Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study

Launched by DIAKONESSENHUIS, UTRECHT · Nov 5, 2024

Keywords

ClinConnect Summary

This is a prospective, observational study looking at how people with jaw muscle pain from temporomandibular disorders (TMD) respond over six months after receiving a Botulinum Toxin Type A (BTX-A) injection. Researchers will follow adults who get BTX-A injections to the jaw muscles (masseter and temporalis) and will track changes in pain, mouth function, and quality of life at baseline, and then about 1, 3, and 6 months after treatment. The main question is whether pain decreases after treatment, with secondary goals to see if overall mouth-related quality of life, jaw function, and how wide the mouth can open improve too.

People who may be eligible are adults (18+) with TMD-related muscle pain who are planned to receive BTX-A injections and can complete Dutch-language questionnaires. Exclusion criteria include inflammatory or connective tissue diseases, recent jaw surgery, dental-origin pain, cognitive issues, certain medicines, allergy to BTX, or pregnancy. The injections are given by one surgeon at a single center in Utrecht, using a standard dose (100 units total: 80 in the masseter and 20 in the temporalis). Participants will complete simple questionnaires and have their mouth opening measured before treatment and at follow-up visits. About 30 participants are expected, and the study is ongoing.

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Eligibility criteria

• Inclusion Criteria:
• • TMD-related myalgia in accordance with the DC/TMD;
• • Accepted BTX-A injections as treatment;
• • Age ≥ 18 years;
• • Understanding of the Dutch language to fill in the questionnaires.
• Exclusion Criteria:
• • Systemic inflammatory and connective tissue diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis);
• • Surgery in the TMJ area \< 12 months ago;
• • Pain of dental origin;
• • Limited cognitive functioning (not allowed to make medical decisions);
• • Use of muscle relaxants, or aminoglycoside antibiotics;
• • A history of allergic reactions to BTX;
• • Pregnancy and lactation.