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Temporomandibular Joint Disorders | Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

Temporomandibular Joint Disorders research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Temporomandibular Joint Disorders

Myofascial Temporomandibular Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PropranololhydrochloridOne single dose of Propranolol tablet of 40 mg randomized in one of the two sessions

Drug:PlaceboOne single dose of placebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Propranolol

Placebo

Study Status

Unknown status

Start Date: August 2011

Completed Date: September 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Pain intensity

Secondary Outcome: Haemodynamic parameters

Study sponsors, principal investigator, and references

Principal Investigator: Peter Svensson, DDS, PhD, Dr.Odont

Lead Sponsor: University of Aarhus

Collaborator: Aarhus University Hospital

More information:https://clinicaltrials.gov/show/NCT01333150

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