NCT01333150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

March 30, 2011

Last Update Submit

March 23, 2012

Conditions

Temporomandibular Joint DisordersMyofascial Temporomandibular Disorders

Keywords

Temporomandibular disordersOrofacial pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Numeric Rating Scale 0-10

    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

    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

Study Arms (2)

Propranolol

EXPERIMENTAL
Drug: Propranololhydrochlorid

Placebo

EXPERIMENTAL
Drug: Placebo

Interventions

PropranololhydrochloridDRUG

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

Also known as: Propranolol "DAK" 40 mg, Nycomed Denmark ApS
Propranolol
PlaceboDRUG

One single dose of placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Aarhus, 8000, Denmark

RECRUITING

Section of Clinical Oral Physiology, Aarhus University

Aarhus C, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial Pain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Svensson, DDS, PhD, Dr.Odont

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina H. Bendixen, DDS, PhD fellow

CONTACT

+004587168259karina.bendixen@odontologi.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 11, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

DK(2)