Medical Policy: 07.01.51
Original Effective Date: August 2010
Reviewed: June 2018
Revised: June 2018
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Various treatments have been advocated for headaches (migraine and non-migrain) and occipital neuralgia. Oral analgesics and anti-inflammatory agents are effective for some patients, but there is a population of patients who do not experience pain relief with these medications. For those patients who are not responsive to initial therapies other treatment modalities to include occipital nerve stimulation (ONS) have been investigated in the treatment of these conditions.
Occipital nerve stimulation is a form of neuromodulation that is reversible and adjustable and can be tailored to an individual’s specific needs. However, the mechanisms of action for the paresthesia patterns and pain relief obtained from an occipital nerve stimulation (OSN) is not completely understood. The device consists of a subcutaneously implanted pulse generator (in the chest wall or abdomen) attached to extension leads that are tunneled to join electrodes placed across one or both occipital nerves at the base of the skull. Continuous or intermittent stimulation may be used.
Prior to permanent implantation, a trial is performed in which leads are placed under the skin and are connected to an external battery. The trial period is typically 4-7 days and the patient keeps a detailed pain diary. A permanent device is considered only if the patient reports significant improvements in pain and quality of life.
There are four types of headache:
Primary (not the result of another condition) chronic headache is defined as headache occurring more than 15 days of the month for at least 3 months. An estimated 45 million Americans experience chronic headaches. For at least half of these people, the problem is severe and sometimes disabling.
Migraine is the most common type of vascular headache. Migraine headaches are usually characterized by severe pain on one or both sides of the head, an upset stomach, and, at times, disturbed vision. One- year prevalence of migraine ranges from 6%–15% in adult geno typical men and from 14%–35% in adult geno typical women. Migraine headaches may last a day or more and can strike as often as several times a week or as rarely as once every few years. Drug therapy for migraine is often combined with behavioral therapy, physical therapy, lifestyle modification (good sleep hygiene, routine meal schedules, regular exercise), and avoidance of migraine triggers. Sumatriptan is commonly used for relief of symptoms. Drugs used to prevent migraine include amitriptyline, propranolol and other beta-blockers, topiramate and other antiepileptic drugs, and verapamil.
Hemicrania continua causes moderate pain with occasional severe pain on only one side of the head. At least one of the following symptoms must also occur; conjunctival injection and/or lacrimation, nasal congestion and/or rhinorrhea, or ptosis and/or miosis. Headache occurs daily and is continuous with no pain-free periods. Hemicrania continua occurs mainly in woman, and its true prevalence is not known. Indomethacin usually provides rapid relief of symptoms. Other NSAIDs, including ibuprofen, celecoxib, and naproxen, can provide some relief from symptoms. Amitriptyline and other tricyclic antidepressants are effective in some patients.
Cluster headache occurs in cyclical patterns or clusters of severe or very severe unilateral orbital or supraorbital and/or temporal pain. The headache is accompanied by at least one of the following autonomic symptoms: ptosis (drooping eyelid), conjunctival injection, lacrimation, rhinorrhea, and, less commonly, facial blushing, swelling, or sweating. Bouts of one headache every other day to 8 attacks per day may last from weeks to months, usually followed by remission periods when the headache attacks stop completely. The pattern varies from one person to another, but most people have one or two cluster periods a year. During remission, no headaches occur for months, and sometimes even years. The intense pain is caused by the dilation of blood vessels, which creates pressure on the trigeminal nerve. While this process is the immediate cause of the pain, the etiology is not fully understood. It is more common in men than in woman. One-year prevalence is estimated to be 0.5 to 1.0/1,000. Management of cluster headache consists of abortive and preventive treatment. Abortive treatments include subcutaneous injection or intranasal sumatriptan, or topical anesthetics sprayed into the nasal cavity. Some patients respond to rapidly inhaled pure oxygen. A variety of other pharmacologic and behavioral methods of aborting and preventing attacks have been reported with wide variation in patient response.
Two systematic reviews of the literature on occipital nerve stimulation (ONS) were published in 2015. Both included RCTs and observational studies. The trial by Chen et al identified 5 RCTs and 7 case series with at least 10 patients. Three of the RCTs were industry-sponsored, multicenter, parallel-group trials and 2 were single-center crossover trials. All five included a sham control group and one trial also included a medication management group. Risk of bias was judged to be high or unclear for all trials. Meta-analyses were performed on 2 outcomes. A pooled analysis of 2 trials did not find a significant difference in response rates between active and sham stimulation (relative risk [RR], 2.07; 95% confidence interval [CI], 0.50 to 8.55; p=0.31) and a pooled analysis of 3 trials showed a significantly greater reduction in the number of days with prolonged moderate-to-severe headache (mean difference, 2.59; 95% CI, 0.91 to 4.27; p=0.003).
In their systematic review, Yang et al (2015) identified the same 5 RCTs as Chen. The Yang review only included studies conducted with patients who had migraines for at least 6 months in duration who did not respond to oral medications. In addition to the RCTs, 5 case series met the inclusion criteria. Yang did not pool study findings. The definition of response rate varied across studies and could include frequency and/or severity of headaches. Response rates in 3 case series with self-reported efficacy were 100% in each, and response rates in the other 2 series were 50% and 89%, respectively. Complication rates in the series ranged from 40% to 100%. Reviewers noted that the case series were subject to biases (e.g, inability to control for the placebo effect), that RCT evidence was limited, and that complication rates were high. The most common complications were lead migration (21% of patients) and infection (7% of patients).
The 2 parallel-group RCTs published as full-text journal articles are detailed next. The Occipital Nerve Stimulation for the Treatment of Intractable Chronic Migraine Headache (ONSTIM) trial, was a multicenter, randomized feasibility study of occipital nerve stimulation (ONS) for treatment of intractable chronic migraine headache refractory to preventive medical management. The trial, reportedby Saper et. al. (2011), evaluated study design and had no primary end point. One hundred ten patients were enrolled, and patients who had a positive response to a short-acting occipital nerve block were randomized as follows: 33 to adjustable stimulation, 17 to preset stimulation of 1 min/d, and 17 to medical management. At the 3-month evaluation, the response rate (percentage of patients who achieve ≥50% reduction in number of headache days per month or a ≥3-point reduction in average overall pain intensity vs baseline) was 39% in the adjustable stimulation group, 6% in the preset stimulation group, and 0% in the medical management group. Twelve (24%) of 51 subjects who had successful ONS device implantation experienced lead migration and 3 (6%) of the 51 subjects were hospitalized for adverse events (infection, lead migration, nausea). Study limitations included a short observation period and ineffective blinding of subjects and investigators to treatment groups.
An industry sponsored, double blind trial, regulated by the U.S. Food and Drug Administration and reported by Silberstein et. al. (2012), randomized 157 patients with chronic migraine refractory to preventative medical management in a 2:1 ratio to active or sham stimulation. Intention-to-treat (ITT) analysis revealed no significant difference between groups in the percentage of patients who achieved 50% or greater reduction in visual analog scale scores for pain at 12 weeks (active 17.1%; control 13.5%). More patients in the occipital nerve stimulation (ONS) group had fewer days with headache, less migraine-related disability, and greater pain relief, although benefits were modest. The most common adverse event was persistent implant site pain. Results from the 52-week open label extension of this trial were published in 2015. Results were reported for the ITT population and for the 125 patients who met selection criteria for intractable chronic migraine. Twenty-four patients were excluded from analysis due to explanation of the ONS system (n=18) or loss to follow-up. Mean headache days at baseline were 21.6 for the ITT population and 24.2 for the intractable chronic migraine group. In the ITT population, headache days were reduced by 6.7 days, and a reduction of 50% or more in the number of headache days and/or pain intensity was observed in 47.8% of this group. Seventy percent of patients experienced at least 1 of 183 device-related adverse events, of which 8.6% of events required hospitalization and 4.7% of events required surgical intervention. Eighteen percent had persistent pain and/or numbness with the device.
Two systematic reviews each identified 5 sham controlled randomized trials. One of the systematic reviews also identified 5 case series. Findings from pooled analyses of randomized controlled trials (RCTs) were mixed. For example, compared with sham stimulation, response rates (i.e. > 50% reduction in VAS score) for occipital nerve stimulation (ONS) did not differ significantly, but the number of days with prolonged moderate-to-severe headache was reduced. ONS was also associated with a substantial number of minor and serious adverse events.
The evidence evaluating the use of occipital nerve stimulation (ONS) for hemicranias continua is limited and consists of a small crossover study by Burns et al (2008) who reported on the efficacy of continuous unilateral ONS in 6 patients. Pain on a 10-point scale was recorded hourly in patient diaries, and the Migraine Disability Assessment was administered at each follow-up visit. Four of 6 patients reported substantially less pain (range, 80%-95% less), 1 reported 30% less pain, and 1 reported 20% worse pain. Adverse events were mild and associated with transient overstimulation.
Several case series assessing cluster headache were identified, with sample sizes ranging from 10 to 67 patients. In 2016, Fontaine et al published a prospective case series of 67 patients with chronic cluster headache (CCH). Data were taken from a French database on occipital nerve stimulation (ONS) for treating refractory headache disorders. Sixty-seven patients with CCH were included in the database; data were available for 52 (78%) patients at 3 months and 44 (66%) patients at 12 months. The primary outcome was a composite score that incorporated patient’s global impression of change, reduction in the frequency of headache attacks, and changes in prophylactic medications. For patients with available data, at 3 months, 34 (65.4%) of 52 were considered to be excellent responders, 9 (17.3%) of 52 were mild responders, and 9 (17.3%) of 52 were non-responders. At 12 months, 22 (48%) of 44 were excellent responders, 10 (21.7%) of 44 were mild responders, and 15 (32.6%) of 44 were non-responders. The series had a large amount of missing data at follow-up.
In 2016, Leone et al published a case series of occiptial nerve stimulation (ONS) in 35 patients with chronic cluster headache (CCH). This series had the longest follow-up (median, 6.1 years; range, 1.6-10.7 years). Selection criteria included daily or almost daily cluster headache attacks in the past year and resistance of prophylactic drugs. Twenty (66.7%) of the 30 patients in the per protocol analysis had 50% or more reduction in headache number per day and were considered responders. In 12 (40%) patients, improvement was considered stable (i.e., ≤3 headache attacks per month). Limitations of the series reporting on cluster headaches included lack of blinding and comparison groups.
Vadivelu et. al. (2012) reported on a case series of 22 patients with Chiari malformation and persistent occipital headaches. Of the 22, 15 (68%) had a successful occipital neurostimulator trial and underwent permanent implantation. At a mean follow-up at 18.9 months (range 6-51 months), 13 (87%) of the 15 patients reported pain relief greater than 50%. Forty percent of patients reported device related complications requiring additional surgery (lead migration, uncomfortable position of generator, wound infection) during follow-up.
Pain in the occipital-cervical area can originate from any structure in the posterior scalp and neck: muscles, joints, ligaments, connective tissue, blood vessels and of course nerves. If the occipital nerves are the cause, then the syndrome is called occipital neuralgia. Neuralgia is a form of neuropathic pain.
The occipital nerves are two paired nerves (right and left) that supply sensation to the posterior scalp, from the crown of the head, down to the top portion of the neck. The occipital nerves originate from posterior branches of the C2 nerve root. The nerve courses just beneath the arch of the C1 vertebrae, then in close proximity to vertebral venous structures, the adjacent atlantoaxial ligament and cervical facet joint. It passes through the semispinalis muscle, and then through the region where the trapezius muscle attaches to the occipital bone. From there, branches of the nerve fan out to innervate the posterior scalp.
Occipital neuralgia can be considered a primary headache disorder, or a secondary headache disorder. The International Headache Society defines primary occipital neuralgia as “a paroxysmal jabbing pain in the distribution of the greater or lesser occipital nerves or of the third occipital nerve, sometimes accompanied by diminished sensation or dysaesthesia in the affected area. It is commonly associated with tenderness over the nerve concerned.” To meet criteria for occipital neuralgia the pain must meet the following criteria:
Occipital nerve block (usually a mixture of local anesthetic plus a glucocorticoid) is usually the treatment of choice for occipital neuralgia. Some other modalities that may be used include: physical therapy; acupuncture; massage therapy; chiropractic treatments; anti-inflammatory medications; muscle relaxants; anticonvulsants; anti-depressants; other percutaneous blocks such as facet joint blocks, medical branch blocks and transforaminal epidural steroid injections; radiofrequency ablation and occipital nerve stimulation (ONS). Occipital nerve stimulation has been investigated in selected cases of severe occipital neuralgia unresponsive to less invasive measures.
A 2015 systemic review by Sweet et. al. identified 9 small case series (< 15 patients each) assessing the efficacy of occipital nerve stimulation for treating medically refractory occipital neuralgia. Reviewers did not pool study findings. Conclusions cannot be drawn on the impact of occipital nerve stimulation (ONS) on occipital neuralgia due to the lack of randomized controlled trials (RTCs) or other controlled studies.
The evidence on occipital nerve stimulation (ONS) consists of case series; no randomized controlled trials (RCTs) or nonrandomized comparative studies were identified. Many of the case series were small; series with over 25 patients were available only for treatment of cluster headache. Although case series tended to find a substantial number of patients improved after ONS, the studies lacked blinding and comparison groups. RCTs are needed to assess outcomes between ONS and comparators (e.g. control for potential placebo effect).
For individuals who have migraine headaches refractory to preventative medical management who receive occipital nerve stimulation (ONS), the evidence includes randomized controlled trials (RCTs), systematic reviews of RCTs, and observational studies. Systematic reviews identified 5 sham-controlled randomized trials. Findings from pooled analyses of these RCTs were mixed. For example, compared with placebo, response rates to ONS did not differ significantly but did reduce the number of days with prolonged moderate-to-severe headache. ONS was also associated with a substantial number of minor or serious adverse events. The evidence is insufficient to determine the effects of the technology on net health outcomes.
For individuals who have non-migraine headaches (e.g. hemicranias continua, cluster headache, headache associated with Chiari malformation or occipital neuralgia) who received occipital nerve stimulation (ONS), the evidence includes case series. Many of the case series had small sample sizes; series with over 25 patients were available only for treatment of cluster headache. Although the case series tended to find that a substantial number of patients improved after ONS, these studies lacked blinding and comparison groups. RTCs are needed to compare outcomes between ONS and comparators (e.g. to control for a potential placebo effect). The evidence is insufficient to determine the effects of the technology on net health outcomes.
Fibromyalgia is a chronic pain disorder that is often difficult to treat. The treatment of fibromyalgia is directed at reducing the major symptoms of this disorder, including chronic widespread pain, fatigue, insomnia and cognitive dysfunction. Interventions include a number of non-pharmacologic and pharmacologic therapies that are often provided in combination. Many patients experience continued symptoms despite initial non-pharmacologic and pharmacologic therapies. Occipital nerve stimulation has been studied for the treatment of fibromyalgia in adults not responsive to initial therapies. Several trials have evaluated the effect of occipital nerve stimulation, while some of the results were positive, the trials were small and not well-controlled.
For individuals with fibromyalgia who receive occipital nerve stimulation the available studies are limited making it difficult to draw conclusions regarding the efficacy of occipital nerve stimulation for the treatment of fibromyalgia. There are no well-designed randomized controlled studies in the medical literature comparing occipital nerve stimulation to established treatment options. Further randomized controlled clinical trials (RCTs) are needed to include larger patient populations with longer follow-up to establish the benefits of occipital nerve stimulation for the treatment for this condition. The evidence is insufficient to determine the effects of occipital nerve stimulation on net health outcomes for the treatment of fibromyalgia.
2012 American Academy of Neurology (AAN) evidence based guideline updated for NSAIDs and other complementary treatments for episodic migraine prevention in adults does not mention local injection therapies, ablative treatments, electrical stimulation or neurosurgeries as complimentary treatments for migraines.
2013 Guidance from the National Institute for Health and Care Excellence (NICE) states: "That the evidence on occipital nerve stimulation (ONS) for intractable chronic migraine shows some efficacy in the short term but there is very little evidence about long term outcomes. With regard to safety, there is a risk of complications, needing further surgery. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research."
2015 evidence based guidelines from the Congress of Neurological Surgeons stated: “the use of occipital nerve stimulation is a treatment of option for patients with medically refractory occipital neuralgia.” The statement had a level III recommendation based on a systemic review of the literature that only identified case series.
Level III recommendation: evidence from case series, comparative studies with historical controls, case reports, and expert opinion, as well as significantly flawed, controlled trials.
Currently, there are no occipital nerve stimulation devices approved or cleared for marketing by the U.S. Food and Drug Administration (FDA) for the treatment of headache or occipital neuralgia.
Occipital nerve stimulation is considered investigational for all indications.
Based on review of the peer reviewed medical literature the available studies are limited and had significant methodological flaws, making it difficult to draw conclusions regarding the efficacy of occipital nerve stimulation for the treatment of headaches (migraine and non-migraine headaches), occipital neuralgia, fibromyalgia and all other indications. There are no well-designed randomized controlled studies in the medical literature comparing occipital nerve stimulation to established treatment options. Further randomized clinical trials (RCTs) with greater number of patients and longer follow up are needed needed to establish the benefits of occipital nerve stimulation for the treatment of headaches (migraine and non-migraine headaches), occipital neuralgia, fibromyalgia and all other indications. The evidence is insufficient to determine the effects of this technology on net health outcomes.
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