693013

research-article2017
AORXXX10.1177/0003489417693013Annals of Otology, Rhinology & LaryngologyPatel et al

Original Article
Annals of Otology, Rhinology & Laryngology
1–6
IncobotulinumtoxinA Injection for © The Author(s) 2017
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DOI: 10.1177/0003489417693013
https://doi.org/10.1177/0003489417693013

A Randomized Controlled Pilot Study journals.sagepub.com/home/aor

Amit A. Patel, MD1, Michael Z. Lerner, MD1,

and Andrew Blitzer, MD, DDS, FACS1

Abstract
Objectives: Temporomandibular disorder (TMD) involves dysfunction of the temporomandibular joint and associated
muscles of mastication causing pain with chewing, limitation of jaw movement, and pain. While the exact pathophysiology
of TMD is not completely understood, it is thought that hyperfunction of the muscles of mastication places stress on
the temporomandibular joint, leading to degeneration of the joint and associated symptoms. We hypothesize that
chemodenervation of the muscles of mastication with IncobotulinumtoxinA (Xeomin) will decrease the stress on the
temporomandibular joint and improve pain associated with temporomandibular joint and muscle disorder (TMJD).
Methods: Twenty patients were randomized to IncobotulinumtoxinA (170 units) or saline injection of the masticatory
muscles. Patient-reported pain scale (0-10) was recorded at 4-week intervals following injection for 16 weeks. Patients
who received saline injection initially were assessed for reduction in pain at the first 4-week interval and if still had
significant pain were rolled over into the IncobotulinumtoxinA arm.
Results: Preinjection pain scores were similar between patients. While there was a statistically significant reduction in pain
score in the placebo group one month, there was an overall larger drop in average pain scores in those patients injected
with IncobotulinumtoxinA initially. All patients initially injected with placebo crossed over into the IncobotulinumtoxinA
group. Similar results were seen when examining the composite masticatory muscle tenderness scores. There was no
significant change in usage of pain medication.
Conclusions: We demonstrate utility of IncobotulinumtoxinA in treating patients with TMD with pain despite pain
medication usage and other conventional treatments.

Keywords
IncobotulinumtoxinA, temporomandibular disorder

Temporomandibular disorder (TMD) is a nonspecific term
used to describe joint and muscle disorders that affect the
masticatory system. It has been reported that about 5% to
12% of the US population is affected by TMD, and the
annual cost of managing TMD, excluding cost related to
imaging, is about $4 billion.1 Plesh and colleagues2 reported
that in the 2000-2005 US National Health Interview Survey
(NHIS), which included a total of 189 977 people, 4.6% (n
= 58 964) of people had experienced temporomandibular
joint and muscle disorder (TMJD).
Symptoms are commonly related to pain surrounding
the joint and may include referred ear pain, headache,
transmitted neck pain, decreased jaw mobility, difficulty
and/or pain while chewing, and crepitus or other noise
within the joint with movement. In general, TMD is divided
into myofascial TMD or arthrogenic TMD. Myofascial
TMD is associated with the pain from hyperfunctioning
muscles of mastication leading to chronic myositis. In con-
trast, arthrogenic TMD is associated with intracapsular
pathology, with pain at the level of the joint itself, often
confused with ear pain.3
Temporomandibular disorder encompasses many clini-
cal abnormalities, which may include spasm of the masse-
ter, temporalis, and/or pterygoid musculature. Pain
associated with TMD may be muscular or joint in origin.
Current treatments for TMD include measures such as exer-
cise and massage; systemic anti-inflammatory medications
1
New York Center for Voice and Swallowing Disorders, New York,
New York, USA
Corresponding Author:
Amit A. Patel, New York Center for Voice and Swallowing Disorders,
425 West 59th Street Floor 10, New York, NY 10019, USA.
Email: ameker@gmail.com