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

March 30, 2011
March 23, 2012
August 2011
September 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01333150 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of Propranolol on the Autonomic Nervous System and Muscle Pain
Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Temporomandibular Joint Disorders
  • Myofascial Temporomandibular Disorders
  • 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
  • Drug: Placebo
    One single dose of placebo
  • Experimental: Propranolol
    Intervention: Drug: Propranololhydrochlorid
  • Experimental: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 60 Years
No
Contact: Karina H. Bendixen, DDS, PhD fellow +004587168259 karina.bendixen@odontologi.au.dk
Denmark
 
NCT01333150
M-20090062
No
University of Aarhus
University of Aarhus
Aarhus University Hospital
Principal Investigator: Peter Svensson, DDS, PhD, Dr.Odont University of Aarhus
University of Aarhus
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP