Skip to content

Vagus nerve stimulation in the auricular region for the treatment of patients with Temporomandibular Dysfunction – Pilot Study

Noninvasive Auricular Vagal Electrical Stimulation for the treatment of patients with Temporomandibular Dysfunction – Pilot Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7d5bnmb
Enrollment
Unknown
Registered
2025-05-06
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

This is a randomized, controlled, two-arm, double-blind clinical study. Experimental group: 12 individuals with temporomandibular dysfunction (noninvasive auricular vagal electrical stimulation on the

Sponsors

Centro de Ciências da Saúde da Universidade Federal do Espírito Santo
Lead Sponsor
Centro de Ciências da Saúde da Universidade Federal do Espírito Santo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults aged 18 years or older; both sexes; diagnosis of temporomandibular dysfunction by the Diagnostic Criteria; completion of the free and informed consent form; change in heart rate variability with sympathetic or parasympathetic index outside the normal range (-1 to 1), in at least 2 of the 3 orthotest moments; minimum pain level of 4 considering an average of 4 values: greatest pain in the last week, least pain in the last week, average pain in the last week and current pain, all on a visual analogue scale from 0 to 10

Exclusion criteria

Exclusion criteria: Neurological impairment; rheumatological diseases such as rheumatoid arthritis and ankylosing spondylitis; cardiac arrhythmia or other cardiovascular conditions using beta-blockers; pregnant women or women who are breastfeeding; patients diagnosed with cancer; epilepsy; skull, cervical or rib fractures; severe osteoporosis

Design outcomes

Primary

MeasureTime frame
It is expected to assess the feasibility of the study through the recruitment rate, adherence rate, acceptability of the intervention, safety of the intervention

Secondary

MeasureTime frame
An improvement in heart rate variability towards normal parameters is expected in the intervention group, assessed before and after the end of the intervention protocol using orthotest;A decrease in pain intensity is expected in the intervention group, assessed before and after the end of the intervention protocol, as well as maintenance of this improvement 30 days later, assessed using the visual numerical scale, with follow-up carried out by telephone;An increase in the pressure pain threshold in the masseter is expected, assessed before and after the end of the intervention protocol using algometry;An improvement in sleep quality is expected in the intervention group, assessed before and after the end of the intervention protocol, as well as maintenance of this improvement 30 days later, assessed using the Pittsburg questionnaire, with follow-up carried out by telephone;An improvement in nonspecific physical symptoms is expected in the intervention group, assessed before and after the end of the intervention protocol, as well as maintenance of this improvement 30 days later, assessed through the Patient Health Questionnaire - 15 questions, with follow-up carried out by telephone;An improvement in anxiety, depression and stress is expected in the intervention group, assessed before and after the end of the intervention protocol, as well as maintenance of this improvement 30 days later, assessed using the Depression, Anxiety and Stress Scale, with follow-up carried out by telephone

Countries

Brazil

Contacts

Public ContactFernanda Liberato

Universidade Federal do Espírito Santo

nandamayrink@yahoo.com.br+55(27)33357317

Outcome results

None listed

Source: REBEC (via WHO ICTRP)