Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

University of Aarhus

Status

Unknown

Conditions

Myofascial Temporomandibular Disorders

Temporomandibular Joint Disorders

Treatments

Drug: Placebo

Drug: Propranololhydrochlorid

Study type

Interventional

Funder types

Other

Identifiers

NCT01333150

M-20090062

Details and patient eligibility

About

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.

Enrollment

16 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.