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

Pain Clinical Trial

— IAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05365932
• Other study ID #: 303/18
• Status: Completed
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: May 2022
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 10, 2019
• Est. primary completion date: May 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mandibular Diseases
• Myofascial Pain
• Pain
• Psychosocial Impairment
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Intra auricular device (IAD)
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

Locations

Country	Name	City	State
Italy	Donnarumma Valeria	Afragola

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Psychosocial domain positive change	Evaluation of psychosocial positive change through psychosocial questionnaires.	Six months from the first use of the device