Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders (IAD)

Federico II University

Status: Completed

Conditions: Temporomandibular Disorder; Myofascial Pain; Psychosocial Impairment; Pain

Treatments: Device: Intra auricular device (IAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT05365932

303/18

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

TMD Pain group

Experimental group

Description:

Arm included patients with TMD Pain intensity \>3 on a VAS scale and with diagnosis of myofascial pain, either alone or in combination with arthralgia, headache attributable to TMD or with disc displacement with reduction. Participants had to be 18 years of age or older. All subjects had to wear the device for 6 months and it should not be used for more than 23 hours in a 24-hour period

Treatment:

Device: Intra auricular device (IAD)