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Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

Primary Purpose

Temporomandibular Joint Disorders, Myofascial Temporomandibular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Propranololhydrochlorid
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular disorders, Orofacial pain

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Section of Clinical Oral Physiology, Aarhus UniversityRecruiting
  • Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propranolol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity
Numeric Rating Scale 0-10

Secondary Outcome Measures

Haemodynamic parameters
Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor.

Full Information

First Posted
March 30, 2011
Last Updated
March 23, 2012
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01333150
Brief Title
Effect of Propranolol on the Autonomic Nervous System and Muscle Pain
Official Title
Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Myofascial Temporomandibular Disorders
Keywords
Temporomandibular disorders, Orofacial pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Propranololhydrochlorid
Other Intervention Name(s)
Propranolol "DAK" 40 mg, Nycomed Denmark ApS
Intervention Description
One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One single dose of placebo
Primary Outcome Measure Information:
Title
Pain intensity
Description
Numeric Rating Scale 0-10
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
Secondary Outcome Measure Information:
Title
Haemodynamic parameters
Description
Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor.
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karina H. Bendixen, DDS, PhD fellow
Phone
+004587168259
Email
karina.bendixen@odontologi.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Svensson, DDS, PhD, Dr.Odont
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section of Clinical Oral Physiology, Aarhus University
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina H. Bendixen, PhD fellow
Phone
+004587168259
Email
karina.bendixen@odontologi.au.dk
First Name & Middle Initial & Last Name & Degree
Peter Svensson, DDS, PhD, Dr.Odont.
First Name & Middle Initial & Last Name & Degree
Karina H. Bendixen, DDS, PhD fellow
Facility Name
Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karina Bendixen, DDS, PhD fellow

12. IPD Sharing Statement

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Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

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