Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT01333150
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01333150
Study Brief:
Protocol Section:
NCT01333150