Clinical trial NCT01333150: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Myofascial Temporomandibular Disorders
Keywords: Temporomandibular disorders
Orofacial pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2011-04-11
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Pain intensity
timeFrame: 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 outcomes:
measure: Haemodynamic parameters
timeFrame: 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
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Section of Clinical Oral Physiology, Aarhus University
city: Aarhus
country: Denmark
facility: Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University
Study officials:
affiliation: University of Aarhus
name: Peter Svensson, DDS, PhD, Dr.Odont
role: PRINCIPAL_INVESTIGATOR
References: