Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of California, San Francisco
With
Mount Zion Health Fund
American Academy of Otolaryngology-Head and Neck Surgery Foundation
PRIMARY OBJECTIVE:
I. To assess the clinical efficacy of the trismus device, as measured by the change in maximum interincisal opening over the six-week treatment period.
SECONDARY OBJECTIVE:
I. To assess participants compliance rates and jaw opening pressures when using this device.
OUTLINE: Participants are assigned to 1 of 2 parts.
PART I: Participants test the trismus device and complete questionnaires on study.
PART II: Participants undergo exercise therapy with the trismus device under supervision of a speech language pathologist on study.
Participants will be on study for up to 6 weeks with a follow-up visit 7 days after completion.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female \>= 18 years of age at visit 1.
Documentation of a radiation-induced trismus diagnosis as evidenced by one or more clinical features consistent with the trismus phenotype (maximum interincisal opening (MIO) \< 35 mm) and a history of head and neck radiation
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
You may not be if
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
Minors (age \< 18 years) or patients with inability to provide informed consent.
