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Completed

NCT Number: NCT05365932

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

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.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Myofascial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Psychosocial Impairment Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Donnarumma Valeria

Afragola, 80021, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra auricular device (IAD)

Device

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

Primary outcomes

  1. Change of Pain (evaluated with Characteristic pain intensity scale)

    Time frame: Six months from the first use of the device

    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

  2. Change of Pain evaluated with instrumental exam( Pain Pressure Threshold)

    Time frame: Six months from the first use of the device

    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.

  3. Psychosocial domain positive change

    Time frame: Six months from the first use of the device

    Evaluation of psychosocial positive change through psychosocial questionnaires.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: IAD

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 9, 2022
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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