Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

This study is currently recruiting participants.

Verified March 2012 by University of Aarhus

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2011

Last Updated Date

March 23, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01333150 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Temporomandibular Joint Disorders
Myofascial Temporomandibular Disorders

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Propranolol
Intervention: Drug: Propranololhydrochlorid
Experimental: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Karina H. Bendixen, DDS, PhD fellow

+004587168259

karina.bendixen@odontologi.au.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01333150

Other Study ID Numbers ^ICMJE

M-20090062

Has Data Monitoring Committee

Responsible Party

University of Aarhus

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Aarhus University Hospital

Investigators ^ICMJE

Principal Investigator:

Peter Svensson, DDS, PhD, Dr.Odont

University of Aarhus

Information Provided By

University of Aarhus

Verification Date

March 2012

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

To Top