Effectiveness of Visceral Manual Therapy in Bruxist Patients

Not Applicable

Recruiting

• Conditions: Bruxism

• 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

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