Name of Policy Facet Joint Injections, Trigger Point Injections, and Epidural Injections of Corticosteroids and/or Local Anesthetics

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1 Name of Policy Facet Joint Injections, Trigger Point Injections, and Epidural Injections of Corticosteroids and/or Local Anesthetics Policy #: 303 Latest Review Date: August 2016 Category: Surgical Policy Grade: B Background/Definitions: As a general rule, benefits are payable under Blue Cross and Blue Shield of Alabama health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage: 1. The technology must have final approval from the appropriate government regulatory bodies; 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes; 3. The technology must improve the net health outcome; 4. The technology must be as beneficial as any established alternatives; 5. The improvement must be attainable outside the investigational setting. Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are: 1. In accordance with generally accepted standards of medical practice; and 2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient s illness, injury or disease; and 3. Not primarily for the convenience of the patient, physician or other health care provider; and 4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient s illness, injury or disease. Page 1 of 24

2 Description of Procedure or Service: Trigger point injections (TPIs) are used to treat extremely painful areas of muscle. Normal muscle contracts and relaxes when it is active. Trigger points are discrete, focal, hyperirritable spots within a taut band of skeletal muscle fibers that produce local and/or referred pain when stimulated. Tender points also produce local pain when stimulated, but lack the taut band of tissue and hyperirritability when palpated. Scar tissue, loss of range of motion, and weakness may develop over time. Injection of an anesthetic agent or botulinum toxin into trigger points and tender points is being evaluated for the management of a variety of pain syndromes. TPIs are used to alleviate myofascial pain syndrome (chronic pain involving tissue that surrounds muscle) that does not respond to other treatment, although there is some debate over its effectiveness. Many muscle groups, especially those in the arms, legs, lower back, and neck, are treated by this method. TPIs also can be used to treat fibromyalgia and tension headaches. During trigger point injections, the patient may be positioned in a recumbent position for the prevention of syncope, assistance in patient relaxation, and decreased muscle tension. The trigger point must then be identified correctly. The palpable band is considered critical in the identification of the trigger point. The physician may mark the trigger point depending on his or her preference. Then, the skin is prepared in a sterile fashion. One common skin preparation technique is to cleanse the skin with a topical alcohol solution followed by a preparation with povidone-iodine. Once the skin is prepared and the trigger point is identified, the overlying skin is grasped between the thumb and index finger or between the index and middle finger. The needle is inserted approximately 1 to 1.5 cm away from the trigger point to facilitate the advancement of the needle into the trigger point at a 30 angle. A fast-in, fast-out technique should be used to elicit a local twitch response (LTR). After entering the trigger point, the needle should be aspirated to ensure that a local blood vessel has not been violated. If the physician chooses to inject an agent, a small volume should be injected at this time. Injection of medication inactivates the trigger point and thus alleviates pain. Dry-needling, not to be confused with acupuncture, without anesthetic or saline can also be effective. The therapeutic effect of dry needle stimulations relies on mechanical disruption or direct stimulation of trigger points. Trigger point injections may be given in sets (i.e., several injections in one setting). Sustained relief usually is achieved with a brief course of treatment. The injection may cause a twitch or pain that lasts a few seconds to a few minutes. Epidural steroid injections (ESIs) with or without local anesthetics have been endorsed by the North American Spine Society and the Agency for Health Care Policy and Research as a part of nonsurgical management of radicular pain from lumbar spine disorders. ESIs are a treatment for back pain that has not responded to conservative measures. Local steroid injections may improve pain by reducing inflammation, thus relieving pressure on nerve roots or other structures that may be the origin of pain. Page 2 of 24

3 Radicular pain is the result of a nerve root lesion or inflammation. Symptoms of radiculopathy include pain that radiates down the leg to below the knee, numbness, weakness, and lack of reflexes in a dermatomal distribution. ESIs have been recommended to deliver steroids in a more localized fashion to the area of affected nerve roots, thereby decreasing the systemic effect of the administered steroid. Studies have indicated that ESIs are most effective in the presence of acute nerve root inflammation. Clinical manifestations of nerve root inflammation include some or all of the following: radicular pain, dermatomal hypesthesia or hyperesthesia, weakness of muscle groups innervated by the involved nerve roots, diminished deep tendon reflexes, and positive straight leg-raising tests. Conservative management is the first-line treatment for most patients with back pain. Nonsteroidal anti-inflammatory drugs or other analgesics are used for symptom relief. These agents should be used for at least several weeks at a dose sufficient to induce a therapeutic response. Additionally, modification of activity in conjunction with some form of exercise therapy is frequently prescribed early in the course of symptoms and typically involves a physical therapist. For patients with persistent nonradicular back pain, current guidelines recommend interdisciplinary rehabilitation, which is defined as an integrated approach using physical rehabilitation in conjunction with a psychological or psychosocial intervention. Epidural injection therapy is one of several second-line therapies available for patients who fail conservative treatment and is one of the most common modalities used in this group of patients. Epidural steroid injections (ESIs) are performed by inserting a needle into the space between the dura and ligamentum flavum and injecting a steroid preparation. There is considerable variability in the technical aspects of epidural injections. Several different approaches may be used for entering the epidural space (translaminar, transforaminal, caudal). In addition, ESIs may be administered with or without fluoroscopic guidance. For example, a national survey published in 2002 reported that 30% of academic institutions and 77% of private practices use fluoroscopy. Some authors have estimated that lack of correct needle position in the epidural space may occur in 25% or more of injections administered. Variability of technique may also involve factors such as the depth of injection into the epidural space, volume of injectate, and the filling patterns of the injectate. ESIs can provide both diagnostic and therapeutic benefits. Diagnostically, ESIs may help identify the region and spinal column of potential pain generation through pain relief after local anesthetic injection to the site of presumed anatomic pathology. In addition, if the patient receives several weeks or more of pain relief, then it may be reasonable to assume that an element of inflammation was involved in his or her pathophysiology. This last element of diagnostic information is also the therapeutic element. Since prolonged pain relief is presumed to be due to a reduction in an inflammatory process, it is also reasonable to assume that during the prolonged pain relief, the affected nerve roots are also relatively protected from the deleterious effects of inflammation. Treatment is generally given as one to three injections, each performed at least one month apart. Some experts recommend no more than three (3) injections in a 12-month period, owing to concerns about the adverse events of chronic steroid administration, both locally and systemically. However, other experts believe that up to six injections per year are safe. See Page 3 of 24

4 Clinical Input Received from Physician Specialty Societies and Academic Medical Centers section for detailed information. Intradiscal injection is performed for both diagnostic and therapeutic purposes. For diagnostic reasons, a local anesthetic is used to temporarily block pain within a disc and determine if the pain is coming from that particular disc. For therapeutic reasons, a steroid is injected to decrease inflammation within a disc. The steroid usually takes two to three days to relieve pain. Note: Facet joint injections are addressed separately in medical policy, #141 Treatment Modalities for Facetogenic Pain. Policy: Effective for dates of services on or after May 16, 2016: Trigger Point Injections Trigger point injections, including dry needling (i.e., injections in several trigger points in one sitting) meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage for chronic neck or back pain or myofascial pain syndrome when: Trigger points have been identified by palpation on physical examination; and Symptoms have persisted despite failure of low grade conservative therapies (i.e., heating or cooling modalities, NSAIDS, analgesics); and In the treatment or therapeutic phase, further injections are covered only if the previous diagnostic injections provided at least 50% relief of pain. Use of corticosteroids in more than four injections during a set of trigger point injections does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Additional trigger point injections, including dry needling do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when the patient does not experience symptom relief. Ultrasound guidance and/or diagnostic ultrasound of trigger points prior to or concurrent with trigger point injections, including dry needling does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Epidural Injections of Corticosteroids Epidural injections of corticosteroids with or without an anesthetic agent performed with imaging guidance meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when: Pain symptoms have been evaluated by physical examination, EMG, or radiographic imaging; and Except in cases of acute disc injury documented on imaging studies, patient s pain symptoms have failed to improve after at least two weeks of conservative therapy* Page 4 of 24

5 Up to 6 epidural injections within a 12 month period meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Epidural injections of corticosteroids with or without an anesthetic agent performed without imaging guidance do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Multiple epidural injections performed at the same spinal level through various approaches (i.e., interlaminar or transforaminal) on the same date of service do not meet Blue Cross and Blue Shield of Alabama medical criteria for coverage and are considered investigational. Simultaneous treatment of 2 vertebral levels meets Blue Cross and Blue Shield of Alabama medical criteria for coverage if criteria are met at each level. Simultaneous treatment of more than 2 vertebral levels does not meet Blue Cross and Blue Shield of Alabama medical criteria for coverage and is considered investigational. Additional injections will be covered on an individual case basis if the patient sustains an additional acute injury. Medical records must clearly document date, type, and location of injury. The use of fluorography (imaging of the epidural space) as a component of epidural steroid injections does not meet Blue Cross and Blue Shield of Alabama medical criteria for coverage is considered investigational. Above coverage requirements do not apply to epidural injections performed for pain management during labor/delivery or surgical procedures or for post-operative pain. Intradiscal injections of steroids or other substances do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered investigational. *Conservative therapy is the use of structured physician-directed modalities which may include: prescription strength analgesics/anti-inflammatory medications if not contraindicated; participation in physical therapy modality(ies) when rendered by an eligible provider (including active exercise). Effective for dates of service on or after October 23, 2014 and prior to May 16, 2016: Trigger Point Injections Trigger point injections, including dry needling (i.e., injections in several trigger points in one sitting) meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage for chronic neck or back pain or myofascial pain syndrome when: Trigger points have been identified by palpation on physical examination; and Symptoms have persisted despite failure of low grade conservative therapies (i.e., heating or cooling modalities, NSAIDS, analgesics); and Page 5 of 24

6 In the treatment or therapeutic phase, further injections are covered only if the previous diagnostic injections provided at least 50% relief of pain. Use of corticosteroids in more than four injections during a set of trigger point injections does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Additional trigger point injections, including dry needling do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when the patient does not experience symptom relief. Ultrasound guidance and/or diagnostic ultrasound of trigger points prior to or concurrent with trigger point injections, including dry needling does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Epidural Injections of Corticosteroids Epidural injections of corticosteroids with or without an anesthetic agent performed with imaging guidance meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when: Pain symptoms have been evaluated by physical examination, EMG, or radiographic imaging; and Except in cases of acute disc injury documented on imaging studies, patient s pain symptoms have failed to improve after at least two weeks of conservative therapy.* Up to 4-6 epidural injections (per region i.e. cervical, thoracic, lumbar, or sacral) within a 12 month period meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Epidural injections of corticosteroids with or without an anesthetic agent performed without imaging guidance do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Multiple epidural injections performed at the same spinal level through various approaches (i.e., interlaminar or transforaminal) on the same date of service do not meet Blue Cross and Blue Shield of Alabama medical criteria for coverage and are considered investigational. Additional injections will be covered on an individual case basis if the patient sustains an additional acute injury. Medical records must clearly document date, type, and location of injury. Above coverage requirements do not apply to epidural injections performed for pain management during labor/delivery or surgical procedures or for post-operative pain. Intradiscal injections of steroids or other substances do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered investigational. *Conservative therapy is the use of structured physician-directed modalities which may include: prescription strength analgesics/anti-inflammatory medications if not contraindicated; Page 6 of 24

7 participation in physical therapy modality(ies) when rendered by an eligible provider (including active exercise). Effective for dates of service on or after January 1, 2010 and prior to October 23, 2014: Trigger Point Injections Trigger point injections (i.e., injections in several trigger points in one sitting) meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage for chronic neck or back pain or myofascial pain syndrome when: Trigger points have been identified by palpation on physical examination; and Symptoms have persisted despite failure of conservative therapies (i.e., heating or cooling modalities, NSAIDS, analgesics); and In the treatment or therapeutic phase, further injections are covered only if the previous diagnostic injections provided at least 50% relief of pain. Use of corticosteroids in more than four injections during a set of trigger point injections does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Additional trigger point injections do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when the patient does not experience symptom relief. Ultrasound guidance and/or diagnostic ultrasound of trigger points prior to or concurrent with trigger point injections does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Epidural Injections of Corticosteroids Epidural injections of corticosteroids with or without an anesthetic agent performed with imaging guidance meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when: Pain symptoms have been evaluated by physical examination, EMG, or radiographic imaging; and Except in cases of acute disc injury documented on imaging studies, patient s pain symptoms have failed to improve after at least two weeks of conservative therapy, (e.g., rest, systemic analgesics, systemic steroids, physical/chiropractic therapy, etc.). Up to 4-6 epidural injections (per region i.e. cervical, thoracic, lumbar, or sacral) within a 12 month period meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Epidural injections of corticosteroids with or without an anesthetic agent performed without imaging guidance do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage. Additional injections will be covered on an individual case basis if the patient sustains an additional acute injury. Medical records must clearly document date, type, and location of injury. Page 7 of 24

8 Above coverage requirements do not apply to epidural injections performed for pain management during labor/delivery or surgical procedures or for post-operative pain. Sacroiliac (SI) Joint Injections Injection into the sacroiliac joint for diagnostic or therapeutic purposes meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage when all the following criteria are met: Performed under imaging guidance; and Somatic or nonradicular low back and lower extremity pain below the level of L5 vertebra; and Duration of pain of at least 3 months; and Average pain levels of >6 on a scale of 0 to 10; and Intermittent or continuous pain causing functional disability; and Failure to respond to more conservative management, including physical therapy modalities with exercises, chiropractic management, and non-steroidal anti-inflammatory agents; and Lack of obvious evidence for disc-related or facet joint pain; and No contraindications with understanding of consent, nature of the procedure, needle placement, or sedation; and No history of allergy to contrast administration, local anesthetics, steroids, or other drugs potentially utilized; and Contraindications or inability to undergo physical therapy, chiropractic management, or inability to tolerate non-steroidal anti-inflammatory drugs; and For therapeutic sacroiliac joint interventions with intra-articular injections or radiofrequency neurotomy, the joint should have been positive utilizing controlled diagnostic blocks. Arthrography of the sacroiliac joint does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Intradiscal injections of steroids or other substances do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered investigational. Blue Cross and Blue Shield of Alabama does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. Blue Cross and Blue Shield of Alabama administer benefits based on the member s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination. Page 8 of 24

9 Key Points: Trigger Point Injections Trigger points are discrete, focal, hyperirritable spots located in a taut band of skeletal muscle. They produce local and/or referred pain when stimulated. Dry needling refers to a procedure whereby a fine needle is inserted into the trigger point to induce a twitch response and relieve the pain. Injection of an anesthetic agent into the trigger points is also being evaluated for the treatment of myofascial pain. Acute trauma or repetitive microtrauma may lead to the development of stress on muscle fibers and the formation of trigger points. Patients may have regional, persistent pain resulting in a decreased range of motion in the affected muscles. These include muscles used to maintain body posture, such as those in the neck, shoulders, and pelvic girdle. Trigger points may also manifest as tension headache, tinnitus, temporomandibular joint pain, decreased range of motion in the legs, and low back pain. Although the pain is usually related to muscle activity, it may be constant. It is reproducible and does not follow a dermatomal or nerve root distribution. Patients report few systemic symptoms, and associated signs such as joint swelling and neurologic deficits are generally absent on physical examination. Palpation of a hypersensitive bundle or nodule of muscle fiber of harder than normal consistency is the physical finding typically associated with a trigger point. Palpation of the trigger point will elicit pain directly over the affected area and/or cause radiation of pain toward a zone of reference and a local twitch response. Trigger-point injection has been shown to be one of the most effective treatment modalities to inactivate trigger points and provide prompt relief of symptoms. In comparative studies, dry needling was found to be as effective as injecting an anesthetic solution such as procaine (Novocain) or lidocaine (Xylocaine). However, postinjection soreness resulting from dry needling was found to be more intense and of longer duration than the soreness experienced by patients injected with lidocaine. Repeated injections in a particular muscle are not recommended if two or three previous attempts have been unsuccessful. Patients are encouraged to remain active, putting muscles through their full range of motion in the week following trigger-point injections, but are advised to avoid strenuous activity, especially in the first three to four days after injection. Myofascial Pain Syndrome Myofascial pain syndrome is a chronic regional pain disorder caused by the activation of at least 1 active trigger point in a muscles, tendons, or muscle fascia. It can cause local or referred pain, tightness, tenderness, stiffness and limitation of movement, muscle weakness, and often autonomic phenomena. The severity of symptoms and degree of functional impairment is variable. Some individuals will have few trigger points with mild symptoms and no functional impairment, while others will have multiple satellite trigger points, pain that is widespread and severe, and major functional impairments. Conditions that can lead to myofascial pain syndrome include chronic repetitive minor muscle strain, poor posture, systemic disease, strain, sprain, enthesopathy, or arthritis. Management of chronic myofascial pain typically includes behavioral and pharmacologic approaches and physical therapy. Injection of a local anesthetic or botulinum toxin has also been reported. Page 9 of 24

10 The evidence on trigger point injections for myofascial pain syndrome includes randomized controlled trials (RCTs). Randomized Controlled Trials Lidoocane Injection Compared to Physical Therapy A 2016 RCT by Lugo et al evaluated the efficacy of lidocaine injection and physical therapy (PT) to treat myofascial pain syndrome. Strengths of this study included the randomization procedures, power analysis, and assessor blinding. Patients (N=127) with shoulder girdle myofascial pain syndrome for at least 6 weeks and visual analog scale (VAS) scores for pain greater than 40 mm received PT, a single injection of lidocaine, or both treatments together. The primary outcome (VAS pain rating at 1 month) was not significantly different across the 3 groups (PT, 37.8; lidocaine, 44.2; combined therapy, 40.8). Most of the secondary outcome measures (measures of function, depression, quality of life) were also similar across groups. Lidocaine Injection Compared to Lidocaine or Placebo Patch A 2009 RCT with 60 patients compared use of a lidocaine patch, placebo patch, or lidocaine infiltration for the treatment of myofascial pain syndrome. Strengths of this study included allocation concealment for the lidocaine and placebo patches, blinded evaluation, and sample size calculations for adequate power. Similar reductions in in pain and pain thresholds with the 2 lidocaine treatments were reported, but significantly less discomfort was associated with the lidocaine patch than with injection (p<0.001). With the lidocaine patch, pain decreased from 84.0 to 17.25; with lidocaine injection, pain decreased from to (baseline vs post-treatment p<0.001; scale range, 0-100). With the placebo patch, pain on movement remained unchanged (78.35 at baseline vs at day 9). Lidocaine Injection Compared to Dry Needling or Sham Stimulation In 2014, Couto et al reported a sham-controlled, double-blind RCT with 78 patients that compared trigger point injections to lidocaine, paraspinal intramuscular stimulation, and sham stimulation. Study strengths included intention-to-treat analysis, adequate power, and Bonferroni correction for multiple comparisons. Lidocaine 0.2-to-0.5 ml was injected with each needle penetration when a visible local twitch response was evoked. Paraspinal dry needling was applied in the spinal segment of the nerve roots associated with the dermatome, myotome, or sclerotome where the trigger points were found. The placebo control used an electroacupuncture device with no current passing through the electrodes. At baseline, VAS scores were similar across the 3 groups, with mean scores ranging from 6.59 to 6.66 out of 10. All 3 groups improved over time for the primary outcomes of pain and pain threshold. Outcomes were significantly better for both intervention groups than for sham, although the difference in VAS scores between the lidocaine injection group and sham stimulation was only 1.01 on a scale of 10. Local anesthetic (n=35) injected into a trigger point was compared to dry needling (n=23) in the upper trapezius muscle in a 1994 study by Hong et al. For the lidocaine injection, a needle was inserted into the trigger point with in-and-out movement within the subcutaneous tissue (20-60 insertions), with a drop of anesthetic released each time the needle was inserted into the taught band. This procedure was followed by stretching exercises at home. Dry needling was performed in the same manner but without administration of lidocaine. Twenty-six (74%) patients treated Page 10 of 24

11 with local anesthetic and 15 (65%) with dry needling exhibited a local twitch response and were included in the analysis. Pain intensity at baseline, measured by a 0-to10 numeric pain scale score, was similar for both groups (lidocaine, 7.88; dry needling, 7.80). All patients who had a local twitch response reported minimal-to-no pain immediately postprocedure. Two weeks posttreatment, pain intensity remained low in the lidocaine group (0.96), which was significantly lower than the dry needling group (4.98). Blinded evaluation found no significant differences between groups for pain threshold or range of motion. Epidural Injections of Corticosteroids and/or Local Anesthetic Agents Epidural injections in the cervical, thoracic, and lumbosacral spine were developed to diagnose and treat spinal pain. Information obtained from epidural injections can be helpful in confirming pain generators that are responsible for a patient's discomfort. Structural abnormalities do not always cause pain and diagnostic injections can help to correlate abnormalities seen on imaging studies with associated pain complaints. In addition, epidural injections can provide pain relief during the recovery of disc or nerve root injuries and allow patients to increase their level of physical activity. Because severe pain from an acute disc injury with or without radiculopathy often is time-limited, therapeutic injections help to manage pain and may alleviate or decrease the need for oral analgesics. The evidence base on the efficacy of epidural steroid injections (ESIs) for back pain is large, with many randomized controlled trials (RCTs) published. In addition to the RCTs, there have been numerous systematic reviews of RCTs published. This literature review will therefore concentrate on a representative sample of the available systematic reviews of RCTs, emphasizing those published most recently. In 2012, Benyamin et al published a systematic review that included RCTs and non-rcts of epidural injections in patients with low back pain and/or leg pain. There were 19 studies that met the inclusion criteria. Most of these trials (13/19) compared epidural steroids with an active control and five of 19 used a placebo control. A qualitative summary of studies was performed, without any quantitative meta-analysis. Subgroup analysis was performed on studies that included patients with disc herniation and radiculopathy. The authors also separated the intervention into studies that used fluoroscopic guidance. Of the eight studies that used fluoroscopic guidance, all reported short-term results that favored ESIs. Among four trials that reported longer term follow-up at one year, results from two were positive and two were negative. In 2009, Chou et al reviewed the evidence for ESIs in the treatment of low back pain with radiculopathy, as part of their examination of nonsurgical interventional therapies for low back pain. The authors identified 17 RCTs reporting on short-term benefit, and four RCTs reporting on longer term benefit. For short-term benefits, the results were mixed. A total of 10 of 17 trials reported no benefit for ESIs, and seven of 17 reported a statistically significant benefit. Of the seven trials that were rated higher quality, four of seven reported a benefit for ESIs and three of seven reported no benefit. Subgroup analysis by type of placebo control (epidural or soft-tissue injection) revealed that most trials using a soft-tissue control injection (5/6) reported a benefit, while most of the trials using an epidural control injection (9/11) reported no benefit. Other Page 11 of 24

12 subgroup analyses based on duration of symptoms, use of imaging to confirm prolapsed disc, and study quality did not show any significant differences. A systematic review by Manchikanti et al in 2012 identified 13 RCTs that evaluated ESIs for the treatment of lumbar radiculopathy. Two of these trials compared epidural steroids with placebo and the remaining compared epidural steroids with an active control. No pooled analysis was performed. The authors reported that most of the trials reported positive effects associated with ESIs for both short- and long-term pain relief. Several individual RCTs have been completed since publication of the most recent systematic reviews. These trials have corroborated the results of previous research, generally reporting a small benefit for treatment with ESI. The largest of these trials was a double-blind, shamcontrolled study that compared ESI with gabapentin in 145 patients with lumbar radiculopathy. There were no differences between groups for the primary outcome of change in pain scores. At one month, the change in pain scores in the ESI group was -2.2 (SD=2.4) versus -1.7 (SD=2.6) in the gabapentin group (p=0.25); at three months, the change in pain scores were -2.0 (SD=2.6) in the ESI group versus -1.6 (SD=2.7) in the gabapentin group (p=0.43). ESI was superior to gabapentin on some secondary outcomes at one month (e.g., percent successful outcome, 66% in ESI group vs 46% in gabapentin group; p=0.02); however, at three months, these differences were no longer significant. In the RCT with the longest follow-up of two years, 120 patients were randomized to ESI or sham control. Primary outcome measures were at least 50% improvement on the Oswestry Disability Index and the numeric pain rating scale. There were no differences between groups reporting a good response, with 57% in the ESI group and 65% in the sham group reporting at least 50% improvement at two years (p=ns). Another RCT randomized 63 patients from general medical practices in the Netherlands to usual care or usual care plus one injection of ESI. The main outcomes were change in numeric pain scores and the Roland-Morris Disability Questionnaire (RMDQ) score. A small, statistically significant difference was found in favor of the ESI group on both outcomes, but was considered too small to be clinically relevant. The use of fluoroscopy for diagnostic and therapeutic epidural injections is commonly recommended for several reasons. As early as 1980, studies were published showing that needle placement without fluoroscopy during epidural injections was incorrect 25% of the time in experienced hands. Deer states in his 2004 American Society of Anesthesiologists (ASA) Refresher Course that in 25% to 35% of the patients, the doctor did not reach the correct location using blind technique when entering the epidural space by the translaminar or caudal route. The success of the blind technique decreases to around 50% in the cervical spine. Based on this information, the author recommends using fluoroscopic imagery whenever possible for performing any spinal injection technique. This becomes the standard of care when performing facet joint, and transforaminal injections, discography, and implantable therapies. Campbell s Operative Orthopaedics recommends the use of fluoroscopy for diagnostic and therapeutic epidural injections. Epidural injections performed without fluoroscopic guidance are Page 12 of 24

13 not always made into the epidural space or the intended interspace. Even in experienced hands, needle misplacement occurs in up to 40% of caudal and 30% of lumbar epidural injections when done without fluoroscopic guidance. Accidental intravascular injections can occur also, and the absence of blood return with needle aspiration before injection is not a reliable indicator of this complication. In the presence of anatomical anomalies, such as a midline epidural septum or multiple separate epidural compartments, the desired flow of epidural injectants to the presumed pain generator will be restricted and remain undetected without fluoroscopy. In addition, if an injection fails to relieve pain, it would be impossible without fluoroscopy to determine whether the failure was caused by a genuine poor response or by improper needle placement. Safety Potential adverse effects of epidural steroid injections can include complications of the injections itself, such as inadvertent puncture of the dura, bleeding, and infections. Additional complications may be related to the administration of steroids including suppression of the hypothalamic-pituitary axis and the immune system. In the systematic review by Chou et al, it was noted that while there are case reports in the literature of serious adverse events (SAEs) such as paralysis and infection due to epidural injections, SAEs were rarely reported in the clinical trials. Of the 17 trials included in the review that reported on the use of epidural injections for treatment of low back pain with radiculopathy, 10 of 17 did not report adverse effects at all, and the adverse effects reported in the other trials were generally transient and mild. In one high-quality trial with systematic reporting of AEs, 3.3% of patients (4/120) experienced a postinjection headache, 0.8% (1/120) experienced post dural puncture headache, 1.7% (2/120) experienced postinjection nausea, and 4.2% (5/120) experienced other AEs. In 2014, FDA issued a drug safety communication on rare but serious neurologic problems associated with ESIs. This communication stated that the safety of ESIs has not been established and that FDA has not approved corticosteroids for this use. Potential serious adverse neurologic events include loss of vision, stroke, paralysis, and death. The FDA subsequently assembled an expert panel that issued a report in This report included a series of recommendations regarding the ESI technique, including clinically relevant issues related to its performance, such as the use of particulate steroids, use of contrast, and use of sedation. Intradiscal Injections There is no convincing evidence that intradiscal glucocorticoids are effective for low back pain. In patients with MRI evidence of degenerative disc disease and a positive response to discography, two trials found no difference between intradiscal steroid and control injection (saline or local anesthetic). A third trial found that in patients with degenerative disc disease who failed an epidural steroid injection, intradiscal steroid injection was superior to discography alone only in the subgroup of patients with inflammatory endplate changes on MRI. However, outcomes were not well defined in this trial and levels of statistical significance were poorly reported. Based on these trials, the American Pain Society guideline recommends against intradiscal glucocorticoid injection for chronic low back pain. Page 13 of 24

14 Tumor necrosis factor (TNF)-alpha has been implicated in the pathogenesis of radiculopathy and discogenic back pain. A small pilot study showed that intradiscal injections of etanercept (interferes with TNF-alpha) did not improve pain or disability scores for patients with lumbosacral radiculopathy or chronic discogenic low back pain Methylene blue is a compound used as a dye or stain which has been studied for various therapeutic purposes. A randomized trial (n = 72) found intradiscal injection of methylene blue for patients with discography-positive, presumed discogenic back pain associated with large improvements in pain (about 40 points on a 100-point pain scale) and function (about 35 points on the 0 to 100 Oswestry Disability Index) compared with a placebo intradiscal injection, with no adverse events such as increased pain, radiculopathy, or infection. However, a smaller (n = 24) randomized trial found no difference between intradiscal methylene blue versus a placebo intradiscal injection in pain or function after one month, and over half of the patients treated with methylene blue reported severe pain immediately after the injection. Longer-term results are not yet available, although the trial is designed to follow patients for one year. Kallewaard and colleagues stated that an estimated 40 % of chronic lumbosacral spinal pain is attributed to the discus intervertebralis. Degenerative changes following loss of hydration of the nucleus pulposus lead to circumferential or radial tears within the annulus fibrosus. Annular tears within the outer annulus stimulate the ingrowth of blood vessels and accompanying nociceptors into the outer and occasionally inner annulus. Sensitization of these nociceptors by various inflammatory repair mechanisms may lead to chronic discogenic pain. The current criterion standard for diagnosing discogenic pain is pressure-controlled provocative discography using strict criteria and at least one negative control level. The strictness of criteria and the adherence to technical detail will allow an acceptable low false-positive response rate. The most important determinants are the standardization of pressure stimulus by using a validated pressure monitoring device and avoiding overly high dynamic pressures by the slow injection rate of 0.05 ml/s. A positive discogram requires the reproduction of the patient's typical pain at an intensity of greater than 6/10 at a pressure of less than 15 psi above opening pressure and at a volume less than 3.0 ml. Perhaps the most important and defendable response is the failure to confirm the discus is symptomatic by not meeting this strict criteria. Various interventional treatment strategies for chronic discogenic LBP unresponsive to conservative care include reduction of inflammation, ablation of intradiscal nociceptors, lowering intra-nuclear pressure, removal of herniated nucleus, and radiofrequency ablation of the nociceptors. Unfortunately, most of these strategies do not meet the minimal criteria for a positive treatment advice. In particular, singleneedle radiofrequency thermo-coagulation of the discus is not recommended for patients with discogenic pain (2 B-). Interestingly, a little used procedure, radiofrequency ablation of the ramus communicans meets the (2 B+) level for endorsement. The authors concluded that there is currently insufficient proof to recommend intradiscal electrothermal therapy (2 B±) and intradiscal biacuplasty. It is advised that ozone discolysis, nucleoplasty, and targeted disc decompression should only be performed as part of a study protocol; future studies should include more strict inclusion criteria. In a systematic review and meta-analysis of RCTs, Magalhaes et al evaluated the therapeutic results of percutaneous injection of ozone for LBP secondary to disc herniation. A comprehensive literature search was conducted using all electronic databases from 1966 through Page 14 of 24

15 September The quality of individual articles was assessed based on the modified Cochrane review criteria for randomized trials and criteria from the Agency for Healthcare Research and Quality. The outcome measure was short-term pain relief of at least six months or long-term pain relief of more than six months. A total of eight observational studies were included in the systematic review and four randomized trials in the meta-analysis. The indicated level of evidence for long-term pain relief was II-3 for ozone therapy applied intradiscally and II-1 for ozone therapy applied paravertebrally. The grading of recommendation was 1C for intradiscal ozone therapy and 1B for paravertebral ozone therapy. The authors concluded that ozone therapy appears to yield positive results and low morbidity rates when applied percutaneously for the treatment of chronic LBP. The main drawbacks of this review were the lack of precise diagnosis and the frequent use of mixed therapeutic agents. The meta-analysis included mainly activecontrol trials. No placebo-controlled trial was found. Clinical Input Received from Physician Specialty Societies and Academic Medical Centers Trigger Point Injections Clinical input obtained in 2016 from 3 academic medical centers and 4 specialty societies (9 reviewers) considered trigger point injections to be medically necessary for select patients with myofascial pain syndrome who had failed conservative therapy, when administered as part of a comprehensive therapy program. Epidural Injections There are several aspects of epidural steroid injection therapy that are not standardized. Expert opinion was sought through clinical vetting on the following issues: The optimal time for assessing a response to epidural steroid injections. Expert opinion supports that response can be assessed anytime from immediately to several weeks after the procedure, with the most popular time to assess response being 1 to 2 weeks after injection. The definition of a clinically significant response to injections. Expert opinion supports that a reasonable definition of response is at least a 20-point improvement on a 0-to-100 visual analog scale, or an improvement of at least 50% in functional status, when measured using a validated scale. The maximum number of injections in one (1) year. There is no agreement on the maximum number of injections that should be given in one (1) year. Some experts agree that no more than three injections should be given in one (1) year, but other experts believe that more than three per year can be used safely. None of the expert opinion supported more than six injections given over a 12-month period. Practice Guidelines and Position Statements Agency for Healthcare Research and Quality (AHRQ) The Agency for Healthcare Research and Quality issued an evidence-based practice center systematic review protocol in Pain Management Injection Therapies for Low-Back Pain states that between 1994 and 2001, the use of epidural injections increased by 271 percent and face joint injections increased by 231 percent among Medicare beneficiaries. Despite these dramatic increases, use of injection therapies for low back pain remains controversial. Systematic reviews of injection therapies have come to conflicting conclusions regarding the benefits of Page 15 of 24

16 injection therapies, and clinical practice guidelines provide discordant recommendations regarding their use. Important challenges in conducting a review of this topic include sparse data from randomized trials for most injection therapies (with the exception of epidural steroids), inconsistency of results across trials, as well as variability across studies in the methods used to select patients for inclusion, the specific techniques used, the comparisons evaluated, and the outcomes assessed. North American Spine Society (NASS) The 2012 North American Spine Society (NASS) clinical guidelines for multidisciplinary spine care diagnosis and treatment of lumbar disc herniation with radiculopathy stated there were no studies available which directly addressed the role of ESIs or selective nerve root blocks in the diagnosis of patient selection for subsequent surgical treatment of a lumbar disc herniation with radiculopathy. In 2011, NASS revised its clinical guidelines for multidisciplinary spine care diagnosis and treatment of degenerative lumbar spinal stenosis. They made the following recommendation: a multiple injection regimen of radiographically-guided transforaminal ESI or caudal injections is suggested to produce medium-term (3 to 36 months) relief of pain in patients with radiculopathy or neurogenic intermittent claudication from lumbar spinal stenosis (grade C recommendation). NASS issued 2010 clinical guidelines for multidisciplinary spine care diagnosis and treatment of cervical radiculopathy from degenerative disorders. They made the following recommendation: Transforaminal ESIs using fluoroscopic or CT guidance may be considered when developing a medical/interventional treatment plan for patients with cervical radiculopathy from degenerative disorders. Due consideration should be given to the potential complications (grade C recommendation). The 2013 NASS issued a review and recommendation statement for lumbar transforaminal epidural steroid injections (LTFESI). The following recommendations were made: Transforaminal epidural steroid injections using fluoroscopic or CT guidance may be considered when developing a medical/interventional treatment plan for patients with cervical radiculopathy from degenerative disorders. Due consideration should be given to the potential complications. Level of evidence III. Patients with lumbar scoliotic stenosis and radiculopathy experience significantly higher success rates if their symptoms were present for less than three months. Level of evidence IV. There is no significant difference between EMG-positive and -negative groups in terms of pain difference, but a mild functional improvement in an EMG-positive patient undergoing LTFESI. Level of evidence V. In 2011 NASS issued a review and recommendation statement for cervical ESIs. The following recommendation was made: Both transforaminal and interlaminar ESIs may be considered to provide short- and long-term relief of cervical radiculitis (grade C recommendation). U.S Preventive Services Task Force Recommendations Not applicable. Page 16 of 24

17 Key Words: Trigger point injections, epidural injections of corticosteroids, epidural steroid injections, ESIs, intradiscal injections, dry needling, myofascial pain Approved by Governing Bodies: Although medications used with invasive trigger point and tender point procedures are regulated by the FDA, trigger and tender point injections are considered procedures and, as such, are not subject to regulation by FDA. Steroids are not FDA approved for use as epidural injections, such use represents off-label use of an FDA approved medication. The specific preparations used for epidural injections are steroids added to a sterile saline solution, which are prepared by a compounding pharmacy. Benefit Application: Coverage is subject to member s specific benefits. Group specific policy will supersede this policy when applicable. ITS: Home Policy provisions apply FEP contracts: Special benefit consideration may apply. Refer to member s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Current Coding: CPT Codes: Injection(s); single or multiple trigger point(s), one or two muscles ; single or multiple trigger points(s), three or more muscles Unlisted procedure, musculoskeletal system, general Injection(s), of diagnostic or therapeutic substance(s) (e.g. anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance. (Effective 01/01/17) ;with imaging guidance (Effective 01/01/17) Injection(s), of diagnostic or therapeutic substance(s) (e.g. anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, lumbar or sacral (caudal); without imaging. (Effective 01/01/17) ;with imaging guidance (i.e. fluoroscopy or CT) (Effective 01/01/17) Injection(s), anesthetic agent and/or steroid, transforaminal epidural with imaging guidance (fluoroscopy or CT); cervical or thoracic, single level Page 17 of 24