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:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT04731233
Eligibility Criteria:
Inclusion Criteria:
* Female
* 40 - 80 years of age
* Unilateral or bilateral TMJ arthralgia
* Osteoarthritis diagnosis according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
* TMJ sounds (crepitus or click or both)
* Mild-moderate masticatory muscle myalgia
* History of non-surgical treatment for at least 6 weeks including such modalities as appliance therapy, NSAID therapy or physical modalities without resolution of pain
Exclusion Criteria:
* Contraindication to sedation including pregnancy or medical history
* Rheumatologic disorders causing arthritis of the temporomandibular joint (i.e., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)
* History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
* History of steroid injection in TMJ
* TMJ pain greater than five years
* History of narcotic drug use on a scheduled basis
* Current active infection
* Fibromyalgia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04731233
Study Brief:
Protocol Section:
NCT04731233