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Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders

RecruitingPhase 3Ages 18 Years - 50 YearsFemaleRegion Stockholm
NCT06941636 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Treatment with BTX during the last 12 months * Treatment for orofacial pain within the last 3 months. * Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) * Widespread pain e.g., fibromyalgia * Neuropathic pain * Neurologic disease (myasthenia gravis) * Pain of dental origin * Use of muscle relaxants, or aminoglycoside antibiotics * Pregnancy or nursing * Hypersensitivity to BTX * Neuropsychiatric conditions. * Difficulties understanding the Swedish language
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What it tests

  • 5U/0,1 ml Botulinum toxin A
  • 10U/0,1 ml Botulinum toxin A
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Where

1 site
Eastman institute Folktandvården Region Stockholm
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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