Treatment of Temporo-Myofascial Disorder of Muscular Origin Using Botulinum Toxin: A Prospective Study
Status:
Unknown status
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular
joint (TMJ), masticatory muscles and associated structures. This broad complex of functional
disorders often affects the face and jaws causing chronic pain, earaches, headaches,
migraines, neck pain, and dysfunction in many people. Patients that do not find benefit with
conservative management require surgical intervention. Recently, the use of botulinum toxin
has proven effective and has the potential to bridge the gap between conservative therapy and
surgical management resulting in less patients requiring invasive surgery. Objective: We aim
to treat TMD of muscular origin using Botulinum toxin injections in the trigger points.
Methods: Patients, whose pain originates from trigger points, will be enrolled in this
prospective trial. This study will evaluate subjective and objective responses to treatment
with botulinum toxin. The pair of masticatory muscles, masseter and temporalis, will be
injected with 30 units and 20 units of botulinum toxin, respectively. Subjective outcomes
such as pain and orofacial function on a visual analog scale as well as objective outcomes
such as maximal interincisal mouth opening, tenderness to palpation to the temporalis and
masseter muscles, maximal bite force measured by electromyogram and the reduction in muscle
bulk due to muscle disuse atrophy will be assessed. Expected Results: We expect trigger
points in these patients to disappear and the associated muscles to become partially
paralyzed and relaxed. Consequently, we expect that the TMJ loading will be reduced and that
the patient's overall functional ability will increase. We also expect that muscular
hypertrophy volume from hyperactivity will decrease due to disuse atrophy and impact their
cosmetic image positively. Overall, we hope these changes will result in a reduction in pain
and headaches which will consequently improve the participant's diet, nutrition,
psychological well being and quality of life.
Phase:
Phase 2
Details
Lead Sponsor:
University of Manitoba
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA