Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborator: Aarhus University Hospital
• Treatments: Propranolol

Criteria

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.