Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT05751694
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Visceral Manual Therapy in Bruxist Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002012', 'term': 'Bruxism'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-03-01', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure pain threshold (PPT) Baseline-1', 'timeFrame': 'Baseline pre-intervention', '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.'}, {'measure': 'PPT Change-1', 'timeFrame': 'Change from "PTT Baseline-1" immediately post-intervention', '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.'}, {'measure': 'PPT Baseline-2', 'timeFrame': 'Baseline pre-intervention at 7 days', '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.'}, {'measure': 'PPT Change-2', 'timeFrame': 'Change from "PTT Baseline-2" immediately post-intervention', '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.'}, {'measure': 'PPT Change-3', 'timeFrame': 'Change from "PTT Baseline-2" and "PTT Change-2" at 1 month', '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.'}, {'measure': 'Heart Rate Variability (HRV) Baseline-1', 'timeFrame': 'Baseline pre-intervention', 'description': '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.'}, {'measure': 'HRV Change-1', 'timeFrame': 'Change from "HRV baseline-1" inmediately post-intervention', 'description': '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.'}, {'measure': 'HRV Baseline-2', 'timeFrame': 'Baseline pre-intervention at 7 days', 'description': '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.'}, {'measure': 'HRV Change-2', 'timeFrame': 'Change from "HRV baseline-2" inmediately post-intervention', 'description': '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.'}, {'measure': 'HRV Change-3', 'timeFrame': 'Change from "HRV baseline-2" and "HRV change-2" at 1 month', 'description': '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.'}, {'measure': 'Myotonometry baseline-1', 'timeFrame': 'Baseline pre-intervention', 'description': '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.'}, {'measure': 'Myotonometry change-1', 'timeFrame': 'Change from "myotonometry baseline-1" inmediately post-intervention', 'description': '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.'}, {'measure': 'Myotonometry baseline-2', 'timeFrame': 'Baseline pre-intervention at 7 days', 'description': '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.'}, {'measure': 'Myotonometry change-2', 'timeFrame': 'Change from "myotonometry baseline-2" inmediately post-intervention', 'description': '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.'}, {'measure': 'Myotonometry change-3', 'timeFrame': 'Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cervical Range of Motion (CROM) Baseline-1', 'timeFrame': 'Baseline pre-intervention', '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."}, {'measure': 'Cervical Range of Motion (CROM) Change-1', 'timeFrame': 'Change from "CROM Baseline-1" immediately post-intervention', '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."}, {'measure': 'Cervical Range of Motion (CROM) Baseline-2', 'timeFrame': 'Baseline pre-intervention at 7 days', '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."}, {'measure': 'Cervical Range of Motion (CROM) Change-2', 'timeFrame': 'Change from "CROM Baseline-2" immediately post-intervention', '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."}, {'measure': 'Cervical Range of Motion (CROM) Change-3', 'timeFrame': 'Change from "CROM Baseline-2" and "CROM Change-2" at 1 month', '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."}, {'measure': 'Perceived Stress Scale (PSS-14) Baseline', 'timeFrame': '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.'}, {'measure': 'PSS-14 Change', 'timeFrame': 'Change from Baseline PSS-14 at 1 month', '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.'}, {'measure': 'Mandibular Mobility Baseline-1', 'timeFrame': 'Baseline pre-intervention', '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.'}, {'measure': 'Mandibular Mobility Change-1', 'timeFrame': 'Change from "Mandibular Mobility Baseline-1" immediately post-intervention', '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.'}, {'measure': 'Mandibular Mobility Baseline-2', 'timeFrame': 'Baseline pre-intervention at 7 days', '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.'}, {'measure': 'Mandibular Mobility Change-2', 'timeFrame': 'Change from "Mandibular Mobility Baseline-2" immediately post-intervention', '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.'}, {'measure': 'Mandibular Mobility Change-3', 'timeFrame': 'Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month', '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.'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI) Baseline', 'timeFrame': '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.'}, {'measure': 'PSQI Change', 'timeFrame': 'Change from Baseline PSQI at 1 month', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bruxism', 'Musculoskeletal Manipulations', 'Physical Therapy Modalities', 'Autonomic Nervous System'], 'conditions': ['Bruxism']}, 'descriptionModule': {'briefSummary': 'Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.\n\nSubjects: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with bruxism diagnosed and referred by a dentist\n* Age: older than 18 years-old.\n\nExclusion Criteria:\n\n* Recent craniofacial, mandibular or cervical trauma or fracture.\n* Temporomandibular joint surgery.\n* Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).\n* Abdominal surgery.\n* Gastric ulcers.\n* Gastritis.\n* Previous or current gastric neoplasm.\n* Neurological or systemic diseases.\n* Pregnant, including the period of breastfeeding.\n* Patients receiving chemotherapy or radiotherapy.\n* Cognitive, psychosomatic or psychiatric illnesses that may affect the data obtained.\n* Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).\n* Cerebrovascular and brain diseases.\n* Arrhythmia and other cardiac problems.\n* Implanted electronic devices.\n* Drug or alcohol abuse, analgesic or sedative therapy, and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics, and anticonvulsants).\n* Patients who have previous experience with manual treatment of the diaphragm'}, 'identificationModule': {'nctId': 'NCT05751694', 'briefTitle': 'Effectiveness of Visceral Manual Therapy in Bruxist Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Effectiveness of Visceral Manual Therapy in Bruxist Patients', 'orgStudyIdInfo': {'id': '070223TDCNR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Visceral manual treatment', 'description': 'The objective of this technique is to reduce the tension of the tissues of the epigastric area.', 'interventionNames': ['Procedure: Visceral manual treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Respiratory listening', 'description': 'It is a maneuver to evaluate the mobility of the ribs during respiration.', 'interventionNames': ['Procedure: Respiratory listening']}], 'interventions': [{'name': 'Visceral manual treatment', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Visceral manual treatment']}, {'name': 'Respiratory listening', 'type': 'PROCEDURE', '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.', 'armGroupLabels': ['Respiratory listening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41009', 'city': 'Seville', 'state': 'Spain', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Lourdes María Fernández-Seguín, PhD', 'role': 'CONTACT'}], 'facility': 'Nursing, Physiotherapy and Podiatry Faculty', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Lourdes M Fernández Seguín, PhD', 'role': 'CONTACT', 'email': 'lfdez@us.es', 'phone': '630258773', 'phoneExt': '+34'}, {'name': 'Cayetano Navarro Rico, Phd Student', 'role': 'CONTACT', 'email': 'cayetanonavarro95@gmail.com', 'phone': '664894442', 'phoneExt': '+34'}], 'overallOfficials': [{'name': 'Lourdes M Fernández Seguín, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Seville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor. Physiotherapy Department', 'investigatorFullName': 'Lourdes María Fernández Seguín', 'investigatorAffiliation': 'University of Seville'}}}}