Effectiveness of Visceral Manual Therapy in Bruxist Patients

Not Applicable

Recruiting

• Conditions: Bruxism
• Interventions: Procedure: Respiratory listening; Procedure: Visceral manual treatment

• Registration Number: NCT05751694
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-02
• Status Verified: 2024-05
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Respiratory listening	Respiratory listening	It is a maneuver to evaluate the mobility of the ribs during respiration.
Visceral manual treatment	Visceral manual treatment	The objective of this technique is to reduce the tension of the tissues of the epigastric area.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold (PPT) Baseline-1	Baseline pre-intervention	The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-1	Change from "PTT Baseline-1" immediately post-intervention	The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Baseline-2	Baseline pre-intervention at 7 days	The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-2	Change from "PTT Baseline-2" immediately post-intervention	The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
PPT Change-3	Change from "PTT Baseline-2" and "PTT Change-2" at 1 month	The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Heart Rate Variability (HRV) Baseline-1	Baseline pre-intervention	Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-1	Change from "HRV baseline-1" inmediately post-intervention	Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Baseline-2	Baseline pre-intervention at 7 days	Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-2	Change from "HRV baseline-2" inmediately post-intervention	Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
HRV Change-3	Change from "HRV baseline-2" and "HRV change-2" at 1 month	Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Myotonometry baseline-1	Baseline pre-intervention	The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-1	Change from "myotonometry baseline-1" inmediately post-intervention	The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry baseline-2	Baseline pre-intervention at 7 days	The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-2	Change from "myotonometry baseline-2" inmediately post-intervention	The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Myotonometry change-3	Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month	The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.

Secondary Outcome Measures

Name	Time	Method
Cervical Range of Motion (CROM) Baseline-1	Baseline pre-intervention	The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Cervical Range of Motion (CROM) Change-1	Change from "CROM Baseline-1" immediately post-intervention	The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Cervical Range of Motion (CROM) Baseline-2	Baseline pre-intervention at 7 days	The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Cervical Range of Motion (CROM) Change-2	Change from "CROM Baseline-2" immediately post-intervention	The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Cervical Range of Motion (CROM) Change-3	Change from "CROM Baseline-2" and "CROM Change-2" at 1 month	The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Perceived Stress Scale (PSS-14) Baseline	Baseline	Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress.
PSS-14 Change	Change from Baseline PSS-14 at 1 month	Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress.
Mandibular Mobility Baseline-1	Baseline pre-intervention	For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Mandibular Mobility Change-1	Change from "Mandibular Mobility Baseline-1" immediately post-intervention	For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Mandibular Mobility Baseline-2	Baseline pre-intervention at 7 days	For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Mandibular Mobility Change-2	Change from "Mandibular Mobility Baseline-2" immediately post-intervention	For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Mandibular Mobility Change-3	Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month	For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Pittsburgh Sleep Quality Index (PSQI) Baseline	Baseline	It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers.
PSQI Change	Change from Baseline PSQI at 1 month	It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers.

Trial Locations

Locations (1)

Nursing, Physiotherapy and Podiatry Faculty; 🇪🇸 Seville, Spain