Tokyo, Nov. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059916) titled 'Study on Simple Jaw Movement and Pain Screening Using Smartphone and Earbuds' on Nov. 28.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Keio University School
Condition:
Condition - Temporomandibular Disorders(TMD),Headache Attributed to TMD,Chronic Headache,
Orofacial PainMyofascial Pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate whether the differences in mandibular movement between the presence and absence of pain can be noninvasively estimated in patients with temporomandibular disorders and masticatory myofascial pain by measuring jaw motion using commercial smart devices (AirPods Pro and iPhone).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will wear AirPods Pro (equipped with IMU sensors) and perform 10 repetitions each of mouth opening and protrusive jaw movements while simultaneously being recorded by an iPhone TrueDepth camera. These measurements will be performed at two time points: (1) initial visit (with pain), and (2) after clinical pain improvement. Each session takes approximately 10 minutes. No drugs or invasive procedures are involved.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 18 years or older who visit the Department of Dentistry and Oral Surgery at Keio University Hospital and are diagnosed with temporomandibular disorders or masticatory myofascial pain during clinical evaluation.
Key exclusion criteria - Individuals with a history of temporomandibular joint surgery
Individuals with cognitive impairment that hinders understanding and participation in the study
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 30 Day
Anticipated trial start date - 2025 Year 12 Month 15 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068474
Disclaimer: Curated by HT Syndication.