- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751694
Effectiveness of Visceral Manual Therapy in Bruxist Patients With Gastroesophageal Reflux
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cayetano Navarro Rico, Phd Student
- Phone Number: +34 664894442
- Email: cayetanonavarro95@gmail.com
Study Contact Backup
- Name: Lourdes M Fernández Seguín, PhD
- Phone Number: +34 630258773
- Email: lfdez@us.es
Study Locations
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Seville, Spain, 41009
- Recruiting
- Nursing, Physiotherapy and Podiatry Faculty
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Contact:
- Lourdes María Fernández-Seguín, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Visceral manual treatment
The objective of this technique is to reduce the tension of the tissues of the epigastric area.
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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.
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Active Comparator: Respiratory listening
It is a maneuver to evaluate the mobility of the ribs during respiration.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastroesophageal Reflux Questionnaire (GERDQ) test Baseline
Time Frame: Baseline
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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.
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Baseline
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GERDQ test Change-1
Time Frame: Change from Baseline GerdQ test at 7 days
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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.
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Change from Baseline GerdQ test at 7 days
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GERDQ test Change-2
Time Frame: Change from Baseline GerdQ test at 1 month
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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.
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Change from Baseline GerdQ test at 1 month
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Pressure pain threshold (PPT) Baseline-1
Time Frame: Baseline pre-intervention
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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.
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Baseline pre-intervention
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PPT Change-1
Time Frame: Change from "PTT Baseline-1" immediately post-intervention
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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.
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Change from "PTT Baseline-1" immediately post-intervention
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PPT Baseline-2
Time Frame: Baseline pre-intervention at 7 days
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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.
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Baseline pre-intervention at 7 days
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PPT Change-2
Time Frame: Change from "PTT Baseline-2" immediately post-intervention
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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.
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Change from "PTT Baseline-2" immediately post-intervention
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PPT Change-3
Time Frame: Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
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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.
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Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
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Mandibular Mobility Baseline-1
Time Frame: Baseline pre-intervention
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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.
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Baseline pre-intervention
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Mandibular Mobility Change-1
Time Frame: Change from "Mandibular Mobility Baseline-1" immediately post-intervention
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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.
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Change from "Mandibular Mobility Baseline-1" immediately post-intervention
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Mandibular Mobility Baseline-2
Time Frame: Baseline pre-intervention at 7 days
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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.
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Baseline pre-intervention at 7 days
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Mandibular Mobility Change-2
Time Frame: Change from "Mandibular Mobility Baseline-2" immediately post-intervention
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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.
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Change from "Mandibular Mobility Baseline-2" immediately post-intervention
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Mandibular Mobility Change-3
Time Frame: Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
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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.
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Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cervical Range of Motion (CROM) Baseline-1
Time Frame: Baseline pre-intervention
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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.
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Baseline pre-intervention
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Cervical Range of Motion (CROM) Change-1
Time Frame: Change from "CROM Baseline-1" immediately post-intervention
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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.
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Change from "CROM Baseline-1" immediately post-intervention
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Cervical Range of Motion (CROM) Baseline-2
Time Frame: Baseline pre-intervention at 7 days
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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.
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Baseline pre-intervention at 7 days
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Cervical Range of Motion (CROM) Change-2
Time Frame: Change from "CROM Baseline-2" immediately post-intervention
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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.
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Change from "CROM Baseline-2" immediately post-intervention
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Cervical Range of Motion (CROM) Change-3
Time Frame: Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
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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.
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Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
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Perceived Stress Scale (PSS-14) Baseline
Time Frame: Baseline
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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.
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Baseline
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PSS-14 Change
Time Frame: Change from Baseline PSS-14 at 1 month
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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.
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Change from Baseline PSS-14 at 1 month
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Pittsburgh Sleep Quality Index (PSQI) Baseline
Time Frame: Baseline
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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.
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Baseline
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PSQI Change
Time Frame: Change from Baseline PSQI at 1 month
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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.
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Change from Baseline PSQI at 1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lourdes M Fernández Seguín, PhD, University of Seville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Tooth Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Bruxism
Other Study ID Numbers
- 070223TDCNR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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