About this trial
Masticatory myofascial pain syndrome (MMPS) is a common and debilitating orofacial pain condition characterized by localized or referred pain originating from trigger points in the masticatory muscles. The condition significantly impairs quality of life, affecting mastication, speech, and psychosocial well-being. The masseter and temporalis muscles are the most frequently targeted muscles in conventional botulinum toxin type A (BoNT-A) therapy for MMPS; however, the medial pterygoid muscle, a primary jaw-closing muscle, is often overlooked due to its deep anatomical location and the technical challenges associated with its injection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of myogenous TMD/myalgia according to DC/TMD.
Pain modified by jaw movement, function, or parafunction.
Familiar pain reproduced during standardized masseter/temporalis examination.
Clinical evidence of medial pterygoid involvement.
Disqualifiers
Predominantly arthrogenous TMD.
Trigeminal neuralgia or other neuropathic facial pain.
Active systemic inflammatory or infectious disease affecting the masticatory muscles.
Significant neuromuscular disease.
Trial design
Parallel
Treatments tested in this trial
conventional BoNT-A treatment
Procedure/Surgerybotulinum toxin type A injection into the bilateral masseter and temporalis muscles
Placebo
Procedure/Surgeryplacebo/sham injection protocol
conventional treatment plus medial pterygoid injection
Procedure/Surgerymasseter and temporalis injections as Group A, in addition to targeted injection of the clinically involved medial pterygoid muscle
Treatment groups
Trial outcomes
Primary outcomes
pain intensity
a 10-point visual analogue scale (VAS), where 0 revealed no pain and 10 represented the worst imaginable pain
Sponsors and contacts
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