Effect of Propranolol on the Autonomic Nervous System and Muscle Pain

NCT ID: NCT01333150

Last Updated: 2012-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Temporomandibular Joint Disorders Myofascial Temporomandibular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propranolol

Group Type EXPERIMENTAL

Propranololhydrochlorid

Intervention Type DRUG

One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions

Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

One single dose of placebo

Interventions

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Propranololhydrochlorid

One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions

Intervention Type DRUG

Placebo

One single dose of placebo

Intervention Type DRUG

Other Intervention Names

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Propranolol "DAK" 40 mg, Nycomed Denmark ApS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Svensson, DDS, PhD, Dr.Odont

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University

Aarhus, , Denmark

Site Status RECRUITING

Section of Clinical Oral Physiology, Aarhus University

Aarhus C, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Karina H. Bendixen, DDS, PhD fellow

Role: CONTACT

+004587168259

Facility Contacts

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Karina H. Bendixen, PhD fellow

Role: primary

+004587168259

Other Identifiers

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M-20090062

Identifier Type: -

Identifier Source: org_study_id

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