Clinical trial NCT05751694: Effectiveness of Visceral Manual Therapy in Bruxist Patients
Official title: Effectiveness of Visceral Manual Therapy in Bruxist Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bruxism
Keywords: Bruxism
Musculoskeletal Manipulations
Physical Therapy Modalities
Autonomic Nervous System
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.

Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Methods: Subjects will be randomized into 2 groups: an experimental group (EG) to which a visceral manual technique will be applied and a control group (CG) to which a placebo manual technique will be administered. Both groups will receive 2 interventions one week apart. The measurements will be made before and after the interventions, and a last measurement will be made one month after the last intervention. Therefore, the patient will visit the center 3 times.


Eligibility criteria: Inclusion Criteria:

* Subjects with bruxism diagnosed and referred by a dentist
* Age: older than 18 years-old.

Exclusion Criteria:

* Recent craniofacial, mandibular or cervical trauma or fracture.
* Temporomandibular joint surgery.
* Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).
* Abdominal surgery.
* Gastric ulcers.
* Gastritis.
* Previous or current gastric neoplasm.
* Neurological or systemic diseases.
* Pregnant, including the period of breastfeeding.
* Patients receiving chemotherapy or radiotherapy.
* Cognitive, psychosomatic or psychiatric illnesses that may affect the data obtained.
* Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).
* Cerebrovascular and brain diseases.
* Arrhythmia and other cardiac problems.
* Implanted electronic devices.
* Drug or alcohol abuse, analgesic or sedative therapy, and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics, and anticonvulsants).
* Patients who have previous experience with manual treatment of the diaphragm

Primary outcomes:
measure: Pressure pain threshold (PPT) Baseline-1
timeFrame: Baseline pre-intervention
measure: PPT Change-1
timeFrame: Change from "PTT Baseline-1" immediately post-intervention
measure: PPT Baseline-2
timeFrame: Baseline pre-intervention at 7 days
measure: PPT Change-2
timeFrame: Change from "PTT Baseline-2" immediately post-intervention
measure: PPT Change-3
timeFrame: Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
measure: Heart Rate Variability (HRV) Baseline-1
timeFrame: Baseline pre-intervention
measure: HRV Change-1
timeFrame: Change from "HRV baseline-1" inmediately post-intervention
measure: HRV Baseline-2
timeFrame: Baseline pre-intervention at 7 days
measure: HRV Change-2
timeFrame: Change from "HRV baseline-2" inmediately post-intervention
measure: HRV Change-3
timeFrame: Change from "HRV baseline-2" and "HRV change-2" at 1 month
measure: Myotonometry baseline-1
timeFrame: Baseline pre-intervention
measure: Myotonometry change-1
timeFrame: Change from "myotonometry baseline-1" inmediately post-intervention
measure: Myotonometry baseline-2
timeFrame: Baseline pre-intervention at 7 days
measure: Myotonometry change-2
timeFrame: Change from "myotonometry baseline-2" inmediately post-intervention
measure: Myotonometry change-3
timeFrame: Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month
Secondary outcomes:
measure: Cervical Range of Motion (CROM) Baseline-1
timeFrame: Baseline pre-intervention
measure: Cervical Range of Motion (CROM) Change-1
timeFrame: Change from "CROM Baseline-1" immediately post-intervention
measure: Cervical Range of Motion (CROM) Baseline-2
timeFrame: Baseline pre-intervention at 7 days
measure: Cervical Range of Motion (CROM) Change-2
timeFrame: Change from "CROM Baseline-2" immediately post-intervention
measure: Cervical Range of Motion (CROM) Change-3
timeFrame: Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
measure: Perceived Stress Scale (PSS-14) Baseline
timeFrame: Baseline
measure: PSS-14 Change
timeFrame: Change from Baseline PSS-14 at 1 month
measure: Mandibular Mobility Baseline-1
timeFrame: Baseline pre-intervention
measure: Mandibular Mobility Change-1
timeFrame: Change from "Mandibular Mobility Baseline-1" immediately post-intervention
measure: Mandibular Mobility Baseline-2
timeFrame: Baseline pre-intervention at 7 days
measure: Mandibular Mobility Change-2
timeFrame: Change from "Mandibular Mobility Baseline-2" immediately post-intervention
measure: Mandibular Mobility Change-3
timeFrame: Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
measure: Pittsburgh Sleep Quality Index (PSQI) Baseline
timeFrame: Baseline
measure: PSQI Change
timeFrame: Change from Baseline PSQI at 1 month
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Nursing, Physiotherapy and Podiatry Faculty
Study officials:
affiliation: University of Seville
name: Lourdes M Fernández Seguín, PhD
role: PRINCIPAL_INVESTIGATOR
References: