Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study
Launched by DIAKONESSENHUIS, UTRECHT · Nov 5, 2024
Trial Information
Current as of September 10, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is a prospective and observational cohort study. The Medical Research Ethics Committees United provided a non-WMO (Medical Research Involving Human Subject Acts) waiver (W23.212) prior to commencement of this study. All participants will be informed and most give their written consent prior to participating, according the requirements of the Declaration of Helsinki (World Medical Association, 2013).
Participants Participants in this study are adults with TMD-related myalgia according to the DC/TMD treated with a BTX-A injection. All participants are recruited at the department of Oral...
Gender
ALL
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.
About Diakonessenhuis, Utrecht
Diakonessenhuis Utrecht is a leading healthcare institution in the Netherlands, renowned for its commitment to providing high-quality patient care and advancing medical research. As a clinical trial sponsor, Diakonessenhuis Utrecht focuses on innovative therapies and treatments across various medical disciplines, fostering collaboration between healthcare professionals and researchers. The institution prioritizes ethical standards and regulatory compliance, ensuring that all trials are designed to enhance patient outcomes and contribute to the scientific community. With a strong emphasis on patient safety and well-being, Diakonessenhuis Utrecht is dedicated to driving advancements in medical science through rigorous research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Utrecht, Netherlands
Patients applied
Trial Officials
Maurits HT de Ruiter, Dr.
Study Director
Diakonessenhuis, Utrecht
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported