Working… Menu

Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333150
Recruitment Status : Unknown
Verified March 2012 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : April 11, 2011
Last Update Posted : March 26, 2012
Aarhus University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Myofascial Temporomandibular Disorders Drug: Propranololhydrochlorid Drug: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain
Study Start Date : August 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Propranolol Drug: Propranololhydrochlorid
One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
Other Name: Propranolol "DAK" 40 mg, Nycomed Denmark ApS

Experimental: Placebo Drug: Placebo
One single dose of placebo

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Haemodynamic parameters [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333150

Layout table for location contacts
Contact: Karina H. Bendixen, DDS, PhD fellow +004587168259

Layout table for location information
Section of Clinical Oral Physiology, Aarhus University Recruiting
Aarhus C, Denmark, 8000
Contact: Karina H. Bendixen, PhD fellow    +004587168259   
Principal Investigator: Peter Svensson, DDS, PhD, Dr.Odont.         
Sub-Investigator: Karina H. Bendixen, DDS, PhD fellow         
Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University Recruiting
Aarhus, Denmark, 8000
Sub-Investigator: Karina Bendixen, DDS, PhD fellow         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Layout table for investigator information
Principal Investigator: Peter Svensson, DDS, PhD, Dr.Odont University of Aarhus

Layout table for additonal information
Responsible Party: University of Aarhus Identifier: NCT01333150     History of Changes
Other Study ID Numbers: M-20090062
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Keywords provided by University of Aarhus:
Temporomandibular disorders
Orofacial pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Neurologic Manifestations
Signs and Symptoms
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents