The Most Effective FDA Cleared Therapy for the
Prevention of Medically Diagnosed Migraine Pain
NTI Tension Suppression System
you wake up...
...do you feel fabulous?
Dr. James P. Boyd, developer of the first medical device to be cleared by the FDA for the prevention of medically diagnosed migraine pain, discusses the most important and most over-looked aspect of the diagnosis of chronic headache and migraine pain.
When you wake up, do
you feel fabulous?
In comparison to the migraine
episodes they experience, their "morning headaches"
are somehow manageable, and therefore in their mind,
not worthy of including in their complaints to
their health care provider.
Unfortunately, unless this critical component of
their condition is acknowledged and resolved,
effective prevention and management of their chronic
migraine and headache pain is unlikely.
They've seen plenty of doctors
for their headaches. They're asked specific
questions regarding the degree of pain that alters
their normal function like, "When do you get your
worst headaches...", and "What makes your headache
worse?", or "How many times per week/month do you
have a migraine?". Rarely, if
ever, is a chronic migraine or headache sufferer
asked, "Exactly when DON'T you have any
degree of headache, even the slightest?".
The biggest obstacle in
successful management and prevention of chronic
migraine and headache pain, is the lack of a complete
diagnosis. A diagnosis of a patient's
condition is NOT simply a medical label that
represents the sufferer's signs and symptoms, that's
just HALF of the diagnosis. Diagnosis
is defined as: "The nature and cause of a
disease or injury", where the signs and symptoms
represent the nature of the disease,
in this case, the description of the nature of the
suffers head pain.
Here's an analogy:
Imagine a woman coming home from a hard day at work,
where for several days, she's been assigned
difficult, stressful tasks. These tasks are not
abnormal to her, but their length and intensity are
more than "normal". She does not address or
consider the effect they might be having on
her. She comes home and discovers her checking
account is overdrawn and the plumbing is backed
up. She enters the kitchen and is asked by her
children, "Where's dinner?"
For any normal person, being
asked, "Where's dinner?" would not illicit an
intensely stern and aggressive reply. Only if
you understood what she's been going through would
you understand why she "snaps" with a stern,
aggressive, irritated response. Her response
isn't caused by any abnormal circumstance,
but by an excessive degree of normal
So how does this relate to the
cause of chronic headache or migraine pain?
Migraine is considered a disorder of the Trigeminal
nerve system. The Trigeminal gets it
name from its three sensory divisions that bring
information to the brain; from the scalp, the
face/sinuses, and jaw. Neurologists who treat
migraine are concerned with the first two divisions,
which bring in information (sensations) from the
scalp/forehead and sinuses. The current
hypothesis in the cause of chronic migraine is that
there must be some kind of negative (or "noxious")
information coming in from these two divisions, such
that the system becomes fatigued or irritable, thus
becoming susceptible to a "trigger" which launches a
painful attack along those same sensory nerves.
By the way, that's the
hypothesis of Botox for prevention of chronic
migraine. By injecting Botox into certain
nerve endings of the scalp, neck and shoulders that
deliver information to the brain, the Botox will
reduce the information flow, thereby reducing the
But what of the remaining third
division of the Trigeminal? The third
division, the mandibular (jaw) has two
roles. Not only does it receive sensory
information from everything in your mouth and
delivers it to the brain, it carries "motor"
information from the brain to the muscles of
chewing, and most importantly for our concerns, the
large clenching muscles that cover the temples (the
Now consider our analogy woman
again, but this time, everything at her work is
great. In fact, everything in her life is
wonderful: work, home, finances, social
life...except for her chronic headaches and
migraines. Every night, without her or her
husband's knowledge, she clenches her jaw while
asleep. Not grinding her teeth, but clenching
her jaw. She therefore is making no
grinding noises and there is no wearing away of her
teeth. In fact, her teeth are beautiful and
her dentist has assured her that she's not grinding
her teeth at all! However, her jaw muscles
have been working very, very hard. Her teeth
are being compressed and crushed into their own
sockets (her teeth are sometimes sensitive to
cold). If she's clenching with her jaw set
slightly to one side or the other, she's exerting
tremendous strain on her jaw joints
(TMJs). The sensory component of the
Trigeminal nerve is essentially bombarding her brain
with noxious (negative) input.
So now, not only does her
chronic jaw clenching cause her to wake with a
degree of headache (or stiff/sore neck, shoulders
and/or jaw), she has become far more susceptible or
irratable to her migraine triggers. So how
does one tell if they might be a chronic jaw
There are two simple questions
to ask in an interview of a headache/migraine
patient that tend to identify the probability of
nocturnal jaw clenching.
Question 1: On a scale of 0-10, with 10 being the worst discomfort above the shoulders that you could imagine (includes neck, jaw, sinus, headache or migraine pain), and 0 being no pain at all, how many mornings per week do you wake with a ZERO, that is, you feel fabulous?
That last part needs to be
emphasized. To anyone else, not having pain
upon waking is normal. Sure, you can still
feel tired, but a lack of pain isn't
remarkable to the normal person. For the
chronic headache and migraine pain sufferer, some
degree of pain/discomfort above the shoulders is
normal. For them, having no discomfort at all
would be, well, fabulous. Perhaps
unintentionally, the chronic headache and migraine
pain sufferer avoids that acknowledgement.
So when asked the above question, most chronic migraine sufferers will hesitate with their reply, and then begin to rationalize their answer before they provide it. They'll begin by stating, "Well, when I get my really bad headaches...", or, "Nobody ever really feels fabulous", or some justification as to why it's "within normal limits" for them to have discomfort upon waking. The practitioner must press on, and confirm how many mornings per week that the patient wakes with ZERO pain.
Experienced practitioners will soon find that being completely pain free every morning upon waking is quite rare for the chronic migraine sufferer. The practitioner can remind the sufferer that waking daily with, say, liver pain or kidney pain is certainly not normal, and so it is with chronic headache pain. The most effective migraine prevention treatment plan cannot be provided to its fullest extent if their entire presentation is not understood.
Question 2: On those days that you don't wake with a ZERO (that is, you have "a number"), what's the average "number" that you have?
Now the practitioner will have
a clearer picture of the patient's condition and
likelihood of the presence of nocturnal jaw
clenching. For example, waking 5 days per week
with a level 4 headache, to some chronic sufferers,
is not worthy of reporting. They have
learned that they must deal with their discomfort
and reserve their complaints for the degree of
migraine pain that alters their daily lives.
They are wary of being labeled "drug overuse"
patients, because in some practitioners minds,
constant headache, especially upon waking, could only
be due to medication overuse. Chronic jaw
clenchers will wake "with a number" more times than
not, with the intensity varying, depending on the
intensity of clenching the night before.
Although waking with a 4 to a 6 wouldn't be unusual,
waking with an 8 or 9 does not surprise them
(while waking with 0 would be very
surprising). To them, it's something that
happens, and if they can get on with their day, they
try to ignore it.
The chronic migraine sufferer
eventually succumbs that their worst headaches and
migraine attacks are far more important to try and
manage than their chronic "normal discomfort"
existence. Besides, no one has been able to
diagnose and alleviate their normal discomfort,
anyway. However, to the practitioner,
this information is critical in the assessment of
the cause and/or perpetuation of their patient's
This is not to suggest that
chronic nocturnal masticatory parafunction (i.e.,
intense jaw clenching) is the cause of chronic
headache or migraine pain. On the contrary, it
is better considered as being a primary complicating
factor and/or perpetuating influence on chronic
headache and migraine pain. Better stated,
habitual nocturnal jaw clenching cannot, by itself,
cause chronic headache or migraine pain, but chronic
headache and migraine pain cannot be completely
managed and prevented in the
presence of undiagnosed and uncontrolled nocturnal
jaw clenching. In fact, without
controlling nocturnal jaw clenching, traditional
medical attempts at migraine prevention may fail
So how is jaw clenching
controlled? There are three aspects of jaw
clenching to consider; the frequency, the duration,
and the intensity. The first two, frequency
and duration, cannot be controlled. The
clencher will close and squeeze no matter what's in
their mouth and will remain clenching with a
duration that is unique to them. The number of
times they clench, and the length of time per
clench, cannot be controlled. However, it's
the intensity of the clenching
that is problematic.
In order for clenching to
achieve pathologic intensities, the back molars
and/or canine (fang) teeth must come into contact
with either each other, or with an object sandwiched
between them. Some people use a common "nightguard"
to protect their teeth from clenching.
Unfortunately for the headache/migraine patient who
clenches, the nightguard allows them to clench more
intensely with it than without it.
NTI therapy uses an NTI device,
which is a far smaller mouthpiece that fits only on
either the upper or lower front teeth. By
preventing the molars (or canines) from engaging
anything, clenching intensity cannot achieve
pathologic levels. At first one might be
concerned that when using an NTI device that their
clenching intensity would damage their front
teeth. However, since the back teeth cannot
touch, clenching intensity remains low and tolerated
by the front incisors.
Following the first month of NTI therapy, the practitioner can re-ask the two questions above. Although the patient might first proclaim, "I'm still having headaches" (as if no improvement had occurred), the practitioner may discover that the patient is now waking less frequently "with a number" and that the level of that number has been reduced. Continually using the two questions above is a handy tool to follow a patient's progress.
By the way, NTI stands for
Nocioceptive Trigeminal Inhibition.
Essentially, the name implies that negative sensory
input (nocioception) to the brain via the trigeminal
nerve is inhibited by the presence of the device
(which prevents high intensity jaw clenching).
How well does it work? In
the clinical trials submitted to the FDA, 82% of
migraine suffers experienced a 77% reduction in
migraine pain events. In 2001, the FDA cleared
the NTI device "For the prevention of medically
diagnosed migraine pain". Note that the NTI
does "cure" migraine, it reduces (sometimes to zero)
the pain events and intensity. (In this follow-up
study of patients who's chronic daily
headaches were deemed "severe and disabling", 65%
had a 71% average reduction in their morning
headache days, while 75% reported a significant
improvement in the quality of their lives).
If the NTI is so effective, why
hasn't it been enthusiastically embraced by the
medical community? The problem is the design
of the study that was submitted to the FDA.
When a drug is tested, it is compared to a placebo,
that is, a similarly shaped sugar pill. The
placebo will always produce the desired effect to
some degree. The goal is to statistically have
the test drug outperform the placebo.
For example, Botox was recently approved by the FDA
for the prevention of chronic migraine. When
compared to the injection of water (the placebo),
Botox patients had 1.5 more "headache free days" per
month. The advertising doesn't tell you that
that means placebo patients had 16.5 headache days
per month while Botox patients had 15.
Unfortunately, there is nothing can be put into one's mouth that cannot produce sensory information, therefore, the NTI cannot be compared to a placebo mouthpiece. Without "placebo controlled" studies, the efficacy of NTI therapy for migraine prevention is not seen as credible in medicine.-James P. Boyd, DDS
Developer of the NTI therapeutic protocol. (more on Dr. Boyd)
To find a dentist near you who provides the NTI device, visit:
|Dr. Boyd on Good Morning
American, September, 2001:
|More from Dr. Boyd on his
background and experience in headache management:
I had been a daily headache sufferer for 12 years, from my senior year in high school in 1977, through 1989, four years out of dental school. Each day I woke with a degree of headache, ranging from a 3 to a 6. For the first few years out of dental school, it was rarely in the low ranges. I consumed nearly a dozen Excedrin tablets per day. Occasionally, it would get out of control, and the nature of the pain would change from squeezing and throbbing to a degree where I was nauseous. Later I leaned those were migraines.
As an undergraduate college student, I had been a "TMJ" patient. My jaw would make loud popping sounds as I chewed, and occasionally would locked closed upon waking in the morning. I was treated with a "splint", a horse-shoe shaped acrylic device that covered my upper teeth. It seemed to help for a few days, but I eventually got used to it and my headaches returned. I learned that if I only used in for a night or two, then went without it for a night or two, then back to wearing it, I wasn't as bad.
Three years out of dental school and my head was pounding all day long. The really frustrating part was that my dental practice emphasized "TMJ treatment", yet I was unable to help myself. The splint I had used while in college helped some patients, but many seemed just like me. No matter what I tried, their headache symptoms persisted.
In 1988 I recalled a lecture I had been to a few years prior, given by one of the experts in Temporomandibular Disorders (the proper name for TMJ). He had said that for the patient in "muscular distress" (meaning clenching like crazy), to place an anterior midline mound on the patient's splint (in dentistry, that's called a "deprogrammer"). Allow the patient to become comfortable over a few days, then remove the addition. Practically in desperation, I added a small elevated mound at the front midline of my splint, so that when I closed my mouth, only the edges of my lower front teeth contacted the mound. No other teeth touched anything.
For me, it was nothing short of miraculous. The next day I woke without a headache. Although it creeped back somewhat later in the day, it was nothing like I was used to. The next three days was the same lack of the usual morning headache. Things were going great until the end of the week when I woke with a type of headache that I was completely unfamiliar with. Pain behind my eyes and at the base of my skull. I assumed this was why I had been instructed to remove the mound after a few days...apparently, it would eventually backfire. However, as I assessed myself while biting on the splint, I discovered that my jaw had "learned" to shift forward enough to avoid the mound! I had learned to clench my back teeth by shifting my jaw forward, thereby also changing the presentation of my headache.
So I began my personal education of the variability of jaw clenching activity. It's not the same for everyone. It's as if the jaw clenching activity looks for a way to maintain itself, doing whatever it takes (like moving way off to one side, forwards, backwards, whatever) to accomplish the goal of making the patient miserable. A simple mound on a splint would fail miserably in most sufferers, as their jaw would shift to clench elsewhere, usually making the patient feel worse. So over the years, dentists had already learned that a deprogrammer should not be used for more than a few consecutive nights. No one really knew why, just that the relief just didn't seem to last. But I wasn't just the dentist. I was the patient, so I set about "enhancing" the deprogrammer. The shape of the mound changed, anticipating the extremes of jaw movements, allowing for a continuous midline contact on the lower teeth no matter where the jaw went. As it turned out, the enhanced design was so unique I received several U.S. and International Patents.
Using an NTI device is certainly not without its precautions. Unlike a medication, the efficacy of an NTI device is directly related to the practitioner's ability, knowledge and insight. The jaw clenching activity may alter its patterns, making the patient present as a "new patient" each time they're seen by their dentist, so he to be on the lookout. The jaw joints are like no other in the human body. Unlike a common hinge joint, the jaw joint allows the lower jaw to move up, down, forwards, backwards, side-to-side. It's actually the jaw muscles that dictate any one position. In some people, after using an NTI device, their jaw musculature's posture changes, after having been chronically tensed for years. Their jaw musculature "normalizes". As the patient's symptoms improve and the jaw muscle tension changes, the relationship between their upper and lower jaw may change, with the patient sometimes noticing a difference in their bite. The majority of the time the change in this small minority of patients is practically unnoticeable. However, there are cases where the change of the jaw's relationship has necessitated the patient to have orthodontics done to regain a bite relationship that is more agreeable to them. These changes occur in the presence of an improvement of symptoms. Although symptom reduction/elimination is the desired outcome, each patient and their practitioner must weigh their risks vs. benefits. In this published study of 90,720 NTI devices delivered, only 1.6% of the practitioners reported undesired changes in their patient's bite.
|AMPSA CS ® is a registered trademark of Therapeutic Solutions International, Inc., a product whose technology has been licensed from Boyd Research. It is the same as the NTI-tss® device and derived from the same patent.|