NCT07074964

Manual Therapy in Vagus Nerve Neuromodulation for the Treatment of Bruxism

Efficacy of Manual Therapy in Indirect Non-Invasive Neuromodulation of the Vagus Nerve in the Treatment of Bruxism in Young Adult Population up to 40 Years Old

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Escoles Universitaries Gimbernat · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2028-12-01
• First posted: 2025-07-20
• Last updated: 2025-07-24

Locations

1 site across 1 country: Spain