Electromyography, Oromandibular Dystonia
Conditions
Keywords
oromandibular dystonia, electromyography, botulinum toxin.
Brief summary
This study evaluates the effectiveness and safety of Electromyography (EMG)-guided Botulinum Toxin type A (BTX-A) injections in treating oromandibular dystonia (OMD) among a sample of Yemeni patients. Oromandibular dystonia is a neurological movement disorder characterized by involuntary contractions of the jaw, tongue, and face muscles, which severely interferes with essential daily functions such as chewing, speaking, and swallowing. A prospective clinical trial was conducted on 20 patients diagnosed with different clinical subtypes of OMD (jaw closing, jaw opening, and jaw deviation). Targeted muscles were injected with BTX-A using EMG guidance to ensure precise placement. Patients were evaluated over a 6-month follow-up period to measure improvements in mastication ability, speech, and functional discomfort, as well as to document any adverse side effects.
Interventions
Electromyography (EMG)-guided intramuscular injections into specific affected masticatory and lower facial muscles. Dosing is tailored to the specific oromandibular dystonia subtype (e.g., jaw closing, jaw opening, or mixed) and targeted muscles (such as the Masseter, Temporal, Medial Pterygoid, Lateral Pterygoid, or Digastric muscles). The injections are administered using an EMG device (e.g., Dantec Clavis) to ensure precise localization of the hyperactive muscles prior to injection.
Sponsors
Study design
Masking description
20
Eligibility
Inclusion criteria
i) Patients with a confirmed diagnosis of OMD based on clinical evaluation. ii) Patients who have been referred to the maxillofacial departments at the Faculty of Dentistry, Sana'a University, specifically for the treatment of OMD. iii) Commitment to follow-up visits
Exclusion criteria
i) The presence of pathological findings at the site of injection, such as fibrous dysplasia, tumors, or cysts. ii) Patients who have known contraindications or allergies to botulinum toxin or its components. iii) Patients who are unlikely to be available for the required follow-up visits or have limited accessibility to the study site. iv) Previously treated with BTX-A within 6 months. v) Pregnant woman.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oromandibular Dystonia Symptoms Following EMG-Guided Botulinum Toxin Type A Injection | Baseline (immediately before BTX-A injection), 1 week, 3 months, and 6 months after injection | The primary outcome was the change in the severity of the main symptoms of oromandibular dystonia following electromyography-guided botulinum toxin type A (BTX-A) injection. The symptoms assessed were mastication ability, discomfort, speech, and pain. Each symptom was evaluated using a 5-point ordinal rating scale ranging from 0 (normal/no symptoms) to 4 (severe impairment). Changes from baseline were assessed during follow-up visits at 1 week, 3 months, and 6 months after BTX-A injection. |
Countries
Yemen