Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

Not Applicable

• Conditions: Temporomandibular Joint Disorders; Myofascial Temporomandibular Disorders
• Interventions: Drug: Propranololhydrochlorid; Drug: Placebo

• Registration Number: NCT01333150
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Study Start: 2011-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26
• Primary Completion: 2012-09
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 16

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Propranolol	Propranololhydrochlorid	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain intensity	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 Outcome Measures

Name	Time	Method
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	Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor.

Trial Locations

Locations (2)

Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University; 🇩🇰 Aarhus, Denmark

Section of Clinical Oral Physiology, Aarhus University; 🇩🇰 Aarhus C, Denmark