Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT05167656
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2021-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Researchers involved in recording outcome measures will not be aware of treatment allocation. Patients will be encouraged to not tell the evaluators about the received treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity', 'timeFrame': 'Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.', 'description': 'Pain intensity measured with numerical pain rating scale which ranges from 0 points (no pain) to 10 points (worst imaginable pain)'}], 'secondaryOutcomes': [{'measure': 'Change in pain pressure threshold', 'timeFrame': 'Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.', 'description': 'Pain pressure threshold measured by a digital algometer at several locations of temporomandibular joint.'}, {'measure': 'Change in range of movement of the temporomandibular joint', 'timeFrame': 'Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.', 'description': 'Active and passive range of movement measured by a digital caliper.'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.', 'description': 'Quality of life measured with Short Form Health Survey (SF-12). SF-12 ranges from 0 (poor quality of life) to 100 (great quality of life).'}, {'measure': 'Change in disability', 'timeFrame': 'Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.', 'description': 'Disability measured with Craniofacial Pain and Disability Inventory (CF-PDI). CF-PDI ranges from 0 (better functional status) to 63 (worse disability).'}, {'measure': 'Change in anxiety', 'timeFrame': 'Baseline, change from baseline at 3-week, change from baseline at 6-week, at 1 month after treatment, after 3 months after treatment, after 6 months after treatment.', 'description': 'Anxiety measured with State-Trait Anxiety Inventory (STAI). STAI ranges from 20 (lower anxiety) to 80 (greater anxiety).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporomandibular Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial is to evaluate the effects of intraoral manual therapy versus extraoral manual therapy and compare them with a control group, in the management of patients with temporomandibular disorders regarding pain, strength, quality of life, disability and anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral temporomandibular pain for more than one month.\n* Older than eighteen.\n* No previous treatment to temporomandibular pain in the last 3 months.\n* Diagnosed based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).\n\nExclusion Criteria:\n\n* Patients with cervical or cranial trauma or whiplash.\n* Diagnosed with systemic disease, like rheumatoid arthritis or fibromyalgia.\n* Diagnosed of any vascular or metabolic disease.\n* Previous cervical or temporomandibular surgery.\n* Dental, medicine or any physical therapy treatment in the last 3 months before the beginning of the interventions.'}, 'identificationModule': {'nctId': 'NCT05167656', 'briefTitle': 'Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Alcala'}, 'officialTitle': 'Intraoral Versus Extraoral Manual Therapy in Subjects With Temporomandibular Disorders. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEID/2021/4/087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoral Manual Therapy plus exercise and education.', 'description': 'Six sessions of intraoral manual therapy plus exercise and counselling.', 'interventionNames': ['Other: Intraoral manual therapy', 'Other: Exercise and counselling']}, {'type': 'EXPERIMENTAL', 'label': 'Extraoral Manual Therapy plus exercise and education.', 'description': 'Six sessions of extraoral manual therapy plus exercise and counselling.', 'interventionNames': ['Other: Extraoral manual therapy', 'Other: Exercise and counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise and education.', 'description': 'Exercise and counselling alone without any manual therapy treatment.', 'interventionNames': ['Other: Exercise and counselling']}], 'interventions': [{'name': 'Intraoral manual therapy', 'type': 'OTHER', 'description': 'Six intraoral manual therapy sessions based on ischemic compression and pain pressure release of the temporomandibular region muscles, applied bilateral.', 'armGroupLabels': ['Intraoral Manual Therapy plus exercise and education.']}, {'name': 'Extraoral manual therapy', 'type': 'OTHER', 'description': 'Six extraoral manual therapy sessions based on ischemic compression, pain pressure release and pressure sliding of the temporomandibular region muscles, applied bilateral.', 'armGroupLabels': ['Extraoral Manual Therapy plus exercise and education.']}, {'name': 'Exercise and counselling', 'type': 'OTHER', 'description': 'Information about etiology, contributing and related factors, natural history and prognostic of the pathology of temporomandibular disorders.\n\nCounselling based on: diet, habits like tabacism, stress and anxiety control, physical activity and awareness of dental clenching.\n\nExercise daily program based on active and passive mobility of the temporomandibular joint, stretching exercises and self massage.', 'armGroupLabels': ['Exercise and education.', 'Extraoral Manual Therapy plus exercise and education.', 'Intraoral Manual Therapy plus exercise and education.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28805', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jorge Ballesteros, PhD Student', 'role': 'CONTACT', 'email': 'jorgeballes10@gmail.com', 'phone': '638332255'}], 'facility': 'University of Alcalá', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}], 'centralContacts': [{'name': 'Jorge Ballesteros Frutos, PhD student', 'role': 'CONTACT', 'email': 'jorgeballes10@gmail.com', 'phone': '638332255'}, {'name': 'Jorge Ballesteros Frutos', 'role': 'CONTACT', 'email': 'jorgeballes10@gmail.com', 'phone': '+34 638 33 22 55'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alcala', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jorge Ballesteros Frutos', 'investigatorAffiliation': 'University of Alcala'}}}}