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.
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.
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
Parallel
5U/0,1 ml Botulinum toxin A
DrugBotox® 100 U (AbbVie) will be dissolved in 2 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 5 U/0.1 mL. Each patient will receive a total dose of 50 U, administered bilaterally into the masseter and temporalis muscles.
10U/0,1 ml Botulinum toxin A
DrugBotox® 100 U (AbbVie) will be dissolved in 1 milliliters of room-temperature sterile isotonic saline, resulting in a solution concentration of 10 U/0.1 mL. Each patient will receive a total dose of 100 U, administered bilaterally into the masseter and temporalis muscles.
Changes in pain and impact of doses on pain relief
Pain level will be assessed using the Numeric rating Scale (NRS, a scale ranging from 0 (no pain) to 10 (worst pain imaginable). A 30% reduction in pain according to the NRS is considered a significant effect. The study compare two doses (low and high)
Changes in quality of life according to The Oral Healthy Impact profile questionnaire (OHIP-5)
The influence of the quality of life will be measured. Scores are categorized as follow: No influence (0-7 p), some influence (8-15 p) and large influence (16-20 p). Higher score mean worse outcomes
Maximum jaw opening in millimeter, with and without pain will be compared to asess treatment outcomes.
Treatment outcome in sub-groups of myogenous TMD.
Changes i pressure pain threshold (PPT)
Sensitivity to pressure induced pain by PPT (pressure pain threshold). PPT will be measured three times and average value will be used.
Changes in psychological factors
According to changes in Axis II (a psykometric form)
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