Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01333150
• Other study ID #: M-20090062
• Status: Recruiting
• Phase: N/A
• First received: March 30, 2011
• Last updated: March 23, 2012
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: March 2012
• Source: University of Aarhus
• Contact: Karina H. Bendixen, DDS, PhD fellow
• Phone: +004587168259
• Email: karina.bendixen[@]odontologi.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Myofascial Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Propranololhydrochlorid
One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
• Placebo
One single dose of placebo

Locations

Country	Name	City	State
Denmark	Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University	Aarhus
Denmark	Section of Clinical Oral Physiology, Aarhus University	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Numeric Rating Scale 0-10	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	No
Secondary	Haemodynamic parameters	Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor.	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	No