SPG Blocks: Miracle Block Treats and Eliminates Migraines & Essential Hypertension But Denied By Insurance

Dr. Shapira Blog 0 Comments

Dr Shapira has utilized Sphenopalatine Ganglion Blocks for over 30 years in his clinical practice.

The amazing SPG Blocks can treat and eliminate chronic daily headache, migraine, cluster headaches and other autonomic cephalgias as well as anxiety and PTSD.

The book “Miracles on Park Avenue” was published in 1986 and detailed the practice of Dr Milton Reder who had patients come from around the world for treatment with SPG Blocks.

A new article published in the International Journal of Cardiology show that a Bilateral SPG Block is also successful at treating Essential Hypertension. (abstract below).  In the past lowering of blood pressure has been seen as positive side effect of treatment.

This study was done with a one time application of the SPG Block. Dr Shapira is the leading advocate of Self-Administered SPG Blocks.

If SPG Blocks are used for treating Essential Hypertension Self-Administration will be the key to successful and cost effective implementation.

SPG Blocks have been successfully utilized for over 100 years but recently insurance companies are rewriting their policies to declare that this treatment is experimental and to fraudulantly deny coverage to patients. Following the abstract are several links to the new Blue Cross Blue Shield policy declaring SPG blocks to be investigational and uncovered by insurance. I have reprinted one of these from Blue Cross of Kansas.

The reason that this is happening is that there are several new devices for delivering SPG Blocks in a series of 10 Blocks over time. These devices include the Sphenocath, the Allevio and the TX360 used for the MIRx protocol. This has become an enormous expense to insurance companies.

I am calling on Blue Cross and other Insurance companies to rethink this poor decision and to work with me in developing a nationwide group to teach Self Administration of SPG Blocks as a cost effective alternative.

I have been treating patients and teaching them to self administer these blocks for 30 years and has lectured to hundreds of dentists and physicians on Spheonpalatine Ganglion Blocks for treating chronic pain and sympathetic overload conditions.

Dr Reder used to see patients twice a day to administer the SPG Blocks my patients often utilize a twice daily protocol initially.  Self Administration brings the cost tper block under $1.00 per bilateral application making it extremely cost effective and more improtant gives patients freedom to control their own pain and avoid ER visits and Emergency room visits.

I created a website focusing on SPG Blocks. https://www.sphenopalatineganglionblocks.com/

Int J Cardiol. 2018 Jan 1;250:233-239. doi: 10.1016/j.ijcard.2017.10.042. Epub 2017 Oct 16.
Bilateral sphenopalatine ganglion block reduces blood pressure in never treated patients with essential hypertension. A randomized controlled single-blinded study.
Triantafyllidi H1, Arvaniti C2, Schoinas A3, Benas D3, Vlachos S3, Palaiodimos L3, Pavlidis G3, Ikonomidis I3, Batistaki C2, Voumvourakis C4, Lekakis J3.
Author information
Abstract
BACKGROUND:
Sympathetic fibers connect sphenopalatine ganglion (SPG) with the central nervous system. We aimed to study the effect of SPG block in blood pressure (BP) in never treated patients with stage I-II essential hypertension.

METHODS:
We performed bilateral SPG block with lidocaine 2% in 33 hypertensive patients (mean age 48±12years, 24 men) and a sham operation with water for injection in 11 patients who served as the control group (mean age 51±12years, 8 men). All patients have been subjected to 24h ambulatory blood pressure monitoring prior and a month after the SBG block in order to estimate any differences in blood pressure parameters. We defined as responders to SBG block those patients with a 24h SBP decrease ≥5mmHg.

RESULTS:
We found that 24h and daytime DBP (p=0.02) as well as daytime DBP load (p=0.03) were decreased in the study group a month after SPG block. In addition, a significant response was noted in 12/33 responders (36%) regarding: a. SBP and DBP during overall 24h and daytime (p<0.001) and night-time periods, b. pre-awake and early morning SBP and c. SBP (daytime and night-time) and DBP (daytime) load. No differences regarding BP were found in the sham operation group.

CONCLUSIONS:
SPG block is a promising, minimally invasive option of BP decrease in hypertensives, probably through SNS modulation. Additionally, due to its anesthetic effect, SPG block might act as a method of selection for those hypertensive patients with an activated SNS before any other invasive antihypertensive procedure.

Copyright © 2017 Elsevier B.V. All rights reserved.

KEYWORDS:
24h blood pressure measurement (24h ABPM); Arterial hypertension; Neural block; Sphenopalatine ganglion

https://www.bcbsri.com/sites/default/files/polices/Sphenopalatine%20Ganglion%20Block%20for%20Headache.pdf

https://www.bcbsks.com/CustomerService/Providers/MedicalPolicies/policies/policies/SphenopalatineGanglionBlock_Headache_2017-09-28.pdf

https://www.bluecrossnc.com/sites/default/files/document/attachment/services/public/pdfs/medicalpolicy/sphenopalatine_ganglion_block_for_headache.pdf

https://www.azblue.com/~/media/azblue/files/healthcare/resources/medical-coverage-guidelines/medicine/o978.pdf

http://www.bluecrossma.com/common/en_US/medical_policies/026%20Sphenopalatine%20Ganglion%20Block%20for%20Headache%20prn.pdf

https://providers.bcbsla.com/-/media/Files/Providers/00563SphenopalatineGanglionBlockforHeadache-pdf.pdf?la=en

http://mcgs.bcbsfl.com/?doc=Nerve%20Block%20Injections

 

BELOW IS A BCBS POLICY STATEMENT FOR KANSAS.  SIMILAR STATEMENTS ARE APPEARING IN MANY STATES ACROSS THE US.

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Medical Policy
An independent licensee of the
Blue Cross Blue Shield Association
Title: Sphenopalatine Ganglion Block for Headache
Professional Institutional
Original Effective Date: November 13, 2017 Original Effective Date: November 13, 2017
Revision Date(s): November 13, 2017 Revision Date(s): November 13, 2017
Current Effective Date: November 13, 2017 Current Effective Date: November 13, 2017
State and Federal mandates and health plan member contract language, including specific
provisions/exclusions, take precedence over Medical Policy and must be considered first in
determining eligibility for coverage. To verify a member’s benefits, contact Blue Cross and
Blue Shield of Kansas Customer Service.
The BCBSKS Medical Policies contained herein are for informational purposes and apply only
to members who have health insurance through BCBSKS or who are covered by a self-insured
group plan administered by BCBSKS. Medical Policy for FEP members is subject to FEP medical
policy which may differ from BCBSKS Medical Policy.
The medical policies do not constitute medical advice or medical care. Treating health care
providers are independent contractors and are neither employees nor agents of Blue Cross
and Blue Shield of Kansas and are solely responsible for diagnosis, treatment and medical
advice.
If your patient is covered under a different Blue Cross and Blue Shield plan, please refer to the
Medical Policies of that plan.
Populations Interventions Comparators Outcomes
Individuals:
• With chronic migraine
headache
Interventions of interest
are:
• Sphenopalatine
ganglion block(s)
Comparators of interest are:
• Medication
• Self-management (eg,
relaxation, exercise)
• Botulinum toxin injection
Relevant outcomes include:
• Symptoms
• Functional outcomes
• Quality of life
• Treatment-related morbidity
Individuals:
• With severe acute
headache treated in the
emergency setting
Interventions of interest
are:
• Sphenopalatine
ganglion block(s)
Comparators of interest are:
• Medication
Relevant outcomes include:
• Symptoms
• Functional outcomes
• Quality of life
• Treatment-related morbidity
Individuals:
• With cluster headache
Interventions of interest
are:
• Sphenopalatine
ganglion block(s)
Comparators of interest are:
• Medication
• Oxygen therapy
Relevant outcomes include:
• Symptoms
• Functional outcomes
• Quality of life
• Treatment-related morbidity
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DESCRIPTION
Chronic migraine and severe headaches are common conditions and the available
treatments are not universally effective. A proposed treatment option is blocking the
sphenopalatine ganglion (SPG) nerve by applying topical anesthetic intranasally. Several
catheters approved by the Food and Drug Administration are available for the SPG
blocking procedure.
OBJECTIVE
The objective of this policy is to evaluate whether sphenopalatine ganglion blocks
improve health outcomes in patients with chronic or severe acute headaches, compared
with other accepted headache treatments.
BACKGROUND
Headaches and Headache Treatments
Headaches are common neurologic disorders and are among the top reasons that
patients seek medical care. Headaches affect approximately 50% of the general
population in a given year and over 90% of people have a lifetime history of headache.1
The 2 most common types of headache are tension-type headaches and migraines.
Tension headaches have a prevalence of approximately 40%.2 Diagnostic criteria include
the presence of at least 2 of the following characteristics: bilateral headache location,
nonpulsating pain, mild-to-moderate intensity, and headache not aggravated by physical
activity.3 Migraines are the second-most common headache disorder, with a 1-year
migraine prevalence of approximately 12% in the United States.2 They are characterized
by severe pain on 1 or both sides of the head, nausea, and, at times, disturbed vision.
Migraines can be categorized by headache frequency, and by the presence or absence of
aura. Chronic migraine is defined as attacks on at least 15 days per month for more than
3 months, with features of migraine on at least 8 days per month.3
Cluster headaches are less common than tension or migraine headaches, with an
estimated prevalence of 0.1% of the population.2 They are characterized by severe
unilateral orbital, supraorbital, and/or temporal pain that also includes other symptoms in
the eye and/or nose on the same side (eg, rhinorrhea, eyelid edema or drooping).
Treatment
A variety of medications are used to treat acute migraine episodes. They include
medications taken at the onset of an attack to abort the attack (triptans, ergotamines)
and medications to treat the pain and other symptoms of migraines once they are
established (nonsteroidal anti-inflammatory drugs, antiemetics). Prophylactic medication
therapy may be appropriate for people with migraines that occur more than 2 days per
week. In addition to medication, behavioral treatments (eg, relaxation, cognitive therapy)
are used to manage migraine headache. Botulinum toxin type A injections are a U.S.
Food and Drug Administration‒approved treatment for chronic migraine.
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Severe acute cluster headaches may be treated with abortive therapy including breathing
100% oxygen, and triptan medications. Other medications used to treat cluster
headaches include steroids, calcium channel blockers, and nerve pain medications. Due
to the severity of pain associated with cluster headaches, patients may seek emergency
treatment. Tension-type headaches are generally treated with over the counter pain
medication.
Sphenopalatine Ganglion Block
Sphenopalatine ganglion (SPG) blocks are a proposed treatment option for chronic
migraines and some severe non−migraine headaches. The SPG is a group of nerve cells
located behind the bony structures of the nose. The nerve bundle is linked to the
trigeminal nerve, the primary nerve involved in headache disorders. The SPG has both
autonomic nerves, which in this case are associated with functions such as tearing and
nasal congestion, and sensory nerves, associated with pain perception. SPG blocks
involve topical application of local anesthetic to mucosa overlying the SPG. The rationale
for using SPG blocks to treat headaches is that local anesthetics in low concentrations
could block the sensory fibers and thereby reduce pain while maintaining autonomic
function.
The proposed procedure for SPG blockade is to insert intranasally a catheter that is
attached to a syringe carrying local anesthetic (eg, lidocaine, bupivacaine). Once the
catheter is in place, the local anesthetic is applied to the posterior wall of the nasal cavity
and reaches the SPG. Some form of SPG blocking procedure has been used for many
years. Originally, SPG blocks were done by inserting a cotton-tipped applicator dabbed
with local anesthetic into the nose; this technique may be less accurate and effective
than the currently proposed procedure. Another variation is to insert a needle into the
cheek and inject local anesthetic but this no longer appears to be used because it is more
invasive and can be painful. Neurostimulation of the SPG and SPG blockade with
radiofrequency lesioning have been used outside of the United States,4 but these
treatments are not cleared or approved by FDA.
Three catheter devices are commercially available in the United States for performing
SPG blocks. The catheters have somewhat different designs but all are attached to
syringes that contain local anesthetic. The catheters are inserted intranasally and, once
in place, the local anesthetic is applied through the catheter. With 2 of the 3
commercially available catheters (the SpenoCath®, Allevio™), patients are positioned on
their back with their nose pointed vertically and their head turned to the side. With the
Tx360® device, patients remain seated.5
The company marketing the Tx360® device proposes its use in the context of the MiRx™
protocol.6 This 2-part protocol includes a medical component for immediate pain relief
and a physical component to reduce headache recurrences. The medical component
involves clinical evaluation and, if the patient is considered eligible, an SPG block
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procedure. The physical component can include any of a number of approaches such as
physical therapy, ergonomic modifications, massage, and dietary recommendations.
The optimal number and frequency of SPG treatments is unclear. Information from the
American Migraine Foundation suggests that the procedure can be repeated as often as
needed to control pain.5 A randomized controlled trial (RCT) has described a course of
treatment for migraines consisting of SPG blocks twice a week for 6 weeks (total, 12
treatments).
SGB blocks are proposed for both short- and long-term treatment of headaches and
migraines. When used in the emergency setting in patients with severe acute headaches,
the goal of treatment is to abort the current headache while the patient is in the
emergency department. In the RCT that provided a 6-week course of treatment with SPG
blocks for chronic migraine (mentioned above), short-term outcomes were assessed up
to 24 hours after each treatment, and the duration and frequency of chronic migraines
were assessed at 1 and 6 months after the course of treatment.
REGULATORY STATUS
The Tx360® Nasal Applicator (Tian Medical), the Allevio™ SPG Nerve Block Catheter
(JET Medical), and the SpenoCath® (Dolor Technologies) are considered class I devices
by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k)
requirements. This classification does not require submission of clinical data regarding
efficacy but only notification of FDA prior to marketing. These 3 devices are all used to
apply numbing medication intranasally.
POLICY
Sphenopalatine ganglion blocks are considered experimental / investigational for all
indications, including, but not limited to, the treatment of migraines and non-migraine
headaches.
RATIONALE
This evidence review was originally created in May 2017 and based on a search of the MEDLINE
database. The most recent literature search was conducted through March 23, 2017.
Assessment of efficacy for therapeutic interventions involves a determination of whether the
intervention improves health outcomes. The optimal study design for this purpose is a
randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes.
Intermediate outcome measures, also known as surrogate outcome measures, may also be
adequate if there is an established link between the intermediate outcome and true health
outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide
useful information on health outcomes, but are prone to biases such as noncomparability of
treatment groups, placebo effect, and variable natural history of the condition.
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Because the placebo response rate is typically high in patients with headache, assessment of the
evidence for this review focuses on randomized, placebo-controlled trials.
Chronic Migraine
The published literature on sphenopalatine ganglion (SPG) blocks to treat chronic migraine
consists of 1 double-blind, placebo-controlled randomized trial7,8 and a case report with 3
patients.9
Findings from the RCT were published in two 2015 publications by Cady et al. The first
publication7 reported on the primary outcome measure and key secondary outcomes, and the
subsequent publication8 reported on supplemental secondary outcomes and longer term followup.
The trial included patients who met International Classification of Headache Disorders-II
diagnostic criteria for chronic migraine10 and had had chronic migraine for at least 3 months.
Patients could use concomitant headache medication, but had to agree not to change medication
use during the study period. Following an initial 28-day baseline period to confirm the diagnosis
of chronic migraine, patients were randomized 2:1 to receive treatment with bupivacaine 0.5% or
saline (placebo) applied using the Tx360 device. Patients received a series of 12 treatments2
treatments a week for 6 weeks. The primary outcome was change in pain severity, measured
using a 0-to-10 numeric rating scale (NRS). Pain severity was assessed 15 minutes, 30 minutes,
and 24 hours after each treatment. Key secondary outcome measures were the Patient’s Global
Impression of Change (PGIC), the Headache Impact Test (HIT-6) questionnaire, and patient
satisfaction with treatment. In addition, patients kept headache diaries throughout the study.
Forty-one patients met eligibility criteria and had chronic migraine diagnoses confirmed during
the baseline period. These patients were randomized to bupivacaine (n=27) or to placebo
(n=13). Mean baseline scores on the NRS were 4.8 in the bupivacaine group and 4.5 in the
placebo group. When findings for all treatments were pooled, patients in the bupivacaine group
reported a significantly greater reduction in NRS scores than the placebo group at 15 minutes, 30
minutes, and 24 hours after treatment. Bupivacaine-treated patients also had significantly lower
PGIC scores than saline-treated patients at 30 minutes and 24 hours posttreatment. No
statistically significant between-group differences were found in HIT-6 scores or in average acute
mediation use. Only 1 serious adverse event was reported and it was not treatment-related.
The second publication by Cady et al reported on 1- and 6- month follow-up results and on
supplemental secondary end points.8 To control for multiple comparisons, the cutoff for statistical
significance for the supplemental secondary end points was p less than 0.01. There were no
statistically significant differences between groups in the reported supplementary secondary
outcomes. These outcomes included the number of headache days per month, the mean pain
score, and quality of life measures. A post hoc power analysis revealed that the trial was
underpowered to detect significant differences in secondary outcomes. Some results were
suggestive of a long-term effect. For example, the bupivacaine group had a lower, albeit
nonsignificant number of headache days in the month posttreatment (17 days) than the placebo
group (23 days). However, a trial with a larger sample size would be needed to confirm whether
1- or 6-month results are significantly better after bupivacaine than after placebo treatment.
Section Summary: Chronic Migraine
One double-blind, placebo-controlled, randomized trial has evaluated transnasal SPG blocks for
chronic migraine. The trial found a significantly greater short-term (up to 24 hours) reduction in
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pain severity after active treatment versus placebo. However, there were no significant longer
term effects on other outcomes (ie, 1 and 6 months after 12 treatments over 6 weeks). The trial
was underpowered to detect outcomes at 1 and 6 months. It had some risks of bias due to a
high rate of dropouts. Additional adequately powered trials are needed to determine the impact
of SPG blocks on health outcomes.
Severe Acute Headache Treated in the Emergency Setting
The published literature on SPG blocks to treat severe acute headache consists of 1 double-blind,
placebo-controlled, randomized trial (2015).11 The trial included patients between the ages of 18
and 65 who presented to the emergency department with a frontal-based crescendo-onset
headache and a negative neurologic examination. The trial focused on frontal-based headaches
because they are considered most likely to respond to SPG blocks. Headaches were not classified
into specific types but patients with sudden-onset headache were excluded. Ninety-three patients
met eligibility criteria and were randomized 1:1 to treatment with bupivacaine 0.5% (n=45) or to
a saline placebo (n=48) applied using the Tx360 device. The intervention consisted of 1
treatment session. The primary outcome was a 50% absolute pain reduction on a 100-mm visual
analog scale (VAS) 15 minutes posttreatment. Four patients, 2 in each group, withdrew before
receiving the intervention and 2 were deemed ineligible after randomization. Thus, 41 patients in
the bupivacaine group and 46 in the placebo group were included in the primary analysis.
For the primary outcome, 20 (49%) patients in the bupivacaine group and 19 (41%) patients in
the placebo group had at least a 50% reduction in the mean VAS score. The difference between
groups (7.5%) did not differ statistically (95% confidence interval, -13% to 27%). Secondary
outcomes, including at least a 19-mm reduction in VAS score, percentage of patients who were
headache-free 15 minutes postintervention, and percentage of patients who were nausea-free 15
minutes postintervention, also did not differ significantly between groups. Seventy-six (88%)
patients were available for follow-up after 24 hours. The percentage of patients headache-free at
24 hours was significantly higher in the bupivacaine group (n=26 [72%]) than in the placebo
group (n=19 [48%]; difference, 25%; 95% CI, 2.6% to 44%). No serious adverse events were
reported in either group. The trialists stated that, in retrospect, outcome assessment at 1 hour
after treatment would have been useful because headache relief at 1 hour, but not at 24 hours,
is clinically relevant for emergency department headache patients.
Section Summary: Severe Acute Headache Treated in the Emergency Setting
One double-blind, placebo-controlled, randomized trial has evaluated a single transnasal SPG
block for treating patients with acute headache presenting to an emergency department. The
authors did not find a statistically significant benefit for active treatment compared with placebo
15 minutes postintervention. Significantly more patients were headache-free at 24 hours in the
active treatment than in the placebo group, but, in the absence of short-term pain relief, SPG
blocks would not be a clinically useful treatment in the emergency setting. Future studies
conducted in the emergency setting should assess outcomes for an intermediate time period (eg,
1 or 2 hours posttreatment).
Cluster Headache
No RCTs or nonrandomized controlled studies were identified that evaluated intranasal SPG
blocks for treating cluster headache. Two case series in patients with chronic drug-resistant
cluster headache were published by a research group in Italy.12,13 Both studies used a needle
(20-gauge in 1 study, 18-gauge in the other) under endoscopic control to inject a mixture of local
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anesthetics and steroid as close as possible to the SPG. The mixture consisted of triamcinolone
acetonide (40 mg), 1% bupivacaine (4 mL), and 2% mepivacaine with 1/100,000 adrenaline (2
mL). The earlier study, published in 2006 by Felisati et al, included 21 patients who received
between 2 and 4 total treatment sessions, provided 1 week apart. Including 1 patient in whom
the treatment could not be applied, 9 (45%) experienced no efficacy, 3 (15%) experienced a
partial benefit, and 8 (40%) experienced a complete temporary benefit. In the 8 patients who
had complete disappearance of attacks, the benefit lasted 2 to 4 weeks in 3 patients, 3 to 6
months in 3 patients, and 12 to 24 months in 2 patients. Four (19%) patients experienced
treatment-related complications, which consisted of 1 case of marked nasal epistaxis 3 days after
the procedure and 3 cases of temporary diplopia.
In 2010, Pipolo reported on 15 patients who received 3 SPG block treatments a mean of 3 days
apart. Eight (53%) of the 15 patients experienced complete remission of cluster headache
symptoms. Three (20%) of these continued to be in remission at last follow-up (mean, 18
months). One (7%) patient experienced partial benefit and 6 (40%) reported either no benefit or
a benefit for less than 2 weeks. Three (20%) patients experienced complications, including 2
cases of severe epistaxis and 1 of reduced buccal opening that resolved after 5 months.
Section Summary: Cluster Headache
The literature includes 2 case series, both of which were published by the same research group
in Italy. The approach to treatment was similar in the 2 studies but differed in terms of
medication and application technique currently used in the United States. It is unclear how the
safety or efficacy of the procedure used in the case series differs from an intranasal SPG block
applying local anesthetics and using an FDA cleared device. In these series, 40% to 50% of
patients experienced complete symptom relief for a variable length of time and about 20% had
treatment-related complications. These studies had small sample sizes and lacked a sham
treatment or alternative therapy for treating cluster headache.
SUMMARY OF EVIDENCE
For individuals who have chronic migraine who receive sphenopalatine ganglion (SPG) block(s),
the evidence includes a randomized controlled trial (RCT) and a case report. Relevant outcomes
are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The
randomized trial evaluated a regimen of 12 SPG blocks over 6 weeks and was double-blind and
placebo-controlled. The trial found significantly greater short-term (up to 24 hours) benefits from
active treatment than from placebo. There were no significant longer term effects (ie, 1 and 6
months after 12 treatments), although the trial was underpowered to detect longer term efficacy.
Given that SPG blocks are being proposed as a preventive therapy for chronic migraines,
evidence demonstrating reduced migraine frequency, severity, or other objective outcomes from
robust trials is still needed. The evidence is insufficient to determine the effects of the technology
on health outcomes.
For individuals who have severe acute headache treated in the emergency setting who receive
SPG block(s), the evidence includes 1 RCT. Relevant outcomes are symptoms, functional
outcomes, quality of life, and treatment-related morbidity. The randomized, double-blind,
placebo-controlled trial was evaluated a single SPG block for severe acute headache of mixed
etiologies. There was no statistically significant difference between active treatment and placebo
for the primary outcome (pain reduction 15 minutes postintervention). The trialists did not collect
pain again data until 24 hours posttreatment, at which time significantly more patients were
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headache-free in the active treatment arm than in the placebo arm. Additional studies, preferably
RCTs, are needed to determine whether SPG blocks are an effective treatment in the emergency
setting. The evidence is insufficient to determine the effects of the technology on health
outcomes.
For individuals who have cluster headache who receive SPG block(s), the evidence includes case
series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatmentrelated
morbidity. Two small case series, both of which evaluate an approach for intranasal SPG
blocks that differs from the intervention currently available in the United States, were identified.
In these series, 40% to 50% of patients experienced complete symptom relief for a variable
length of time and about 20% had treatment-related complications. However, it is not clear from
these series the degree to which the procedures evaluated differ in safety and efficacy from an
intranasal SPG block using a device cleared by the Food and Drug Administration. Additional
studies, preferably RCTs, are needed to evaluate SPG blocks for treating cluster headaches. The
evidence is insufficient to determine the effects of the technology on health outcomes.
PRACTICE GUIDELINES AND POSITION STATEMENTS
No guidelines or statements were identified.
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Not applicable.
ONGOING AND UNPUBLISHED CLINICAL TRIALS
Some currently unpublished trials that might influence this review are listed in Table 1.
Table 1. Summary of Key Trials
NCT No. Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT02365909 Study Evaluating Sphenopalatine Ganglion Block (SPGB) for
Treatment of Postdural Puncture Headache (PDPH)
30 Dec 2017
NCT02090998 Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of
Transformed Migraines
200 May 2018
NCT: national clinical trial.
CODING
The following codes for treatment and procedures applicable to this policy are included below
for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s)
does not constitute or imply member coverage or provider reimbursement. Please refer to the
member’s contract benefits in effect at the time of service to determine coverage or noncoverage
of these services as it applies to an individual member.
CPT/HCPCS
64400 Injection, anesthetic agent; trigeminal nerve, any division or branch
64505 Injection, anesthetic agent; sphenopalatine ganglion
64999 Unlisted procedure, nervous system
• This service is reported by some providers with CPT code 64505 along with the CPT code
for trigeminal block: 64400.
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ICD-10 Diagnoses
Experimental / Investigational for all diagnoses related to this medical policy.
REVISIONS
11-13-2017 Policy added to the bcbsks.com web site on 09-28-2017 with an effective date of
11-13-2017.
REFERENCES
1. International Association for the Study of Pain (IASP). Epidemiology of Headache. 2011;
http://www.iasppain.org/files/Content/ContentFolders/GlobalYearAgainstPain2/HeadacheFactSheets/1-
Epidemiology.pdf. Accessed April 10, 2017.
2. Singh A, Soares WE. Management strategies for acute headache in the emergency department.
Emerg Med Pract. Jun 2012;14(6):1-23; quiz 23-24. PMID 22830180
3. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. Jul
2013;33(9):629-808. PMID 23771276
4. American Migraine Foundation. Sphenopalatine Ganglion Blocks in Headache Disorders. 2016;
https://americanmigrainefoundation.org/understanding-migraine/sphenopalatine-ganglion-blocks-inheadache-disorders/.
Accessed April 14, 2017.
5. The MiRx™ Protocol http://www.mirxprotocol.com/. Accessed April 14, 2017.
6. Cady R, Saper J, Dexter K, et al. A double-blind, placebo-controlled study of repetitive transnasal
sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine.
Headache. Jan 2015;55(1):101-116. PMID 25338927
7. Cady RK, Saper J, Dexter K, et al. Long-term efficacy of a double-blind, placebo-controlled,
randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360
device for treatment of chronic migraine. Headache. Apr 2015;55(4):529-542. PMID 25828648
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