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Botulinumtoxin A as a treatment for myalgia and myofacial pain in patient with temporomandibulardisorders – a quality study associated to a new treatment routine.
EU CTIS ID: 2023-504033-44-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- a) Female gender b) age 18-45 years c) diagnos of myalgia, myofacial pain or myofascial pain with refered pain according to DC/TMD d) an average pain due to NRS ≥ 3 for more than three months e) treatment for orofacial pain > three months ago.f) with adequate contraceptives and a negative pregnancy test. Patients will still be included even if they have one or more co-diagnoses 1) Discdisplacement with or without reduction according to DC/TMD 2) degenerative joint disease 3) arthralgia
You likely can't join if
- 1) treatment with BTX during the last six months 2) treatment for orofacial pain within the last 3 months. 3) systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) 4) fibromyalgia 5) neuropathic pain 6) neurologic disease (myastenia gravis) 7) pain of dental origin 8) use of muscle relaxants or aminoglycoside antibiotics 9) pregnancy or nursing 10) hypersensitivity to BTX 11) neuropsychiatric conditions.12) difficulties understanding the Swedish language.13) Trauma to head, neck or face, including orthognatic surgery
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.