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

Study Overview
=================
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

Official Title
-----------------
Prospective Longitudinal Study for the Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders

Conditions
-----------------
Pain, Temporomandibular Disorder, Psychosocial Impairment, Myofascial Pain

Intervention / Treatment
-----------------
* Device: Intra auricular device (IAD)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMD Pain group<br>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 | Device: Intra auricular device (IAD)<br>* The Intra Auricular Device (IADs) are a pair of inconspicuous, custom fit auricular prosthetic devices.The ear inserts are manufactured using computer-aided design/computer-aided manufacturing (CAD/CAM) technology and are made from a liquid, photo-reactive acrylate (EShell 300), used in hearing aid shells and otoplastics for the last 10 years. They are designed to be placed into the outer third of the ear canals, and they have a small retraction post used to facilitate removal . A red or blue dot, respectively, indicates the right and the left side. The device do not interfere with hearing or speech<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain (evaluated with Characteristic pain intensity scale) | This questionnaire is a valid instrument assessing pain intensity, numbers of days with interference and pain-related disability in the last month. The characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain | Six months from the first use of the device | 
| Change of Pain evaluated with instrumental exam( Pain Pressure Threshold) | Pain Pressure Threshold were assessed by a single examiner at the anterior temporalis and masseter muscles (respectively TdxM; TsxM; MdxM; MsxM). An additional measurement was performed at the right thenar muscle (TenM) selected as a control muscular site. | Six months from the first use of the device | 
| Psychosocial domain positive change | Evaluation of psychosocial positive change through psychosocial questionnaires. | Six months from the first use of the device | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pressure Pain Threshold, Intra auricular device