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Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study
Sponsor: Diakonessenhuis, Utrecht
Summary
The aim of this study was to evaluate the clinical course in terms of pain, function and quality of life of patients with TMD-related myalgia during six months after receiving BTX-A injections. The research question was: What are the outcomes in pain, quality of life and function of patients with TMD-related myalgia receiving BTX-A during 6 months? The hypothesis to be tested was that patients receiving a BTX-A injection due to TMD-related myalgia will have a reduction in pain and increase in quality of life and function after one, three- and six- months.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2024-01-26
Completion Date
2025-02-01
Last Updated
2024-11-06
Healthy Volunteers
No
Interventions
Botulinum Toxin, Type A
All participants will receive a solution of BTX-A (Xeomin, Merz Pharma GmbH, Frankfurt am Main, Germany) in the masseter and temporalis muscles (total of 100 units reconstituted with 4cc unpreserved 0.9% sodium chloride). The injection will be provided by the same maxillofacial surgeon. The participants are asked to clench their teeth to determine the site of the most intense muscle activity in the masseter and temporal muscles with palpation. Intramuscular BTX-A injections are administered on both sides at the location of the most intense muscle activity of the masseter (80 units) and temporalis (20 units).
Locations (1)
Diakonessenhuis Utrecht
Utrecht, Utrecht, Netherlands