Manual Therapy in Vagus Nerve Neuromodulation for the Treatment of Bruxism
NCT07074964 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-07-24
Summary
Introduction:
Sleep bruxism is defined as the repetitive activity of the masticatory muscles, characterized by clenching or grinding of the teeth. Studies confirm the association between sleep bruxism and episodes of masticatory muscle activity, with an increase in autonomic sympathetic activity observed during transient periods of sleep. This is associated with nocturnal awakenings, related to increased cardiac, cerebral (cortical arousal), respiratory, and muscular activity.
Objectives: The main objectives are "To study the mean power frequency (MPF) of the masticatory muscles measured by surface electromyography (sEMG) in the general population (with and without bruxism according to ICSD-3 and DC/TMD criteria)"; and "to assess the effectiveness of manual therapy applied to structures adjacent to the vagus nerve based on its impact on orofacial pain and symptomatology in patients with bruxism".
Material and Methods:
A cross-sectional observational study and a randomized controlled experimental study were designed. The first will analyze data collected by sEMG in the masticatory muscles, at rest and during maximum clenching, comparing results between bruxists and non-bruxists. The second will analyze, compared to the control group, data collected on signs (range of motion alteration, presence of sounds), symptomatology (pain, headaches, sensation of blockage, functional limitation) caused by bruxism, sleep quality (Pittsburgh Sleep Quality Index (PSQI)), oral health-related quality of life (OHIP-14), stress and anxiety status (Perceived Stress Scale and GAD-7 (Generalized Anxiety Disorder-7), respectively), and sympathetic-vagal balance (Heart Rate Variability in its frequency and time domains) before and after a manual therapy intervention on structures adjacent to the vagus nerve pathway (head, neck, thorax, diaphragm, abdomen). The collected data will be analyzed using IBM SPSS® version 25.0.0.
Conditions
- Bruxism, Sleep
Interventions
- OTHER
-
Autonomic nervous system intervention
Manual therapy applied to structures adjacent to the vagus nerve along its pathway. Head: CV4 tecnique and Jugular foramen tecnique; Neck: stretching and mobilization of the superficial and deep layers; Thorax: Longitudinal and transverse translations of the mediastinum; Diaphragm tecniques, Abdomen: Stretching of the gastro-phrenic ligament with lowering of the stomach and general treatment of the small intestine and the mesentery. Stretching, compression and traction movements will be carried out on these structures.
- OTHER
-
Slight finger pressure
The hands will be placed on areas similar to those in the intervention group, with the fingertips in contact with the skin of the area. A slight finger pressure will be applied, which would not have the same effect as the proposed techniques, since those techniques require a greater intensity of manipulation of the described tissues and structures.
Sponsors & Collaborators
-
Universitat Internacional de Catalunya
collaborator OTHER -
Escoles Universitaries Gimbernat
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2027-10-01
- Completion
- 2028-12-01
Countries
- Spain
Study Locations
More Related Trials
-
Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Tragus and Tongue Stimulation.
NCT06549205 ·Status: COMPLETED ·Phase: NA
-
International Focus Group Discussion on Neuromuscular Monitoring.
NCT06945341 ·Status: SUSPENDED
-
Vagal Nerve Stimulation to Treat Disorders of Consciousness
NCT06681168 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Vagal Nerve Stimulation to Treat Disorders of Consciousness
NCT07077135 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
NCT04130893 ·Status: TERMINATED ·Phase: NA
-
Blinding and Adverse Effects of Ultrasonic Vagus Nerve Stimulation (U-VNS) in Tinnitus
NCT07291648 ·Status: COMPLETED ·Phase: NA
-
Non-invasive Vagus Nerve Stimulation and Sleep in Healthy Volunteers.
NCT06928441 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
tVNS and Myofascial Release in Tinnitus
NCT07155733 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Effects of taVNS on Postoperative Pain in Complex Spinal Surgery
NCT07330973 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Noninvasive Vagus Nerve Stimulation (VNS) for Neuromotor Adaptations
NCT03628976 ·Status: COMPLETED ·Phase: NA
-
Effects of Trancutaneous Auriculotemporal Nerve Stimulation
NCT07184190 ·Status: COMPLETED ·Phase: NA
-
Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.
NCT06421051 ·Status: RECRUITING ·Phase: NA
-
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals.
NCT03217929 ·Status: UNKNOWN ·Phase: NA
-
Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness
NCT04065386 ·Status: COMPLETED ·Phase: NA
-
Effect of Transauricular Vagus Nerve Stimulation on Postoperative Pain Management in Video Assisted Thoracic Surgery
NCT06912399 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effects of Transcutaneous Vagus Nerve Stimulation in Older Adults
NCT07292623 ·Status: COMPLETED ·Phase: NA
-
Pupil-Indexed Noninvasive Neuromodulation
NCT06282406 ·Status: RECRUITING ·Phase: NA
-
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
NCT01253616 ·Status: COMPLETED ·Phase: NA
-
tACS and tRNS Studies on Brain Control of Swallowing
NCT04040803 ·Status: COMPLETED ·Phase: NA
-
Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depression in Chronic Shoulder Pain Patients
NCT07198737 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effects of Transcutaneous Electrical Stimulation on the Autonomous Nerve System in Healthy Young People
NCT05289817 ·Status: COMPLETED ·Phase: NA
-
Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness
NCT02791893 ·Status: COMPLETED ·Phase: NA
-
Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder
NCT06134323 ·Status: RECRUITING ·Phase: NA
-
Vagus Nerve Stimulation for Autonomic Nervous System Activity
NCT05906940 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients
NCT03619135 ·Status: COMPLETED ·Phase: NA