Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux

Gastroesophageal Reflux Clinical Trial

Official title:

Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751694
• Other study ID #: 070223TDCNR
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: University of Seville
• Contact: Lourdes M Fernández Seguín, PhD
• Phone: 630258773
• Email: lfdez[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bruxism
• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Nursing, Physiotherapy and Podiatry Faculty	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroesophageal Reflux Questionnaire (GERDQ) test 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.	Baseline
Primary	GERDQ test Change-1	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.	Change from Baseline GerdQ test at 7 days
Primary	GERDQ test Change-2	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.	Change from Baseline GerdQ test at 1 month
Primary	Pressure pain threshold (PPT) Baseline-1	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.	Baseline pre-intervention
Primary	PPT Change-1	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.	Change from "PTT Baseline-1" immediately post-intervention
Primary	PPT Baseline-2	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.	Baseline pre-intervention at 7 days
Primary	PPT Change-2	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.	Change from "PTT Baseline-2" immediately post-intervention
Primary	PPT Change-3	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.	Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
Primary	Mandibular Mobility Baseline-1	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.	Baseline pre-intervention
Primary	Mandibular Mobility Change-1	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.	Change from "Mandibular Mobility Baseline-1" immediately post-intervention
Primary	Mandibular Mobility Baseline-2	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.	Baseline pre-intervention at 7 days
Primary	Mandibular Mobility Change-2	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.	Change from "Mandibular Mobility Baseline-2" immediately post-intervention
Primary	Mandibular Mobility Change-3	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.	Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
Secondary	Cervical Range of Motion (CROM) Baseline-1	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.	Baseline pre-intervention
Secondary	Cervical Range of Motion (CROM) Change-1	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.	Change from "CROM Baseline-1" immediately post-intervention
Secondary	Cervical Range of Motion (CROM) Baseline-2	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.	Baseline pre-intervention at 7 days
Secondary	Cervical Range of Motion (CROM) Change-2	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.	Change from "CROM Baseline-2" immediately post-intervention
Secondary	Cervical Range of Motion (CROM) Change-3	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.	Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
Secondary	Perceived Stress Scale (PSS-14) 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.	Baseline
Secondary	PSS-14 Change	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.	Change from Baseline PSS-14 at 1 month
Secondary	Pittsburgh Sleep Quality Index (PSQI) 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.	Baseline
Secondary	PSQI Change	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.	Change from Baseline PSQI at 1 month