Does Addition of Medial Pterygoid Muscle Injection Improve the Outcome of Botulinum Toxin Therapy for Masticatory Myofascial Pain Syndrome?

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFayoum University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • conventional BoNT-A treatment

    Procedure/Surgery

    botulinum toxin type A injection into the bilateral masseter and temporalis muscles

  • Placebo

    Procedure/Surgery

    placebo/sham injection protocol

  • conventional treatment plus medial pterygoid injection

    Procedure/Surgery

    masseter and temporalis injections as Group A, in addition to targeted injection of the clinically involved medial pterygoid muscle

Treatment groups

111 Participants
are divided into 3 treatment groups
Group A: Group AActive comparator 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

pain intensity

a 10-point visual analogue scale (VAS), where 0 revealed no pain and 10 represented the worst imaginable pain

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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