Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Temporomandibular Joint Disorders, Myofascial Temporomandibular Disorders

Intervention / Treatment
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* Drug: Propranololhydrochlorid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol<br> | Drug: Propranololhydrochlorid<br>* One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions<br>* Other names: Propranolol DAK 40 mg, Nycomed Denmark ApS;|
| Experimental: Placebo<br> | Drug: Placebo<br>* One single dose of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporomandibular disorders, Orofacial pain