CTIS2023-504033-44-00
Active, not recruiting
Phase 1
Botulinumtoxin A as a treatment for myalgia and myofacial pain in patient with temporomandibulardisorders – a quality study associated to a new treatment routine. - BTXclinicaltrialEA
Region Stockholm Folktandvarden0 sites1 target enrollmentOctober 26, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Temporomandibular disorder
- Sponsor
- Region Stockholm Folktandvarden
- Enrollment
- 1
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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