Back to resultsEffectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux
Primary Purpose
Bruxism, Gastroesophageal Reflux
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Visceral manual treatment
Respiratory listening
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism focused on measuring Bruxism, Gastroesophageal Reflux, Musculoskeletal Manipulations, Physical Therapy Modalities
Eligibility Criteria
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
Sites / Locations
- Nursing, Physiotherapy and Podiatry FacultyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visceral manual treatment
Respiratory listening
Arm Description
The objective of this technique is to reduce the tension of the tissues of the epigastric area.
It is a maneuver to evaluate the mobility of the ribs during respiration.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05751694
First Posted
February 8, 2023
Last Updated
September 27, 2023
Sponsor
University of Seville
1. Study Identification
Unique Protocol Identification Number
NCT05751694
Brief Title
Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux
Official Title
Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Gastroesophageal Reflux
Keywords
Bruxism, Gastroesophageal Reflux, Musculoskeletal Manipulations, Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Visceral manual treatment
Arm Type
Experimental
Arm Description
The objective of this technique is to reduce the tension of the tissues of the epigastric area.
Arm Title
Respiratory listening
Arm Type
Active Comparator
Arm Description
It is a maneuver to evaluate the mobility of the ribs during respiration.
Intervention Type
Procedure
Intervention Name(s)
Visceral manual treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Respiratory listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastroesophageal Reflux Questionnaire (GERDQ) test Baseline
Description
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.
Time Frame
Baseline
Title
GERDQ test Change-1
Description
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.
Time Frame
Change from Baseline GerdQ test at 7 days
Title
GERDQ test Change-2
Description
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.
Time Frame
Change from Baseline GerdQ test at 1 month
Title
Pressure pain threshold (PPT) Baseline-1
Description
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.
Time Frame
Baseline pre-intervention
Title
PPT Change-1
Description
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.
Time Frame
Change from "PTT Baseline-1" immediately post-intervention
Title
PPT Baseline-2
Description
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.
Time Frame
Baseline pre-intervention at 7 days
Title
PPT Change-2
Description
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.
Time Frame
Change from "PTT Baseline-2" immediately post-intervention
Title
PPT Change-3
Description
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.
Time Frame
Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
Title
Mandibular Mobility Baseline-1
Description
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.
Time Frame
Baseline pre-intervention
Title
Mandibular Mobility Change-1
Description
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.
Time Frame
Change from "Mandibular Mobility Baseline-1" immediately post-intervention
Title
Mandibular Mobility Baseline-2
Description
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.
Time Frame
Baseline pre-intervention at 7 days
Title
Mandibular Mobility Change-2
Description
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.
Time Frame
Change from "Mandibular Mobility Baseline-2" immediately post-intervention
Title
Mandibular Mobility Change-3
Description
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.
Time Frame
Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
Secondary Outcome Measure Information:
Title
Cervical Range of Motion (CROM) Baseline-1
Description
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.
Time Frame
Baseline pre-intervention
Title
Cervical Range of Motion (CROM) Change-1
Description
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.
Time Frame
Change from "CROM Baseline-1" immediately post-intervention
Title
Cervical Range of Motion (CROM) Baseline-2
Description
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.
Time Frame
Baseline pre-intervention at 7 days
Title
Cervical Range of Motion (CROM) Change-2
Description
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.
Time Frame
Change from "CROM Baseline-2" immediately post-intervention
Title
Cervical Range of Motion (CROM) Change-3
Description
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.
Time Frame
Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
Title
Perceived Stress Scale (PSS-14) Baseline
Description
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.
Time Frame
Baseline
Title
PSS-14 Change
Description
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.
Time Frame
Change from Baseline PSS-14 at 1 month
Title
Pittsburgh Sleep Quality Index (PSQI) Baseline
Description
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.
Time Frame
Baseline
Title
PSQI Change
Description
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.
Time Frame
Change from Baseline PSQI at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lourdes M Fernández Seguín, PhD
Phone
630258773
Ext
+34
Email
lfdez@us.es
First Name & Middle Initial & Last Name or Official Title & Degree
Cayetano Navarro Rico, Phd Student
Phone
664894442
Ext
+34
Email
cayetanonavarro95@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lourdes M Fernández Seguín, PhD
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nursing, Physiotherapy and Podiatry Faculty
City
Seville
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lourdes María Fernández-Seguín, PhD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux
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