Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain

University of Aarhus2 sites in 1 country16 target enrollmentAugust 2011

ConditionsTemporomandibular Joint Disorders Myofascial Temporomandibular Disorders

InterventionsPropranololhydrochlorid Placebo

DrugsPropranololhydrochlorid Placebo

Overview

Phase: Not Applicable
Intervention: Propranololhydrochlorid
Conditions: Temporomandibular Joint Disorders
Sponsor: University of Aarhus
Enrollment: 16
Locations: 2
Primary Endpoint: Pain intensity
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

September 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

University of Aarhus

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Propranolol

Intervention: Propranololhydrochlorid

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Pain intensity

Time Frame: 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 Outcomes

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)