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

NCT05365932 | Completed

• 1 other identifier: 303/18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder; Pain; Psychosocial Impairment; Myofascial Pain

Keywords

Pressure Pain Threshold; Intra auricular device

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

TMD Pain group

EXPERIMENTAL

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)

Interventions

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

TMD Pain group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Donnarumma Valeria

Afragola, 80021, Italy

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: May 9, 2022
• Study Start: November 29, 2018
• Primary Completion: May 8, 2019
• Study Completion: December 10, 2019
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

IT (1)