Temporomandibular Joint DisordersNCT01333150
Effect of Propranolol on the Autonomic Nervous System and Muscle Pain
A study testing Propranololhydrochlorid in people with Temporomandibular Joint Disorders and Myofascial Temporomandibular Disorders, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Temporomandibular Joint Disorders, Myofascial Temporomandibular Disorders
- What is being tested?
- Propranololhydrochlorid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesDenmark
- Study dates
- Aug 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 2 recruiting
- Recruiting
Section of Clinical Oral Physiology,Department of Dentistry,HEALTH. Aarhus University
Aarhus, 8000
Karina Bendixen, DDS, PhD fellow
- Recruiting
Section of Clinical Oral Physiology, Aarhus University
Aarhus C, 8000
Karina H. Bendixen, PhD fellow, +004587168259, karina.bendixen@odontologi.au.dk
Peter Svensson, DDS, PhD, Dr.Odont.
About this study
Official title: Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain
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.
- Being tested
- Propranololhydrochlorid, Placebo
- Keywords
- Temporomandibular disorders, Orofacial pain
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololhydrochloridDrug
Also called Propranolol "DAK" 40 mg, Nycomed Denmark ApS
One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
PlaceboDrug
One single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Propranolol | Experimental | Not described Receives: Drug: Propranololhydrochlorid |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Numeric Rating Scale 0-10
Measured: 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 (1)
Haemodynamic parameters
Monitoring of pulse and blodpressurevariability, respiration, baroreceptor sensitivity, measured non-invasively by Task Force Monitor.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Peter Svensson, DDS, PhD, Dr.Odont, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333150
- Sponsor's protocol ID
- M-20090062
- Status last verified
- Mar 2012
- First submitted
- 30 Mar 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Low-dose Propranolol on a Stress Induced Autonomic Response and on Muscle Pain
- ClinicalTrials.gov ID
- NCT01333150
- Acronym / sponsor ID
- M-20090062
- Keywords
- Temporomandibular disorders, Orofacial pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propranolol | Experimental | Drug: Propranololhydrochlorid |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololhydrochloridAlso: Propranolol "DAK" 40 mg, Nycomed Denmark ApSOne single dose of Propranolol tablet of 40 mg randomized in one of the two sessions | Drug | Propranolol |
| PlaceboOne single dose of placebo | Drug | Placebo |
Primary outcome
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
Numeric Rating Scale 0-10
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Svensson, DDS, PhD, Dr.Odont principal investigator
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propranololhydrochlorid in people with Temporomandibular Joint Disorders and Myofascial Temporomandibular Disorders, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karina H. Bendixen, DDS, PhD fellow (+004587168259, karina.bendixen@odontologi.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2012.