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Treatment of Temporo-Myofascial Disorder of Muscular Origin Using Botulinum Toxin: A Prospective Study

NCT02810015 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-06-22

No results posted yet for this study

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.

Conditions

  • Temporo-Myofascial Disorder

Interventions

DRUG

Botulinum Toxin Type A

BTX-A will be reconstituted as directed by the manufacturer. 2.5 mL of diluent (0.9% Saline) per 100 U vial will be used to reconstitute the solution while swirling. This creates a solution with a concentration of 4 U/0.1 mL. Patients will be seated and all usual precautions of sterility and skin preparation will be completed (i.e. alcohol wipes) Injections will be administered unilateral and/or bilaterally in accordance with the topography of the corresponding muscles (temporalis and masseter) into areas of maximal tenderness and pain. Plastic single use insulin syringes with 30 gauge needles will be used to inject 30 U intramuscularly into each masseter, divided evenly into 5 sites and 20 U will be injected into each temporalis, divided evenly over 5 sites. Injections will be completed by the principal investigator and supervisors who will be trained in botulinum toxin injections.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Reda Elgazzar, DMD · University of Manitoba

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-07-31
Completion
2019-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810015 on ClinicalTrials.gov