Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A
Temporomandibular Disorders
About this trial
This is an interventional diagnostic trial for Temporomandibular Disorders focused on measuring Temporomandibular Disorders, Botulinum Toxin A, Myalgia, Randomized, Clinical Trial, Pain, Gene, Neural Plasticity
Eligibility Criteria
Inclusion Criteria: a diagnosis of TMDM myalgia or myofascial pain according to the DC/TMD criteria females with adequate contraceptives and a negative pregnancy test pain upon digital palpation of at least one of the masseter muscle a characteristic pain intensity of > 40/100. Exclusion Criteria: difficulties understanding the Swedish language systemic inflammatory connective tissue diseases widespread pain neuromuscular disorders diagnosed or severe psychiatric disease neuropathic pain pain of dental origin history of trauma to the face, head or neck pregnancy or nursing known allergy to botulinum toxin or antibiotics use of muscle relaxants, antidepressant, neuropsychiatric, anticoagulant drugs, or aminoglycoside antibiotics previous treatment with botulinum toxin during the last 12 months use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy skin infection over injection/biopsy site
Sites / Locations
- Department of Dental Medicine, Karolinska InstitutetRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Botulinum toxin
Isotonic saline
Single bilateral injection into three standardized points of the masseter muscles and two of the anterior temporalis muscle. The total dose administered is 100 U (10 U/point) which is dissolved in 1 mL of isotonic saline. Thus, 0.1 ml of botulinum toxin solution is injected in each point.
Single injection of 1 mL isotonic saline (0.9 mg/mL) into the same five points per side in a similar manner as for botulinum toxin.