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:
University of Aarhus
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Temporomandibular Joint Disorders Myofascial Temporomandibular Disorders |
Drug: Propranololhydrochlorid Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain |
Resource links provided by NLM:
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 16 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Propranolol |
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
|
| Experimental: Placebo |
Drug: Placebo
One single dose of placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333150
Contacts
| Contact: Karina H. Bendixen, DDS, PhD fellow | +004587168259 | karina.bendixen@odontologi.au.dk |
Locations
| Denmark | |
| Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University | Recruiting |
| Aarhus, Denmark, 8000 | |
| Sub-Investigator: Karina Bendixen, DDS, PhD fellow | |
| Section of Clinical Oral Physiology, Aarhus University | Recruiting |
| Aarhus C, Denmark, 8000 | |
| Contact: Karina H. Bendixen, PhD fellow +004587168259 karina.bendixen@odontologi.au.dk | |
| Principal Investigator: Peter Svensson, DDS, PhD, Dr.Odont. | |
| Sub-Investigator: Karina H. Bendixen, DDS, PhD fellow | |
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
| Principal Investigator: | Peter Svensson, DDS, PhD, Dr.Odont | University of Aarhus |
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01333150 History of Changes |
| Other Study ID Numbers: | M-20090062 |
| Study First Received: | March 30, 2011 |
| Last Updated: | March 23, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency Denmark: The Regional Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
Temporomandibular disorders Orofacial pain |
Additional relevant MeSH terms:
|
Joint Diseases Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Musculoskeletal Diseases Craniomandibular Disorders Mandibular Diseases Jaw Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Propranolol Anti-Arrhythmia Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents |
ClinicalTrials.gov processed this record on May 19, 2013