Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders - a Quality Study Associated to a New Treatment Routine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent. The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• Has given a written consent
• Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according
• Average pain due to NRS ≥ 3 for more than three months
• Palpationpain in masseter or temporalis.
• Eventual treatment for orofacial pain \> three months ago.
• Adequate contraceptives and a negative pregnancy test.
⁃ Patients will still be included even if they have one or more co-diagnoses
• Discdisplacement with or without reduction
• Degenerative joint disease
• Arthralgia
Locations
Other Locations
Sweden
Eastman institute Folktandvården Region Stockholm
RECRUITING
Stockholm
Contact Information
Primary
Veronica de Flon
veronica.deflon@regionstockholm.se
+ 46 702182623
Backup
Hajer Jasim
hajer.jasim@reigionstockholm.se
Time Frame
Start Date:2025-05-01
Estimated Completion Date:2026-12-01
Participants
Target number of participants:90
Treatments
Active_comparator: BTX-L for myogenous TMD
Patients (n=45) with myogenious TMD will receive treatment with 50 U of Botox®100 U, AbbVie. The drug will be dissolved in 2 millilitres of room-temperate sterile isotonic saline. This gives 5U/0,1 ml solution and each patient will receive a total o 50 U as described in the protocol
Active_comparator: BTX-H for myogenous TMD
Patients (n=45) with myogenious TMD will receive treatment with 100 U of Botox®100 U, AbbVie. The drug will be dissolved in 1 millilitre of room-temperate sterile isotonic saline. This gives 10U/0,1 ml solution and each patient will receive a total of 100 U as described in the protocol