Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01333150
First received: March 30, 2011
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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 Intervention
Temporomandibular Joint Disorders
Myofascial Temporomandibular Disorders
Drug: Propranololhydrochlorid
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Numeric Rating Scale 0-10


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor.


Estimated Enrollment: 16
Study Start Date: August 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333150

Contacts
Contact: Karina H. Bendixen, DDS, PhD fellow +004587168259 karina.bendixen@odontologi.au.dk

Locations
Denmark
Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University Recruiting
Aarhus, Denmark, 8000
Sub-Investigator: Karina Bendixen, DDS, PhD fellow         
Section of Clinical Oral Physiology, Aarhus University Recruiting
Aarhus C, Denmark, 8000
Contact: Karina H. Bendixen, PhD fellow    +004587168259    karina.bendixen@odontologi.au.dk   
Principal Investigator: Peter Svensson, DDS, PhD, Dr.Odont.         
Sub-Investigator: Karina H. Bendixen, DDS, PhD fellow         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Peter Svensson, DDS, PhD, Dr.Odont University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01333150     History of Changes
Other Study ID Numbers: M-20090062
Study First Received: March 30, 2011
Last Updated: March 23, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Temporomandibular disorders
Orofacial pain

Additional relevant MeSH terms:
Mandibular Diseases
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Myalgia
Musculoskeletal Diseases
Craniomandibular Disorders
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on August 19, 2014