Botulinumtoxin A as a treatment for myalgia and myofacial pain in patient with temporomandibulardisorders – a quality study associated to a new treatment routine.
- Conditions
- Temporomandibular disorderTherapeutic area: Diseases [C] - Stomatognathic Diseases [C07]Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2023-504033-44-00
- Lead Sponsor
- Region Stockholm Folktandvarden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method