Duration of average pain relief with each procedure was 14.8 +/- 7.9 weeks in the non-steroid group and 12.5 +/- 3.3 weeks in the steroid group, with no significant differences among the groups. Therapeutic lumbar facet joint nerve blocks with local anesthetic, with or without Sarapin or steroids, may be effective in the treatment of chronic low back pain of facet joint origin.

In addition to transient local pain at the injection sites, risks involved with facet joint injections include potential infection, hemorrhage, neurologic damage, and chemical meningitis as well as x-ray exposure from fluoroscopy.

Facet joint injections incur the general risks of bleeding, infection, local tissue damage, allergic reaction, or adverse drug effects. If needles are improperly placed, there is the possibility of intravascular injection, subarachnoid spread, and spinal anesthesia. Improper placement with percutaneous radiofrequency facet denervation risks dysesthetic pain, radicular pain, or neurologic damage (Dreyer et al., 1997).

Epidural Steroid and Facet Injections for Spinal Pain- Commercial Medical Management Guideline Professional Societies American College of Radiology (ACR): Current recommendations from the ACR regarding diagnosis of causes of chronic back pain state that facet injection is useful for patients with multilevel disease diagnosed by any imaging modality to identify the specific level(s) producing symptoms (Daffner, 2005).

American Society of Anesthesiologists (ASA): The ASA has not issued any statements specific to the diagnosis of facet joint syndrome or the treatment of chronic back pain due to facet joint syndrome with percutaneous radiofrequency facet denervation or injection into or around the facet joints with local anesthetics and/or corticosteroids. However, the ASA Task Force on Pain Management, Chronic Pain Section (ASA, 1997) supports the use of diagnostic local anesthetic blockade for chronic pain management (chronic pain defined as persistent or episodic pain of a duration or intensity that adversely affects the function or well-being of the patient attributable to any nonmalignant etiology). Practice guidelines issued by the Task Force state that, "Neural blockade with local anesthetic, including somatic and autonomic blocks, may be useful in determining the site and etiology of chronic pain" (ASA, 1997). The guidelines also recommend that multiple modalities (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. The guidelines list local anesthetic as an example of neural blockade.

According to the ASA practice guidelines, there is insufficient data regarding the prognostic value of neural blockade before neuroablative techniques. They are supportive of neurolytic techniques in symptom management but neutral regarding the other health effects. It is important to conduct followup evaluations of pain and other heath effects at regular intervals (ASA, 1997).

American Society of Interventional Pain Physicians (ASIPP): According to the ASIPP, during the diagnostic phase, a patient may receive 2 facet joint injections at intervals of no more frequent than 1 week and preferably 2 weeks (Boswell, 2005).



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