Clinical trial NCT05365932: Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders
Official title: Prospective Longitudinal Study for the Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Pain
Psychosocial Impairment
Myofascial Pain
Keywords: Pressure Pain Threshold
Intra auricular device
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: An innovative, non-invasive, and reversible Intra Auricular Device (IAD) has recently been introduced to treat temporomandibular muscle and joint disorders.Aim: To evaluate the effects of the IAD on pain, psychosocial domain and Pressure Pain Threshold (PPT) of masticatory muscles in patients with TMD pain. Methods: Ten subjects with TMD pain and with pain intensity higher than 30 mm on a VAS scale were included in the study. Patients received the IAD and counselling. Assessments included questionnaires of the DC/TMD Axis II questionnaires (Characteristic Pain Index, Interference, Jaw Functional Limitation Scale, Patient Health Questionnaire 9, Patient Health Questionnaire 15, Generalized Anxiety Disorder scale, Oral Behavior Checklist and Oral Health Impact Profile-22, Axis I clinical examination and PPTs at baseline (T0), after one month (T1), three months (T2) and six months (T3) from the first use of the device. PPTs were measured at anterior temporalis muscles, masseter muscles and right thenar as a control site.The Shapiro-Wilk test was used for the normal distribution of data. The difference among the longitudinal timepoints for variable was analysed with ANOVA. Statistical significance was accepted at p \< 0.05.

Detailed description: The goal of ths study is to evaluate the effects of a new intra auricular device, the IAD, on pain, psychosocial domain and Pressure Pain Threshold (PPT) of facial muscles in patients with diagnosis of TMD pain according to the Diagnostic Criteria of Temporomandibular Disorders

Eligibility criteria: Inclusion Criteria:

* age \>18
* TMD-pain diagnosed according to the DC/TMD (myalgia, myofascial pain, arthralgia, headache attributable to TMD)
* disc displacement with reduction

Exclusion Criteria:

* disc displacement without reduction
* intermittent locking
* degenerative TMJ disorder
* craniofacial anomaly
* history of prior TMJ
* orthognathic surgery
* recent (within the past six months) trauma to the face or jaw
* current, active orthodontic treatment
* severe mental health disorder

Primary outcomes:
measure: Change of Pain (evaluated with Characteristic pain intensity scale)
timeFrame: Six months from the first use of the device
measure: Change of Pain evaluated with instrumental exam( Pain Pressure Threshold)
timeFrame: Six months from the first use of the device
measure: Psychosocial domain positive change
timeFrame: Six months from the first use of the device
Secondary outcomes:
Other outcomes:
Locations:
city: Afragola
country: Italy
facility: Donnarumma Valeria
Study officials:
References: