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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Manitoba
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Participant's with trigger points in their masticatory muscles including, but not limited to: masseter and temporalis either bilateral or unilateral and secondly

• have tried conservative management for at least 3 months and have shown to be refractory to these interventions.

Exclusion Criteria:

• participant's that do not satisfy the inclusion criteria

• currently are breastfeeding or pregnant

• participant's whose TMD is not muscular in origin

• inability to speak or understand English

• the inability to provide meaningful informed consent due to physical, cognitive or psychiatric disability

• a previous known allergy to Botulinum toxin

• multiple sclerosis

• pre-existing neuromuscular disorders

• Lambert-Eaton syndrome

• chronic centrally mediated neuralgic pain patients.