Manual Therapy in Vagus Nerve Neuromodulation for the Treatment of Bruxism

Official title

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

Overview

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.

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
• 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.

Primary outcome measures

• Orofacial Pain [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]

Secondary outcome measures (12)

• Orofacial Pain (Masseter and Temporalis) [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Chronic Orofacial Pain [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Range of Motion (subjective) [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Range of Motion (Objective) [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Jaw Funcionality [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Oral behavior [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Functional impact of Headaches in daily life [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Sleep Quality [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Oral health-related quality of life [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Motor recruitment pattern of the masseter, temporalis, and suprahyoid muscles [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Stress [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]
• Anxiety [Time frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.]

Eligibility criteria

Inclusion criteria

• Sleep bruxism diagnosed according to the ICSD-III (International Classification of Sleep Disorders, 3rd edition):

• Regular or frequent tooth grinding sounds occurring during sleep and the presence of one or more of the following clinical signs and symptoms:

• Abnormal tooth wear consistent with reports of clenching/grinding the teeth during sleep
• Transient morning pain or fatigue in the jaw muscles; and/or temporal headaches; and/or jaw locking upon awakening, consistent with reports of clenching/grinding the teeth during sleep
• Sleep bruxism diagnosed according to the RDC/TMD:

• Interview: During the interview, subjects are asked about the following symptoms: reports of regular or frequent tooth grinding during sleep, muscle fatigue, temporal headache, transient morning muscle pain in the jaw, and jaw locking upon awakening.
• Physical examination: Presence or signs suggesting abnormal dental wear, such as teeth with flattened cusps and/or loss of contour with dentin exposure.

• Hypertrophy of the masticatory muscles
• Dental impressions on the tongue
• Linea alba on the cheeks along the bite line
• Damage to dental tissue
• Excessive dental wear
• A minimum pain intensity score of 3 on the Visual Analogue Scale at the masseter and temporal algometry points.
• EMGs with elevated mean power frequency for the masseter and temporalis muscles (to be defined in the first clinical phase-observational study).
• Age between 18 and 40 years.

Exclusion criteria

• Having suffered direct trauma, mandibular fractures, or surgeries in the orofacial region.
• Loss of more than 2 teeth, except for the third molar.
• Use of muscle relaxant medication or medications that may influence motor behavior.
• Having received botulinum toxin treatment in the last 6 months.
• Periodontal disorders or current orthodontic treatment or prosthesis.
• Partial or total dentures.
• History of medical disorders (severe psychiatric, physiological, or neurological conditions).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Universitat International de Catalunya (UIC) — Sant Cugat del Vallès

Publications

• Nalamliang N, Sumonsiri P, Thongudomporn U. Masticatory performance is influenced by masticatory muscle activity balance and the cumulative occlusal contact area. Arch Oral Biol. 2021 Jun;126:105113. doi: 10.1016/j.archoralbio.2021.105113. Epub 2021 Mar 30. PMID 33826961
• Merletti R, Muceli S. Tutorial. Surface EMG detection in space and time: Best practices. J Electromyogr Kinesiol. 2019 Dec;49:102363. doi: 10.1016/j.jelekin.2019.102363. Epub 2019 Oct 19. PMID 31665683
• Lobbezoo F, Aarab G, Ahlers MO, Baad-Hansen L, Bernhardt O, Castrillon EE, Giannakopoulos NN, Gronbeck A, Hauschild J, Holst-Knudsen M, Skovlund N, Thymi M, Svensson P. Consensus-based clinical guidelines for ambulatory electromyography and contingent electrical stimulation in sleep bruxism. J Oral Rehabil. 2020 Feb;47(2):164-169. doi: 10.1111/joor.12876. Epub 2019 Sep 11. PMID 31430389
• Lodetti G, Mapelli A, Musto F, Rosati R, Sforza C. EMG spectral characteristics of masticatory muscles and upper trapezius during maximum voluntary teeth clenching. J Electromyogr Kinesiol. 2012 Feb;22(1):103-9. doi: 10.1016/j.jelekin.2011.10.008. Epub 2011 Nov 17. PMID 22100151
• Berni KC, Dibai-Filho AV, Pires PF, Rodrigues-Bigaton D. Accuracy of the surface electromyography RMS processing for the diagnosis of myogenous temporomandibular disorder. J Electromyogr Kinesiol. 2015 Aug;25(4):596-602. doi: 10.1016/j.jelekin.2015.05.004. Epub 2015 May 27. PMID 26054969
• Kadioglu MB, Sezer M, Elbasan B. Effects of Manual Therapy and Home Exercise Treatment on Pain, Stress, Sleep, and Life Quality in Patients with Bruxism: A Randomized Clinical Trial. Medicina (Kaunas). 2024 Dec 4;60(12):2007. doi: 10.3390/medicina60122007. PMID 39768887
• Wojcik M, Siatkowski I. The effect of cranial techniques on the heart rate variability response to psychological stress test in firefighter cadets. Sci Rep. 2023 May 13;13(1):7780. doi: 10.1038/s41598-023-34093-z. PMID 37179419
• von Piekartz H, Bleiss S, Herzer S, Hall T, Ballenberger N. Does combining oro-facial manual therapy with bruxism neuroscience education affect pain and function in cases of awake bruxism? A pilot study. J Oral Rehabil. 2024 Sep;51(9):1692-1700. doi: 10.1111/joor.13740. Epub 2024 Jun 18. PMID 38894567

Identifiers

NCT: NCT07074964 · TMBruxism

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗