ORIGINAL CONTRIBUTIONS
ARTICLE 3
Effectiveness of botulinum toxin
type A for the treatment of chronic
masticatory myofascial pain
A case series
Jason S. Baker, DMD; Patrick J. Nolan, DDS
M
yofascial pain is the most common form
of temporomandibular
Segun Investigacion
disorder (TMD)
under the Research Diagnostic Criteria
for Temporomandibular Disorders
Eje Representa Casi
Axis I, accounting for almost one-half of cases.1
Commonly, facial pain manifests as multiple symp-
Mal Puede
toms or poorly localized pain that may originate from
multiple causes. Possible sources of facial pain are
odontogenic, muscular, intracapsular, neuropathic,
migraine, referred pain, and others. Complicating
Adeucado
proper diagnosis are patient-specific factors, such as
an inherent higher sensitivity to pain, psychological
and psychosocial disorders, and the patient’s ability to
Precisamente2
describe his or her symptoms accurately. Treatment
Exito
success depends on the ability to diagnose the correct
Dividir en secciones
cause of the pain or compartmentalize multifactorial
Tratar cada
pain and treat each component.
The cause of masticatory myofascial pain (MMP) is
Endiente
understood poorly. Single or recurrent episodes of
biomechanical overloading can cause muscle injury.3
Blandos Tejidos Sobrecarga
When facial soft tissues are exposed to overloading or
parafunction, nociceptive irritation of the tendons and
fascia of the masseter and temporalis muscles can
Ademas
occur.4 Furthermore, excessive muscle function causes
Vasos sanguineos
compression of small blood vessels and tissue
Conduce Liberacion
ischemia, which leads to bradykinin release and
5
sensitization of nociceptors.
Historically, clinicians have treated masticatory
Mediante el uso
myalgia symptoms by using pharmacologic
This article has an accompanying online continuing education activity
available at: http://jada.ada.org/ce/home.
Copyright ª 2017 American Dental Association. All rights reserved.
ABSTRACT
Background. The aim of this study is to evaluate the
effectiveness of botulinum toxin type A (BTX-A) for the
treatment of chronic masticatory myofascial pain (MMP) over
12 months and to test a standardized protocol.
Methods. This is a prospective case series of consecutive adult
patients with chronic MMP treated with injection of BTX-A
into the bilateral temporalis and masseter muscles. The authors
used the same anatomic landmarks and dosage and followed
each patient for 12 months. The primary outcome variables
were reduction in pain measured with visual analog scale (VAS)
and Physician Global Assessment (PGA). Secondary outcome
Tal
variables were change in maximum pain-free opening, change
Habilidad
in palpatory pain points in the face and oral cavity, and
change in results from a questionnaire measuring disability,
dysfunction, and psychosocial effects of the disease.
Results. The authors included 15 women and 4 men (mean
[standard deviation] age, 32.7 [6.9] years) in the study. Pain
decreased significantly as measured with the VAS (P < .0001)
and PGA (P < .0001). Maximum pain-free opening increased
significantly (P ¼ .010), but maximum voluntary opening
Lesiones
did not change significantly (P ¼ .837). The number of pal-
patory pain points (P < .0001) and the symptom questionnaire
score decreased over time (P < .0001).
Conclusions. The results of this case series suggest that
injecting BTX-A into the bilateral temporalis and masseter
muscles may be a safe and effective treatment for chronic
MMP.
Practical Implications. Controlled clinical trials are
needed to confirm whether administration of BTX-A is
effective in treating facial pain.
Key Words. Myofascial pain; pain; orofacial; myalgia;
botulinum toxin; clinical protocols.
JADA 2017:148(1):33-39
http://dx.doi.org/10.1016/j.adaj.2016.09.013
JADA 148(1) http://jada.ada.org January 2017 33
 ORIGINAL CONTRIBUTIONS
intervention, such as nonsteroidal anti-inflammatory
Comportamiento
drugs and muscle relaxants, and behavior modification.
Ferula Grados
Occlusal splint therapy has had varying degrees of
6-12 Cumplimiento
success. Splint therapy requires strict patient compli-
ance, and not all patients can tolerate it.
Botulinum toxin (BTX) is a biological neuromuscular
Periferica
blocking agent. After peripheral administration, BTX is
endocytosed into presynaptic nerveTerminaciones endings of neuro-
Uniones Adhiere
muscular junctions where it cleaves proteins necessary
for acetylcholine exocytosis. By inhibiting the release of
acetylcholine, BTX causes chemical denervation at the
Deja
junction and leaves the innervated structure paralyzed.
BTX targets neuromuscular junctions and structures
innervated by autonomic cholinergic nerve fibers, such
as glands. BTX causes a reduction in muscle tone and
Flujo Brotar
improved blood flow to muscles.5 Axons begin to sprout
from the motor end plate as a result of the chemical
denervation, causing reduction in the effect of BTX by
the fourth to the sixth month.5,13
In 1994, Girdler14 described the use of BTX type A
(BTX-A) to treat chronic MMP. Over the last 2 decades,
Mostrado Con respecto
study results have shown mixed evidence in regard to the
effectiveness of BTX-A to reduce the pain, severity, and
Discapacidad
disability associated with MMP.15-22 The varying results
may Ser
be debido
due to patient selection, Falta lack of standardization
of terminology and classification, controversy in diag-
nostic testing, the injection protocol used, and varying
Dosis
dosages. Limitations of previous studies include a short-
Plazo
term follow-up and use electromyography for injections.
The purpose of this prospective case series was to
Medir
measure the effectiveness of BTX-A in reducing pain in
patients with chronic MMP by using a standard injection
protocol and dosage. We hypothesized that BTX-A
injected into the bilateral masseter and temporalis muscles
would result in decreased pain in patients with chronic
MMP. The specific aim of the case series was to support the
effectiveness of the proposed protocol in treating patients
with chronic MMP by measuring the change in pain,
Sensibilidad
change in muscle palpation tenderness (at 16 points of
Sin dolor
potential facial pain), and change in maximum pain-free
Durante
mouth opening after the injection of BTX-A over 1 year.
METHODS
Study design and enrollment criteria. We conducted
this prospective case series at the Division of Oral and
Maxillofacial Surgery at the Montefiore Medical Center
(Bronx, NY). The institutional review board at our
institution approved the case series, and we conducted it
in accordance with the ethical principles of the Declara-
tion of Helsinki.23 The case series meets the requirements
for exemption from the Investigational New Drug regu-
lations of the U.S. Food and Drug Administration.
We derived the sample from patients older than 18
years with chronic MMP (less than 6 months’ duration)
of moderate to severe intensity ($ 5 centimeters on a
10-cm horizontal visual analog scale [VAS]) who sought
34 JADA 148(1) http://jada.ada.org January 2017
care at our institution between November 2012 and April
2015. This method is consistent with the Research
Diagnostic Criteria for Temporomandibular Disorders.24
We did not exclude patients because of previous con-
servative therapy (for example, splint therapy, analgesics,
soft diet, and muscle relaxant medications). We excluded
them if they had radiographic signs of temporoman-
dibular joint osteoarthrosis, rheumatoid arthritis, previ-
ous open joint surgery, prior treatment with BTX-A in
the head and neck region, BTX-A in the last 6 months, or
an allergy to BTX-A. We excluded patients with tri-
geminal neuralgia. We also excluded patients undergoing
long-term pain management, immunosuppression, or
anticoagulation or women who were pregnant or nursing.
Contraindications to BTX are certain neuromuscular
junction disorders—including myasthenia gravis,
Lambert-Eaton syndrome, and orofacial tardive dyski-
nesia—or medications causing neuromuscular trans-
mission interactions—aminoglycosides and dopamine-
blocking drugs—so we excluded them. Patients enrolled
in the study signed informed consent forms.
Case series variables. We collected data before
treatment and at the 6-week and 4-, 8-, and 12-month
postinjection evaluations. Patient-reported outcomes
included trends in pain intensity and physical and
emotional function, as recommended by the Initiative
on Methods, Measurement, and Pain Assessment in
Clinical Trials.25
Subjective evaluation. We evaluated patient self-
assessment of facial pain intensity with a VAS. Par-
ticipants made a mark on a 10-cm horizontal line, with
0 indicating no pain and 10 indicating pain as bad as
you can imagine, to indicate the worst level of facial
pain experienced over the last 24 hours.
We completed a clinical examination in accordance
with the Research Diagnostic Criteria for Temporoman-
dibular Disorders examination.24 We each marked our
assessment of disease activity and pain on the Physician
Global Assessment (PGA). We marked the assessment
on a 10-cm horizontal line, with 0 indicating no pain and
10 indicating severe pain. To confirm that the inclusion
criteria were met, we both examined every participant.
All participants completed a subjective symptom
questionnaire measuring disability, pain, dysfunction,
and psychosocial effects of the disease process (Figure 1).
For each question, participants indicated the ability
to do a specific task by marking a score from 0 (able
to perform the task without difficulty) to 3 (unable to
perform the task). We developed the questionnaire from
the Research Diagnostic Criteria for Temporomandibular
ABBREVIATION KEY. BTX: Botulinum toxin. BTX-A:
Botulinum toxin type A. MMP: Masticatory myofascial pain.
PGA: Physician Global Assessment. TMD: Temporomandib-
ular disorder. VAS: Visual analog scale.
 ORIGINAL CONTRIBUTIONS

Disorders24 and the

multidimensional health Are you able to: Without any With some With much Unable to do
difficulty difficulty difficulty
assessment question-
naire published by Pin- 1. Move your jaw in the morning
when you wake up?
26
cus and colleagues.
2. Eat breads, bagels, salads, and
Objective exam- chewy foods?
ination. An objective
3. Open your jaw wide?
physical examination
consisted of evaluating 4. Speak for 5 minutes or more?
16 points of potential
facial pain. Points 5. Concentrate during the day?
included the anterior,
6. Sleep through the night without
middle, and posterior waking up?
temporalis muscles 7. Sleep through the night without
approximately 2 to 3 cm pain?
below the temporal ridge 8. Deal with anxiety or being
of the skull; the anterior nervous?

and posterior masseter 9. Deal with feelings of sadness or

depression?
muscles overlying the
angle of the mandible;
the preauricular area
Figure 1. Symptom questionnaire.
overlying the temporo-
mandibular joint; the
temporalis muscle insertion on the coronoid notch
intraorally; and the masseter muscle lateral to the ramus
intraorally. We held digital pressure over the points
for 2 seconds. We scored each point as a 0 for no pain
or a 1 for pain. We measured maximum pain-free
opening and maximum voluntary opening from the
incisal edge of the maxillary and mandibular right central
incisors in millimeters.
Injection technique. We used sterile, preservative-
free 0.9% sodium chloride to reconstitute 100-unit vials
of freeze-dried BTX-A (Botox, Allergan) according to
manufacturer recommendations. We diluted 100-U vials
with 4.0 milliliters of sodium chloride, resulting in a dose
of 2.5 U per 0.1 mL.27 We used an 18-gauge needle to
administer the sodium chloride. We used gentle swilling
to reconstitute the vacuum-dried BTX-A to avoid dis-
rupting the large molecular size. We then split the
BTX-A into 4 1.0-mL syringes. We administered all skin
injections by using a 1-inch 30-gauge needle.
One of the authors (P.J.N.) administered all injections
throughout the study. He prepared all sites with chlor-
hexidine 3.15% and isopropyl alcohol 70% swabs. To
identify the muscle properly before administering the
injection, He asked participants to clench their teeth
followed by relaxation. He inserted the needle perpen-
dicular to the skin and established a subperiosteal depth
by contacting bone. He then withdrew the needle
through the periosteum into the muscle. After per-
forming aspiration, he administered injections slowly to
minimize the spread of BTX-A into adjacent anatomic
spaces; administering a superficial injection or injection
while withdrawing the needle can result in inadvertent
paralysis because of the proximity of the facial nerve.
He administered injections at 5 sites per side
(Figure 2). He administered 90 U of BTX-A in each
participant, 25 U into each temporalis muscle, and 20 U
into each masseter muscle. The anterior, middle, and
posterior temporalis muscles received 12.5, 7.5, and 5 U,
respectively. He used a theoretical line tangent to the
tragus and a separate line tangent to the posterior helix
to identify the middle and posterior temporalis muscle
injection sites. He administered BTX-A in the more
prominent areas of the muscles on the tangent lines. The
anterior and posterior masseter muscles over the ramus
of the mandible received 10 U each. We modified these
injection sites and dosages from a previous report.27
He provided postinjection instructions to each participant.
Statistical analysis. We based the sample size on
previous evidence that a 30% reduction on an 11-point
numerical pain rating scale (that is, in which 0 represents
“no pain” and 10 represents “worst pain ever”)
represents a clinically important difference.28 For a
1-group paired analysis (before and after), assuming a
correlation of 0.75 and a mean (standard deviation
[SD]) reduction in pain over 8 weeks of 1.9 (3.1) cm as
measured on a horizontal VAS,22 we required 17 patients
to obtain a power of 90% with a at .05 for a 2-tailed test.
For continuous variables, we presented descriptive
statistics as means and SDs if normally distributed or
otherwise as medians and ranges. We presented relative
frequencies for short-scale ordinal and categorical vari-
ables. We derived mixed effects models to assess the
significance of trends in pain, opening, and subjective
disease activity over time. We performed Spearman rank
correlations between pain measures (VAS versus PGA).
We conducted all tests by using an overall a level of .05,

JADA 148(1) http://jada.ada.org January 2017 35

 ORIGINAL CONTRIBUTIONS
Figure 2. Injection sites for botulinum toxin type A (Botox, Allergan):
anterior, middle, and posterior temporalis muscle and anterior and
posterior masseter muscle with dosage. U: Unit.
and all were 2-tailed. We used SAS Version 9.3 (SAS
Institute).
RESULTS
We included 25 consecutive participants who met the
inclusion criteria in the case series. Nineteen participants
(15 women and 4 men) with a mean (SD) age of 32.7
(6.9) years (range, 21-50 years) completed the case series.
We lost 6 participants to follow-up. We dismissed 1
patient because she received a diagnosis of trigeminal
neuralgia at her 4-month follow-up. Another patient left
because she elected to have orthognathic surgery, which
disqualified her from the case series. One patient with-
drew after 1 follow-up. The other 3 patients did not
return after receiving the initial injections. The table
shows the primary and secondary variables over time.
Subjective pain (VAS and PGA scores). The baseline
mean (SD) VAS pain intensity score the participants re-
ported was 8.1 (1.9). There was a statistically significant
decrease in participant-reported pain over time after
administering the injection (P < .0001). In our case
report, 84.2% (16 of 19) of patients reported at least 30%
reduction in pain between baseline and 6 weeks, indi-
cating much improvement, and 79.0% (15 of 19) of pa-
tients reported a pain reduction of at least 50% between
baseline and 6 weeks, indicating pain was improved ac-
cording to the Initiative on Methods, Measurement, and
Pain Assessment in Clinical Trials.25
36 JADA 148(1) http://jada.ada.org January 2017
The baseline mean (SD) PGA for disease activity and
pain was 8.2 (1.0). There was a statistically significant
decrease in pain over time after administering the in-
jection (P < .0001). VAS and PGA showed high corre-
lations at all postinjection evaluations (r ¼ 0.7703,
P ¼ .0001 at 6 weeks; r ¼ 0.8387, P < .0001 at 4 months;
r ¼ 0.7841, P < .0001 at 8 months; r ¼ 0.6640, P ¼ .0018
at 12 months).
Palpatory pain points. We tested 16 points for pain.
The mean (SD) number of pain points at baseline was
9.3 (3.7). A decrease in the mean number of pain
points was statistically significant over time after
administering the injection (P < .0001).
Maximum pain-free opening and maximum
voluntary opening outcomes. The table lists the
maximum pain-free opening and maximum voluntary
opening outcomes over time. The mean (SD) maximum
pain-free opening at baseline was 38.7 (6.8), and the
mean (SD) maximum voluntary opening at baseline
was 48.4 (6.0). The increase in pain-free opening was
statistically significant over time after administering
the injection (P ¼ .010); however, the maximum volun-
tary opening did not change significantly over time
(P ¼ .837).
Symptom questionnaire outcomes. Of a possible
total of 27 points, the mean (SD) symptom questionnaire
score at baseline was 11.4 (5.8). A decrease in the mean
questionnaire score was statistically significant over time
after administering the injection (P < .0001).
DISCUSSION
The primary purpose of our case series was to evaluate
the effectiveness of the protocol we used in treating
patients with chronic MMP. We hypothesized that
administering an injection of BTX-A into the bilateral
temporalis and masseter muscles would decrease pain.
We measured change in pain, muscle palpation tender-
ness, and maximum pain-free mouth opening over 1 year.
We found a significant reduction in mean pain score,
as measured with VAS and PGA, after treatment at 6
weeks and 4, 8, and 12 months. A high correlation be-
tween VAS and PGA existed, indicating that the patients’
subjective pain intensity matched the pain we observed.
The secondary outcome variables we evaluated were
change in palpatory pain points, change in maximum
pain-free opening, and change in a symptom question-
naire score after BTX-A therapy. The mean number of
pain points on examination decreased significantly at the
6-week and 4-, 8-, and 12-month follow-up evaluations.
Maximum pain-free opening increased, but maximum
voluntary opening did not change over time. This finding
shows that patients were able to open larger without pain
after treatment. The symptom questionnaire we used in
this study measured physical and emotional functioning,
such as the ability to adequately sleep, eat, speak,
concentrate, deal with anxiety, and deal with feelings of
 ORIGINAL CONTRIBUTIONS

depression. The ques- TABLE

tionnaire score Summary of variables over time.
decreased significantly
over time. VARIABLE TIME, MEAN (SD*) [95% CI†] P VALUE
Although few Baseline 6 wks 4 mo 8 mo 12 mo
studies exist, the Pain (0-10 on VAS‡) 8.1 (1.9) 2.7 (2.6) 3.0 (3.0) 2.9 (2.7) 3.2 (2.6) < .0001§
effectiveness of BTX-A [7.2-9.0] [1.4-3.9] [1.6-4.5] [1.6-4.2] [1.9-4.4]
for treating MMP Pain (0-10 on PGA¶) 8.2 (1.0) 1.9 (1.9) 2.5 (2.3) 2.1 (2.4) 1.9 (1.9) < .0001§
[7.7-8.7] [0.9-2.8] [1.4-3.6] [1.0-3.2] [1.0-2.8]
varies in the literature.
< .0001§
Although investigators Palpatory Pain Points (Sum of the 9.3 (3.7)
Presence or Absence of 16 Site- [7.5-11.1]
3.0 (2.4)
[1.9-4.2]
3.8 (3.5)
[2.1-5.5]
3.8 (4.0)
[1.9-5.7]
4.4 (4.2)
[2.4-6.5]
in many studies Specific Pain Points)
attempt to follow the Symptom Questionnaire Score 11.4 (5.8) 5.3 (4.4) 4.5 (4.2) 5.4 (4.5) 5.2 (4.2) < .0001§
Research Diagnostic (Total 27 Points) [8.7-14.2] [3.2-7.5] [2.5-6.6] [3.2-7.5] [3.1-7.2]
Criteria for Temporo- Maximum Pain-Free Opening, 38.7 (6.8) 44.1 (8.1) 45.2 (8.9) 44.4 (7.7) 44.2 (7.9) .010§
Millimeters [35.4-41.9] [40.1-48.0] [40.9-49.5] [40.7-48.1] [40.4-48.0]
mandibular Disor-
Maximum Voluntary Opening, mm 48.4 (6.0) 49.0 (6.5) 49.8 (6.9) 49.7 (6.3) 50.4 (7.2) .837
ders,29 diagnosis and [45.6-51.3] [45.8-52.1] [46.5-53.2] [46.7-52.7] [46.9-53.9]
terminology still are * SD: Standard deviation.
not standardized. † CI: Confidence interval.
Muscles receiving in- ‡ VAS: Visual analog scale. 0 represents “no pain” and 10 represents “worst pain ever.”
§ Significant P value.
jections, number of ¶ PGA: Physician Global Assessment. 0 represents “no pain” and 10 represents “worst pain ever.”
injections, dosage,
technique, reinjection,
and follow-up vary greatly across studies. Reduction in group. In our case series, pain as measured with the VAS
pain after treatment with BTX-A is consistent with and the PGA did not increase significantly after the
the findings of Freund and colleagues,15 von Lindern,16 6 months. The therapeutic window of BTX-A varies
von Lindern and colleagues,17 Seedorf and colleagues,18 according to the muscle being treated and the dosage
and Kurtoglu and colleagues.19 Kurtoglu and colleagues19 used.30 We re-treated 4 of the 19 participants again
and von Lindern and colleagues17 conducted randomized after the 12-month observation period because of partial
and placebo-controlled trials with 20 and 90 patients, or full return of pain. The other 15 participants did not
respectively. These studies had limitations. The von require further treatment. At the conclusion of the
Lindern and colleagues17 protocol was not standardized 12-month observation, we asked every participant who
for dosage, number of injections, or muscles receiving finished the study whether they would participate in the
injections. von Lindern16 included patients who required 1, treatment again. Every participant answered yes. No
2, or 3 series of injections. Kurtoglu and colleagues19 and complications occurred after treatment in our case series.
von Lindern and colleagues17 followed patients for only We have 2 theories about why the duration of pain
4 weeks, whereas Seedorf and colleagues18 and Freund and relief seemed to outlast the expected therapeutic effect of
colleagues15 followed patients for 8 weeks. Freund and BTX-A. One theory is that MMP could be cyclic in na-
colleagues,15 Kurtoglu and colleagues,19 Nixdorf and col- ture, and it is possible that a patient’s symptoms
leagues,22 and von Lindern16 used electromyography for improved over time independent of the BTX-A treat-
injections. We standardized administration of BTX-A by ment. Without a control group, we cannot discount
site and dosage. We administered injections in all patients the potential for spontaneous resolution of MMP or
once without the use of electromyography. regression to the mean. To evaluate the magnitude of
Ernberg and colleagues21 investigated the effectiveness regression to the mean because of self-selection for
of BTX-A in patients with myofascial TMD pain treatment, Whitney and Von Korff31 compared partici-
through a randomized, placebo-controlled, crossover pants who sought treatment for TMD pain with a
multicenter study. They administered injections in 3 sites random sample of participants with TMD pain. They
within the masseter muscle. They followed 21 participants showed no significant difference in chronic TMD pain
for 3 months. After a 1-month washout period, reduction in participants seeking treatment and control
crossover occurred, but a crossover study with so little participants over 1 year. They attributed this finding to a
time between injections may not allow for complete regression to the mean.
washout. The second theory involves breaking a cycle of
We have observed therapeutic effects of BTX-A behavior that results in MMP. The cause of MMP is
longer than the theoretical 4 to 6 months. No previous often hyperactivity of the associated muscles. BTX-A
study investigators, to our knowledge, have followed irreversibly blocks nerve impulses at the motor end plate
pain variables for 1 year after treatment. The major by blocking the ability to be hyperactive. Initially, the
limitation of our case series is the lack of a control decreased hyperfunction would lead to decreased pain

JADA 148(1) http://jada.ada.org January 2017 37

 ORIGINAL CONTRIBUTIONS
and inflammation, which would be consistent with the
reported results. Long term, the physiologic process
that is creating the hyperactivity may be interrupted,
resulting in an extended period of decreased symptoms.
We used a larger dose of BTX-A than that used in
previous studies. The dosages we used have evolved with
clinical experience. Other investigators have described
administering a lower dose and titrating up at subse-
quent appointments if clinically necessary.27
Pharmacologic treatment of MMP consists of
nonsteroidal anti-inflammatory drugs, muscle relaxants,
benzodiazepines, and antipsychotics. All systemic medi-
cations have potential adverse effects. Occlusal splint
therapy effectiveness is controversial and can cause
severe changes in occlusion.6-8,11 Strict patient compli-
ance is required for pharmacologic treatment and splint
therapy to be successful. BTX-A treatment removes
patient compliance as a determinant of success.
At the commencement of this case series, the
Research Diagnostic Criteria for Temporomandibular
Disorders Axis I and Axis II were the protocols accepted
by the International Association for Dental Research.23
In 2014, the Axis I diagnostic algorithms were revised to
increase sensitivity and specificity, and the Axis II pro-
tocol was augmented; the new evidence-based Diagnostic
Criteria for Temporomandibular Disorders now are
accepted for clinical and research applications.29 This
acceptance is important in the development of a diag-
nostic protocol for practitioners treating TMDs and
standardization of terms used within the literature. The
Diagnostic Criteria for Temporomandibular Disorders
define localized masticatory myalgia as pain of muscle
origin (temporalis or masseter) localized to the site of
palpation affected by jaw movement, function, or par-
afunction and define myofascial pain as pain of muscle
origin that spreads beyond the site of palpation within
the muscle boundary.29 Our case series includes patients
with myalgia and patients with myofascial pain accord-
ing to these new diagnostic criteria.
Because this was not a controlled clinical trial, there
was no comparison group, and we were not masked or
calibrated. However, the results of this case series suggest
a potential benefit to using BTX-A for treatment of
chronic MMP. A future prospective study with a control
group and masked examiners is required to confirm
effectiveness.
CONCLUSIONS
Within the stated limitations, the results from this case
series suggest that administering an injection of BTX-A
into the bilateral temporalis and masseter muscles may be
a safe and effective treatment for chronic MMP. Myo-
fascial pain has many causes, and the pain levels often
fluctuate over time. Because of the natural course of
MMP, we cannot conclude that BTX-A is responsible for
the long-term pain reduction. Controlled clinical trials are
38 JADA 148(1) http://jada.ada.org January 2017
needed to prove the effectiveness of BTX-A for treating
facial pain. n
Dr. Baker is an attending dentist, Division of Oral and Maxillofacial
Surgery, Department of Dentistry, Montefiore Medical Center, and a clinical
instructor, Albert Einstein College of Medicine, Bronx, NY.
Dr. Nolan is an attending dentist, Division of Oral and Maxillofacial
Surgery, Department of Dentistry, Montefiore Medical Center, and a clinical
instructor, Albert Einstein College of Medicine, Bronx, NY. Address cor-
respondence to Dr. Nolan at Department of Dentistry, Montefiore Medical
Center, 3332 Rochambeau Ave., Bronx, NY 10467, e-mail pnolan@
montefiore.org.
Disclosure. Drs. Baker and Nolan did not report any disclosures.
We thank Richard Kraut, DDS, and the Department of Dentistry at the
Montefiore Medical Center for financial assistance with the project; Jairo
Bastidas, DMD, Mauricio Wiltz, DDS, and Kayvan Fathimani, DDS, for
their help in patient recruitment; and Kathy Freeman, DrPH, for statistical
analysis.
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