Medical Policy: 07.01.66 

Original Effective Date: November 2014 

Reviewed: August 2018 

Revised: August 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

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.

 

Description:

Occipital neuralgia and cervicogenic headache are conditions whose diagnosis and treatment have been debated in the medical literature due to lack of expert consensus regarding their etiology and treatment. The terminology refers to specific types of headache thought to arise from impingement or entrapment of the occipital nerves and/or the upper spinal vertebrae. Compression and injury of the occipital nerves within the muscles of the neck and compression of the second and third cervical spinal nerve roots are generally felt to be responsible for the symptoms, including unilateral and occasionally bilateral head, neck and arm pain.

 

The clinical features of cervicogenic headache may mimic those associated with primary headache disorders (e.g. tension-type headaches, migraine, or hemicrania continua), making it difficult to distinguish among headache types. The International Headache Society (IHS), created a headache classification system, the IHS criteria is regarded as the gold standard for diagnosis of all types of headaches. Headache and facial pain is classified into primary, secondary and other etiologies (painful cranial neuropathies, other facial pains and other headaches). Primary headaches are without obvious causative factors and include migraine, tension and cluster headaches. Secondary headaches include headaches attributed to injury or disorders to the head and neck (i.e. cervicogenic headache) and cranial neuralgias (i.e. occipital neuralgia).

 

Numerous treatments for headaches (e.g. migraine, cluster headaches, tension type headaches and cervicogenic headache), occipital neuralgia and persistent idiopathic facial pain (PIFP) (atypical facial pain) have been proposed, with varying levels success. The consensus on standard treatment does not exist, because of the variability in patient selection and clinical outcomes. Pharmacological treatment with oral analgesics, anti-inflammatory medications, tricyclic antidepressants, and anticonvulsant medications have been used alone or in combination with other treatment modalities. Other treatment modalities suggested are: the use of cervical collar during the acute phase; physical therapy with stretching and strengthening exercises; postural training; relaxation exercises; transcutaneous nerve stimulation (TENS); and manual therapy including spinal manipulation and spinal mobilization. Pharmacological and alternative treatment modalities are not effective for some individuals, and therefore, other treatment methods have been proposed, such as local injections of anesthetics and/or steroids, epidural steroid injections and ablative treatments to include but not limited to pulsed radiofrequency ablation (PRFA); radiofrequency ablation (RFA); cooled radiofrequency; chemical neurolysis (chemical ablation or chemodenervation); and cyroneurolysis (cyroablation, cryotherapy or cryoanalgesia), to attempt to denervate the occipital and/or upper cervical nerve(s) for pain relief.

 

Ablative procedures may be performed in attempt to denervate the occipital nerve (greater or lesser), upper cervical nerve (e.g. second cervical nerve also known as C2), supraorbital, supratrochlear or sphenopalatine ganglion. The proposed goal of denervation is to “shut off” the pain signals that are sent to the brain from the joints and nerves. An additional purported objective is to reduce the likelihood of, or to delay, any recurrence that may occur by selectively destroying pain fibers without causing excessive sensory loss, motor dysfunction or other complications. Ablative treatments for occipital neuralgia, chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches) and persistent idiopathic facial pain (atypical facial pain) have been proposed for pain relief.

 

Headaches

  • Chronic Migraine: Migraine is a common disabling primary headache disorder. Chronic migraine headache is defined as greater than or equal to 15 days per month lasting 4 hours a day or longer in an adult patient.
  • Chronic tension type headache: Frequent episodic tension type headache, with daily or very frequent episodes of headache, typically bilateral, pressing to tightening in quality and of mild to moderate intensity, lasting hours, to days or unremitting. The pain does not worsen with routine physical activity, but may be associated with mild nausea, photophobia or phonophobia.
  • Chronic cluster headache: Chronic cluster headaches is one of the trigeminal autonomic cephalagias (TACs), a group of primary headache disorders characterized by unilateral trigeminal distribution pain that occurs in association with ipsilateral cranial autonomic features. Cluster headache is characterized by attacks of severe unilateral, orbital, supraorbital or temporal pain. In the episodic form, attacks occur daily, usually one to eight times a day for several weeks, followed by a period of remission. The chronic form of cluster headaches occur for more than 1 year without remissions, or with remission periods lasting less than 1 month.
  • Cervicogenic headache: The clinical features of cervicogenic headache may mimic those associated with primary headache disorders (e.g. tension-type headache, migraine, or hemicranias continua), making it difficult to distinguish among headache types. Cervicogenic headaches is characterized by continuous, unilateral head pain radiating from the occipital areas to the front area, with associated neck pain and ipsilateral shoulder or arm pain. The headache is moderate in intensity with non-throbbing character. It is described as dull, boring, dragging pain that can fluctuate in intensity. The duration of the headache may range from a few hours to several days, and in some cases several weeks. The pain can be exacerbated by neck movements and is usually caused by neck trauma.
    • The anatomic point for cervicogenic headache is the trigeminocervical nucleus in the upper cervical spinal cord, where sensory nerve fibers in the descending tract of the trigeminal nerve are believed to interact with sensory fibers from the upper cervical roots. This functional intersection of upper cervical and trigeminal sensory pathways is through to allow bidirectional transmission of pain signals between the neck and the trigeminal sensory receptor fields of the face and head.
    • Cervicogenic headache is typically caused by a disorder of the cervical spine and its component bony, disc and/or soft tissue elements, usually but not invariably accompanied by neck pain.

 

The first three cervical spine nerves and their rami are the primary peripheral nerve structures that can refer to pain to the head:

  • The C1 spinal nerve (suboccipital nerve) supplies the atlanto-occipital joint. Pathology or injury affecting this joint is a potential source for pain that is referred to the occipital region of the head.
  • The C2 spinal nerve and its dorsal root ganglion have a close proximity to the lateral capsule of the atlanto-axial (C1-2) zygapoplyseal joint and supply the atlanto-axial and C2-3 zygapophyseal joints. Trauma to, or pathologic changes around, these joints can be a source of referred head pain.
  • The third occipital nerve (dorsal ramus C3) has a close anatomic proximity to, and supplies, the C2-3 zygapophyseal joint. Pan from the C2-3 zygapophyseal joint is referred to the occipital, frontotemporal and periorbital regions of the head (third occipital headache).

 

Occipital Neuralgia

Occipital neuralgia can be a cause of a headache in the occipital region which can be intermittent or continuous. The pain of occipital neuralgia has a sudden onset. It is described as severe, stabbing, electric, shock-like, sharp or shooting. It originates in the nuchal region and immediately spreads towards the vertex. The bouts of pain may start spontaneously or be provoked by a specific maneuver such as brushing the hair, exposure to cold or moving the neck. Other causes can include myofacial tightening, trauma of C2 nerve root (whiplash injury), prior skull or suboccipital surgery, other types of nerve entrapment, idiopathic causes, sustained muscle contraction, and spondylosis of cervical facet joints.

 

On examination, pressure, palpation, or percussion over the occipital nerve trunks may reveal local tenderness, trigger painful paroxysms (increase of symptoms), or elicit paresthesia along the distribution of the affected nerve. Percussion of the nerve often reproduces the distribution of pain. Also, cervical range of motion may be restricted and local posterior neck muscle spasms may be found.

 

Occipital neuralgia is sometimes accompanied by diminished sensation or dysesthesia (abnormal sensation) in the affected area. The remainder of the neurological examination is typically normal. An abnormal neurological examination is an alert for potential alternative or underlying causes of the symptoms.

 

Diagnostic local anesthetic nerve blocks may be required for a definitive diagnosis to be obtained. The relief of pain after a diagnostic local anesthetic block of the greater and lesser occipital nerves is generally confirmatory of the diagnosis of occipital neuralgia.

 

Persistent Idiopathic Facial Pain (PIFP) (Atypical Facial Pain)

Persistent idiopathic facial pain (also known as atypical facial pain), is characterized by persistent facial pain that does not have the characteristics of cranial neuralgias and cannot be attributed to a different disorder. The pain is usually of long duration, lasting most of the day (if not continuous), is generally limited to one particular area on one side of the face at onset, is deep and poorly localized, and is not associated with sensory loss or other neurologic deficits. Investigations including x-ray of the face and jaw or cranial computed tomography (CT) or magnetic resonance imaging (MRI) do not demonstrate any relevant abnormality. The pain may be initiated by surgery or injury to the face, teeth, or gums, but it persists without any demonstrable cause.

 

Persistent idiopathic facial pain (atypical facial pain) is rare, and studies are scarce.

 

The pathophysiology of persistent idiopathic facial pain (PIFP) (atypical facial pain) is unknown. The available literature suggests that abnormal sensitization of the trigeminal nociceptive system may play a crucial role in the development of PIFP.

 

Medical treatment of persistent idiopathic facial pain (atypical facial pain) include anticonvulsants and antidepressants (e.g. tricyclic antidepressants, selective serotonin uptake inhibitors and norepinephrine reuptake inhibitors) are the preferred treatment. Ablative treatments have been proposed for the treatment of persistent idiopathic facial pain (PIFP) (atypical facial pain) for pain relief.

 

The literature on ablative treatments for persistent idiopathic facial pain (atypical facial pain) is very limited.

 

In 2017, Weiss et. al. reported on comprehensive evidence based review on atypical facial pain. PIFP is an excruciating disorder of the face often misdiagnosed as trigeminal neuralgia (TN) However, unlike TN symptoms, the pain is persistent rather than intermittent, usually unilateral, and without autonomic signs or symptoms. When a clinician encounters a patient with neuropathic facial pain whose symptoms are incongruent with the more common etiologies, the diagnosis of atypical facial pain must be entertained. The purpose of the article was to focus on atypical facial pain or persistent idiopathic facial pain (PIFP). It is considered an underdiagnosed condition with limited treatment options. New interventional modalities such as pulsed radiofrequency ablation (PFRA) of the sphenopalatine ganglion, peripheral nerve field stimulators (PNFS), and botulinum toxin injections have promising results. In summary, more prospective studies such as randomized controlled trials are necessary to explore the possibility of their more widespread use as viable procedures for the treatment of PIFP.

 

Unfortunately, few randomized controlled trials for the treatment of PIFP exist. However, there are a select number of pharmacological, non-pharmacological, and interventional treatment options that have proven to be moderately effective.

 

In 2017, Benoliel et. al. reported on persistent idiopathic facial pain (PIFP) in which the authors concluded, The underlying pathophysiology in PIFP is still enigmatic, however neuropathic mechanisms may be relevant. PIFP needs interdisciplinary collaboration to rule out and manage secondary causes, psychiatric comorbidities and other facial pain syndromes, particularly trigeminal neuralgia. Burden of disease and psychiatric comorbidity screening is recommended at an early stage of disease, and should be addressed in the management plan. Future research is needed to establish clear diagnostic criteria and treatment strategies based on clinical findings and individual pathophysiology.

 

The available evidence is insufficient to conclude that ablative treatments including but not limited to radiofrequency ablation, pulsed radiofrequency ablation, cooled radiofrequency, cryoneurolysis (cryoablation, cryotherapy or cryoanalgesia) or chemical neurolysis (chemical ablation or chemodenervation) are effective treatments for persistent idiopathic facial pain (PIFP) (atypical facial pain). Well-designed studies are needed to establish the safety and efficacy of ablative treatments for the treatment of PIFP (atypical facial pain). The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Ablative Procedures

Pulsed Radiofrequency Ablation

Pulsed radiofrequency (PRF) ablation has been proposed as a possibly safer alternative to non-pulsed or continuous radiofrequency ablation (RFA) in the treatment of a variety pain syndromes. Pulsed radiofrequency uses short bursts of radiofrequency current (heat is dissipated during the silent period), rather than the continuous current, which allows the needle to remain relatively cool so that the tissue cools slightly between each burst, reducing the risk of destroying nearby tissue. Pulsed radiofrequency causes the transmission across small unmyelinated nerve fibers to be disrupted, but not permanently damaged. This is because the temperature will not exceed 42 degrees Celsius, versus 80 degrees Celsius reached in non-pulsed or continuous radiofrequency ablation (RFA).

 

In a prospective study, Vanedleren et. al. (2010) reported on the results of six months of follow-up in which patients presenting with clinical findings suggestive of occipital neuralgia and positive test block of the occipital nerves underwent a pulsed radiofrequency (PRF) procedure of the nerves. Mean score for pain, quality of life, and medication intake were measured at 1, 2 and 6 months after the procedure. Pain was measured by the visual analog and Likert scales, quality of life was measured by a modified brief pain questionnaire, and medication intake was measured by a Medication Quantification Scale. During a 29-month period, 19 patients were included in the study. Mean visual analog scale and median Medication Quantification Scale scores declined by 3.6 units (P = 0.002) and 8 units (P = 0.006), respectively, during 6 months. Approximately 52.6% of patients reported a score of 6 (pain improved substantially) or higher on the Likert scale after 6 months. No complications were reported. This study was limited by design of the study and lack of long term outcomes. The authors concluded pulsed radiofrequency treatment of the greater and/or lesser occipital nerve is promising treatment of occipital neuralgia. This study warrants further placebo-controlled trials.

 

In a prospective study, Halim et. al. (2010) reported on 86 patients who had undergone lateral C1-C2 joint pulsed radiofrequency application, for cervicogenic headache in a single pain center. The percentage of patients who had > 50% pain relief at two months, six months, and one year were 50% (43/86), 50% (43/86), and 44.2% (38/86), respectively. Long-term pain relief at 6 months and 1 year were predicted reliably by >or=50% pain relief at 2 months (P < 0.001). One patient complained of increased severity of occipital headache lasting several hours. This study was limited by design of the study and lack of long-term outcomes.

 

In a case series report, Zhang, et. al. (2011) reported on pulsed radiofrequency for two patients with cervicogenic headache. After initial positive response to the greater occipital nerve block, pulse radiofrequency (PRF) was performed on the position of the second cervical ganglion (C2). Two patients reported 100% pain relief lasting for 6 months. The lateral puncture is safer and more comfortable than the posterior site. The authors concluded this case study demonstrates effectiveness of PRF to treat cervicogenic headache originating from the C2 nerve. However, we need to further evaluate the results using more samples.

 

In a retrospective study, Huang et. al. (2012) reported on pulsed radiofrequency (PRF) for occipital neuralgia to determine whether any demographic, clinical or treatment characteristics are associated with success. A total of 102 patients with primary diagnosis of occipital neuralgia were treated with PRF of the greater or and/or lesser occipital nerve. A positive primary outcome was predefined as > 50% pain relief lasting at least 3 months. The secondary outcome measure was procedural satisfaction. A total of 51% of the patients experienced > 50% pain relief and satisfaction with treatment lasting three months. This study was limited by design and lack of long term outcomes.

 

In a systematic review, Grandhi et. al. (2018) investigated the use of radiofrequency ablation (RFA) and pulsed radiofrequency ablation (PRFA) for the management of cervicogenic headache (CHA). A total of 10 studies met inclusion for review. There were 3 randomized controlled trials, three prospective trials, and four retrospective trials that were evaluated for the impact of RFA or PRFA for cervicogenic headache. The criteria for inclusion were based on identification of articles discussion cervicogenic headaches which were previously treatment resistant and occurred without any other pathology of the craniofacial region or inciting event such as trauma. The systematic review indicated that RFA and PRFA provided a very limited benefit in the management of cervicogenic headache. The authors reported that although numerous case reports have demonstrated benefit, presently there are no high-quality randomized controlled trials (RCTs) and/or strong non-RCTs to support the use of RFA and PRFA in the management of cervicogenic headache.

 

The available evidence from published studies is insufficient to conclude that pulsed radiofrequency ablation is an effective treatment for occipital neuralgia and chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches). Further larger well-designed studies with longer periods of follow-up are needed to evaluate the use of pulsed radiofrequency ablation for these conditions and to identify which patients would benefit from this procedure. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Radiofrequency Ablation (RFA)

A variety of terms may be used to describe percutaneous radiofrequency denervation including radiofrequency ablation (RFA), radiofrequency neuroablation, radiofrequency lesioning, radiofrequency neurotomy, radiofrequency rhizotomy and radiofrequency articular rhizolysis.

 

Radiofrequency ablation (RFA) is performed under local anesthetic with fluoroscopic guidance. RFA is is a minimally invasive method that involves the use of heat and coagulation necrosis to destroy tissue. A needle electrode is inserted through the skin and then into the tissue to be ablated. A high frequency electrical current is applied to the target tissue. A small sphere of tissue is coagulated around the needle by the heat generated (80 to 85°C). It is theorized that the thermal lesioning of the nerve destroys peripheral sensory nerve endings, resulting in the alleviation of pain. However, the results are typically not permanent as the nerves may regenerate which can cause the pain to return and may require the repetition of the RFA procedure to alleviate the pain. Radiofrequency ablation (RFA) has been proposed for the treatment of pain associated with occipital neuralgia and chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches) for pain relief.

 

Stovner et. al. reported on a randomized double blind sham-controlled study for radiofrequency denervation of facet joints C2-C6 in cervicogenic headache. Twelve patients with disabling, long standing and treatment resistant unilateral cervicogenic headache were included. Six were randomized to receive radiofrequency neurotomy of facet joints C2-C6 ipsilateral to the pain, and six were randomized to sham treatment. Patients were followed for 2 years with diary registration of pain for 14-days periods after 1, 3, 6, 12, 18 and 24 months, and also followed with algometry and neck mobility measurements at 3, 12 and 24 months. Side-effects were minor and short-lasting, and those patients who were treated with neurotomy were somewhat improved at 3 months, but later there were no marked differences between the groups. In conclusion, the procedure is probably not beneficial in cervicogenic headache.

 

Hamer et. al. (2014) reported on a single center retrospective observational study of 40 patients with refractory cervicogenic headaches or occipital neuralgia following treatment with radiofrequency ablation of the C2 dorsal root ganglion and/or third occipital nerves. Patients were all referred by a headache specialty clinic for evaluation for radiofrequency ablation of the C2 dorsal root ganglion and/or third occipital nerves. After treatment, patients were followed for a minimum of 6 months to a year. Patient demographics and results of radiofrequency ablation were recorded on the same day, after 3-4 days and at 6 months to 1 year following treatment. Thirty-five percent of patients reported 100% pain relief and 70% reported 80% or greater pain relief. The mean duration of improvement was 22.35 weeks. Complication rate was 12-13%. This study was limited by design and lack of long term outcomes.

 

Nagar et. al. (2015) reported on systematic review of radiofrequency (RF) ablation and pulsed radiofrequency (PRF) for management of cervicogenic headache (CHA). The primary outcome measures were reduction in pain scores and improvement in quality of life. Twenty five studies were identified for full text review of these, 9 studies met inclusion criteria. There were 5 non-randomized, among them 4/5 were of moderate quality, 3/5 showed RF ablation and 1/5 showed PRF as an effective intervention for cervicogenic headache. There were 4 randomized trials among them 2/4 were of high quality, 3/4 investigated RF ablation as an intervention for CHA, 1/4 investigated PRF ablation as an intervention for CHA and none of the randomized studies showed strong evidence for RF and PRF ablation as an effective intervention for CHA. In the selected studies there were inconsistencies between randomized trials, flaws in trial design, and gaps in the chain of evidence. The authors concluded, there is limited evidence to support RF ablation for management of CHA as there are no high quality randomized controlled trials (RCTs) and/or multiple consistent non-RCTs without methodological flaws. There is poor evidence to support PRF for CHA as there are no high quality RCTs or Non-RCTs.

 

In 2016, Hamer et. al. reported on a single center retrospective observational study of 23 patients with recurrent cervicogenic headaches and/or occipital neuralgia treated with repeated radiofrequency ablation (RFA) of the C2 dorsal root ganglion and/or third occipital nerves. All patients receiving treatment from January 2010 to July 2014 were included. This was an IRB approved medical chart review study. Twenty-two of 23 patients underwent follow-up. An average of 86.5% of participants reported pain relief on average of 25.4 weeks at time of follow-up. Forty-one percent reported side effects including suboccipital hyperesthesia and/or ear discomfort, 95% reported a willingness to repeat the procedure again if severe symptoms occurred, 59% of patients reported the most recent RF ablation had the same results as the first, 32% reported the most recent RFA was the most effective and 9% reported that the first RFA was the most effective. The authors concluded repeated RFA is feasible option for recurrent cervicogenic headaches and/or occipital neuralgia. Effectiveness is the same or better than the first ablation, and high likelihood of side effects include suboccipital neuralgia and/or ear discomfort, although side effects were generally well tolerated. Further research is needed to determine if there is a long-term sequela of numerous radiofrequency ablations (RFA), particularly if patients undergo 3 or more ablations. A prospective study with control group would be helpful.

 

The available evidence from published studies is insufficient to conclude that radiofrequency ablation (RFA) is an effective treatment for occipital neuralgia and chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches).

 

Additional randomized controlled clinical trials (RCTs) with longer follow up and larger patient populations are needed. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Cooled Radiofrequency Ablation

Cooled Radiofrequency ablation is a newer alternative to continuous radiofrequency ablation (RFA) and pulsed radiofrequency ablation (PRFA). With cooled radiofrequency ablation a special device is used that utilizes a water cooled radiofrequency probe to ablate the lesion (nerve). Cooled radiofrequency ablation applies more energy at the desired location without excessive heat diffusing beyond the area, causing less tissue injury away from the nerve. The goal for ablating the nerve is the same as RFA and PRFA.

 

In 2014, Vu et. al. reported on a case report of a 35 year old female with bilateral greater occipital neuralgia treated with cooled radiofrequency ablation. This patient had trialed numerous other treatment options including several nerve blocks, physical therapy, adjuvant pain and nerve medications, and pulsed and continuous radiofrequency ablation. The patient could not tolerate continuous radiofrequency ablation and it was found to be minimally effective. Cooled RFA was provided as an alternative that provided 75% relief in a very difficult to treat case of greater occipital neuralgia. However, the authors noted that the usage of cooled RFA in greater occipital neuralgia has not been documented in the literature and the full effects of this treatment related to this case cannot be determined without follow-up 3, 6 and 12 months.

 

The available evidence from published studies includes a case report for the treatment of occipital neuralgia, no studies were found using cooled radiofrequency ablation (RFA) in the treatment of chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches). Additional randomized controlled clinical trials (RCTs) with longer follow up and larger patient populations are needed. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Cryoneurolysis

Cryoneurolysis, also called cryoablation, cryotherapy or cryoanalgesia uses freezing temperatures to treat chronic pain of either sensory or motor nerves and uses a wide range of temperatures with treatment often occurring at temperature as cold as -196°C (liquid nitrogen coolant) or -20 to -140°C or colder (nitrous oxide coolant). Because peripheral nerve function is disrupted due to the destruction of the axon and myelin sheath, the desired result provides pain relief until the nerve(s) regenerate. Cryodenervation has been used for patients with various types of pain.

 

In 2015, Chong et. al. reported on a retrospective evaluation on the efficacy and safety of cryoablation for the treatment of occipital neuralgia (ON) in an academic university based pain management center. All patients received local anesthetic injections of ON. Patients with greater than or equal to 50% relief and less than 2 week duration of relief were treated with cryoablation. Thirty eight patients were included. Of the 38 patients 20 were treated for unilateral greater occipital neuralgia (ON), 10 for unilateral greater and lesser ON, and 8 for bilateral greater ON. There were 10 men and 28 women, with an average age of 45.2 years and 51.1 years respectively. The average relief for all local anesthetic injections was 71.2%, 58.3% for patients who reported 50-74% relief (Group 1) and 82.75% for patients who reported greater than 75% relief (Group 2). The average improvement of pain relief with cryablation was 57.9% with an average duration of 6.1 months overall. Group 1 reported an average of 45.2% relief for an average of 4.1 months with cryoablation. In comparison, Group 2 reported an average of 70.5% relief for 8.1 months. The percentage of relief (P=0.007) and duration of relief (P=0.0006) was significantly improved in those reporting at least 75% relief of pain with local anesthetic injections (Group 2 vs Group 1). Though no significance in improvement from cryoablation was found in men, significance was seen in women with at least 75% benefit with local anesthetic injections in terms of duration (P=0.03) and percentage (P=0.001) of pain relief with cryoablation. The average pain score prior to cryoablation was 8 (0-10 visual analog scale, VAS), this improved to 4.2, improvement of 3.8 following cryoablation at 6 months (P=0.03). Of the 38 patients, 3 (7.8%) adverse effects were seen. Two patients reported post procedure neuritis and one was monitored for procedure related hematoma. Study limitations included the retrospective nature of the study. Additionally, only the percentage relief, pain score and duration of relief were collected. This study was limited by design and lack of long term outcomes.

 

Based on review of the peer reviewed medical literature, the literature is limited to a retrospective study. No randomized controlled trials were found. The evidence is insufficient to establish the safety and efficacy of this technique in the treatment of pain associated with occipital neuralgia and/or chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches). Further larger well-designed studies with longer periods of follow-up are needed to evaluate the use of cryoneurolysis (cryoablation, cryotherapy or cryoanalgesia) for these conditions and to identify which patients would benefit from this procedure. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Chemical Neurolysis (Chemodenervation)

Chemical neurolysis is also referred to as chemical ablation or chemodenervation, involves an injection of neurolytic agent(s) such as phenol, alcohol, glycerol or hypertonic saline to cause destruction of nerve(s) by causing a temporary degeneration of the nerve(s) fibers to interrupt the transmission of nerve(s) signals for pain relief. These agents are typically used for nerve blocks, but may also be used as local neurolytic injection. However, there is lack of published data to support the safety and efficacy of this technique in the treatment of pain associated with occipital neuralgia and chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches). Well-designed randomized controlled trials are needed to establish the safety and effectiveness of this treatment modality for these indications. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Summary of Evidence

The evidence in the peer reviewed published literature evaluating nerve destruction using pulsed radiofrequency ablation (PRFA); radiofrequency ablation (RFA); cooled radiofrequency ablation, cyroneurolysis (also called cyroablation, cryotherapy or cryoanalgesia); and chemical neurolysis (chemodenervation) for the treatment of occipital neuralgia, chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches) and persistent idiopathic facial pain (PIFP) (atypical facial pain) is primarily from case reports, prospective and retrospective studies, systematic reviews and few randomized controlled clinical trials (RCTs). The evidence is limited by small sample populations, lack of control groups and lack of long term clinical outcomes, therefore strong evidence based conclusions regarding safety and efficacy cannot be made. Well-designed studies are needed to establish the safety and efficacy of these ablative procedures for these indications. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Practice Guidelines and Position Statements

American Society of Anesthesiologists Task Force and American Society of Regional Anesthesia and Pain Medicine

In 2010, the American Society of Anesthesiologists Task Force and American Society of Regional Anesthesia and Pain Medicine issued a practice guidelines for chronic pain management which included the following:

 

Ablative techniques include chemical denervation, cryoneurolysis or cryoablation, thermal intradiscal procedures (i.e. intervertebral disc annuloplasty (IDET), transdiscal bioaculopathy), and radiofrequency ablation.

 

Recommendations for Ablative Techniques:

  • Chemical denervation: (e.g. alcohol, phenol or high concentration local anesthetic) should not be used in the routine care of patients with chronic non-cancer pain.
  • Cryoablation: may be used in the care of selected patients (e.g. post-thoracotomy pain syndrome, low back pain (medial branch), and peripheral nerve pain)

 

American Academy of Neurology (AAN)

In 2012, the American Academy of Neurology (AAN) issued an evidence based guideline update on NSAIDs and other complementary treatments for episodic migraine prevention in adults which does not mention ablative treatments.

 

The American Association of Neurological Surgeons (AANS)

The American Association of Neurological Surgeons (AANS) patient website on occipital neuralgia states: “The goal of treatment is to alleviate pain. Often symptoms will improve or disappear with heat, rest, and/or physical therapy, including message, anti-inflammatory medications and muscle relaxants. Oral anticonvulsant medications such as carbamazepine and gabapentin also may help alleviate pain. Percutaneous nerve blocks not only may be helpful in diagnosing occipital neuralgia, but they can help alleviate pain. Nerve blocks involved either the occipital nerves or in some patients the C2 and/or C3 ganglion nerves. Surgical interventions (i.e. microvascular decompression) may be considered when the pain is chronic and severe and does not respond to conservative treatment” (AANS 2018). This information does not mention ablative treatments.

 

Regulatory Status

Radiofrequency ablation (RFA) is a procedure and, therefore, is not subject to regulation by the FDA. However, the devices used to perform RFA are regulated by the FDA premarket approval process. There are numerous devices listed in the FDA 510(k) premarket approval process.

 

Prior Approval:

Prior approval is required.

 

Policy:

See Related Medical Policies

  • 07.01.41 Pulsed Radiofrequency
  • 07.01.58 Facet Joint Denervation*
  • 07.01.73 Ablative Procedures of the Peripheral Nerves to Treat Pain*
  • 07.01.51 Occipital Nerve Stimulation
  • 02.01.52 Application/Injections of Local Anesthetic for Headaches

 

Ablative treatments, including but not limited to the following, for the treatment of occipital neuralgia and/or chronic headaches (e.g. cervicogenic headaches, migraines, cluster headaches, tension headaches) or persistent idiopathic facial pain (PIFP) (atypical facial pain) is considered investigational:

  • Radiofrequency ablation (RFA) (also known as radiofrequency denervation; radiofrequency neurotomy; radiofrequency rhizotomy)
  • Pulsed radiofrequency ablation
  • Cooled radiofrequency ablation
  • Cryoneurolysis (cryoablation, cryotherapy, cryanalgesia)
  • Chemical neurolysis (chemical ablation or chemodenervation)

 

The evidence in the peer reviewed published literature evaluating nerve destruction using pulsed radiofrequency ablation (PRFA); radiofrequency ablation (RFA); cooled radiofrequency ablation, cyroneurolysis (also called cyroablation, cryotherapy or cryoanalgesia); and chemical neurolysis (chemodenervation) for the treatment of occipital neuralgia, chronic headaches (including but not limited to cervicogenic headache, migraines, cluster headaches, tension headaches) and persistent idiopathic facial pain (PIFP) (atypical facial pain) is primarily from case reports, prospective and retrospective studies, systematic reviews and few randomized controlled clinical trials (RCTs). The evidence is limited by small sample populations, lack of control groups and lack of long term clinical outcomes, therefore strong evidence based conclusions regarding safety and efficacy cannot be made. Well-designed studies are needed to establish the safety and efficacy of these ablative procedures for these indications. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 64600 Destruction by neurolytic agent, trigeminal nerve; supraorbital, infraorbital, mental, or inferior alveolar branch
  • 64633 Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guideance (fluoroscopy or CT); cervical or thoracic, single facet joint
  • 64640 Destruction by neurolytic agent other peripheral nerve or branch

 

Selected References:

  • American Headache Society American Headache Society Urges Caution in Using any Surgical Intervention in Migraine Treatment. Issued April 13, 2012.
  • International Headache Society (IHS) The International Classification of Headache Disorders (ICHD).
  • American Association of Neurological Surgeons (AANS) Patient Information Occipital Neuralgia. Updated February 2013.
  • National Institute of Neurological Disorders and Stroke Occipital Neuralgia.
  • Practice Guidelines for Chronic Pain Management: An Updated Report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology 2010, V 112, no 4.
  • The American Academy of Pain Medicine Occipital Nerve Radiofrequency Ablation for Occipital Neuralgia and Headaches: Use in Special Patient Populations (Case Study).
  • The American Academy of Pain Medicine Incidence of Third Occipital Neuralgia Following Radiofrequency Denervation of the C2-3 Facet Joint.
  • National Guideline Clearing House Neck and Upper Back (Acute and Chronic), Work Loss Data Institute; 2011.
  • David M. Biondi, D.O., Cervicogenic Headache: A Review of Diagnostic and Treatment Strategies, JAOA supplement 2, Vol 105, No 4 April 2005
  • Vibhu Kapoor, et.al., Refractory Occipital Neuralgia: Preoperative Assessment with CT-Guided Nerve Block Prior to Dorsal Cervical Rhizotomy. American Journal of Neuroradiolgoy
  • J Govind, et.al., Radiofrequency Neurotomy for the Treatment of Third Occipital Headache, J Neural Neurosug Psychiatry 2003; 74:88-93. Journal of Neurology, Neurosurgery & Psychiatry
  • PubMed. Response of Cervicogenic Headaches and Occipital Neuralgia to Radiofrequency Ablation of the C2 Dorsal Root Ganglion and/or Third Occipital Nerve. Headache 2014 Mar;54(3):500-10.
  • Tiffany Vu and Akhil Chhatre, Case Report Cooled Radiofrequency Ablation for Bilateral Greater Occipital Neuralgia. Case Reports in Neurological Medicine Volume 2014, Article ID 257373. Case Reports in Neurological Medicine
  • UpToDate. Occipital Neuralgia. Ivan Garza, M.D., Topic last updated August 25, 2017.
  • UpToDate. Cervicogenic Headache. David M. Biondi, M.D., Zahid H. Bajwa, M.D.. Topic last updated May 1, 2018.
  • UpToDate. Tension Type Headache in Adults: Acute Treatment. Frederick R. Taylor, M.D.. Topic last updated July 6, 2016.
  • UpToDate. Cluster Headache: Treatment and Prognosis. Arne May, M.D.. Topic last updated March 15, 2017.
  • UpToDate. Overview of Chronic Daily Headache. Ivan Garza, M.D., Todd J. Schwedt, M.D., MSCI. Topic last updated October 26, 2016.
  • UpToDate. Chronic Migraine. Ivan Garza, M.D., Todd J. Schwedt, M.D., MSCI. Topic last updated February 14, 2018.
  • Clinical Trials
  • Institute for Clinical Systems Improvement (ICSI) Healthcare Guideline Diagnosis and Treatment of Headache. Updated January 2013.
  • Slavin Konstantin, Nersesyan Hrachya, et.al. Current Algorithm for the Surgical Treatment of Facial Pain, Head and Face Medicine July 2007
  • American Society of Anesthesiologists and American Society of Regional Anesthesia and Pain Medicine, Practice Guideline for Chronic Pain Management, Anesthesiology 2010 Vol 112. No 4
  • Medscape. Radiofrequency Treatment in Chronic Pain, Expert Rev Neurother 2010;10(3):469-474.
  • American Academy of Neurology and American Headache Society, Evidence Based Guideline Update: NSAIDs and Other Complementary Treatments for Episodic Migraine Prevention in Adults. Neurology 2012;78:1346-1363  This guideline has been retired and is no longer valid or supported by AAN
  • UpToDate. Overview of Craniofacial Pain, Zahid H. Bajwa M.D., Charles C. Ho, M.D., Sajid A. Khan M.D., Ivan Garza, M.D., Topic last updated April 27, 2018.
  • Cohen S, Peterlin LB, Fulton L, et. al. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain 2015 December; 156(12):2585-2594
  • UpToDate. Acute Treatment of Migraine in Adults. Zahid H Bajwa M.D., Jonathan H. Smith, M.D., Topic last updated June 1, 2016.
  • UpToDate. New Daily Persistent Headache. Ivan Garza M.D., Todd J. Schwedt M.D., MSCI, Topic last updated May 23, 2016.
  • Nagar VR, Birthi P, Grider JS, et. al. Systematic review of radiofrequency ablation and pulsed radiofrequency for management of cervicogenic headache. Pain Physician 2015 Mar-Apr 18(2):109-30. PMID 25794199
  • British Association for the Study of Headache (BASH). Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type Headache, Cluster Headache, Medication-Overuse Headache.
  • Govind J, King W, Bailey B, Bogduk N. Radiofrequency neurotomy for the treatment of third occipital headache. J Neurol Neurosurg Psychiatry. 2003 Jan;74(1):88-93.
  • Halim W, Chua NH, Vissers KC. Long-term pain relief in patients with cervicogenic headaches after pulsed radiofrequency application into the lateral atlantoaxial (C1—2) joint using an anterolateral approach. Pain Pract. 2010 Jul-Aug;10(4):267-71
  • Haspeslagh SR, Can Suijlekom HA, Lame IE. et. al. Randomized controlled trial  of cervical radiofrequency lesions as a treatment for cervicogenic headache. BMC Anesthesiol 2006 Feb 16;6:1. PMID 16483374
  • Huang JH, Galvagno SM Jr, Hammed M, et. al. Occipital nerve pulsed radiofrequency treatment: a multi-center study evaluating predictors of outcome. Pain Med. 2012 Apr;13(4):489-98. PMID 22390409
  • Institute for Clinical Systems Improvement (ICSI). Health Care Guideline: Diagnosis and Treatment of Headache.
  • Lee JB, Park JY, Park J, et. al. Clinical efficacy of radiofrequency cervical zygapophyseal neurotomy in patients with chronic cervicogenic headache. Korean Med Sci 2007 Apr;22(2):326-9. PMID 17449944
  • Manolitsis N, Elahi F. Pulsed radiofrequency for occipital neuralgia. Pain Physician 2014 Nov-Dec;17(6):E709-17. PMID 25415786
  • Nagar VR, Birthi P, Grider JS, et. al. Systematic review of radiofrequency ablation and pulsed radiofrequency for management of cervicogenic headache. Pain Physician 2015 Mar-Apr;18(2):109-30. PMID 25794199
  • National Clinical Guideline Center (NICE). Headaches in over 12s: diagnosis and management. Clinical Guideline (CG 150) Published 2012, Last updated November 2015.
  • Stovner LJ, Kolstad F, Helde G. Radiofrequency denervation of facet joints C-2-C6 in cervicogenic headache: a randomized, double blind, sham-controlled study. Cephalgia. 2004 Oct;24(10):821-30. PMID 15377312
  • Vanelderen P, Rouwette T, De Vooght P, et. al. Pulsed radiofrequency for the treatment of occipital neuralgia: a prospective study with 6 months of follow-up. Reg Anesth Pain Med 2010 Mar-Apr;35(2):148-51. PMID 20301822
  • Zhang J, Shi DS, Wang R. Pulsed radiofrequency of the second cervical ganglion (C2) for the treatment of cervicogenic headache. J Headache Pain 2011 Oct;12(5):569-71. PMID 21611808     
  • UpToDate. Preventative Treatment of Migraines in Adults. Zahid H. Bajwa M.D. Jonathan H. Smith M.D. Topic last updated May 31, 2017.  
  • UpToDate. Tension Type Headaches in Adults: Preventative Treatment. Frederick R. Taylor M.D., Topic last updated June 16, 2016.
  • American Association of Neurological Surgeons (AANS) Patient Information Occipital Neuralgia. 
  • Cho SJ, Song TJ, Chu MK. Treatment update of chronic migraine. Curr Pain Headache Rep 2017 Jun;21(6):26. PMID 28424953
  • Choi I, Jeon SR. Neuralgias of the Head: Occipital Neuralgia. J Koren Med Sci 2016 Apr;31(4):479-88. PMID 27051229
  • Gande AV, Chivukula A, Moosy JJ et. al. Long-term outcomes of intradural cervical dorsal root rhizotomy for refractory occipital neuralgia. J Neurosurg 2016 Jul;125(1):102-10. PMID 26684782
  • Grandhi RK, Kaye AD, Abd-Elsayed A. Systematic Review of Radiofrequency Ablation and Pulsed Radiofrequency for Management of Cervicogenic Headaches. Curr Pain Headache Rep 2018 Feb 23;22(3):18. PMID 29476360
  • Zhang J, Shi DS, Wang R. Pulsed radiofrequency of the second cervical ganglion (C2) for the treatment of cervicogenic headache. J Headache Pain 2011 Oct;12(5):569-71. PMID 21611808
  • Benoliel R, Gual C. Persistent idiopathic facial pain. Cephalgia 2017 Jun;37(7):680-691. PMID 28425324
  • Weiss AL, Ehrhardt KP, Tolba R. Aytpical facial pain: a comprehensive evidence based review. Curr Pain Headache Rep 2017 Feb;21(2):8. PMID 28251523
  • Vu T, Chhatre A. Case report cooled radiofrequency ablation for bilateral greater occipital neuralgia. Case Reports in Neurological Medicine Volume 2014 Article ID 257373
  • International Association for the Study of Pain (IASP) Trigeminal Neuralgia and Persistent Idiopathic Facial Pain
  • Krolczyk S. MedScape – Persistant idiopathic facial pain treatment and management. Updated October 12, 20116. 
  • Chong H, Kim MD, Wayen HU, et. al. Cryablation for the Treatment of Occipital Neuralgia. Pain Physicians 2015;18:E363-E368
  • Hamer JF, Purath TA. Response of cervicogenic headaches and occipital neuralgia to radiofrequency ablation of the C2 dorsal root ganglion and/or third occipital nerve. Headache 2014 Mar;54(3):500-10. PMID 24433241
  • Hamer JF, Purath TA. Repeat RF ablation of C2 and third occipital nerves for recurrent occipital neuralgia and cervicogenic headaches. World Journal of Neuroscience 2016, 6, 236-242

 

Policy History:

  • August 2018 - Annual Review, Policy Revised
  • August 2017 - Annual Review, Policy Revised
  • October 2016 - Annual Review, Policy Revised
  • October 2015 - Annual Review, Policy Revised
  • November 2014 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.