Intramuscular Injections of Botulinum Toxin in Lateral Pterygoid Muscle in the Treatment of Temporomandibular Dysfunctions: Studying the Interest of MRI Guidance and Ultrasound Guidance

Centre Hospitalier Universitaire de Besancon4 enrolled

Overview

The main hypothesis is that a significant pain improve (measured with Visual Analogic Scale \[VAS\]) can be observed after injection of botulinum toxin A, meaning the success of the guidance device.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mandibular Dysfunction

Interventions

MRI guidanceDEVICE

Injections of botulinum toxin performed using MRI guidance

Ultrasound guidanceDEVICE

Injections of botulinum toxin performed using ultrasound guidance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients suffering from muscular TemporoMandibular Dysfunctions (TMD) with clinical diagnosis: myofascial pain, limited opening of the mouth, articular noise. * \>= 18 years old * with signed informed consent form Exclusion Criteria: * articular TMD: arthritis or other inflammatory disease of temporomandibular joint, arthrosis, bone deformation, previous fracture of condylar area ; * electromyographic hypoactivity, pure muscular diseases ; * oro-mandibular dystonia ; * botulinum toxin allergy, * risk of bleeding * recent or active infection * intercurrent antibiotic treatment (drug interaction) ; * vaccination during the 15 days preceding the injection.

Locations (1)

CHu de Besançon

Besançon, France

Outcomes

Primary Outcomes

Pain improvement

Significant improvement of the pain measured with VAS (0 to 10), corresponding to at least 30% decrease of the pain after injection of botulinum toxin A

Time frame: Month 2

Data from ClinicalTrials.gov

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