Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux

Sponsor

University of Seville (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05751694

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Objective: check the effectiveness of visceral manual therapy on bruxist patients with gastroesophageal reflux.

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) and gastroesophageal reflux (evidenced by the GERDQ test).

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.

Condition or Disease	Intervention/Treatment	Phase
Bruxism Gastroesophageal Reflux	Procedure: Visceral manual treatment Procedure: Respiratory listening	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Visceral manual treatment The objective of this technique is to reduce the tension of the tissues of the epigastric area.	Procedure: Visceral manual treatment The patient will be placed in a reclining sitting position and triple flexion of the lower limbs to keep the abdominal region relaxed. The therapist will be placed to the right of the patient at the height of the abdomen, with the hands placed in the epigastric area. He will make a skin fold that reduces tension in the area, so that the contact is focused on the visceral tissue of the area. The patient will be asked to take deep breaths, and during the exhalation, the therapist will perform a zigzag movement with vibration of the hands while pulling the tissue caudally. This procedure will be performed for 5 minutes.
Active Comparator: Respiratory listening It is a maneuver to evaluate the mobility of the ribs during respiration.	Procedure: Respiratory listening The patient and the therapist will be placed in the same position as in the experimental group. The therapist will place his hands in contact with the lower rib cage, and the patient will be asked to take a deep breath. The therapist will not exert any pressure, nor place restrictions on the tissues or movements of the ribcage.

Arm

Intervention/Treatment

Experimental: Visceral manual treatment

The objective of this technique is to reduce the tension of the tissues of the epigastric area.

Procedure: Visceral manual treatment

The patient will be placed in a reclining sitting position and triple flexion of the lower limbs to keep the abdominal region relaxed. The therapist will be placed to the right of the patient at the height of the abdomen, with the hands placed in the epigastric area. He will make a skin fold that reduces tension in the area, so that the contact is focused on the visceral tissue of the area. The patient will be asked to take deep breaths, and during the exhalation, the therapist will perform a zigzag movement with vibration of the hands while pulling the tissue caudally. This procedure will be performed for 5 minutes.

Active Comparator: Respiratory listening

It is a maneuver to evaluate the mobility of the ribs during respiration.

Procedure: Respiratory listening

The patient and the therapist will be placed in the same position as in the experimental group. The therapist will place his hands in contact with the lower rib cage, and the patient will be asked to take a deep breath. The therapist will not exert any pressure, nor place restrictions on the tissues or movements of the ribcage.

Outcome Measures

Primary Outcome Measures

Gastroesophageal Reflux Questionnaire (GERDQ) test Baseline [Baseline]
It is a recognized and validated test to evaluate the symptoms of gastroesophageal reflux, which also allows health professionals to demonstrate and manage gastroesophageal reflux without being referred by a specialist or performing endoscopy. Contains 6 items about gastroesophageal reflux symptoms in the last 7 days. The test score can range from 0 to 18, such that a score > 8 indicates that the patient has gastroesophageal reflux.
GERDQ test Change-1 [Change from Baseline GerdQ test at 7 days]
It is a recognized and validated test to evaluate the symptoms of gastroesophageal reflux, which also allows health professionals to demonstrate and manage gastroesophageal reflux without being referred by a specialist or performing endoscopy. Contains 6 items about gastroesophageal reflux symptoms in the last 7 days. The test score can range from 0 to 18, such that a score > 8 indicates that the patient has gastroesophageal reflux.
GERDQ test Change-2 [Change from Baseline GerdQ test at 1 month]
It is a recognized and validated test to evaluate the symptoms of gastroesophageal reflux, which also allows health professionals to demonstrate and manage gastroesophageal reflux without being referred by a specialist or performing endoscopy. Contains 6 items about gastroesophageal reflux symptoms in the last 7 days. The test score can range from 0 to 18, such that a score > 8 indicates that the patient has gastroesophageal reflux.
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.
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.

Secondary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with bruxism diagnosed and referred by a dentist
Subjects with gastroesophageal reflux: score >8 in the GerdQ test.
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