Masticatory Myofascial Pain Syndrome
Conditions
Keywords
Masticatory myofascial pain syndrome, masseter muscle, Temporalis muscle, medial pterygoid
Brief summary
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.
Detailed description
Current evidence supports the efficacy of BoNT-A in reducing pain and improving mandibular function in patients with localized MMPS. However, the specific contribution of targeted medial pterygoid injection to overall treatment outcomes remains unclear. This study aims to address this gap by evaluating whether the addition of targeted medial pterygoid injection enhances the clinical efficacy of conventional masseter and temporalis BoNT-A therapy.
Interventions
PROCEDUREconventional BoNT-A treatment
botulinum toxin type A injection into the bilateral masseter and temporalis muscles
PROCEDUREPlacebo
placebo/sham injection protocol
PROCEDUREconventional treatment plus medial pterygoid injection
masseter and temporalis injections as Group A, in addition to targeted injection of the clinically involved medial pterygoid muscle
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Medial pterygoid provocation reproduces the patient's familiar pain. * Symptoms present for at least 3 months. * No major competing odontogenic cause for the patient's pain.
Exclusion criteria
* Predominantly arthrogenous TMD. * Trigeminal neuralgia or other neuropathic facial pain. * Active systemic inflammatory or infectious disease affecting the masticatory muscles. * Significant neuromuscular disease. * Pregnancy or breastfeeding. * Previous BoNT-A injection into the relevant masticatory muscles during the predefined washout period. * Known hypersensitivity to the study medication or formulation components. * Local infection at the injection site. * Significant bleeding disorder. * Clinically significant uncontrolled anticoagulation. * Previous major surgery involving the medial pterygoid region that could alter anatomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain intensity | 6 months | a 10-point visual analogue scale (VAS), where 0 revealed no pain and 10 represented the worst imaginable pain |
Countries
Egypt
Contacts
CONTACTAlshaimaa Mohamed, PhD
CONTACTIslam Kassem, PhD
PRINCIPAL_INVESTIGATORAlshaimaa Mohamed
Fayoum University
Outcome results
None listed