Myofascial Temporomandibular Disorders, Temporomandibular Joint Disorders
Conditions
Keywords
Temporomandibular disorders, Orofacial pain
Brief summary
The project's primary purpose is to test the hypothesis that oral administration of a low single dose of β-antagonist propranolol (40 mg) reduces pain sensitivity in patients with masticatory muscle pain.
Interventions
DRUGPropranololhydrochlorid
One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
DRUGPlacebo
One single dose of placebo
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Meet Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) for myofascial TMD diagnosis corresponding to group 1a or 1b * Characteristic Pain Intensity (CPI) more than or equal to 20 (Axe II, RDC/TMD questionnaire) * Women of childbearing potential must use adequate contraception * Signed consent statement
Exclusion criteria
* Other acute pain cause such as acute toothache or a pain condition the investigator estimates to be contraindicated for participation in the experiment * Recognized existing malignancy or within last 5 years * Known HIV * Abuse of drugs including alcohol * Recognized Raynaud's syndrome * Former sympathectomy * Known cardiovascular disease including abnormal EKG and blood pressure (ECG-12 is recorded before the first trial session and assessed by the physician) * Recognized lung insufficience, including bronchial asthma * Known severe hepatic or renal dysfunction * Known diabetes mellitus * Known severe depression * Pregnancy (tests performed in both sessions 1 and 2 before the start of a session) * Fertility Treatment * Lactation * Post-menopausal * Previous adverse reaction when taking beta-blocker, including hypersensitivity to propranolol or to any of the excipients * Patients who can not read and understand the written information * Patients who can not follow the protocol * Patients who do not agree to comply with the requirements for participation in both studies regarding food intake, physical activity, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Participants will be asked to score their actual pain level in both of the two experimental sessions they will participate in; an expected average of two weeks between the two sessions | Numeric Rating Scale 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemodynamic parameters | Participants will be monitored during the entire session in both of the two experimental sessions they will participate in; an expected average of two weeks between the two sessions | Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor. |
Countries
Denmark
Contacts
Primary ContactKarina H. Bendixen, DDS, PhD fellow
Outcome results
None listed