Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism

NCT ID: NCT06386809

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-11-01

Brief Summary

Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (TAVNS) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions.

Detailed Description

Our study was designed as a randomized, single-blind experimental clinical trial. It was planned to include 40 individuals diagnosed with bruxism in our research. Outcome measurements and assessments will be performed immediately after the participants are recruited and at the end of the 8-week program. Pain intensity, oral health quality of life, stress level and sleep quality will be assessed by self-report through questionnaires. Pressure pain threshold and muscle activation for the masseter muscle and heart rate variables measurements will be performed by physiotherapists. After completing the initial evaluations, the participants will be randomly divided into two groups. An eight-week exercise program will be applied to the control group. In the TAVNS group, in addition to the eight-week exercise program, TAVNS will be used twice weekly for 16 sessions with the VAGUSTIM device.

Conditions

Bruxism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TAVNS group

Group Type: EXPERIMENTAL

TAVNS

Intervention Type: DEVICE

TAVNS is a recently introduced treatment involving transcutaneous electrical stimulation of the auricular branch of the vagus nerve with VAGUSTIM device.

Exercise program

Intervention Type: OTHER

Rocabado 6x6 exercises will be applied in our study. Rocabado exercise, which is the most commonly used exercise method in the literature, is a set of exercises for the craniocervical and craniomandibular system.

Exercise group

Group Type: OTHER

Exercise program

Intervention Type: OTHER

Rocabado 6x6 exercises will be applied in our study. Rocabado exercise, which is the most commonly used exercise method in the literature, is a set of exercises for the craniocervical and craniomandibular system.

Interventions

TAVNS

TAVNS is a recently introduced treatment involving transcutaneous electrical stimulation of the auricular branch of the vagus nerve with VAGUSTIM device.

Intervention Type: DEVICE

Exercise program

Rocabado 6x6 exercises will be applied in our study. Rocabado exercise, which is the most commonly used exercise method in the literature, is a set of exercises for the craniocervical and craniomandibular system.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with bruxism between the ages of 18-65,
• A history of bruxism for at least 6 months,
• Individuals with masseter muscle pain GAS≥4 at rest and during mastication

Exclusion Criteria

• Masseter botox application in the last 6 months,
• Regular use of analgesics and anti-inflammatories that affect the OSS,
• Presence of infection or tumoral structures within intraoral structures,
• Wearing multiple ear piercings,
• With TMJ disc displacement and joint degeneration,
• Musculoskeletal problem with evidence of cervical or TMJ fracture, systemic disease, specific pathologic condition,
• Any surgical operation related to a cervical or TMJ problem,
• Less than 6 months of cervical or TMJ-related physiotherapy and rehabilitation services,
• The one with facial paralysis,
• Diagnosed psychiatric illness

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bandırma Onyedi Eylül University

OTHER

Sponsor Role: lead

Responsible Party

Hazel Çelik Güzel

Assist. Prof. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bandırma Onyedi Eylül University

Balıkesir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024 -25

Identifier Type: -

Identifier Source: org_study_id